PainNCT05466656
Sumamos Excelencia 2022
A study testing Continuous quality improvement cycle model in people with Pain and Incontinence, Urinary, run by Teresa Moreno Casbas at 1 site in Spain.
Trial summary
There is a gap between research and clinical practice, leading to variability in decision-making. Clinical audits are an effective strategy for improving implementation of best practices. Quasi-experimental, multicentre, before and after. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain, Incontinence, Urinary, Obesity, Childhood
- What is being tested?
- Continuous quality improvement cycle model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteSpain
- Study dates
- 25 Nov 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Unit inclusion criteria:
- NHS units and nursing homes which voluntary adhere to the project.
- NHS units and nursing homes providing direct patient care and commit to implement evidence-based recommendations on hand hygiene and one of the following topics: pain assessment and management, urinary incontinence management, obesity prevention and breastfeeding promotion. For the purposes of this study, a "unit" is defined as any service, centre or institution that delivers health services to a homogeneous group of patients who share similar characteristics.
- Patient inclusion criteria: The study will include all patients attended in the units participating in the study, who meet the following criteria, depending on the recommendations to be implemented in each unit:
- Pain:
- People susceptible to suffering some type of pain regardless of age.
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- Patients treated in acute or chronic health institutions (Hospitals, Nursing Homes or Primary Care).
- Urinary incontinence:
- Patients 18 years or older.
- Patients with uncomplicated stress, urge or mixed urinary incontinence
- At least 7 days of admission or possibility of continuity of care preferably up to 6 weeks.
- Obesity:
- Babies and preschool children up to 12 years old.
- For ages 2 to 12 years (inclusive), children must not be overweight or obese 1 year prior to baseline measurement (in February 2021 or at the closest review to February 2021 at which BMI is recorded).
- Good general health.
- Breastfeeding:
- Lactating people.
- Healthy neonates of gestational age greater than 36 weeks, with birth weight greater than or equal to 2500 gr.
- Couples and relatives within the support network.
- Postpartum period and up to 6 months of life of the baby (183 days of life, included).
- In primary care, only non-urgent care will be included.
- Hand hygiene:
- All health professionals who care for patients in the units participating in the study.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto de Salud Carlos III - Unidad de Investigación en Cuidados y Servicios de Salud
Madrid
About this study
Official title: SUMAMOS EXCELENCIA Project: Assessment of Implementation of Best Practices in a National Health System (Second Edition)
There is a gap between research and clinical practice, leading to variability in decision-making. Clinical audits are an effective strategy for improving implementation of best practices. Quasi-experimental, multicentre, before and after. Primary care, hospital units and nursing homes, and the patients attended at both. Implementation of evidence-based recommendations by application of a continuous quality improvement cycle model (process of improvement by reference to a prior baseline clinical audit. Data will be collected at baseline and, during the first year of follow up, at months (3, 6, 12)
Read the detailed description
Aim: To assess the effectiveness of implementing evidence-based recommendations using a continuous quality improvement cycle model on patient outcomes and healthcare quality. Design: Quasi-experimental, multicentre, before-and-after. Methods: NHS units and Nursing Homes, patients attended by them and professionals implementing the recommendations. Intervention: implementation of evidence-based recommendation with a continuous quality improvement cycle's model (process of improvement by reference to a prior baseline clinical audit). Variables: Process and outcome criteria with respect to assessment and management of pain, management of urinary incontinence, prevention of child obesity, promotion of breastfeeding, promotion of hand hygiene, competencies in evidence-based practice, barriers to the implementation and strategies for overcoming them. Data will be collected at baseline and, during the first year of follow-up, at months 3, 6 and 12, with data on patients and indicators being drawn from clinical histories and records. Descriptive analysis and comparison of the effectiveness of the intervention by means of inferential analysis and analysis of trends across follow-up. 95% confidence level. This project is partially funded by The Spanish Centre for Evidence Based Nursing and Healthcare. Project duration 2022-2024.
This project is a second edition of The SUMAMOS EXCELENCIA Project: Assessment of Implementation of Best Practices in a National Health System (NCT03725774), with a similar design but with changes in some of the themes.
- Conditions
- Pain, Incontinence, Urinary, Obesity, Childhood, Breastfeeding
- Being tested
- Continuous quality improvement cycle model
- Keywords
- Implementation Science, Evidence-Based Practice, Evidence-Based Nursing, Nursing Care, Quality of Health Care, Clinical Audit
- Medical subject headings
- Pain, Urinary Incontinence, Pediatric Obesity, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous quality improvement cycle modelOther
The continuous quality improvement cycle model consist in a process of improvement by reference to a prior baseline clinical audit. It implies a local situation analysis, identifying barriers to improvements in clinical practice, and drawing up and implementing a plan of action for improving adherence to pre-established criteria. The goal is to establish interprofessional processes within the teams, in order to: examine the barriers that hinder the use of evidence in fostering best practices; and contribute to the development of implementation programmes for overcoming such obstacles.
| Study group | Role | What they receive |
|---|---|---|
| Quasi-experimental uncontrolled, before-and-after. | Experimental | The intervention will consist of the use of a continuous quality improvement cycle model and implementation of its strategies in clinical practice, according to the study unit in question and the scope of action. Receives: Other: Continuous quality improvement cycle model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary incontinence assessment
Assessment of presence of urinary incontinence. Total number of patients in whom the presence of urinary incontinence has been initially assessed, and who are registered / Total number of patients with positive detection of urinary incontinence during the data collection period) * 100
Measured: 15 months
Voiding diary
Record of all urination and leakage for 3 consecutive days. (Total number of patients with a voiding diary of 3 days recorded / Total number of patients with urinary incontinence discharged or attended during the data collection period) * 100
Measured: 15 months
Scheduled urination
Using verbal and physical prompts or signals to make people pay attention to their dry/wet situation and the need to go to the bathroom. (Total number of patients with a scheduled urination care plan, and it is registered / Total number of patients with urinary incontinence and a 3-day voiding diary discharged or attended in the data collection period) * 100
Measured: 15 months
Bladder training
Program of education and programmed evacuation in which the intervals of micturition are gradually adjusted. (Total number of patients with a bladder training care plan, and it is registered / Total number of patients with urinary incontinence and a 3-day voiding diary discharged or attended in the data collection period) * 100
Measured: 15 months
Pelvic floor exercises
The individualized education and training of pelvic floor exercises. (Total number of patients with a pelvic floor exercise care plan, and it is registered / Total number of patients with urinary incontinence and a 3-day voiding diary discharged or attended in the data collection period) * 100
Measured: 15 months
Severity
Severity of urinary incontinence. Total number of patients with different levels of urinary incontinence 24 hours prior to assessment / Total number of patients with urinary incontinence during the data collection period) x 100
Measured: 15 months
Impact
Impact of urinary incontinence. (Total number of patients whose urinary incontinence has an impact on their quality of life, in the 24 hours prior to the assessment / Total number of patients with urinary incontinence during the data collection period) x 100
Measured: 15 months
Improvement
Perception of improvement in urinary incontinence. (Total number of patients who perceive an improvement 6 weeks after the intervention / Total number of patients with urinary incontinence before the start of the intervention) x100
Measured: 15 months
Detection of pain at admission
Detection of pain at admission. (Total number of patients in whom pain detection was performed upon admission or at the start of care, and it is registered / Total number of patients discharged or attended in the collection period data) x100
Measured: 15 months
Pain related to a procedure likely to cause pain
Detection of pain related to a procedure likely to cause pain. This indicator evaluates whether the assessment of pain linked to the painful procedure is carried out before and after the procedure, it is also recommended to assess pain during the procedure in cases where it is possible. (Total number of patients in whom pain has been detected after a procedure likely to cause pain, and is registered / Total number of patients in whom a procedure likely to cause pain has been performed in the data collection period data) x100
Measured: 15 months
Pain after a change in the patient's clinical situation
Detection of pain after a change in the patient's clinical situation (clinical situation: significant clinical change, in the general condition of the patient or in their pain, which requires the referral of the patient to a professional with the skills to resolve it). (Total number of patients in whom pain has been detected after a change in their clinical situation, and it is registered / Total number of patients with a change in their clinical situation in the data collection period) x100
Measured: 15 months
Pain intensity assessment
Pain assessment measured with a pain intensity assessment tool. (Total number of patients who have an assessment of pain intensity, and it is recorded / Total number of patients with positive detection of pain in the data collection period) x100
Measured: 15 months
Comprehensive pain assessment
Comprehensive pain assessment takes into account various factors related to pain, including: location of pain, circumstances related to the onset of pain, type of pain, pain intensity, associated symptoms, effect of pain on activities, effect of pain on patient rest and sleep, treatment, relevant medical history, factors that influence pain management. To be considered a comprehensive assessment, at least 60% of the 10 criteria must be performed and recorded. (Total number of patients who have done a comprehensive pain assessment, and it is registered / Total number of patients with positive pain detection in the data collection period) x100
Measured: 15 months
Pain management care plan
Establishing and implementing a pain management care plan for the patient based on the results of the person's assessment, which would include: pharmacological and non-pharmacological measures, the person's goals and appropriate and effective pain management strategies. (Total number of patients with a care plan for acute or chronic pain, and it is registered / Total number of patients with positive detection of pain or susceptible to have pain in the data collection period) x100
Measured: 15 months
Patient or/and caregiver education on pain
Patient or/and caregiver education on the importance of communicating pain, pharmacological, physical and psychological pain management options, how to take the analgesic medication, manage the possible side effects and how the follow-up will be done and who can be consulted with possible doubts. (Total number of patients, family members or caregivers who have received education on pain management, at least once during the care process, and it is registered / Total number of patients with positive detection of pain or likely to have pain in the data collection period) x100
Measured: 15 months
Intensity of pain on admission or in the first 24 hours after surgery or at the start of care
Intensity of pain on admission or in the first 24 hours after surgery or at the start of care measured in numerical format, with the value that corresponds to the scale used in the unit for the assessment of pain, units must indicate on the form the scale they have used. (Sum of pain intensity of patients with positive pain detection or likely to have pain / Total number of patients with assessed pain intensity in the data collection period)
Measured: 15 months
Maximum pain
Maximum scored reported by patients and registered by nurses after pain intensity assessment using an assessment tool. Units must indicate on the form the assessment tool they have used. (Sum of the maximum intensity of pain during the stay or care of patients with positive detection of pain or likely to have pain / Total number of patients with pain intensity assessed in the data collection period)
Measured: 15 months
Skin-to-skin contact
Skin-to-skin contact is the placement of a newborn, naked or with a diaper and cap, in a prone position on the bare chest of a person, covered with a previously heated blanket to prevent heat loss. It should be facilitated immediately (up to 1 hour) after birth or once the child and the nursing person are clinically stable. (Number of infants performing skin-to-skin immediately after birth or with clinically stable dyad /Total number of infants) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Measured: 15 months
Postpartum assessment of breastfeeding
Assessment of breastfeeding completed within the first 24 hours of the newborn life. The objective is that in the first 24 hours the breastfeeding person is able to identify: proper position and grip, efficient breast milk transfer, support networks, breastfeeding self-efficacy, risks of mood disorders, assessment of the newborn in relation to breastfeeding. To carry out the assessment, a breastfeeding assessment tool may be used. (Number of dyads assessed on the breastfeeding process in the first 24 hours/Total number of dyads) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Measured: 15 months
Assessment of breastfeeding after the first 24 hours and before discharge
Assessment of breastfeeding completed after first 24 hours of the newborn life and before hospital discharge. The objective is that before hospital discharge the breastfeeding person is able to identify: proper position and grip, efficient breast milk transfer, support networks, breastfeeding self-efficacy, risks of mood disorders, assessment of the newborn in relation to breastfeeding. To carry out the assessment, a breastfeeding assessment tool may be used. (Number of dyads assessed on the breastfeeding process after the first 24 hours and before hospital discharge / Total number of dyads) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Measured: 15 months
Early assessment of breastfeeding in primary care
In Primary Care, early assessment is considered completed between birth and day 8 of the neonate's life (included). To carry out the assessment, a breastfeeding assessment tool may be used. (Number of dyads assessed early on the process of breastfeeding (between birth and 8 days of life / Total number of dyads between birth and 8 days of life of the newborn) x 100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Measured: 15 months
Follow-up assessment of breastfeeding in primary care (from 9 days of life to 6 months)
In Primary Care, the follow-up evaluation is carried out between 9 days of life and 6 months/183 days of life of the neonate (included). To carry out the assessment, a breastfeeding assessment tool may be used. (Number of dyads assessed on the breastfeeding process from 9 days of life to 6 months / Total number of dyads from 9 days of life to 6 months of the newborn) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Measured: 15 months
Breastfeeding education for the breastfeeding person
In Hospital Care, it is considered completed if postpartum training has been carried out and resources have been provided to the mother by the interprofessional team in breastfeeding before hospital discharge. In Primary Care, it is considered completed if training has been carried out and resources have been provided to the mother after hospital discharge by the interprofessional team in breastfeeding, at least once in the period after discharge to 8 days or in the period from 9 days to 6 months, in the same visit or in successive visits. (Number of lactating persons receiving education in breastfeeding / Total number of dyads) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Measured: 15 months
Breastfeeding education and support for family members
In hospital care, it is considered completed if education and support in breastfeeding has been carried out for family members before hospital discharge. In Primary Care, it is considered accomplished if breastfeeding education and support has been provided to family members, at least once in the period after discharge to 8 days or in the period from 9 days to 6 months, in the same visit or on successive visits. (Number of dyads whose family has received education and support in breastfeeding / Total number of dyads) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Measured: 15 months
Type of breastfeeding of the newborn during the hospital stay
Type of breastfeeding of the newborn during the hospital stay. (Number of infants exclusively breastfed, receiving mixed breastfeeding or not breastfed during hospital stay / Total number of infants discharged) x100 Exclusive breastfeeding: The infant receives directly or indirectly breast milk. He does not receive any other type of solid or liquid food.
Mixed breastfeeding: The infant receives breast milk as well as other solid and liquid foods (including water), including non-human milk or formula.
Non-breastfeeding: The infant receives artificial milk and/or animal milk. The infant does not receive breast milk.
Measured: 15 months
Type of breastfeeding of the newborn in early stage
Type of breastfeeding of the newborn from birth to 8 days of life assessed in Primary care. (Number of newborns who were exclusively breastfed, received mixed breastfeeding or were not breastfed from birth to 8 days of life / Total number of newborns between 0 and 8 days of life) x100 Exclusive breastfeeding: The infant receives directly or indirectly breast milk. He does not receive any other type of solid or liquid food.
Mixed breastfeeding: The infant receives breast milk as well as other solid and liquid foods (including water), including non-human milk or formula.
Non-breastfeeding: The infant receives artificial milk and/or animal milk. The infant does not receive breast milk.
Measured: 15 months
Type of breastfeeding of the newborn in follow-up 1
Type of breastfeeding of the newborn from 9 to 90 days of life, assessed in Primary Care. (Number of infants exclusively breastfed, receiving mixed breastfeeding or not breastfed from 9 days to 90 days of life / Total number of infants from 9 to 90 days of life) x100 Exclusive breastfeeding: The infant receives directly or indirectly breast milk. He does not receive any other type of solid or liquid food.
Mixed breastfeeding: The infant receives breast milk as well as other solid and liquid foods (including water), including non-human milk or formula.
Non-breastfeeding: The infant receives artificial milk and/or animal milk. The infant does not receive breast milk.
Measured: 15 months
Type of breastfeeding of the newborn in follow-up 2
Type of breastfeeding of the newborn from 91 to 182 days of life assessed in Primary care (Number of newborns who received exclusive breastfeeding, receiving mixed breastfeeding or not breastfed from 91 days to 182 days of life / Total number of newborns from 91 to 182 days of life) x100 Exclusive breastfeeding: The infant receives directly or indirectly breast milk. He does not receive any other type of solid or liquid food.
Mixed breastfeeding: The infant receives breast milk as well as other solid and liquid foods (including water), including non-human milk or formula.
Non-breastfeeding: The infant receives artificial milk and/or animal milk. The infant does not receive breast milk.
Measured: 15 months
Exclusive breastfeeding at 6 months
Number of newborns who received exclusive breastfeeding on day 183 of life (Number of newborns who received exclusive breastfeeding on day 183 of life / Total number of newborns with 183 days completed) x100
Measured: 15 months
Training of health professionals
Number of health professionals who have received advanced training and/or continuing education in breastfeeding. The training must have a minimum of 18 hours and include theoretical training and practical application of skills. (Number of health professionals who have received advanced training and/or continuing education in breastfeeding / Total number of health professionals) x100
Measured: 15 months
Assessment to prevent obesity
At least one comprehensive assessment including the assessment of nutrition, physical activity, sedentary behaviour, growth and family environment has been completed in infants from birth to 12 years of age. (Total number of children from birth to 12 years of age who have undergone a comprehensive assessment to prevent obesity, and are registered / Total number of children from birth to 12 years of age with one or more well-child follow-up visits in the previous year) x100
Measured: 15 months
Education and support for parents/primary caregivers
Parents or primary caregivers have received education and support including: breastfeeding, role modelling, children's eating practices, family physical activity, screen time, physical activity, healthy eating; and it is documented. (Total number of children from birth to 12 years of age whose parents or caregivers have received education to promote healthy eating or physical activity habits, by child's age, and is registered / Total number of children from birth to 12 years with one or more well-child follow-up visits in the previous year) x100
Measured: 15 months
Exclusive breastfeeding, children from birth to 6 months of age
Children from 0 to 183 days inclusive who have received exclusive breastfeeding, directly from the breast or stored. (Number of children 0-6 months (or-183 days) who received EXCLUSIVE breastfeeding in the previous 24 hours, and is registered / Total number of children 0-6 months with one or more visits well-infant-child follow-up in the previous year) x100
Measured: 15 months
Breastfeeding, children from 6 months of age up to 2 years
Children with more than 183 days of life who received breastfeeding directly from the breast or stored. (Number of children >6 months and up to 2 years (more than 183 days-2 years) who received breastfeeding in the previous 24 hours, and is registered / Total number of children >6 months - and up 2 years with one or more well-infant-child follow-up visits in the previous year) x100
Measured: 15 months
Sedentary behaviour
Number of children from birth to 12 years old who spent the recommended time for their age in front of a screen. (Number of children from birth to 12 years old, whose daily screen time is the recommended for their age, as of parents' declaration, and is registered / Total number of children from births up to 12 years of age with one or more follow-up visits to the well-child infant in the previous year, with assessment of screen time or comprehensive assessment) x100
Measured: 15 months
Daily physical activity
Number of children from birth to 12 years of age who meet the recommendations on amount of daily physical activity. (Number of children from birth to 12 years of age who meet the recommendations on amount of daily exercise, and are registered / Total number of children from birth to 12 years of age with one or more follow-up visits of the healthy infant-child in the previous year, with assessment of physical activity or comprehensive assessment) x100
Measured: 15 months
Incidence of childhood obesity
Incidence of childhood obesity. (Number of children between 2 and 12 years old (included) whose BMI for their age exceeds the percentile to be considered obese according to WHO standards, at the LAST follow-up VISIT of the infant/well-child, and is registered / Number of children between 2 and 12 years of age (included) with one or more well-child infant follow-up visits in the previous year, whose BMI has been assessed in the measurement period) x100
Measured: 15 months
ICU beds with alcohol-based preparations at the point of care
Availability of the alcohol-based preparations in the Intensive Care Units (Hospital care) as close as possible to the place where an activity that requires contact with the patient and/or their immediate environment is going to be carried out and without having to leave the patient's area. Point of care is the place where the patient, the health professional and the care or treatment that involves contact with the patient coincide. (Number of ICU beds in the unit, with base alcoholic preparations at the point of care / Number of ICU beds in the unit) x100
Measured: 15 months
Hospital beds with alcohol-based preparations at the point of care
Availability of the alcohol-based preparations in the hospital units (excluding ICU beds) as close as possible to the place where an activity that requires contact with the patient and/or their immediate environment is going to be carried out and without having to leave the patient's area. Point of care is the place where the patient, the health professional and the care or treatment that involves contact with the patient coincide. (Number of hospitalization beds in the unit, with alcohol-based preparations at the point of care)/(Number of beds in the unit) x100
Measured: 15 months
Consumption of alcohol-based preparations in hospitalization
Litres of alcohol-based preparations consumed in hospitalization units with admission, including ICU (Number of litres of alcohol-based preparations delivered / Total number of stays in the evaluated period) x1000 Total number of stays in the evaluated period: It refers to the stays of hospitalized patients, where stay = Date of discharge - Date of admission, during the indicator calculation period.
Measured: 15 months
Consumption of alcohol-based preparations in Primary Care centers
Litres of alcohol-based preparations consumed in primary care centres. (Number of liters of alcohol-based preparations delivered in primary care / Total number of consultations in the evaluated period) x10000
Measured: 15 months
Consumption of alcohol-based preparations in hospital units without admission
Litres of alcohol-based preparations consumed in hospital units without admission (outpatient consultations, day hospital, etc.). (Number of liters of alcohol-based preparations@delivered in a hospital unit without admission / Total number of consultations in the evaluated period) x1000
Measured: 15 months
Consumption of alcohol-based preparations in Nursing Homes.
Litres of alcohol-based preparations consumed in Nursing Homes (Number of liters of alcohol-based preparations delivered in Nursing Homes / Total number of residents in the evaluated period) x100
Measured: 15 months
Secondary outcomes (23)
Type of institution
Hospital unit, primary care unit or nursing home unit.
Measured: 15 months
Size of hospital unit
Average number of admissions received per year.
Measured: 15 months
Size of Nursing home
Total number of beds in the nursing home unit.
Measured: 15 months
Size of primary care unit
Average number of appointments per day in the units.
Measured: 15 months
No. Nurses
Total number of nurses working in the unit by November 2021.
Measured: 15 months
No. Healthcare assistants
Total number of healthcare assistants working in the unit by November 2021.
Measured: 15 months
Type of unit
Age, health problems and care required by the patients attended by the unit on a regular basis.
Measured: 15 months
Date of discharge
Patients discharge date in case of hospital admissions.
Measured: 15 months
Date of attention
Date when patients were attended in case of primary care.
Measured: 15 months
Date of residence
Date when patients were a resident in case of socio-healthcare centres.
Measured: 15 months
Age
Age of patients.
Measured: 15 months
Sex
Sex of patients.
Measured: 15 months
Mother´s age
Age of the mother.
Measured: 15 months
Breastfeeding for the first time
First time the mother is facing breastfeeding or not.
Measured: 15 months
Type of birth
Way in which the newborn was born: vaginal delivery, instrumental birth, caesarean section.
Measured: 15 months
Weeks of gestation
Number of weeks of pregnancy.
Measured: 15 months
Weight at birth
Weight of the newborn at birth, measured in grams.
Measured: 15 months
Child weight
Child's weight measured in kilograms.
Measured: 15 months
Size
Height: child's height measured in centimetres.
Measured: 15 months
Reason for admission/consultation
Reason for admission/consultation of patients. Reason for the patient to be admitted to the Hospital or to attend the consultation.
Measured: 15 months
Past-medical history
History of previous illness, surgery or painful experiences of the patient.
Measured: 15 months
Barriers
Barriers for the implementation of evidence-based recommendations in the units assessed using a questionnaire adapted from the TICD checklist.
Measured: 15 months
EBP competencies
Competencies in evidence-based practice of the healthcare professionals working in the units that are implementing evidence-based recommendations, assessed with the questionnaire EBP-COQ Prof©.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start25 Nov 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-experimental, uncontrolled, before-and-after study
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teresa Moreno Casbas
- Sponsor type
- Other government
- Collaborators
- The Spanish Centre for Evidence Based Nursing and Healthcare
- Responsible party
- Sponsor-investigator, Teresa Moreno Casbas, Instituto de Salud Carlos III
- Investigators
- María Teresa Moreno-Casbas, Doctor, Study director, Instituto de Salud Carlos IIIEsther González-María, Doctor, Principal investigator, Instituto de Salud Carlos IIILeticia Bernués-Caudillo, PhD Candidate, Study chair, Instituto de Salud Carlos IIICandela Cameselle-Lago, PhD Candidate, Study chair, Instituto de Salud Carlos IIILaura Albornos-Muñoz, PhD Candidate, Study chair, Instituto de Salud Carlos III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466656
- Sponsor's protocol ID
- SE_CECBE_2022
- Status last verified
- Jan 2024
- First submitted
- 15 Jul 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kreindler SA. What if implementation is not the problem? Exploring the missing links between knowledge and action. Int J Health Plann Manage. 2016 Apr;31(2):208-26. doi: 10.1002/hpm.2277. Epub 2014 Nov 25.
PubMed 25424863Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011 Dec;104(12):510-20. doi: 10.1258/jrsm.2011.110180.
PubMed 22179294Squires JE, Estabrooks CA, Gustavsson P, Wallin L. Individual determinants of research utilization by nurses: a systematic review update. Implement Sci. 2011 Jan 5;6:1. doi: 10.1186/1748-5908-6-1.
PubMed 21208425Meijers JM, Janssen MA, Cummings GG, Wallin L, Estabrooks CA, Y G Halfens R. Assessing the relationships between contextual factors and research utilization in nursing: systematic literature review. J Adv Nurs. 2006 Sep;55(5):622-35. doi: 10.1111/j.1365-2648.2006.03954.x.
PubMed 16907795Ortuno-Soriano I, Munoz-Jimenez D, Moreno-Casbas T, Albornos-Munoz L, Gonzalez-Maria E; en nombre del Grupo de Trabajo del Programa de implantacion de buenas practicas en Centros Comprometidos con la Excelencia en Cuidados(R). Evaluation of implementation strategies of the Best Practices Spotlight Organisations (BPSO) Project in Spain. Enferm Clin (Engl Ed). 2020 May-Jun;30(3):222-230. doi: 10.1016/j.enfcli.2019.10.027. Epub 2020 May 7. English, Spanish.
PubMed 32389600Powell BJ, Fernandez ME, Williams NJ, Aarons GA, Beidas RS, Lewis CC, McHugh SM, Weiner BJ. Enhancing the Impact of Implementation Strategies in Healthcare: A Research Agenda. Front Public Health. 2019 Jan 22;7:3. doi: 10.3389/fpubh.2019.00003. eCollection 2019.
PubMed 30723713Lewis CC, Boyd MR, Walsh-Bailey C, Lyon AR, Beidas R, Mittman B, Aarons GA, Weiner BJ, Chambers DA. A systematic review of empirical studies examining mechanisms of implementation in health. Implement Sci. 2020 Apr 16;15(1):21. doi: 10.1186/s13012-020-00983-3.
PubMed 32299461Allen P, Pilar M, Walsh-Bailey C, Hooley C, Mazzucca S, Lewis CC, Mettert KD, Dorsey CN, Purtle J, Kepper MM, Baumann AA, Brownson RC. Quantitative measures of health policy implementation determinants and outcomes: a systematic review. Implement Sci. 2020 Jun 19;15(1):47. doi: 10.1186/s13012-020-01007-w.
PubMed 32560661Moreno-Casbas T. Perspectives: Implementation strategies to adopt and integrate evidence-based nursing. What are we doing? J. Res. Nurs. 2015;20:729-33.
Lau R, Stevenson F, Ong BN, Dziedzic K, Treweek S, Eldridge S, Everitt H, Kennedy A, Qureshi N, Rogers A, Peacock R, Murray E. Achieving change in primary care--causes of the evidence to practice gap: systematic reviews of reviews. Implement Sci. 2016 Mar 22;11:40. doi: 10.1186/s13012-016-0396-4.
PubMed 27001107Almazrou SH, Alfaifi SI, Alfaifi SH, Hakami LE, Al-Aqeel SA. Barriers to and Facilitators of Adherence to Clinical Practice Guidelines in the Middle East and North Africa Region: A Systematic Review. Healthcare (Basel). 2020 Dec 15;8(4):564. doi: 10.3390/healthcare8040564.
PubMed 33333843Davies B, Edwards N, Ploeg J, Virani T. Insights about the process and impact of implementing nursing guidelines on delivery of care in hospitals and community settings. BMC Health Serv Res. 2008 Feb 2;8:29. doi: 10.1186/1472-6963-8-29.
PubMed 18241349Ploeg J, Davies B, Edwards N, Gifford W, Miller PE. Factors influencing best-practice guideline implementation: lessons learned from administrators, nursing staff, and project leaders. Worldviews Evid Based Nurs. 2007;4(4):210-9. doi: 10.1111/j.1741-6787.2007.00106.x.
PubMed 18076464Mickan S, Burls A, Glasziou P. Patterns of 'leakage' in the utilisation of clinical guidelines: a systematic review. Postgrad Med J. 2011 Oct;87(1032):670-9. doi: 10.1136/pgmj.2010.116012. Epub 2011 Jun 29.
PubMed 21715571Fleiszer AR, Semenic SE, Ritchie JA, Richer MC, Denis JL. A unit-level perspective on the long-term sustainability of a nursing best practice guidelines program: An embedded multiple case study. Int J Nurs Stud. 2016 Jan;53:204-18. doi: 10.1016/j.ijnurstu.2015.09.004. Epub 2015 Sep 8.
PubMed 26453418
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUMAMOS EXCELENCIA Project: Assessment of Implementation of Best Practices in a National Health System (Second Edition)
- ClinicalTrials.gov ID
- NCT05466656
- Acronym / sponsor ID
- SE_CECBE_2022
- Conditions
- Pain, Incontinence, Urinary, Obesity, Childhood, Breastfeeding
- Keywords
- Implementation Science, Evidence-Based Practice, Evidence-Based Nursing, Nursing Care, Quality of Health Care, Clinical Audit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Teresa Moreno CasbasOther government
- Collaborators
- The Spanish Centre for Evidence Based Nursing and Healthcare
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a gap between research and clinical practice, leading to variability in decision-making. Clinical audits are an effective strategy for improving implementation of best practices. Quasi-experimental, multicentre, before and after. Primary care, hospital units and nursing homes, and the patients attended at both. Implementation of evidence-based recommendations by application of a continuous quality improvement cycle model (process of improvement by reference to a prior baseline clinical audit. Data will be collected at baseline and, during the first year of follow up, at months (3, 6, 12)
Detailed description
Aim: To assess the effectiveness of implementing evidence-based recommendations using a continuous quality improvement cycle model on patient outcomes and healthcare quality. Design: Quasi-experimental, multicentre, before-and-after. Methods: NHS units and Nursing Homes, patients attended by them and professionals implementing the recommendations. Intervention: implementation of evidence-based recommendation with a continuous quality improvement cycle's model (process of improvement by reference to a prior baseline clinical audit). Variables: Process and outcome criteria with respect to assessment and management of pain, management of urinary incontinence, prevention of child obesity, promotion of breastfeeding, promotion of hand hygiene, competencies in evidence-based practice, barriers to the implementation and strategies for overcoming them. Data will be collected at baseline and, during the first year of follow-up, at months 3, 6 and 12, with data on patients and indicators being drawn from clinical histories and records. Descriptive analysis and comparison of the effectiveness of the intervention by means of inferential analysis and analysis of trends across follow-up. 95% confidence level. This project is partially funded by The Spanish Centre for Evidence Based Nursing and Healthcare. Project duration 2022-2024.
This project is a second edition of The SUMAMOS EXCELENCIA Project: Assessment of Implementation of Best Practices in a National Health System (NCT03725774), with a similar design but with changes in some of the themes.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-experimental, uncontrolled, before-and-after study
| Arm | Type | Receives |
|---|---|---|
| Quasi-experimental uncontrolled, before-and-after. | Experimental | Other: Continuous quality improvement cycle modelThe intervention will consist of the use of a continuous quality improvement cycle model and implementation of its strategies in clinical practice, according to the study unit in question and the scope of action. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- Unit inclusion criteria:
- Patient inclusion criteria: The study will include all patients attended in the units participating in the study, who meet the following criteria, depending on the recommendations to be implemented in each unit:
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous quality improvement cycle modelThe continuous quality improvement cycle model consist in a process of improvement by reference to a prior baseline clinical audit. It implies a local situation analysis, identifying barriers to improvements in clinical practice, and drawing up and implementing a plan of action for improving adherence to pre-established criteria. The goal is to establish interprofessional processes within the teams, in order to: examine the barriers that hinder the use of evidence in fostering best practices; and contribute to the development of implementation programmes for overcoming such obstacles. | Other | Quasi-experimental uncontrolled, before-and-after. |
Primary outcome
Urinary incontinence assessment
Time frame: 15 months
Assessment of presence of urinary incontinence. Total number of patients in whom the presence of urinary incontinence has been initially assessed, and who are registered / Total number of patients with positive detection of urinary incontinence during the data collection period) * 100
Voiding diary
Time frame: 15 months
Record of all urination and leakage for 3 consecutive days. (Total number of patients with a voiding diary of 3 days recorded / Total number of patients with urinary incontinence discharged or attended during the data collection period) * 100
Scheduled urination
Time frame: 15 months
Using verbal and physical prompts or signals to make people pay attention to their dry/wet situation and the need to go to the bathroom. (Total number of patients with a scheduled urination care plan, and it is registered / Total number of patients with urinary incontinence and a 3-day voiding diary discharged or attended in the data collection period) * 100
Bladder training
Time frame: 15 months
Program of education and programmed evacuation in which the intervals of micturition are gradually adjusted. (Total number of patients with a bladder training care plan, and it is registered / Total number of patients with urinary incontinence and a 3-day voiding diary discharged or attended in the data collection period) * 100
Pelvic floor exercises
Time frame: 15 months
The individualized education and training of pelvic floor exercises. (Total number of patients with a pelvic floor exercise care plan, and it is registered / Total number of patients with urinary incontinence and a 3-day voiding diary discharged or attended in the data collection period) * 100
Severity
Time frame: 15 months
Severity of urinary incontinence. Total number of patients with different levels of urinary incontinence 24 hours prior to assessment / Total number of patients with urinary incontinence during the data collection period) x 100
Impact
Time frame: 15 months
Impact of urinary incontinence. (Total number of patients whose urinary incontinence has an impact on their quality of life, in the 24 hours prior to the assessment / Total number of patients with urinary incontinence during the data collection period) x 100
Improvement
Time frame: 15 months
Perception of improvement in urinary incontinence. (Total number of patients who perceive an improvement 6 weeks after the intervention / Total number of patients with urinary incontinence before the start of the intervention) x100
Detection of pain at admission
Time frame: 15 months
Detection of pain at admission. (Total number of patients in whom pain detection was performed upon admission or at the start of care, and it is registered / Total number of patients discharged or attended in the collection period data) x100
Pain related to a procedure likely to cause pain
Time frame: 15 months
Detection of pain related to a procedure likely to cause pain. This indicator evaluates whether the assessment of pain linked to the painful procedure is carried out before and after the procedure, it is also recommended to assess pain during the procedure in cases where it is possible. (Total number of patients in whom pain has been detected after a procedure likely to cause pain, and is registered / Total number of patients in whom a procedure likely to cause pain has been performed in the data collection period data) x100
Pain after a change in the patient's clinical situation
Time frame: 15 months
Detection of pain after a change in the patient's clinical situation (clinical situation: significant clinical change, in the general condition of the patient or in their pain, which requires the referral of the patient to a professional with the skills to resolve it). (Total number of patients in whom pain has been detected after a change in their clinical situation, and it is registered / Total number of patients with a change in their clinical situation in the data collection period) x100
Pain intensity assessment
Time frame: 15 months
Pain assessment measured with a pain intensity assessment tool. (Total number of patients who have an assessment of pain intensity, and it is recorded / Total number of patients with positive detection of pain in the data collection period) x100
Comprehensive pain assessment
Time frame: 15 months
Comprehensive pain assessment takes into account various factors related to pain, including: location of pain, circumstances related to the onset of pain, type of pain, pain intensity, associated symptoms, effect of pain on activities, effect of pain on patient rest and sleep, treatment, relevant medical history, factors that influence pain management. To be considered a comprehensive assessment, at least 60% of the 10 criteria must be performed and recorded. (Total number of patients who have done a comprehensive pain assessment, and it is registered / Total number of patients with positive pain detection in the data collection period) x100
Pain management care plan
Time frame: 15 months
Establishing and implementing a pain management care plan for the patient based on the results of the person's assessment, which would include: pharmacological and non-pharmacological measures, the person's goals and appropriate and effective pain management strategies. (Total number of patients with a care plan for acute or chronic pain, and it is registered / Total number of patients with positive detection of pain or susceptible to have pain in the data collection period) x100
Patient or/and caregiver education on pain
Time frame: 15 months
Patient or/and caregiver education on the importance of communicating pain, pharmacological, physical and psychological pain management options, how to take the analgesic medication, manage the possible side effects and how the follow-up will be done and who can be consulted with possible doubts. (Total number of patients, family members or caregivers who have received education on pain management, at least once during the care process, and it is registered / Total number of patients with positive detection of pain or likely to have pain in the data collection period) x100
Intensity of pain on admission or in the first 24 hours after surgery or at the start of care
Time frame: 15 months
Intensity of pain on admission or in the first 24 hours after surgery or at the start of care measured in numerical format, with the value that corresponds to the scale used in the unit for the assessment of pain, units must indicate on the form the scale they have used. (Sum of pain intensity of patients with positive pain detection or likely to have pain / Total number of patients with assessed pain intensity in the data collection period)
Maximum pain
Time frame: 15 months
Maximum scored reported by patients and registered by nurses after pain intensity assessment using an assessment tool. Units must indicate on the form the assessment tool they have used. (Sum of the maximum intensity of pain during the stay or care of patients with positive detection of pain or likely to have pain / Total number of patients with pain intensity assessed in the data collection period)
Skin-to-skin contact
Time frame: 15 months
Skin-to-skin contact is the placement of a newborn, naked or with a diaper and cap, in a prone position on the bare chest of a person, covered with a previously heated blanket to prevent heat loss. It should be facilitated immediately (up to 1 hour) after birth or once the child and the nursing person are clinically stable. (Number of infants performing skin-to-skin immediately after birth or with clinically stable dyad /Total number of infants) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Postpartum assessment of breastfeeding
Time frame: 15 months
Assessment of breastfeeding completed within the first 24 hours of the newborn life. The objective is that in the first 24 hours the breastfeeding person is able to identify: proper position and grip, efficient breast milk transfer, support networks, breastfeeding self-efficacy, risks of mood disorders, assessment of the newborn in relation to breastfeeding. To carry out the assessment, a breastfeeding assessment tool may be used. (Number of dyads assessed on the breastfeeding process in the first 24 hours/Total number of dyads) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Assessment of breastfeeding after the first 24 hours and before discharge
Time frame: 15 months
Assessment of breastfeeding completed after first 24 hours of the newborn life and before hospital discharge. The objective is that before hospital discharge the breastfeeding person is able to identify: proper position and grip, efficient breast milk transfer, support networks, breastfeeding self-efficacy, risks of mood disorders, assessment of the newborn in relation to breastfeeding. To carry out the assessment, a breastfeeding assessment tool may be used. (Number of dyads assessed on the breastfeeding process after the first 24 hours and before hospital discharge / Total number of dyads) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Early assessment of breastfeeding in primary care
Time frame: 15 months
In Primary Care, early assessment is considered completed between birth and day 8 of the neonate's life (included). To carry out the assessment, a breastfeeding assessment tool may be used. (Number of dyads assessed early on the process of breastfeeding (between birth and 8 days of life / Total number of dyads between birth and 8 days of life of the newborn) x 100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Follow-up assessment of breastfeeding in primary care (from 9 days of life to 6 months)
Time frame: 15 months
In Primary Care, the follow-up evaluation is carried out between 9 days of life and 6 months/183 days of life of the neonate (included). To carry out the assessment, a breastfeeding assessment tool may be used. (Number of dyads assessed on the breastfeeding process from 9 days of life to 6 months / Total number of dyads from 9 days of life to 6 months of the newborn) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Breastfeeding education for the breastfeeding person
Time frame: 15 months
In Hospital Care, it is considered completed if postpartum training has been carried out and resources have been provided to the mother by the interprofessional team in breastfeeding before hospital discharge. In Primary Care, it is considered completed if training has been carried out and resources have been provided to the mother after hospital discharge by the interprofessional team in breastfeeding, at least once in the period after discharge to 8 days or in the period from 9 days to 6 months, in the same visit or in successive visits. (Number of lactating persons receiving education in breastfeeding / Total number of dyads) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Breastfeeding education and support for family members
Time frame: 15 months
In hospital care, it is considered completed if education and support in breastfeeding has been carried out for family members before hospital discharge. In Primary Care, it is considered accomplished if breastfeeding education and support has been provided to family members, at least once in the period after discharge to 8 days or in the period from 9 days to 6 months, in the same visit or on successive visits. (Number of dyads whose family has received education and support in breastfeeding / Total number of dyads) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Type of breastfeeding of the newborn during the hospital stay
Time frame: 15 months
Type of breastfeeding of the newborn during the hospital stay. (Number of infants exclusively breastfed, receiving mixed breastfeeding or not breastfed during hospital stay / Total number of infants discharged) x100 Exclusive breastfeeding: The infant receives directly or indirectly breast milk. He does not receive any other type of solid or liquid food. Mixed breastfeeding: The infant receives breast milk as well as other solid and liquid foods (including water), including non-human milk or formula. Non-breastfeeding: The infant receives artificial milk and/or animal milk. The infant does not receive breast milk.
Type of breastfeeding of the newborn in early stage
Time frame: 15 months
Type of breastfeeding of the newborn from birth to 8 days of life assessed in Primary care. (Number of newborns who were exclusively breastfed, received mixed breastfeeding or were not breastfed from birth to 8 days of life / Total number of newborns between 0 and 8 days of life) x100 Exclusive breastfeeding: The infant receives directly or indirectly breast milk. He does not receive any other type of solid or liquid food. Mixed breastfeeding: The infant receives breast milk as well as other solid and liquid foods (including water), including non-human milk or formula. Non-breastfeeding: The infant receives artificial milk and/or animal milk. The infant does not receive breast milk.
Type of breastfeeding of the newborn in follow-up 1
Time frame: 15 months
Type of breastfeeding of the newborn from 9 to 90 days of life, assessed in Primary Care. (Number of infants exclusively breastfed, receiving mixed breastfeeding or not breastfed from 9 days to 90 days of life / Total number of infants from 9 to 90 days of life) x100 Exclusive breastfeeding: The infant receives directly or indirectly breast milk. He does not receive any other type of solid or liquid food. Mixed breastfeeding: The infant receives breast milk as well as other solid and liquid foods (including water), including non-human milk or formula. Non-breastfeeding: The infant receives artificial milk and/or animal milk. The infant does not receive breast milk.
Type of breastfeeding of the newborn in follow-up 2
Time frame: 15 months
Type of breastfeeding of the newborn from 91 to 182 days of life assessed in Primary care (Number of newborns who received exclusive breastfeeding, receiving mixed breastfeeding or not breastfed from 91 days to 182 days of life / Total number of newborns from 91 to 182 days of life) x100 Exclusive breastfeeding: The infant receives directly or indirectly breast milk. He does not receive any other type of solid or liquid food. Mixed breastfeeding: The infant receives breast milk as well as other solid and liquid foods (including water), including non-human milk or formula. Non-breastfeeding: The infant receives artificial milk and/or animal milk. The infant does not receive breast milk.
Exclusive breastfeeding at 6 months
Time frame: 15 months
Number of newborns who received exclusive breastfeeding on day 183 of life (Number of newborns who received exclusive breastfeeding on day 183 of life / Total number of newborns with 183 days completed) x100
Training of health professionals
Time frame: 15 months
Number of health professionals who have received advanced training and/or continuing education in breastfeeding. The training must have a minimum of 18 hours and include theoretical training and practical application of skills. (Number of health professionals who have received advanced training and/or continuing education in breastfeeding / Total number of health professionals) x100
Assessment to prevent obesity
Time frame: 15 months
At least one comprehensive assessment including the assessment of nutrition, physical activity, sedentary behaviour, growth and family environment has been completed in infants from birth to 12 years of age. (Total number of children from birth to 12 years of age who have undergone a comprehensive assessment to prevent obesity, and are registered / Total number of children from birth to 12 years of age with one or more well-child follow-up visits in the previous year) x100
Education and support for parents/primary caregivers
Time frame: 15 months
Parents or primary caregivers have received education and support including: breastfeeding, role modelling, children's eating practices, family physical activity, screen time, physical activity, healthy eating; and it is documented. (Total number of children from birth to 12 years of age whose parents or caregivers have received education to promote healthy eating or physical activity habits, by child's age, and is registered / Total number of children from birth to 12 years with one or more well-child follow-up visits in the previous year) x100
Exclusive breastfeeding, children from birth to 6 months of age
Time frame: 15 months
Children from 0 to 183 days inclusive who have received exclusive breastfeeding, directly from the breast or stored. (Number of children 0-6 months (or-183 days) who received EXCLUSIVE breastfeeding in the previous 24 hours, and is registered / Total number of children 0-6 months with one or more visits well-infant-child follow-up in the previous year) x100
Breastfeeding, children from 6 months of age up to 2 years
Time frame: 15 months
Children with more than 183 days of life who received breastfeeding directly from the breast or stored. (Number of children >6 months and up to 2 years (more than 183 days-2 years) who received breastfeeding in the previous 24 hours, and is registered / Total number of children >6 months - and up 2 years with one or more well-infant-child follow-up visits in the previous year) x100
Sedentary behaviour
Time frame: 15 months
Number of children from birth to 12 years old who spent the recommended time for their age in front of a screen. (Number of children from birth to 12 years old, whose daily screen time is the recommended for their age, as of parents' declaration, and is registered / Total number of children from births up to 12 years of age with one or more follow-up visits to the well-child infant in the previous year, with assessment of screen time or comprehensive assessment) x100
Daily physical activity
Time frame: 15 months
Number of children from birth to 12 years of age who meet the recommendations on amount of daily physical activity. (Number of children from birth to 12 years of age who meet the recommendations on amount of daily exercise, and are registered / Total number of children from birth to 12 years of age with one or more follow-up visits of the healthy infant-child in the previous year, with assessment of physical activity or comprehensive assessment) x100
Incidence of childhood obesity
Time frame: 15 months
Incidence of childhood obesity. (Number of children between 2 and 12 years old (included) whose BMI for their age exceeds the percentile to be considered obese according to WHO standards, at the LAST follow-up VISIT of the infant/well-child, and is registered / Number of children between 2 and 12 years of age (included) with one or more well-child infant follow-up visits in the previous year, whose BMI has been assessed in the measurement period) x100
ICU beds with alcohol-based preparations at the point of care
Time frame: 15 months
Availability of the alcohol-based preparations in the Intensive Care Units (Hospital care) as close as possible to the place where an activity that requires contact with the patient and/or their immediate environment is going to be carried out and without having to leave the patient's area. Point of care is the place where the patient, the health professional and the care or treatment that involves contact with the patient coincide. (Number of ICU beds in the unit, with base alcoholic preparations at the point of care / Number of ICU beds in the unit) x100
Hospital beds with alcohol-based preparations at the point of care
Time frame: 15 months
Availability of the alcohol-based preparations in the hospital units (excluding ICU beds) as close as possible to the place where an activity that requires contact with the patient and/or their immediate environment is going to be carried out and without having to leave the patient's area. Point of care is the place where the patient, the health professional and the care or treatment that involves contact with the patient coincide. (Number of hospitalization beds in the unit, with alcohol-based preparations at the point of care)/(Number of beds in the unit) x100
Consumption of alcohol-based preparations in hospitalization
Time frame: 15 months
Litres of alcohol-based preparations consumed in hospitalization units with admission, including ICU (Number of litres of alcohol-based preparations delivered / Total number of stays in the evaluated period) x1000 Total number of stays in the evaluated period: It refers to the stays of hospitalized patients, where stay = Date of discharge - Date of admission, during the indicator calculation period.
Consumption of alcohol-based preparations in Primary Care centers
Time frame: 15 months
Litres of alcohol-based preparations consumed in primary care centres. (Number of liters of alcohol-based preparations delivered in primary care / Total number of consultations in the evaluated period) x10000
Consumption of alcohol-based preparations in hospital units without admission
Time frame: 15 months
Litres of alcohol-based preparations consumed in hospital units without admission (outpatient consultations, day hospital, etc.). (Number of liters of alcohol-based preparations@delivered in a hospital unit without admission / Total number of consultations in the evaluated period) x1000
Consumption of alcohol-based preparations in Nursing Homes.
Time frame: 15 months
Litres of alcohol-based preparations consumed in Nursing Homes (Number of liters of alcohol-based preparations delivered in Nursing Homes / Total number of residents in the evaluated period) x100
23 secondary outcomes
Type of institution
Time frame: 15 months
Size of hospital unit
Time frame: 15 months
Size of Nursing home
Time frame: 15 months
Size of primary care unit
Time frame: 15 months
No. Nurses
Time frame: 15 months
No. Healthcare assistants
Time frame: 15 months
Type of unit
Time frame: 15 months
Date of discharge
Time frame: 15 months
Date of attention
Time frame: 15 months
Date of residence
Time frame: 15 months
Age
Time frame: 15 months
Sex
Time frame: 15 months
Mother´s age
Time frame: 15 months
Breastfeeding for the first time
Time frame: 15 months
Type of birth
Time frame: 15 months
Weeks of gestation
Time frame: 15 months
Weight at birth
Time frame: 15 months
Child weight
Time frame: 15 months
Size
Time frame: 15 months
Reason for admission/consultation
Time frame: 15 months
Past-medical history
Time frame: 15 months
Barriers
Time frame: 15 months
EBP competencies
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Background: PubMed 25424863Kreindler SA. What if implementation is not the problem? Exploring the missing links between knowledge and action. Int J Health Plann Manage. 2016 Apr;31(2):208-26. doi: 10.1002/hpm.2277. Epub 2014 Nov 25.
- Background: PubMed 22179294Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011 Dec;104(12):510-20. doi: 10.1258/jrsm.2011.110180.
- Background: PubMed 21208425Squires JE, Estabrooks CA, Gustavsson P, Wallin L. Individual determinants of research utilization by nurses: a systematic review update. Implement Sci. 2011 Jan 5;6:1. doi: 10.1186/1748-5908-6-1.
- Background: PubMed 16907795Meijers JM, Janssen MA, Cummings GG, Wallin L, Estabrooks CA, Y G Halfens R. Assessing the relationships between contextual factors and research utilization in nursing: systematic literature review. J Adv Nurs. 2006 Sep;55(5):622-35. doi: 10.1111/j.1365-2648.2006.03954.x.
- Background: PubMed 32389600Ortuno-Soriano I, Munoz-Jimenez D, Moreno-Casbas T, Albornos-Munoz L, Gonzalez-Maria E; en nombre del Grupo de Trabajo del Programa de implantacion de buenas practicas en Centros Comprometidos con la Excelencia en Cuidados(R). Evaluation of implementation strategies of the Best Practices Spotlight Organisations (BPSO) Project in Spain. Enferm Clin (Engl Ed). 2020 May-Jun;30(3):222-230. doi: 10.1016/j.enfcli.2019.10.027. Epub 2020 May 7. English, Spanish.
- Background: PubMed 30723713Powell BJ, Fernandez ME, Williams NJ, Aarons GA, Beidas RS, Lewis CC, McHugh SM, Weiner BJ. Enhancing the Impact of Implementation Strategies in Healthcare: A Research Agenda. Front Public Health. 2019 Jan 22;7:3. doi: 10.3389/fpubh.2019.00003. eCollection 2019.
- Background: PubMed 32299461Lewis CC, Boyd MR, Walsh-Bailey C, Lyon AR, Beidas R, Mittman B, Aarons GA, Weiner BJ, Chambers DA. A systematic review of empirical studies examining mechanisms of implementation in health. Implement Sci. 2020 Apr 16;15(1):21. doi: 10.1186/s13012-020-00983-3.
- Background: PubMed 32560661Allen P, Pilar M, Walsh-Bailey C, Hooley C, Mazzucca S, Lewis CC, Mettert KD, Dorsey CN, Purtle J, Kepper MM, Baumann AA, Brownson RC. Quantitative measures of health policy implementation determinants and outcomes: a systematic review. Implement Sci. 2020 Jun 19;15(1):47. doi: 10.1186/s13012-020-01007-w.
- BackgroundMoreno-Casbas T. Perspectives: Implementation strategies to adopt and integrate evidence-based nursing. What are we doing? J. Res. Nurs. 2015;20:729-33.
- Background: PubMed 27001107Lau R, Stevenson F, Ong BN, Dziedzic K, Treweek S, Eldridge S, Everitt H, Kennedy A, Qureshi N, Rogers A, Peacock R, Murray E. Achieving change in primary care--causes of the evidence to practice gap: systematic reviews of reviews. Implement Sci. 2016 Mar 22;11:40. doi: 10.1186/s13012-016-0396-4.
- Background: PubMed 33333843Almazrou SH, Alfaifi SI, Alfaifi SH, Hakami LE, Al-Aqeel SA. Barriers to and Facilitators of Adherence to Clinical Practice Guidelines in the Middle East and North Africa Region: A Systematic Review. Healthcare (Basel). 2020 Dec 15;8(4):564. doi: 10.3390/healthcare8040564.
- Background: PubMed 18241349Davies B, Edwards N, Ploeg J, Virani T. Insights about the process and impact of implementing nursing guidelines on delivery of care in hospitals and community settings. BMC Health Serv Res. 2008 Feb 2;8:29. doi: 10.1186/1472-6963-8-29.
- website fron the The Spanish Centre for Evidence Based Nursing and Healthcare with the project informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Teresa Moreno-Casbas, Doctor study director
Instituto de Salud Carlos III
Esther González-María, Doctor principal investigator
Instituto de Salud Carlos III
Leticia Bernués-Caudillo, PhD Candidate study chair
Instituto de Salud Carlos III
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous quality improvement cycle model in people with Pain and Incontinence, Urinary, run by Teresa Moreno Casbas at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary incontinence assessment (time frame: 15 months). The study lists 43 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05466656, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.