Age ProblemNCT03725774
The SUMAMOS EXCELENCIA Project: Assessment of Implementation of Best Practices in a National Health System
A study testing GRIP (Getting Research into Practice) model in people with Age Problem, run by Teresa Moreno Casbas.
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
- Age Problem
- What is being tested?
- GRIP (Getting Research into Practice) model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2017
- 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. The study will cover all SNHS units and associated socio-healthcare structures which voluntarily adhere to the project and undertake to implement recommendations relating to pain, urinary incontinence and prevention falls.
- 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 at units participating in the study, who meet the following criteria, depending on the recommendations to be implemented at each unit:
- Pain: persons admitted to hospital centres who may potentially suffer from some type of pain. Patients will be classified according to whether they are adults or children (paediatric patients), and according to whether they experience chronic pain, acute postoperative pain, or acute pain due to other causes.
- Incontinence: community-dwelling or institutionalised persons prone to present with urinary incontinence. Patients will be classified according to whether they are 65 years of age or over.
- Falls: persons aged over 65 years who display one or more fall risk factors according to the assessment criteria established by the risk assessment instrument used.
Who cannot join
- -
About this study
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 and hospital-care units and associated socio-healthcare structures, and the patients attended at both. Implementation of evidence-based recommendations by application of the Getting Research into Practice 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, 9,12)
Read the detailed description
Aim: To assess the effectiveness of a model of implementation of evidence-based recommendations, in terms of patient outcomes and healthcare quality. Desing: Quasi-experimental, multicentre, before-and-after. Methods Primary-care and hospital-care units and associated socio-healthcare structures, and the patients attended at both. Intervention: Implementation of evidence-based recommendations by application of the Getting Research into Practice model (process of improvement by reference to a prior baseline clinical audit). Variables: Process and outcome criteria with respect to pain, urinary incontinence and fall prevention. Data will be collected at baseline and, during the first year of follow up, at months (3, 6, 9,12), 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 funded by Spanish Strategic Health Action November 2014. Project duration 2015-2017.
- Conditions
- Age Problem
- Being tested
- GRIP (Getting Research into Practice) model
- Keywords
- pain, accidental falls, urinary incontinence, clinical audit
- Medical subject headings
- Pain, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRIP (Getting Research into Practice) modelOther
The intervention will consist of the use of the GRIP (Getting Research into Practice) model and implementation of its strategies in clinical practice, according to the study unit in question and the scope of action.
The GRIP model is a process of improvement by reference to a prior baseline clinical audit. It implies a local situation analysis, identifying the obstacles to improvements in clinical practice, and drawing up and implementing a plan of action for the purpose of improving adherence to pre-established criteria. The goal is to establish interprofessional processes within the teams, in order to: examine the obstacles 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 the GRIP (Getting Research into Practice) model and implementation of its strategies in clinical practice, according to the study unit in question and the scope of action Receives: Other: GRIP (Getting Research into Practice) model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary incontinence
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 discharged in the assessment period) * 100
Measured: 15 month
Detection of pain, at admission
Total number of patients who have been assessed for the presence of pain and is registered / Total number of patients discharged during the measurement period) * 100 The assessment of the presence of pain will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of pain assessment with a Visual Analogic Scale (VAS; 10 cm, 0=no pain, 10=maximum pain) or Numerical rating scale (NRS; 0=no pain, 10 =worse pain), or the FLACC scale tool or paediatric patients,(Face, Leg, Activity, Cry, Consolability). Categories is scored from 0-2. Total scale: 0 is relaxed and comfortable, 1-2 Moderate discomfort, 3-6 Moderate pain and 7-10 Severe pain/discomfort f or PAINAD scale tool for patient with dementia. Measure breathing, negative vocalization, facial expression, body language and capacity for relief. Each item can get a maximum score of 2. The total scores can be from 0 (no pain) to 10 (maximum pain)
Measured: 15 month
Risk of falls
Assessment of fall risk with a validated tool, at admission or onset of care.(Total number of patients to whom the risk of falls with a validated tool was initially assessed and registered / Total number of patients discharged during the measurement period) * 100 The assessment of fall risk in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of fall risk with a validated tools.Tools: Hendrich II Fall Risk Model, score: 0-16. Patient without risk (0), risk (1-4 points) and high risk (>5 points). H. Downton scale, score from 0 to 12. Patient without risk (0), low risk (1-2) and high risk (> 3 points). Morse Falls Scale, score from 0 to 150. Patient without risk (0-25), low risk (25-50) and high risk (> 50 points). Stratify or Stratify modified scale assesment includes five questions with dichotomous answer; obtaining two or more positive answer would classify the individual as a high risk patient to suffer a fall.
Measured: 15 month
Secondary outcomes (31)
Type of institution
hospital unit, primary care unit or socio-healthcare unit
Measured: 15 month
Size of primary care unit
Population coverage will describe the size of primary care center.Number of patient assigned to the nurse
Measured: 15 month
Size of socio-healthcare centres
The number of the beds assigned to the socio-healthcare
Measured: 15 month
Size of hospital unit
number of beds assigned to the unit
Measured: 15 month
nurse/patient ratio
number of patients per nurse
Measured: 15 month
Age
Age of patients
Measured: 15 month
Sex
Sex of patients
Measured: 15 month
Reason for admission/consultation
Reason for admission/consultation of the patients. Reason for the patient to be admitted to the Hospital or to attend the consultation
Measured: 15 month
Days of stay
days of stay in the case of admissions
Measured: 15month
Impact of urinary incontinence
Impact of urinary incontinence.[Total number of patients with different urinary-incontinence impact levels 24 hours prior to assessment / Total number of patients attended during the data-collection period] * 100
Measured: 15 month
Severity of incontinence
Patient education, urinary Incontinence management.[Total number of patients with different levels of severity of urinary incontinence 24 hours prior to assessment/ Total number of patients attended during the data-collection period] * 100
Measured: 15 month
Type of urinary incontinence
Assessment of type of urinary incontinence. (Total number of incontinent patients with identification of type of incontinence, who are registered / Total number of incontinent patients) * 100
Measured: 15 month
Patient education, urinary incontinence management.
(Number of patients with incontinence who receive (patients, family members or carers) incontinence management education at least once during the care process, and who are registered / Total number of patients with incontinence)*100
Measured: 15 month
Urinary incontinence management
To establish and implement a comprehensive care plan to manage incontinence that includes: evaluation of results, believes, knowledge and level of comprehension of the patient, personal characteristics and incontinence characteristics. (Total number of incontinent patients that have a registered, multifactorial urinary incontinence management plan / Total number of incontinent patients) * 100
Measured: 15 month
Pain at admission in paediatric patient
Detection of pain, at admission. (Total number of paediatric patients who have been assessed for the presence of pain and is registered / Total number of patients discharged during the measurement period) * 100 The assessment of the presence of pain will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of pain assessment with the FLACC scale tool (Face, Leg, Activity, Cry, Consolability). Categories is scored from 0-2. Total scale: 0 is relaxed and comfortable, 1-2 Moderate discomfort, 3-6 Moderate pain and 7-10 Severe pain/discomfort
Measured: 15 month
Pain at admission in patient with dementia
Detection of pain, at admission. (Total number of patients with dementia who have been assessed for the presence of pain and is registered / Total number of patients discharged during the measurement period) * 100 The assessment of the presence of pain will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of pain assessment with the PAINAD scale (pain assesment in advanded dementia): tool for patient with dementia. Measure breathing, negative vocalization,facial expression, body language and capacity for relief. Each item can get a maximum score of 2. The total scores can be from 0 (no pain) to 10 (maximum pain)
Measured: 15 month
Pain at admission in patient with mechanic ventilation
Detection of pain, at admission. (Total number of patients with mechanic ventilation who have been assessed for the presence of pain and is registered / Total number of patients discharged during the measurement period) * 100 The assessment of the presence of pain will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of pain assessment with the ESCID scale (Scale of Behavior Indicators of Pain). Mesaure: Facial expression, tranquility (movements), muscle tone, comfort and adaptation to mechanic ventilation. Each item is scored from 0 to 2; being 0 the minimum score and 10 the maximum.
Measured: 15 month
Pain after a change in clinical status in adult patientfor pain
Detection of pain, after a change in clinical status. (Total number of adult patients who have been assessed for the presence of pain after change of clinical situation and is registered / Total number of adults patients discharged during the measurement period) * 100 The assessment of the presence of pain after a change in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of pain assessment with with a Visual Analogic Scale (VAS; 10 cm, 0=no pain, 10=maximum pain) or Numerical rating scale (NRS; 0=no pain, 10 =worse pain).
Measured: 15 month
Pain after a change in clinical status in paediatric patient
Detection of pain, after a change in clinical status. (Total number of paediatric patients who have been assessed for the presence of pain after change of clinical situation and is registered / Total number of patients discharged during the measurement period) * 100 The assessment of the presence of pain after a change in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of pain assessment with a FLACC scale (Face, Leg, Activity, Cry, Consolability): tool for paediatric patient. Categories is scored from 0-2. Total scale: 0 is relaxed and comfortable, 1-2 Moderate discomfort, 3-6 Moderate pain and 7-10 Severe pain/discomfort
Measured: 15 month
Pain after a change in clinical status in patient with dementia
Detection of pain, after a change in clinical status. (Total number of patients with dementia who have been assessed for the presence of pain after change of clinical situation and is registered / Total number of patients discharged during the measurement period) * 100 The assessment of the presence of pain after a change in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of pain assessment with a PAINAD scale (pain assesment in advanded dementia): tool for patient with dementia. Measure breathing, negative vocalization,facial expression, body language and capacity for relief. Each item can get a maximum score of 2. The total scores can be from 0 (no pain) to 10 (maximum pain)
Measured: 15 month
Pain after a change in clinical status in patient with mechanic ventilation
Detection of pain, after a change in clinical status. (Total number of patients with dementia who have been assessed for the presence of pain after change of clinical situation and is registered / Total number of patients discharged during the measurement period) * 100 The assessment of the presence of pain after a change in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of pain assessment with a ESCID scale (Scale of Behavior Indicators of Pain). Tool for patient with mechanic ventilation. Mesaure: Facial expression, tranquility (movements), muscle tone, comfort and adaptation to mechanic ventilation. Each item is scored from 0 to 2; being 0 the minimum score and 10 the maximum.
Measured: 15 month
Pain assessment
Pain assessment is defined as overall pain assessment in persons in whom the presence of pain has been detected, and identification of the type of pain (acute, chronic, nociceptive or neuropathic). (Total number of patients with identification of the type of pain and is registered / Total number of patients with pain) * 100 The assessment of the pain in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of the type of pain (acute, chronic, nociceptive or neuropathic)
Measured: 15 month
Pain management
Establishing and implementing an overall pain management care plan for the patient which would include: evaluation of his/her outcomes, beliefs, knowledge, level of understanding and personal characteristics, and characteristics of the pain.(Total number of patients with pain who have a registered and multifactorial plan for pain management / Total number of patients with pain) * 100 The Pain management in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of evaluation of his/her outcomes, beliefs, knowledge, level of understanding and personal characteristics, and characteristics of the pain.
Measured: 15 month
Patient education in pain
Patient education: collaborating with the patient in the identification of pain-control targets and appropriate strategies for an integrated approach to the care plan. (Number of patients with pain they receive (they, their family or caregivers) education about pain management at least once during the care process, and is registered / Total number of patients with pain) * 100
Measured: 15 month
Intensity of Pain
ntensity of Pain assessment using a validated tool, for record-keeping purposes. [Total number of patients with pain intensity measurement / (Total number of patients attended during the data collection period] * 100
The assessment of the intensity of pain in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of of the intensity of pain.
The intensity of pain will be measured with different validated tools, according to whether the patient is an adult or paediatric, if he is conscious or not and if he has difficulty communicating.The tools are : Visual Analogic Scale (VAS), Numerical rating scale (NRS),FLACC Scale (Face, Leg, Activity, Cry, Consolability), PAINAD scale ( pain assesment in advanded dementia), ESCID scale (Scale of Behavior Indicators of PAin)
Measured: 15 month
Maximum pain
Maximum score reported by a patient after pain-intensity assessment using a validated tool.
The intensity of pain will be measured with different validated tools, according to whether the patient is an adult or paediatric, if he is conscious or not and if he has difficulty communicating.The tools are : Visual Analogic Scale (VAS), Numerical rating scale (NRS),FLACC Scale (Face, Leg, Activity, Cry, Consolability), PAINAD scale ( pain assesment in advanded dementia), ESCID scale (Scale of Behavior Indicators of PAin)
Measured: 15 month
Risk after a fall
Assessment of fall risk with validated tool, after a fall. (Total number of patients who have been assessed the risk of falls with a validated tool after a fall and is registered / Total number of patients discharged in the measurement period) * 100 The assessment of fall risk after a fall in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of fall risk after a fall with a validated tools.Tools: Hendrich II Fall Risk Model, score: 0-16. Patient without risk (0), risk (1-4 points) and high risk (>5 points). H. Downton scale, score:0-12. Patient without risk (0), low risk (1-2) and high risk (> 3 points). Morse Falls Scale, score: 0-150. Patient without risk (0-25), low risk (25-50) and high risk (> 50 points). Stratify or Stratify modified scale assesment includes five questions with dichotomous answer; obtaining two or more positive answer would classify the individual as a high risk patient to suffer a fall.
Measured: 15 month
Prevention of falls
Percentage of patients who are detected to be at risk using a fall-prevention plan or fall-injury reduction programme, based on a multifactorial approach, and are registered.
The prevention of falls in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of are detected to be at risk using a fall-prevention plan or fall-injury reduction programme, based on a multifactorial approach, and are registered.
Measured: 15 month
Use of restraints
Percentage of patients who are used restraints are physical, chemical or environmental measures used to control a person's physical or behavioural activity or a part of his/her body
Measured: 15 month
Incidence of falls
Number of falls with or without injury among patients, per 1000 patients/day (acute care/rehabilitation/long stay) Total number of falls with or without injury, per 1000 patients (primary care)
Measured: 15 month
Falls that cause injury
Percentage of falls resulting in mild, moderate, severe injury or death, according to the WHO classification.
Injury is defined as bodily harm suffered as a consequence of a fall.
Measured: 15 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study startJun 2016
- Primary completionSep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Age ProblemStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Uncontrolled before-and-after study
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teresa Moreno Casbas
- Sponsor type
- Other government
- Collaborators
- Fondo de Investigacion Sanitaria
- Responsible party
- Sponsor-investigator, Teresa Moreno Casbas, Instituto de Salud Carlos III
- Investigators
- TERESA MORENO CASBAS, DOCTOR, Study director, Instituto de Salud Carlos IIIESTHER GONZALEZ MARIA, DOCTOR, Study chair, Instituto de Salud Carlos IIIISABEL ORTS CORTÉS, DOCTOR, Study chair, UNIVERSIDAD DE ALICANTECLARA SANCHEZ PABLO, RN, Study chair, Instituto de Salud Carlos III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725774
- Sponsor's protocol ID
- PI14CIII/00044
- Status last verified
- May 2018
- First submitted
- 18 Apr 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albornos-Muñoz, L., González-María, E., Moreno-Casbas, T. (2015). Implantación de Guías de Buenas Prácticas en España. Programa de Centros Comprometidos con la Excelencia en Cuidados® (Best Practice Guidelines Implementation in Spain. Best Practice Spotlight Organizations ® Programme). MedUNAB, 17(3), pp. 163-69.
Baker R, Camosso-Stefinovic J, Gillies C, Shaw EJ, Cheater F, Flottorp S, Robertson N. Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD005470. doi: 10.1002/14651858.CD005470.pub2.
PubMed 20238340Bauer MS, Damschroder L, Hagedorn H, Smith J, Kilbourne AM. An introduction to implementation science for the non-specialist. BMC Psychol. 2015 Sep 16;3(1):32. doi: 10.1186/s40359-015-0089-9.
PubMed 26376626Bero LA, Grilli R, Grimshaw JM, Harvey E, Oxman AD, Thomson MA. Closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings. The Cochrane Effective Practice and Organization of Care Review Group. BMJ. 1998 Aug 15;317(7156):465-8. doi: 10.1136/bmj.317.7156.465. No abstract available.
PubMed 9703533Bornbaum CC, Kornas K, Peirson L, Rosella LC. Exploring the function and effectiveness of knowledge brokers as facilitators of knowledge translation in health-related settings: a systematic review and thematic analysis. Implement Sci. 2015 Nov 20;10:162. doi: 10.1186/s13012-015-0351-9.
PubMed 26589972Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
PubMed 19664226Davies 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 18241349Dobbins M, Cockerill R, Barnsley J, Ciliska D. Factors of the innovation, organization, environment, and individual that predict the influence five systematic reviews had on public health decisions. Int J Technol Assess Health Care. 2001 Fall;17(4):467-78.
PubMed 11758291Estabrooks CA. The conceptual structure of research utilization. Res Nurs Health. 1999 Jun;22(3):203-16. doi: 10.1002/(sici)1098-240x(199906)22:33.0.co;2-9.
PubMed 10344701Flodgren G, Deane K, Dickinson HO, Kirk S, Alberti H, Beyer FR, Brown JG, Penney TL, Summerbell CD, Eccles MP. Interventions to change the behaviour of health professionals and the organisation of care to promote weight reduction in overweight and obese people. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD000984. doi: 10.1002/14651858.CD000984.pub2.
PubMed 20238311Forbes A, Griffiths P. Methodological strategies for the identification and synthesis of 'evidence' to support decision-making in relation to complex healthcare systems and practices. Nurs Inq. 2002 Sep;9(3):141-55. doi: 10.1046/j.1440-1800.2002.00146.x.
PubMed 12199878Mc Goldrick EL, Crawford T, Brown JA, Groom KM, Crowther CA. Identifying the barriers and enablers in the implementation of the New Zealand and Australian Antenatal Corticosteroid Clinical Practice Guidelines. BMC Health Serv Res. 2016 Oct 28;16(1):617. doi: 10.1186/s12913-016-1858-8.
PubMed 27793150Graham ID, Logan J, Harrison MB, Straus SE, Tetroe J, Caswell W, Robinson N. Lost in knowledge translation: time for a map? J Contin Educ Health Prof. 2006 Winter;26(1):13-24. doi: 10.1002/chp.47.
PubMed 16557505Grimshaw JM, Russell IT. Effect of clinical guidelines on medical practice: a systematic review of rigorous evaluations. Lancet. 1993 Nov 27;342(8883):1317-22. doi: 10.1016/0140-6736(93)92244-n.
PubMed 7901634Grimshaw J, Eccles M, Thomas R, MacLennan G, Ramsay C, Fraser C, Vale L. Toward evidence-based quality improvement. Evidence (and its limitations) of the effectiveness of guideline dissemination and implementation strategies 1966-1998. J Gen Intern Med. 2006 Feb;21 Suppl 2(Suppl 2):S14-20. doi: 10.1111/j.1525-1497.2006.00357.x.
PubMed 16637955
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SUMAMOS EXCELENCIA Project: Assessment of Implementation of Best Practices in a National Health System
- ClinicalTrials.gov ID
- NCT03725774
- Acronym / sponsor ID
- PI14CIII/00044
- Conditions
- Age Problem
- Keywords
- pain, accidental falls, urinary incontinence, clinical audit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Teresa Moreno CasbasOther government
- Collaborators
- Fondo de Investigacion Sanitaria
- Study start
- Jun 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 31 Oct 2018 (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 and hospital-care units and associated socio-healthcare structures, and the patients attended at both. Implementation of evidence-based recommendations by application of the Getting Research into Practice 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, 9,12)
Detailed description
Aim: To assess the effectiveness of a model of implementation of evidence-based recommendations, in terms of patient outcomes and healthcare quality. Desing: Quasi-experimental, multicentre, before-and-after. Methods Primary-care and hospital-care units and associated socio-healthcare structures, and the patients attended at both. Intervention: Implementation of evidence-based recommendations by application of the Getting Research into Practice model (process of improvement by reference to a prior baseline clinical audit). Variables: Process and outcome criteria with respect to pain, urinary incontinence and fall prevention. Data will be collected at baseline and, during the first year of follow up, at months (3, 6, 9,12), 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 funded by Spanish Strategic Health Action November 2014. Project duration 2015-2017.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Uncontrolled before-and-after study
| Arm | Type | Receives |
|---|---|---|
| Quasi-experimental uncontrolled, before-and-after | Experimental | Other: GRIP (Getting Research into Practice) modelThe intervention will consist of the use of the GRIP (Getting Research into Practice) 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 (6 listed)
- Unit-inclusion criteria. The study will cover all SNHS units and associated socio-healthcare structures which voluntarily adhere to the project and undertake to implement recommendations relating to pain, urinary incontinence and prevention falls.
- 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 at units participating in the study, who meet the following criteria, depending on the recommendations to be implemented at each unit:
- Pain: persons admitted to hospital centres who may potentially suffer from some type of pain. Patients will be classified according to whether they are adults or children (paediatric patients), and according to whether they experience chronic pain, acute postoperative pain, or acute pain due to other causes.
- Incontinence: community-dwelling or institutionalised persons prone to present with urinary incontinence. Patients will be classified according to whether they are 65 years of age or over.
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 |
|---|---|---|
| GRIP (Getting Research into Practice) modelThe intervention will consist of the use of the GRIP (Getting Research into Practice) model and implementation of its strategies in clinical practice, according to the study unit in question and the scope of action. The GRIP model is a process of improvement by reference to a prior baseline clinical audit. It implies a local situation analysis, identifying the obstacles to improvements in clinical practice, and drawing up and implementing a plan of action for the purpose of improving adherence to pre-established criteria. The goal is to establish interprofessional processes within the teams, in order to: examine the obstacles 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
Time frame: 15 month
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 discharged in the assessment period) * 100
Detection of pain, at admission
Time frame: 15 month
Total number of patients who have been assessed for the presence of pain and is registered / Total number of patients discharged during the measurement period) * 100 The assessment of the presence of pain will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of pain assessment with a Visual Analogic Scale (VAS; 10 cm, 0=no pain, 10=maximum pain) or Numerical rating scale (NRS; 0=no pain, 10 =worse pain), or the FLACC scale tool or paediatric patients,(Face, Leg, Activity, Cry, Consolability). Categories is scored from 0-2. Total scale: 0 is relaxed and comfortable, 1-2 Moderate discomfort, 3-6 Moderate pain and 7-10 Severe pain/discomfort f or PAINAD scale tool for patient with dementia. Measure breathing, negative vocalization, facial expression, body language and capacity for relief. Each item can get a maximum score of 2. The total scores can be from 0 (no pain) to 10 (maximum pain)
Risk of falls
Time frame: 15 month
Assessment of fall risk with a validated tool, at admission or onset of care.(Total number of patients to whom the risk of falls with a validated tool was initially assessed and registered / Total number of patients discharged during the measurement period) * 100 The assessment of fall risk in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of fall risk with a validated tools.Tools: Hendrich II Fall Risk Model, score: 0-16. Patient without risk (0), risk (1-4 points) and high risk (>5 points). H. Downton scale, score from 0 to 12. Patient without risk (0), low risk (1-2) and high risk (> 3 points). Morse Falls Scale, score from 0 to 150. Patient without risk (0-25), low risk (25-50) and high risk (> 50 points). Stratify or Stratify modified scale assesment includes five questions with dichotomous answer; obtaining two or more positive answer would classify the individual as a high risk patient to suffer a fall.
31 secondary outcomes
Type of institution
Time frame: 15 month
Size of primary care unit
Time frame: 15 month
Size of socio-healthcare centres
Time frame: 15 month
Size of hospital unit
Time frame: 15 month
nurse/patient ratio
Time frame: 15 month
Age
Time frame: 15 month
Sex
Time frame: 15 month
Reason for admission/consultation
Time frame: 15 month
Days of stay
Time frame: 15month
Impact of urinary incontinence
Time frame: 15 month
Severity of incontinence
Time frame: 15 month
Type of urinary incontinence
Time frame: 15 month
Patient education, urinary incontinence management.
Time frame: 15 month
Urinary incontinence management
Time frame: 15 month
Pain at admission in paediatric patient
Time frame: 15 month
Pain at admission in patient with dementia
Time frame: 15 month
Pain at admission in patient with mechanic ventilation
Time frame: 15 month
Pain after a change in clinical status in adult patientfor pain
Time frame: 15 month
Pain after a change in clinical status in paediatric patient
Time frame: 15 month
Pain after a change in clinical status in patient with dementia
Time frame: 15 month
Pain after a change in clinical status in patient with mechanic ventilation
Time frame: 15 month
Pain assessment
Time frame: 15 month
Pain management
Time frame: 15 month
Patient education in pain
Time frame: 15 month
Intensity of Pain
Time frame: 15 month
Maximum pain
Time frame: 15 month
Risk after a fall
Time frame: 15 month
Prevention of falls
Time frame: 15 month
Use of restraints
Time frame: 15 month
Incidence of falls
Time frame: 15 month
Falls that cause injury
Time frame: 15 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- BackgroundAlbornos-Muñoz, L., González-María, E., Moreno-Casbas, T. (2015). Implantación de Guías de Buenas Prácticas en España. Programa de Centros Comprometidos con la Excelencia en Cuidados® (Best Practice Guidelines Implementation in Spain. Best Practice Spotlight Organizations ® Programme). MedUNAB, 17(3), pp. 163-69.
- Results publication: PubMed 20238340Baker R, Camosso-Stefinovic J, Gillies C, Shaw EJ, Cheater F, Flottorp S, Robertson N. Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD005470. doi: 10.1002/14651858.CD005470.pub2.
- Results publication: PubMed 26376626Bauer MS, Damschroder L, Hagedorn H, Smith J, Kilbourne AM. An introduction to implementation science for the non-specialist. BMC Psychol. 2015 Sep 16;3(1):32. doi: 10.1186/s40359-015-0089-9.
- Results publication: PubMed 9703533Bero LA, Grilli R, Grimshaw JM, Harvey E, Oxman AD, Thomson MA. Closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings. The Cochrane Effective Practice and Organization of Care Review Group. BMJ. 1998 Aug 15;317(7156):465-8. doi: 10.1136/bmj.317.7156.465. No abstract available.
- Results publication: PubMed 26589972Bornbaum CC, Kornas K, Peirson L, Rosella LC. Exploring the function and effectiveness of knowledge brokers as facilitators of knowledge translation in health-related settings: a systematic review and thematic analysis. Implement Sci. 2015 Nov 20;10:162. doi: 10.1186/s13012-015-0351-9.
- Results publication: PubMed 19664226Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
- Results publication: 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.
- Results publication: PubMed 11758291Dobbins M, Cockerill R, Barnsley J, Ciliska D. Factors of the innovation, organization, environment, and individual that predict the influence five systematic reviews had on public health decisions. Int J Technol Assess Health Care. 2001 Fall;17(4):467-78.
- Results publication: PubMed 10344701Estabrooks CA. The conceptual structure of research utilization. Res Nurs Health. 1999 Jun;22(3):203-16. doi: 10.1002/(sici)1098-240x(199906)22:33.0.co;2-9.
- Results publication: PubMed 20238311Flodgren G, Deane K, Dickinson HO, Kirk S, Alberti H, Beyer FR, Brown JG, Penney TL, Summerbell CD, Eccles MP. Interventions to change the behaviour of health professionals and the organisation of care to promote weight reduction in overweight and obese people. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD000984. doi: 10.1002/14651858.CD000984.pub2.
- Results publication: PubMed 12199878Forbes A, Griffiths P. Methodological strategies for the identification and synthesis of 'evidence' to support decision-making in relation to complex healthcare systems and practices. Nurs Inq. 2002 Sep;9(3):141-55. doi: 10.1046/j.1440-1800.2002.00146.x.
- Results publication: PubMed 27793150Mc Goldrick EL, Crawford T, Brown JA, Groom KM, Crowther CA. Identifying the barriers and enablers in the implementation of the New Zealand and Australian Antenatal Corticosteroid Clinical Practice Guidelines. BMC Health Serv Res. 2016 Oct 28;16(1):617. doi: 10.1186/s12913-016-1858-8.
- 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.
TERESA MORENO CASBAS, DOCTOR study director
Instituto de Salud Carlos III
ESTHER GONZALEZ MARIA, DOCTOR study chair
Instituto de Salud Carlos III
ISABEL ORTS CORTÉS, DOCTOR study chair
UNIVERSIDAD DE ALICANTE
Questions about this trial
What is this clinical trial studying?
A study testing GRIP (Getting Research into Practice) model in people with Age Problem, run by Teresa Moreno Casbas.
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 6 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: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 15 month). The study lists 3 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 NCT03725774, which also lists 36 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 31 Oct 2018.