AzTrials
AzTrials

Community Health ServicesATDOM_SPNCT04399616

Map of Risks in Home Care From Primary Health Care, an Approach From Health Care Quality.

A study testing Risk Map in people with Community Health Services, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Background: Home health care is very complex. The registration of many disassembled information makes it difficult to interpret and does not allow the identification of critical areas for risk management. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Community Health Services
What is being tested?
Risk Map
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteSpain
Study dates
1 Jan 2025to 31 Dec 2025
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • patients included in the primary care home care program

Who cannot join

  • refusal of the patient to participate in the study

Trial locations and contacts

1 site in 1 country.

Cristina Rey-Reñones, PhD contact

34977778515 ext. 405

crey.tgn.ics@gencat.cat

Spain1 site
  • IDIAP Jordi Gol

    Barcelona, 08007

    Cristina Rey-Reñones, PhD, 977778515 ext. 405, crey.tgn.ics@gencat.cat

Other trials in Spain

About this study

Official title: Map of Risks in Home Care From Primary Health Care.

Background: Home health care is very complex. The registration of many disassembled information makes it difficult to interpret and does not allow the identification of critical areas for risk management.

Hypothesis / Research question: The availability of a risk map, with visual alerts to identify the critical areas, will facilitate the implementation of safe practices and improve the safety of patients included in the DOMicillary care program (ATDOM).

Read more

Objectives: To design and evaluate the effectiveness of the availability of a Visual Risks Map (MRV) in the computerized medical histories of ATDOM patients in the improvement of their safety and quality of life.(QL).

Methods: Once MRV is designed, the investigators will conduct a randomized clinical trial by conglomerates (Primary Care centers) to evaluate whether the fact of having this MRV (intervention) in the medical histories of ATDOM patients reduces avoidable income, falls and wounds and improves QL.

Analysis plan: Baseline description: socio-demographic characteristics, risk's levels in the different areas and other covariates in the control and intervention groups. Chi-square test to compare frequency of outcomes between control and intervention groups. Cox regression model to estimate time until the outcomes appear, adjusting for the different variables.

Expected results: The frequency of avoidable hospital admissions / emergencies' visits, falls and sores / infections will be significantly lower in the group of patients who have MRV in their clinical histories. Their qL wil be better.

Applicability and Relevance: It is a feasible and easy-to-implement project. It provides a practical utility for a lot of information that the investigators record and affects a key aspect of quality of care.

Read the detailed description

Design:1st phase: Visual Risk Map Design (MRV); 2nd Phase: Randomized clinical trial by conglomerates (Primary Care Centers).

Study population (indicate inclusion and exclusion criteria):

Patients included in the Home Care program (ATDOM) assigned to the Primary Care Centers in the territory who agree to participate in the study. The only exclusion criterion will be the patient's refusal to participate in the study

Sample size and sampling procedure:

The study will be conducted in 8 Centers; 4 will be randomly assigned to intervention and 4 to control. If approximately 80% of patients have had an admission in the previous year and the investigators intend that, with our intervention, this percentage drops to 70%, for a confidence of 95% (alpha error of 5%) and a statistical power of 80%, the investigators will need a sample of 231 patients and, if the investigators have a 15% loss, 272 patients per group (control and intervention). Each Center will be able to provide approximately 50 ATDOM patients. All patients will be invited to participate. They will be given a brief explanation of the study and invited to sign informed consent (in case the patient has a significant cognitive impairment, their guardian will sign the consent). All patients who meet inclusion criteria will be included.The basic morbidity and mortality characteristics of the sample will be compared with the MSIQ (health and quality monitoring) record of CatSalut (catalonia health services).

Dependent and independent variables (for quantitative studies):

Dependent variables: Percentage of patients with: hospital admissions / avoidable hospital emergency room visits (main variable) during the follow-up year sores falls. Death and final institutionalization will also be considered dependent variables In addition to the percentage of patients with admissions, the investigators will also consider the total number of preventable admissions and visits to hospital emergencies during the follow-up period. Another dependent variable will be the quality of life, which the investigators will measure using the EuroQol-5D index (see appendix 1), a record currently available at the e-cap clinical station.

Independent variables: The main independent variable is "intervention".

Intervention: The intervention consists of the availability in the patient's medical history of the visual risk map. Patients in the intervention group will have a risk map in their medical history and any professional who treats them will have immediate access to this map, which the investigators think will help them prioritize the implementation of the relevant practices. safe (in relation to the areas that appear in red) Patients in the control group will have in their clinical histories the usual records of comprehensive geriatric assessment

Risk areas: Other independent variables will be the risk areas: Patient identification, Functional autonomy and quality of life, Caregiver, Management and safe use of medications, Risk of falls, Risk of pressure injuries and ulcers, Control of symptoms, Risk of infection associated with health care, Values and beliefs of the patient and the family, Social risk, Unplanned hospital admissions / proactive follow-up, Continuity of care 7 days X 24 hours , Transfers (between levels of care), Security culture and Nursing work environment.

During the first stage of the project, the 15 variables (indicators) corresponding to the aforementioned Risk Areas (RAs) will be created based on the integration of one or more variables. the investigators detail all the "primary" variables that will be considered for inclusion in the 15 indicators ("secondary" variables) corresponding to the 15 RAs, which will generate 1 synthetic indicator of the overall risk of the patient. The selection of the variables to be included was made based on the bibliographic search; their final inclusion and the relative contribution of each will depend on the consensus among the members of the interdisciplinary team of professionals (doctors, nurses, social workers) experts in ATDOM. For the weighting (contribution of each of the variables to the final indicator) will be taken into account on the one hand the magnitude / severity of the problem measured by the variable and on the other the existence of feasible interventions (safe practices) that have proven its effectiveness in improving it. The same team will also decide the cut points; that is, from which values of the new variables / indicators (operated from the weighted "primary" variables) is it considered moderate risk and when it goes to high risk. For this recoding and fusion of primary variables will have the support of a mathematical expert and the professionals of the Technologies of the Information and the Communication (TIC) will be the commissions.

Most of the data will be collected from the records in the e-cap (primary care clinical station): socio-demographic variables, scores at different scales, diagnostic codes. Other sources of information will be direct observation, interviews with patients and caregivers, exchange of information with other professionals involved (social services, professionals from other care devices ...).

Once the first phase of the study has been completed with the "construction" of the 15 variables corresponding to the risk areas, the investigators will make a descriptive analysis: the investigators will determine the mean and standard deviation for quantitative variables and frequencies (percentages) for qualitative ones. Based on the categorization of risk areas, the investigators will analyze the distribution of these categories (low, moderate or high risk) for each of the 15 RAs.

The investigators will do a baseline comparative analysis (using Chi-square test and Student's t, as the investigators compare qualitative or quantitative variables) between control group and intervention to check that there are no significant differences between groups.

Finally, the investigators will compare the outcome variables (outcomes) between groups using the chi-square test and the investigators will also do a multivariate analysis (Cox regression) introducing in the model adjustment variables: socio-demographic, risk areas and covariates mentioned above, and considering the time to the event of the outcome variables: admission, fall, sore or infection, institutionalization, and success. For the variable quality of life the investigators will compare the scores (averages and percentiles) of the scale between control group and intervention and also at the beginning and end of the intervention.

Being tested
Risk Map
Keywords
Patient Safety, Quality of Healthcare, Information Technology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Risk MapOther

    The tool we test in this project (the visual hazard map) aims to enable the practitioner to quickly identify critical areas for systematically implementing relevant safe practices (appropriate for each situation).

Study groups in NCT04399616
Study groupRoleWhat they receive
ExperimentalExperimentalThe intervention consists of the availability in the patient's medical history of the visual risk map. The patients in the intervention group will have a risk map in their medical history similar to the one presented in image (annex 2), and any care provider will have immediate access to this map which we think will help them to prioritize the implementation of the relevant practices. safe (in relation to the areas that appear in red). Areas of risk: Other independent variables will be the areas of risk: * Identification of the patient * Functional autonomy and quality of life * Caregiver * Safe management and use of medicines * Risk of falls * Risk of injuries and pressure ulcers * Symptom control * Risk of infection associated with health care * Patient and family values and beliefs * Social risk * Unplanned hospital admissions / proactive monitoring * Continuity of care 7X24 h * Transfers (between care levels) * Safety culture * Nursing work environment
Receives: Other: Risk Map
No interventionNo interventionThe patients in the control group will have in their medical records the usual records of the comprehensive geriatric assessment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modification of the number of visits to hospital centers, emergency consultations, falls, sores and infections of the study participants.

    Data will be collected in relation to the number of hospital visits and emergency visits to calculate avoidable visits. Events such as falls, the presence of sores and / or infections of the study participants will be compiled, taking into account their inclusion in the intervention group or control group to which they have been assigned. The data will be extracted from the clinical history (eCAP) according to the corresponding diagnosis.

    Measured: 1 year

Secondary outcomes (5)
  1. Rate of admissions and visits to preventable hospital emergencies

    Calculation of the rate of preventable hospital admissions and hospital visits in patients included in the ATDOM program. The number of visits to hospital centers and the number of visits to the emergency services as recorded in the medical record (eCAP) will be recorded.

    Measured: 1 year

  2. Infections and sores

    Frequency of infections and / or sores in patients included in the ATDOM program according to their inclusion in the control or intervention group. The corresponding diagnosis will be taken into account according to the medical record (eCAP).

    Measured: 1 year

  3. Quality of live in ATDOM patients

    Modification in the quality of life in the patients included in the ATDOM program according to their inclusion in the intervention or control group. Quality of life will be assessed according to the EuroQol-5D index (validated questionnaire)

    Measured: 1 year

  4. Sores, falls, hospital admissions, final institutionalization and death.

    Register of sores, falls, hospital admissions, institutionalization and registered deaths of the participants according to intervention or control group. The data will be collected according to registration in the clinical history (eCAP) through corresponding diagnoses.

    Measured: 1 year

  5. Risk management in ATDOM patients

    Changes in risk management in patients with ATDOM through the implementation of safe practices based on the rapid identification and prioritization of critical areas through a visual risk map. For the evaluation of this indicator, the implementation of nursing care plans will be quantified. The implementation of nursing care plans orients towards prevention measures and improving the quality of care. Nursing care plans are a tool available in the medical record (eCAP) from which preventive activities and care based on clinical evidence can be established.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2020
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04399616
Sponsor's protocol ID
4R19/006
Acronym
ATDOM_SP
Status last verified
Feb 2024
First submitted
24 Mar 2020
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: not yet decided as future studies are being considered and may be considered

Publications

  • Hernandez-Vidal N, Pujol-Vidal M, Mengibar-Garcia Y, Ayala-Villuendas D, Contel-Segura JC, Martinez-Torres S, Bordas A, Oriol-Colominas E, Martin-Vergara N, Martin-Lujan F, Astier-Pena MP, Gens-Barbera M. Design, Implementation, and Evaluation of Healthcare Visual Map Tool for Health Workers to Improve Quality of Life of Home Care Patients: Study Protocol. Healthcare (Basel). 2025 Mar 13;13(6):626. doi: 10.3390/healthcare13060626.

    PubMed 40150476

Questions about this trial

What is this clinical trial studying?

A study testing Risk Map in people with Community Health Services, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina 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 1 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 8 May 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?

Contact Cristina Rey-Reñones, PhD (34977778515 ext. 405, crey.tgn.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modification of the number of visits to hospital centers, emergency consultations, falls, sores and infections of the study participants. (time frame: 1 year). 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 NCT04399616, which also lists 1 linked publication.

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 8 May 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in