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

NCT04399616 | Not Yet Recruiting

• 1 other identifier: 4R19/006
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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). 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.

Conditions

Community Health Services

Keywords

Patient Safety; Quality of Healthcare; Information Technology

Outcome Measures

Primary Outcomes (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.

  1 year

Secondary Outcomes (5)

• Rate of admissions and visits to preventable hospital emergencies

  1 year

• Infections and sores

  1 year

• Quality of live in ATDOM patients

  1 year

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

  1 year

• Risk management in ATDOM patients

  1 year

Study Arms (2)

Experimental

EXPERIMENTAL

The 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

Other: Risk Map

No intervention

NO INTERVENTION

The patients in the control group will have in their medical records the usual records of the comprehensive geriatric assessment.

Interventions

Risk Map OTHER

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).

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients included in the primary care home care program

You may not qualify if:

• refusal of the patient to participate in the study

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Institut Català de la Salut: collaborator

Study Sites (1)

IDIAP Jordi Gol

Barcelona, 08007, Spain

Location

Related Publications (1)

• 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.

  PMID: 40150476 DERIVED

Study Officials

• Cristina Rey-Reñones, PhD

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Rey-Reñones, PhD

CONTACT

34977778515; crey.tgn.ics@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: May 22, 2020
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2 years
• Access Criteria: The data will be entered on the IDIAP J Gol institution platform

Locations

ES (1)