Establish an Evaluation Scale for the Quality of Primary Care in Multi-professional Health Centres and Homes Integrating the Point of View of Patients in Complex Care Situations and Their Caregivers. (Qualsoprim_3)

The prevalence of multimorbid patients and complex care is increasing in France and elsewhere in the world. It concerns 60% of the over 65 years old. Comprehensive care, the involvement of the patient and his caregivers appear as the solutions for the management of these new care situations. The structures of multi-professional grouping, developing a coordinated exercise (GECO), appear as the privileged place to take care of these patients. These structures become the main place of exercise in France (improved working conditions for professionals, financial incentives, public policy, etc.); they have shown their ability to formulate patient care protocols, to produce coordinated exercise, to better involve the patient and caregivers in their care. The question of improving the quality of care arises. To date, there is no data on the subject apart from some evaluations mainly medico-economic. The patient's place in the evaluation showed his interest with the existence of a proven correlation between patient satisfaction in particular and his compliance and health outcomes.

Study Overview

• Status: Completed
• Conditions: Patients in Complex Situations
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

• Study Contact: Name: Jean-Yves Le Reste, Dr; Phone Number: +33 2 98 67 51 03; Email: lereste@univ-brest.fr
• Study Contact Backup: Name: Jérémy Derriennic, Dr; Phone Number: +33 2 98 67 51 03; Email: jeremy_derriennic@hotmail.com

Study Locations

• France
  • Bannalec, France, 29380
    • Maison de santé de Bannalec
  • Châteauneuf-du-Faou, France, 29520
    • Maison de santé de Châteauneuf-du-Faou
  • Coray, France, 29370
    • Maison de santé de Coray
  • Lanmeur, France, 29620
    • Pôle de santé de Lanmeur
  • Trébeurden, France, 22560
    • Maison de santé de Trébeurden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient followed in the primary care center and being in a complex care situation, benefiting from a multi-professional care

Description

Inclusion Criteria:

• Patients over 18 years of age, followed in primary care centers, able to participate, speaking and understanding French,
• Patient in a complex care situation, benefiting from a multi-professional management (at least two different professionals from the center including the general practitioner),
• No opposition from the patient.

Exclusion Criteria:

• Patient not in a complex care situation
• Patient followed only by the the exercise coordinated group general practitioner
• Refusal to participate
• Patients who have already participated in phase 2 of the Qualsoprim project
• Adults under legal protection or unable to express their consent
• Persons deprived of their liberty by a judicial or administrative decision

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability of questionnaire	The main objective of this phase of the protocol is to confirm on an independent sample the reliability of the primary care quality assessment questionnaire scales provided within the coordinated exercise groups from the point of view of patients in complex care situations, their caregivers and health professionals.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concurrent validity of questionnaire	Test the concurrent validity by comparison with EUROPEP questionnaire to verify that it does indeed measure the latent trait it is supposed to measure. The EUROPEP questionnaire is a 23-item validated and internationally standardized measure of patient evaluations of general practice care.	1 day
Anchor variables	Test anchor variables that can be used later to assess sensitivity to change (comparison of means test if the candidate variable is qualitative and Spearman correlation if it is quantitative).	1 day
Standardized scoring guide	To construct a standardized scoring guide if a satisfactory questionnaire is obtained.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2021
• Primary Completion (Actual): February 6, 2023
• Study Completion (Actual): February 6, 2023

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Caregivers; Multimorbidity; Exercise coordinated groups (GECO)
• Other Study ID Numbers: 29BRC21.0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of BrestUH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No