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OpenTrials
Completed

NCT Number: NCT05057520

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.

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.

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Key information

Conditions

Patients in Complex Situations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maison de santé de Bannalec, Bannalec, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

Completion of the questionnaire by the patient after consultation with the general practitioner

Primary outcomes

  1. Reliability of questionnaire

    Time frame: 1 day

    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.

Secondary outcomes

  1. Concurrent validity of questionnaire

    Time frame: 1 day

    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.

  2. Anchor variables

    Time frame: 1 day

    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).

  3. Standardized scoring guide

    Time frame: 1 day

    To construct a standardized scoring guide if a satisfactory questionnaire is obtained.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: Qualsoprim_3

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 27, 2021
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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