Integration of Chronic Disease Rehabilitation Services Into Primary Care (PR1MaC)

September 27, 2021 updated by: Martin Fortin

Adaptation, Implementation and Evaluation of an Intervention Involving the Integration of Chronic Disease Rehabilitation Services Into Primary Care

The aim of PR1MaC is to establish a clinical intervention that will adapt and permanently integrate rehabilitation services into primary care settings, which would be the reference point in the health care system for people with Chronic diseases (CD). More specifically, the intervention will aim to: (1) clinically operationalize the mechanisms and tools necessary for delivery of integrated CD services, promoting continuity of care in response to the needs expressed by stakeholders; (2) implement and deploy rehabilitation services adapted to the realities of various clinical primary care settings and develop tools to ensure the sustainability of interventions beyond the rehabilitation period; and (3) support clinical primary care teams in the acquisition and maintenance of evidence-based practices for the targeted CDs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Since 2001, professionals in the Saguenay-Lac-Saint-Jean (SLSJ) region in Quebec province, Canada, have been mobilized to deal with the challenges of CD management by the introduction of the SLSJ Trajectory of Integrated Rehabilitation Services for CD (Trajectoire des services de réadaptation intégrés pour MC du SLSJ), hereafter referred to as the "Trajectoire." This Trajectoire, deployed across the region, constitutes a solid network of rehabilitation services, due as much to the resources granted to it and its evidence-based approach as to the appreciation that patients and professionals within the regional health system have for it. The changes and new directions that have taken place in recent years suggest it is time to improve this Trajectoire by promoting greater integration with primary care services to improve accessibility, the complementarity of services and better post-rehabilitation continuity. The proposed intervention involves the adaptation and integration of rehabilitation services under the Trajectoire's leadership within primary care settings (FMG or medical clinics), so that collaborative work routines are developed and implemented directly at the main place of contact with health services for people with a CD. The intervention will be implemented at the CSSSs in Chicoutimi and Jonquière. This logic model was developed in collaboration with researchers, clinicians and decision-makers involved in this application and discussed at meetings for the preparation of this application. The model's first component (objective 1) will consist of a consultation with stakeholders (primary care professionals, Trajectoire professionals) by sharing information about the current range of services. In each area, the consultation will include a needs evaluation and a reflection on the Trajectoire's services that can be adapted for targeted clients. As each clinic where an intervention will be deployed has its own mode of operation and clientele characteristics, the clinical intervention will be specifically adapted to these considerations and prepared in collaboration with each clinical setting to ensure a range of services that meets the expressed needs.

The second component (objective 2) will be to implement and deploy a range of concerted interdisciplinary services adapted to the client services and professional resources already in place. Services that do not require specialized equipment or adapted premises (a gym, for example) can be integrated, including educational/teaching services (self-care, support to stop smoking, nutrition, etc.). In medical clinics currently not offering these services, the addition will be net, while in those that already rely on the services of nurse practitioners (FMG), the addition of these services will complement existing services. During this period, various mechanisms and clinical information sharing tools will be implemented jointly by professionals. The third component will be to implement a support mechanism and ongoing evaluation within the clinical setting to ensure harmonious integration. If necessary, training workshops will be provided to implement or maintain evidence-based practices and to plan longer-term follow-up of clientele and continuity of interventions.

The intervention: (a) will be educational in nature, patient-centred and based on the Trajectoire; (b) will last at least three months and involve at least three meetings; (c) may include meetings with small patient groups or the involvement of a close relative of the patient (spouse or primary caregiver); (d) will be carried out based on a referral from the primary care team according to defined criteria; (e) will allow an exchange with the primary care team and will be integrated into the primary care medical records; (f) will provide for a transfer of responsibility to the primary care team to ensure ongoing long-term follow-up.

Study Type

Interventional

Enrollment (Actual)

326

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • CSSS de Chicoutimi, Unité de médecine de famille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • present at least one of the following conditions: type 2 diabetes, CVD, heart failure, risk factors (smoking, obesity, hyperlipidemia, glucose intolerance, and metabolic syndrome), COPD or asthma.
  • have the potential for rehabilitation

Exclusion Criteria:

  • serious cognitive problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Intervention group(n = 163)
Behavioral: Support, management, educational, counselling, follow-up
The project offers a range of activities (educational, counselling, follow-up) by several professionals. The varied range of services is spread out over six months and may include individual or group meetings with professionals. Informational documents and follow-up tools are provided to patients based on their condition, to facilitate the acquisition and maintenance of knowledge, self-management, and changes in risk behaviour.
Other Names:
  • dietetics, respiratory therapy, smoking cessation, physical activity, Stress management, Psychosocial support, Drug compliance
Active Comparator: Group B
Delayed intervention (n = 163)
Behavioral: Support, management, educational, counselling, follow-up
The project offers a range of activities (educational, counselling, follow-up) by several professionals. The varied range of services is spread out over six months and may include individual or group meetings with professionals. Informational documents and follow-up tools are provided to patients based on their condition, to facilitate the acquisition and maintenance of knowledge, self-management, and changes in risk behaviour.
Other Names:
  • dietetics, respiratory therapy, smoking cessation, physical activity, Stress management, Psychosocial support, Drug compliance
No Intervention: Group C
No intervention group (n = 163)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of effects
Time Frame: T1: Initial evaluation; T2: after three months; T3: one year after T1

Short term:

  • Self-Efficacy Managing Chronic Disease scale: SEMCD
  • Health Education Impact questionnaire: heiQ

Medium term:

  • Risk factors
  • Functional health status/quality of life: SF12
  • Psychological well being: K6

Other:

  • Socio-demographic: SD
  • comorbidity
  • co-intervention (CI)

Visites:

  • 1:(week:- 2) : Group A and B: DBMA; SD; SF12; K6; SEMCD, heiQ
  • 2a:(week:0) : Group A, (week:12) for Group B: SEMCD, heiQ; CI
  • 2b, 2c: (weeks:4, 8) : Group A: CI
  • 3:(weeks:12) : Group A: SEMCD, heiQ; CI
  • 4:(weeks:52) : Group A: SF12, K6; SEMCD, heiQ; CI
T1: Initial evaluation; T2: after three months; T3: one year after T1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin Fortin

Collaborators

Pfizer
Fonds de la Recherche en Santé du Québec
Centre de santé et de services sociaux de Chicoutimi
Ministere de la Sante et des Services Sociaux
Centre de santé et de services sociaux de Jonquière

Investigators

  • Principal Investigator: Martin Fortin, MD, M.Sc., Université de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

March 21, 2011

First Submitted That Met QC Criteria

March 21, 2011

First Posted (Estimate)

March 22, 2011

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRSQ-24423

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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