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

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ClinicalTrials.gov Identifier: NCT01319656
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : December 10, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Cardiovascular Disease Heart Failure Chronic Obstructive Pulmonary Disease Asthma Diabetes Behavioral: Support, management, educational, counselling, follow-up

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Adaptation, Implementation and Evaluation of an Intervention Involving the Integration of Chronic Disease Rehabilitation Services Into Primary Care
Study Start Date : February 2011
Primary Completion Date : July 2012
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: dietetics, respiratory therapy, smoking cessation, physical activity, Stress management, Psychosocial support, Drug compliance
No Intervention: Group C
No intervention group (n = 163)


Outcome Measures

Primary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319656


Locations
Canada, Quebec
CSSS de Chicoutimi, Unité de médecine de famille
Chicoutimi, Quebec, Canada, G7H 5H6
Sponsors and Collaborators
Martin Fortin
Pfizer
Fonds de la Recherche en Santé du Québec
Ministere de la Sante et des Services Sociaux
Centre de santé et de services sociaux de Chicoutimi
Centre de santé et de services sociaux de Jonquière
Université du Québec à Chicoutimi
Investigators
Principal Investigator: Martin Fortin, MD, M.Sc. Université de Sherbrooke
More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martin Fortin, Dr, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01319656     History of Changes
Other Study ID Numbers: FRSQ-24423
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013

Keywords provided by Martin Fortin, Université de Sherbrooke:
Chronic diseases
Primary care
Rehabilitation
Chronic Care Model
Patient centered medical home

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Cardiovascular Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Heart Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes