Integration of Chronic Disease Rehabilitation Services Into Primary Care (PR1MaC)
Primary Purpose
Cardiovascular Disease, Heart Failure, Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Support, management, educational, counselling, follow-up
Sponsored by
About this trial
This is an interventional supportive care trial for Cardiovascular Disease focused on measuring Chronic diseases, Primary care, Rehabilitation, Chronic Care Model, Patient centered medical home
Eligibility 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
Sites / Locations
- CSSS de Chicoutimi, Unité de médecine de famille
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Group A
Group B
Group C
Arm Description
Intervention group(n = 163)
Delayed intervention (n = 163)
No intervention group (n = 163)
Outcomes
Primary Outcome Measures
Evaluation of effects
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01319656
First Posted
March 21, 2011
Last Updated
September 27, 2021
Sponsor
Martin Fortin
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT01319656
Brief Title
Integration of Chronic Disease Rehabilitation Services Into Primary Care
Acronym
PR1MaC
Official Title
Adaptation, Implementation and Evaluation of an Intervention Involving the Integration of Chronic Disease Rehabilitation Services Into Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Martin Fortin
Collaborators
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
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Heart Failure, Chronic Obstructive Pulmonary Disease, Asthma, Diabetes
Keywords
Chronic diseases, Primary care, Rehabilitation, Chronic Care Model, Patient centered medical home
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
326 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Intervention group(n = 163)
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Delayed intervention (n = 163)
Arm Title
Group C
Arm Type
No Intervention
Arm Description
No intervention group (n = 163)
Intervention Type
Behavioral
Intervention Name(s)
Support, management, educational, counselling, follow-up
Other Intervention Name(s)
dietetics, respiratory therapy, smoking cessation, physical activity, Stress management, Psychosocial support, Drug compliance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of effects
Description
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
Time Frame
T1: Initial evaluation; T2: after three months; T3: one year after T1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Fortin, MD, M.Sc.
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
CSSS de Chicoutimi, Unité de médecine de famille
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
11816692
Citation
Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating evidence into action. Health Aff (Millwood). 2001 Nov-Dec;20(6):64-78. doi: 10.1377/hlthaff.20.6.64.
Results Reference
background
PubMed Identifier
16095434
Citation
Tsai AC, Morton SC, Mangione CM, Keeler EB. A meta-analysis of interventions to improve care for chronic illnesses. Am J Manag Care. 2005 Aug;11(8):478-88.
Results Reference
background
PubMed Identifier
18429737
Citation
Dennis SM, Zwar N, Griffiths R, Roland M, Hasan I, Powell Davies G, Harris M. Chronic disease management in primary care: from evidence to policy. Med J Aust. 2008 Apr 21;188(S8):S53-6. doi: 10.5694/j.1326-5377.2008.tb01745.x.
Results Reference
background
PubMed Identifier
12558376
Citation
Rothman AA, Wagner EH. Chronic illness management: what is the role of primary care? Ann Intern Med. 2003 Feb 4;138(3):256-61. doi: 10.7326/0003-4819-138-3-200302040-00034.
Results Reference
background
PubMed Identifier
20234224
Citation
Chreim S, Williams BE, Janz L, Dastmalchian A. Change agency in a primary health care context: the case of distributed leadership. Health Care Manage Rev. 2010 Apr-Jun;35(2):187-99. doi: 10.1097/HMR.0b013e3181c8b1f8.
Results Reference
background
PubMed Identifier
18474705
Citation
Hogg W, Lemelin J, Moroz I, Soto E, Russell G. Improving prevention in primary care: Evaluating the sustainability of outreach facilitation. Can Fam Physician. 2008 May;54(5):712-20. Erratum In: Can Fam Physician. 2008 Jun;54(6):851.
Results Reference
background
PubMed Identifier
16263889
Citation
Clark AM, Hartling L, Vandermeer B, McAlister FA. Meta-analysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med. 2005 Nov 1;143(9):659-72. doi: 10.7326/0003-4819-143-9-200511010-00010.
Results Reference
background
PubMed Identifier
18456040
Citation
Peytremann-Bridevaux I, Staeger P, Bridevaux PO, Ghali WA, Burnand B. Effectiveness of chronic obstructive pulmonary disease-management programs: systematic review and meta-analysis. Am J Med. 2008 May;121(5):433-443.e4. doi: 10.1016/j.amjmed.2008.02.009.
Results Reference
background
PubMed Identifier
12535399
Citation
Gibson PG, Powell H, Coughlan J, Wilson AJ, Abramson M, Haywood P, Bauman A, Hensley MJ, Walters EH. Self-management education and regular practitioner review for adults with asthma. Cochrane Database Syst Rev. 2003;(1):CD001117. doi: 10.1002/14651858.CD001117.
Results Reference
background
PubMed Identifier
14729296
Citation
Ellis SE, Speroff T, Dittus RS, Brown A, Pichert JW, Elasy TA. Diabetes patient education: a meta-analysis and meta-regression. Patient Educ Couns. 2004 Jan;52(1):97-105. doi: 10.1016/s0738-3991(03)00016-8.
Results Reference
background
PubMed Identifier
12854339
Citation
Gary TL, Genkinger JM, Guallar E, Peyrot M, Brancati FL. Meta-analysis of randomized educational and behavioral interventions in type 2 diabetes. Diabetes Educ. 2003 May-Jun;29(3):488-501. doi: 10.1177/014572170302900313.
Results Reference
background
PubMed Identifier
17636778
Citation
Smith SM, Allwright S, O'Dowd T. Effectiveness of shared care across the interface between primary and specialty care in chronic disease management. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004910. doi: 10.1002/14651858.CD004910.pub2.
Results Reference
background
PubMed Identifier
20057254
Citation
Oelke ND, Cunning L, Andrews K, Martin D, MacKay A, Kuschminder K, Congdon V. Organizing care across the continuum: primary care, specialty services, acute and long-term care. Healthc Q. 2009;13 Spec No:75-9. doi: 10.12927/hcq.2009.21102.
Results Reference
background
PubMed Identifier
20057258
Citation
Delon S, Mackinnon B; Alberta Health CDM Advisory Committee. Alberta's systems approach to chronic disease management and prevention utilizing the expanded chronic care model. Healthc Q. 2009;13 Spec No:98-104. doi: 10.12927/hcq.2009.21106.
Results Reference
background
PubMed Identifier
17622997
Citation
Walsh K, Duke J, Foureur M, Macdonald L. Designing an effective evaluation plan: a tool for understanding and planning evaluations for complex nursing contexts. Contemp Nurse. 2007 May-Jun;25(1-2):136-45. doi: 10.5172/conu.2007.25.1-2.136.
Results Reference
background
PubMed Identifier
17027221
Citation
Nolte S, Elsworth GR, Sinclair AJ, Osborne RH. The extent and breadth of benefits from participating in chronic disease self-management courses: a national patient-reported outcomes survey. Patient Educ Couns. 2007 Mar;65(3):351-60. doi: 10.1016/j.pec.2006.08.016. Epub 2006 Oct 5.
Results Reference
background
PubMed Identifier
31010425
Citation
Contant E, Loignon C, Bouhali T, Almirall J, Fortin M. A multidisciplinary self-management intervention among patients with multimorbidity and the impact of socioeconomic factors on results. BMC Fam Pract. 2019 Apr 22;20(1):53. doi: 10.1186/s12875-019-0943-6.
Results Reference
derived
PubMed Identifier
30626313
Citation
Fortin M, Chouinard MC, Diallo BB, Bouhali T. Integration of chronic disease prevention and management services into primary care (PR1MaC): findings from an embedded qualitative study. BMC Fam Pract. 2019 Jan 9;20(1):7. doi: 10.1186/s12875-018-0898-z.
Results Reference
derived
PubMed Identifier
28018871
Citation
Fortin M, Chouinard MC, Dubois MF, Belanger M, Almirall J, Bouhali T, Sasseville M. Integration of chronic disease prevention and management services into primary care: a pragmatic randomized controlled trial (PR1MaC). CMAJ Open. 2016 Oct 12;4(4):E588-E598. doi: 10.9778/cmajo.20160031. eCollection 2016 Oct-Dec.
Results Reference
derived
PubMed Identifier
23565674
Citation
Fortin M, Chouinard MC, Bouhali T, Dubois MF, Gagnon C, Belanger M. Evaluating the integration of chronic disease prevention and management services into primary health care. BMC Health Serv Res. 2013 Apr 8;13:132. doi: 10.1186/1472-6963-13-132.
Results Reference
derived
Links:
URL
http://www.usherbrooke.ca/crmcspl/en/
Description
CIHR Applied Research Chair - Health Services and Policy Research on Chronic Diseases in Primary Care
URL
http://www.santesaglac.gouv.qc.ca/
Description
Agence de la santé et des services sociaux du Saguenay-Lac-Saint-Jean
URL
http://www.usherbrooke.ca
Description
Université de Sherbrooke
URL
http://www.uqac.ca
Description
Université du Québec à Chicoutimi
Learn more about this trial
Integration of Chronic Disease Rehabilitation Services Into Primary Care
We'll reach out to this number within 24 hrs