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DiabetesRCMNCT01326130

Implementation of an Integrated Primary Care Network for Prevention and Management of Cardiometabolic Risks

A study testing Chronic care management 1-6 in people with Diabetes and Hypertension, run by Public Health Department, Montreal at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

CONTEXTE: L'Agence de la santé et des services sociaux de Montréal (ASSS) invited our research team to evaluate the implementation of an integrated and interdisciplinary primary care network for prevention and management of cardiometabolic risks (diabetes and hypertension) (PCR). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Hypertension
What is being tested?
Chronic care management 1-6
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,000 participants
Where
1 siteCanada
Study dates
Apr 2011to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diabetic adults with borderline fasting blood sugar or glucose intolerance or treated with diet only or treated with only one medication or treated with multiple medications but with Hb A1c ≤ 8%;
  • Adults with blood pressure in office ≥ 140/90 mm Hg (if diabetes present, BP ≥ 130/80 mm Hg)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Pierre Tousignant Tousignant, MD contact

514-528-2400 ext. 3569

ptousi@santepub-mtl.qc.ca

Canada1 site
  • Public Health Department

    Montreal, Quebec, H2L 1M3

    Pierre Tousignant, MD, 514-528-2400 ext. 3569, ptousi@santepub-mtl.qc.ca

    Pierre Tousignant, MD

Other trials in Canada

About this study

Official title: Implementation of an Integrated Primary Care Network for Prevention and Management of Cardiometabolic Risks (RCM)

CONTEXTE: L'Agence de la santé et des services sociaux de Montréal (ASSS) invited our research team to evaluate the implementation of an integrated and interdisciplinary primary care network for prevention and management of cardiometabolic risks (diabetes and hypertension) (PCR). The intervention is based on the Chronic Care Model and the development of an integrated services network. PCR is to be implemented in 6 territories of "Centre de santé et de services sociaux (CSSS)". A first application for funding was made to Fonds Pfizer-FRSQ-MSSS for an evaluation that has to be completed in the first 24 month after the beginning of the implementation. This application to the PHSI program at CIHR is complementary and will ensure an evaluation of the sustainability of PCR and of long term effects (40 months after the beginning of the implementation) for patients and for their primary care physicians.

In each CSSS, PCR plans for : 1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors of "Réseau local de services (RLS)" insuring clinical information transfer required for efficient patient management.

Read more

OBJECTIVES: 1-evaluate PCR effects according to territory, time and degree of exposure (specifically benefits to registered patients and support to participating primary care physicians); 2- identify the degree of implementation of PCR in each CSSS territory and the related contextual factors; 3- examine the relationship between the effects identified, the degree of implementation of PCR and the related contextual factors; 4- assess the impact of implementing PCR on the strengthening of RLS.

METHODS: The proposed evaluation will be done through a mixed design including two complementary strategies. Using a "quasi-experiment/before-after" design, the first strategy is a quantitative approach looking at the program effects and their variation between territories. This analysis will use data from the PCR clinical database (ex.: HbA1c, BP, lifestyle) and from patient questionnaire inquiring about care experience, utilization of services, chronic care follow-up, self-management and quality of life. Around 3000 patients will be enlisted. A primary care physician questionnaire will enquire about PCR effects on their practice. Using primarily a qualitative and a case study approach, each of the 6 territories being one case, the second strategy will identify the degree of implementation of PCR and the explanatory contextual factors. This analysis with use data obtained from semi-structured interviews with program managers. The results of this analysis will be summarized in a monograph for each territory. According to the type of indicator analyzed, objective 3 will be fulfilled using linear models or longitudinal multilevel models supplemented with an interpretive approach using the information from monographs and discussion groups. The impact of implementing PCR on RLS will be assessed through interviews with key informants.

RESULTS AND EXPECTED IMPACT: Our study will identify the effectiveness of PCR and contextual factors associated with successful implementation and sustainability of PCR. Detailed contextual information will allow application of our results to other environments that have similar context and to other chronic conditions that could benefit from an integrated services network.

KNOWLEDGE TRANSFER: Since decision makers, clinicians and researchers did and will take part in all phases of PRC evaluation (planning, data collection, analysis and interpretation), diffusion of information regarding the program is an integral part of the research process. In addition, results will be presented at local, regional, provincial and national conferences and published in reports and articles widely distributed. More specifically, a regional symposium will be organized to share evaluation results with all CSSS in the region (n=12) and with all our local and regional partners.

Being tested
Chronic care management 1-6
Keywords
Integrated care network, Chronic care model, Health services research
Medical subject headings
Diabetes Mellitus, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chronic care management 1-6Behavioural

    1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors insuring clinical information transfer required for efficient patient management.

Study groups in NCT01326130
Study groupRoleWhat they receive
Chronic care management 1Active comparatorContent of chronic care model implemented in territory 1 and level of implementation
Receives: Behavioral: Chronic care management 1-6
Chronic care management 2Active comparatorContent of chronic care model implemented in territory 2 and level of implementation
Receives: Behavioral: Chronic care management 1-6
Chronic care management 3Active comparatorContent of chronic care model implemented in territory 3 and level of implementation
Receives: Behavioral: Chronic care management 1-6
Chronic care management 4Active comparatorContent of chronic care model implemented in territory 4 and level of implementation
Receives: Behavioral: Chronic care management 1-6
Chronic care management 5Active comparatorContent of chronic care model implemented in territory 5 and level of implementation
Receives: Behavioral: Chronic care management 1-6
Chronic care management 6Active comparatorContent of chronic care model implemented in territory 6 and level of implementation
Receives: Behavioral: Chronic care management 1-6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diabetes and Hypertension control

    Biomedical indicators of diabetes (Hb A1c ≤7%) and hypertension (blood pressure ≤ 140/90) control

    Measured: 24 months after registration

Secondary outcomes (6)
  1. Effects on patient's behavior

    Life-style improvement (physical activity, nutrition, smoking)

    Measured: 24 months after registration

  2. Effects on patient's autonomy

    Self-care

    Measured: 24 months after registration

  3. Effects on patient's health

    Quality of live

    Measured: 24 months after registration

  4. Effects on follow-up of chronic diseases

    Chronic care management

    Measured: 24 months after registration

  5. Effects on process of care

    Indexes of continuity, accessibility, comprehensiveness and perceived quality of care

    Measured: 24 months after registration

  6. Effects on physician practice

    Physician perception regarding effects of program on patients, inter-professional collaboration, development of knowledge, management of diabetes and hypertension

    Measured: 24 months after registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionJun 2014 (estimated)
  4. Study completionJun 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01326130
Sponsor's protocol ID
RisqueCardioMetabolique
Other IDs
FRSQ 22425
Acronym
RCM
Status last verified
Mar 2011
First submitted
28 Mar 2011
Last updated
30 Mar 2011
Results posted
No
Data monitoring committee
No

Publications

  • Provost S, Pineault R, Tousignant P, Hamel M, Da Silva RB. Evaluation of the implementation of an integrated primary care network for prevention and management of cardiometabolic risk in Montreal. BMC Fam Pract. 2011 Nov 10;12:126. doi: 10.1186/1471-2296-12-126.

    PubMed 22074614

Questions about this trial

What is this clinical trial studying?

A study testing Chronic care management 1-6 in people with Diabetes and Hypertension, run by Public Health Department, Montreal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pierre Tousignant Tousignant, MD (514-528-2400 ext. 3569, ptousi@santepub-mtl.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diabetes and Hypertension control (time frame: 24 months after registration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01326130, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2011.

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