- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07543718
Group Medical Visits for Patients With Dyslipidemia (PARTAGE-D)
Improving Care Through Group Medical Visits for Patients With Dyslipidemia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The healthcare system is in crisis. On one hand, the population requires more healthcare services due to aging and the increasing prevalence of chronic diseases. On the other hand, proportionally fewer healthcare professionals are available to meet the demand. Ample evidence suggests that strengthening the primary healthcare system could improve the population's health, particularly among individuals with chronic diseases, including cardiovascular diseases. The introduction of group medical visits (GMVs) is one proposed innovation to revitalize primary healthcare. GMVs are a type of medical appointment offered to a group of patients with similar medical conditions, replacing the traditional one-on-one consultation format. During a GMV, patients can receive a health assessment, education about their condition, including the prevention of complications, as well as prescriptions, lab test requests, or referrals to other healthcare professionals. GMVs have been integrated into primary healthcare systems in other countries (primarily to promote healthy lifestyle modifications) and are associated with clinically significant improvements in patient behaviors and health outcomes. Other studies have also shown that GMVs improve access to primary healthcare, reduce emergency department visits, and enhance quality of life, self-efficacy, and patient satisfaction with care. However, most studies assessing the effectiveness of GMVs focused on patients with diabetes, meaning there is little information on the impact of GMVs on patients with other conditions predisposing to cardiovascular diseases. However, several barriers to implementing GMVs have been identified, including uncertainty about remuneration for the intervention. The government of New Brunswick recently approved a billing code allowing family physicians to be compensated for providing GMVs to patients with specific conditions, including dyslipidemia - which is at the origin of most cases of cardiovascular diseases, and which can be effectively managed with lifestyle interventions. Nevertheless, this code has seen little to no use due to uncertainty surrounding how best to implement GMVs. The main objective is to assess the implementation of GMVs for patients with dyslipidemia in a NB-based primary healthcare clinic serving over 15,000 patients. This is meant to prepare the ground for a large trial.
It is estimated that >4,000 patients at the study clinic have dyslipidemia. A new series of VMGs will be launched every 3-6 months and 20 patients with dyslipidemia will be invited for each series. Simultaneously with the implementation of GMVs, a data collection process will take place to evaluate the quality of implementation using the RE-AIM framework. Through this process, Reach will be represented by the proportion of invited patients who participate in GMVs. Additionally, sociodemographic data from the clinics' electronic medical record (EMR) system will be used to assess whether participating patients are representative of all eligible patients. Effectiveness will be assessed by administering pre- and post-GMV questionnaires to measure changes in patient knowledge, self-efficacy, behavioral change intentions, and actual behaviors (using surveys from the Canadian Health Measures Survey by Statistics Canada). Effectiveness will also be assessed by comparing the clinical outcomes (i.e., lipids, hospitalisation for cardiovascular conditions) of the patients recruited with those of matched controls identified through the EMR. Adoption will be assessed as the proportion of eligible patients invited to GMVs by their primary care providers. Implementation will be evaluated through a modified interactive assessment grid to evaluate which key elements of the initiative were delivered as planned. All challenges encountered and any adaptations made to the implementation plan will also be considered as part of the implementation assessement. Maintenance: physicians and clinic managers will be surveyed about their willingness to continue offering GMVs for patients with dyslipidemia. Additionally, the number of GMVs delivered through every six month period will be monitored to track variations in service delivery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mathieu Belanger, PhD
- Phone Number: 5068632221
- Email: mathieu.f.belanger@usherbrooke.ca
Study Locations
-
-
New Brunswick
-
Dieppe, New Brunswick, Canada, E1A1G6
- Recruiting
- Unité de médecine familiale du Grand-Moncton
-
Contact:
- Mathieu Belanger, PhD
- Phone Number: 5068632221
- Email: mathieu.f.belanger@usherbrooke.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of dyslipidemia according to the guidelines of the Canadian Cardiovascular Society, i.e., at a minimum: an intermediate cardiovascular risk according to the Framingham Risk Score (10-19.9%) WITH LDL-C ≥ 3.5 mmol/L or non-HDL-C ≥ 4.2 mmol/L or ApoB ≥ 1.05 g/L
Exclusion Criteria:
Patients unable to participate in GMV sessions or to provide informed consent
- Patients with a mental health condition likely to limit their ability to benefit from GMV sessions and discussions (Examples: severe dementia or an acute psychiatric decompensation occurring within the past six months)
- A diagnosis of terminal illness or a life expectancy of less than 12 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
The intervention consists of regular care supplemented by a series of group medical visits (GMVs).
Each series of GMVs will last 9-12 months and will include eight sessions of 90-120 minutes covering topics related to lifestyle medicine within the context of dyslipidemia management.
These sessions will be offered to groups of 8 to 12 patients and delivered by a mix of family physicians, dietitians, kinesiologists, and psychologists, all trained to deliver GMVs.
Each session will begin with a revision of the goals established in the previous session, followed by a didactic component including demonstrations, questioning, and experiential activities.
Emphasis will be placed on health self management and on developing realistic, specific, and observable personal goals.
The sessions will include opportunities for social interaction among participants and will offer opportunities for brief one on one consultations patients and health professionals if needed.
|
Group medical visits are designed to improve knowledge of participants and promote self-management.
|
|
No Intervention: Usual care group
Participants in the usual-care group will have access to their regular follow-up with their primary care providers.
They will also have the option to take part in the GMVs after the project's final evaluation period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lipid profile
Time Frame: 12 months
|
Low-Density Lipoprotein; High-Density Lipoprotein; Total cholesterol; Triglycerides
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment proportion
Time Frame: 12 months
|
Proportion of patients invited to participate in GMVs who actually take part;
|
12 months
|
|
Representativeness of eligible patients
Time Frame: 12 months
|
Comparision of sociodemographic data among patients recruited and those representative of the target population
|
12 months
|
|
Attitudes of health professionals towards GMVs
Time Frame: 12 months
|
Health professionnals perceptions related to GMVs and to their ability to deliver GMVs.
This is assessed through 10 items asking professionals to rate their level of confidence on a 0 to 100% scale raled to their: motivation to recommend GMVs; likelihood to recommend; confidence in discussing it with patients; confidence it will improve patients' knowledge; confidence it will provide appropriate care; confidence it will improve behaviours; confidence it will improve lipid profile; confidence it will improve primary care access; confidence it will reduce needs for individual appointments; confidence it will reduce risk of developing complications.
|
12 months
|
|
Frequency of access to healthcare
Time Frame: 12 months
|
Patients patterns of primary care and emergency health service utilization will be described using data from electronic medical records.
This will be summarized as the number of individual primary care and emergency visits per year.
|
12 months
|
|
Patients' self-efficacy
Time Frame: 12 months
|
Patient sense of self-efficacy; confidence in their ability to manage their health condition.
|
12 months
|
|
Patients' stage of behaviour change
Time Frame: 12 months
|
Self reported stage of behaviour change in accordance with Prochaska and DiClemente's Transtheoretical Model.
One question asks participants to identify their stage of change regarding their eating habits and one question asks participants to identify their stage of change regarding their exercise habits.
|
12 months
|
|
Patients' physical activity level
Time Frame: 12 months
|
Physical activity is assessed with the short form (7 questions) of the International Physical Activity Questionnaire (IPAQ)
|
12 months
|
|
Patients' eating habits
Time Frame: 12 months
|
Eating behaviours are assessed with the Mini-EAT (Eating Assessment Tool), which is a 9 item questionnaire that assesses frequency of consumption of: fruits, vegetables, legumes, fish, whole grains, regined grains, low-fat dairy, high-fat dairy, and sweets.
|
12 months
|
|
Proportion invited
Time Frame: 24 months
|
Proportion of eligible patients invited to participate in GMVs who receive such an invitation from their primary care providers
|
24 months
|
|
Offer of GMVs
Time Frame: 24 months
|
Proportion of primary care providers who offer their patients to participate in GMVs.
|
24 months
|
|
Implementation fidelity
Time Frame: 24 months
|
Description of whether the intervention components were delivered as planned and of adjustments made to address challenges encountered.
|
24 months
|
|
Plans to maintain GMVs
Time Frame: 24 months
|
Description of intentions to continue offering GMVs along with description of the infrastructure and resources dedicated to sustain the delivery of GMVs.
This documents steps taken to incorporate the intervention into core organisational standard practices rather than treating it as a temporary project, if applicable.
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIHR550827
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Dyslipidemias
-
IlDong Pharmaceutical Co LtdCompletedMixed DyslipidemiasKorea, Republic of
-
Orient Pharma Co., Ltd.CompletedPrimary Hypercholesterolemia | Mixed DyslipidemiasTaiwan, Australia, New Zealand
-
Bisirna Therapeutics (Suzhou) Co., Ltd.Not yet recruiting
-
Shandong Suncadia Medicine Co., Ltd.Not yet recruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruiting
-
U.G.A. NutraceuticalsNot yet recruiting
-
Shandong Suncadia Medicine Co., Ltd.RecruitingHyperlipidemiasChina
-
NUR International UniversityCompletedDyslipidaemiaPakistan
-
Riphah International UniversityCompleted
-
Shenzhen Salubris Pharmaceuticals Co., Ltd.Salubris (Chengdu) Biotechnology Co., Ltd.CompletedHyperlipidemiasChina
Clinical Trials on Group medical visits
-
University of Southern CaliforniaTerminatedOveractive Bladder | Urge Incontinence | Urinary UrgencyUnited States
-
University of ManitobaRecruitingMental Health Care | Pilot Study | Anxiety and DepressionCanada
-
University of British ColumbiaYMCA; Vancouver Foundation; Mood Disorders Association of BCUnknownMajor Depressive Disorder | Bipolar, DepressionCanada
-
VA Office of Research and DevelopmentCompleted
-
MaineHealthEnrolling by invitation
-
Brigham and Women's HospitalRecruitingMusculoskeletal Pain | Chronic PainUnited States
-
Boston Medical CenterBoston University; National Institute of Diabetes and Digestive and Kidney... and other collaboratorsCompleted
-
Massachusetts General HospitalAmerican Heart AssociationRecruitingStroke | Hypertension | Implementation Research | Home Blood Pressure MonitoringUnited States
-
University of California, San FranciscoNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingChronic PainUnited States
-
University of California, San FranciscoNational Institute on Minority Health and Health Disparities (NIMHD)Completed