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Recruiting NCT07543718

Group Medical Visits for Patients With Dyslipidemia

No phase Interventional Dyslipidemias

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group medical visits.
Who it may be relevant to
Registry conditions: Dyslipidemias. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Improving Care Through Group Medical Visits for Patients With Dyslipidemia

Overview

Physicians' interventions to promote the improvement of lifestyle habits have been shown to be effective. However, such interventions remain underutilized due to barriers such as lack of time, confidence, and compensation. Group medical visits (GMVs) can help overcome several of these barriers and effectively improve clinical indicators as well as patients' quality of life. GMVs could also reduce pressure on the healthcare system by improving access to primary care through a more efficient use of resources. The literature suggests that GMVs can be effective in improving access to care and reducing disease complications for patients with several conditions and risk factors, but they have not been assessed specifically among patients with dyslipidemia, which is at the origin of most cases of cardiovascular diseases. In this context, GMVs will be implemented among 144 patients with dyslipidemia. The objective for this project is to evaluate implementation of GMVs. The implementation evaluation will follow the RE-AIM framework. These steps will position the research team to develop more complex and large-scale studies in lifestyle medicine. In the meantime, the project will contribute to improve access to primary care for the prevention of cardiovascular diseases.

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.

Interventions

  • Behavioral Group medical visits
    Group medical visits are designed to improve knowledge of participants and promote self-management.

Primary outcome measures

  • Lipid profile [Time frame: 12 months]
Secondary outcome measures (12)
  • Recruitment proportion [Time frame: 12 months]
  • Representativeness of eligible patients [Time frame: 12 months]
  • Attitudes of health professionals towards GMVs [Time frame: 12 months]
  • Frequency of access to healthcare [Time frame: 12 months]
  • Patients' self-efficacy [Time frame: 12 months]
  • Patients' stage of behaviour change [Time frame: 12 months]
  • Patients' physical activity level [Time frame: 12 months]
  • Patients' eating habits [Time frame: 12 months]
  • Proportion invited [Time frame: 24 months]
  • Offer of GMVs [Time frame: 24 months]
  • Implementation fidelity [Time frame: 24 months]
  • Plans to maintain GMVs [Time frame: 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Canada · 1 center
  • Unité de médecine familiale du Grand-Moncton — Dieppe

Identifiers

NCT: NCT07543718 · CIHR550827

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗