Unité de médecine familiale du Grand-Moncton
Dieppe, New Brunswick, E1A1G6, Canada
Location status: Recruiting
NCT Number: NCT07543718
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.
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Request Info40 year and older
All sexes
Interventional
Not applicable
Dieppe, New Brunswick, E1A1G6, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group medical visits are designed to improve knowledge of participants and promote self-management.
Time frame: 12 months
Low-Density Lipoprotein; High-Density Lipoprotein; Total cholesterol; Triglycerides
Time frame: 12 months
Proportion of patients invited to participate in GMVs who actually take part;
Time frame: 12 months
Comparision of sociodemographic data among patients recruited and those representative of the target population
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.
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.
Time frame: 12 months
Patient sense of self-efficacy; confidence in their ability to manage their health condition.
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.
Time frame: 12 months
Physical activity is assessed with the short form (7 questions) of the International Physical Activity Questionnaire (IPAQ)
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.
Time frame: 24 months
Proportion of eligible patients invited to participate in GMVs who receive such an invitation from their primary care providers
Time frame: 24 months
Proportion of primary care providers who offer their patients to participate in GMVs.
Time frame: 24 months
Description of whether the intervention components were delivered as planned and of adjustments made to address challenges encountered.
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.
Contact information is provided by the study sponsor or research team.
Université de Sherbrooke
Other
Improving Care Through Group Medical Visits for Patients With Dyslipidemia
Acronym: PARTAGE-D
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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