Group Medical Visits (GMVs) in Primary Care: An RCT of Group-Based Versus Individual Appointments to Reduce HbA1c in Older People
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 试验地点
- 4
- 主要终点
- Patients' control (decreased levels) of HemoglobinA1C (clinical)
研究概览
简要总结
Type 2 diabetes is a major problem of older people; its prevalence is greater than 20% in those aged over 65 years. Treatment such as medication, healthy nutritional choices & body weight management, as well as physical activity can reduce the impact of diabetes.
Older patients with type 2 diabetes can potentially benefit from Group Appointments, in which 8-12 patients share one appointment of about 60-120 minutes with a team of health professionals.
The team of investigators (3 people) will see the 'Group' 4 times/yr for two years. Their key measure of success will be control of glycosylated hemoglobin - HbA1C.
To address their primary and secondary research objectives the investigators will focus upon patients aged 65 years or older who have T2DM and who are being treated with oral hypoglycemic agents and diet, or diet alone.
The investigators will compare patients randomized to (A) eight Group Appointments over a 24 month period (i.e., 4 per year), led by a primary care physician [Intervention] with, (B) patients randomized to eight traditional one-to-one usual care appointments also provided by a primary care physician (Individual Appointment; [Control]). The investigators will compare (A) and (B) on selected clinical, patient-rated, and economic outcome measures.
SIGNIFICANCE: Seven Canadian provinces already have Group Appointment billing codes for physicians who lead Group Appointments. If the study's proposed health care innovation demonstrates benefits, it would be possible to 'roll out' / 'scale up' the model province- or nation-wide in Primary Care settings.
详细描述
Type 2 diabetes mellitus (T2DM) in older people is an undisputed health problem. More than 1.1 million people diagnosed with diabetes mellitus (DM) in Canada are over the age of 65 years. Rates of T2DM in older people are accelerating even when adjusted for age. Thus, total community prevalence is increasing based on the greater number of older people, an increased rate among those older people, and improved survival rates of people with DM.
The financial burden of DM to the Canadian health care system will approach $17 billion/year by 2020. Beyond the direct health burden of T2DM, the condition is an independent risk factor for falls and dementia -two of the 'geriatric giants'. T2DM is 'an important unresolved issue previously unacknowledged' and is considered to increase 'biological age' by 2 years in those aged over 70 years.
Although treatment can improve the clinical trajectory of older people with T2DM, many do not receive guideline care. Combinations of drug treatment, physical activity, nutrition advice and body weight management, reduce risk factors, delay onset of disease and lessen the rate of complications.
Group Appointments (GAs) - also called Group Medical Visits or Shared Medical Appointments may contribute to improved T2DM care for older people in the primary care setting. The innovation in this study is to undertake research in one study to determine 1) the clinical effectiveness; 2) quality of life; and 3) economic implications of Group Appointments for older people with T2DM.
'Group Appointments' exist in various forms. Their origin is often attributed to Noffsinger and also Ward. In a Group Appointment, one physician works with a nurse and a 'behaviourist' (described on page 12c) to care for eight to twelve patients during one 60-120 minute appointment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged ≥ 65 years old;
- •have at least a 12-month history of T2DM based on the Canadian Diabetes Guidelines;
- •be community-dwelling;
- •live within 30km of their GP clinic in Abbotsford, BC (Canada);
- •able to comply with scheduled visits, treatment plan, and other trial procedures;
- •read, write, and speak English;
- •acceptable auditory acuity to participate in the Group Appointments and visual acuity to participate in the research;
- •provide a personally signed and dated informed consent;
- •able to walk independently;
- •Inclusion will be based on medical history, vital signs, physical examination by study physicians, and written recommendation by family physician, indicating the patient's appropriateness to participate.
排除标准
- •using insulin to treat diabetes to increase the homogeneity of the sample;
- •at high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level (i.e., Class C of the American Heart Risk Stratification Criteria);
- •Mini-Mental State Examination (MMSE)[51] score of ≤ 24 at screening;
- •have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility;
- •taking medications that may negatively affect the ability to undertake a simple walking program safely (e.g. beta blockers);
- •planning to participate, or already enrolled in, a clinical drug trial concurrent to this study.
研究组 & 干预措施
Individual Appointments (IAs)
Participants randomly assigned to the "IAs" group will receive eight traditional 1-to-1 appointments, seeing their physician quarterly as per standard care in BC. They will be referred to ancillary services such as nutrition advice, counseling, and physical activity promotion according to 'usual care' practice. In addition, we will organize 4 1-hour social events for these participants annually. The 4 social events will be 1) a potluck lunch; 2) a movie night; 3) an event chosen by participants; and 4) a talent show. From our experience, these events enhance compliance to reporting and minimize dropouts. These events also serve to minimize 'socialization bias' that may otherwise potentially influence health measures including quality of life.
干预措施: Individual Appointments (IAs) (Behavioral)
Group Appointments (GAs)
Participants randomly assigned to the intervention group will participate in GAs of 8 patients for 1.5 hours, every 3 months for 2 years. The 3-member Care Team (MD, nurse, behaviorist) will attend each session. The nurse facilitates the session and curriculum. The MD responds to specific health questions. Patients may schedule time before or after to review their clinical results with the MD/nurse (e.g. HbAIC).
Key elements include 1) completed pre-appt questionnaires used to identify a patient's educational needs; 2) patients use goal setting and action plans to initiate and maintain healthy behaviors; 3) each class has a designated purpose and learning objectives; 4) sessional feedback, which is used to adapt the next class (3 months later) based on patient needs.
干预措施: Group Appointments (Behavioral)
结局指标
主要结局
Patients' control (decreased levels) of HemoglobinA1C (clinical)
时间窗: Changes from baseline at 24 months
The investigators will measure Hemoglobin A1C (%, primary outcome), utilizing the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
次要结局
- Resting systolic blood pressure (mmHg)) (clinical)(Changes from baseline at 36 months (1-year post-intervention))
- C-reactive protein (mg/L) (clinical)(Changes from baseline at 36 months (1-year post-intervention))
- Resting diastolic blood pressure (mmHg)) (clinical)(Changes from baseline at 36 months (1-year post-intervention))
- Fasting low-density lipoprotein (LDL; mmol/L) (clinical)(Changes from baseline at 36 months (1-year post-intervention))
- Electrical activity of the heart (ECG) (clinical)(Changes from baseline at 36 months (1-year post-intervention))
- plasma glucose (mmol/L) (clinical)(Changes from baseline at 36 months (1-year post-intervention))
- High-density lipoprotein - cholesterol (HDL-C; mmol/L) (clinical)(Changes from baseline at 36 months (1-year post-intervention))
- Triglycerides (mmol/L) (clinical)(Changes from baseline at 36 months (1-year post-intervention))
- Physical Activity (PASE)(Changes from baseline at 36 months (1-year post-intervention))
- Goal Setting and Action Planning(Changes from baseline at 36 months)
- Food Diary(Changes from baseline at 36 months (1-year post-intervention))
- Height (cm), weight (kg), waist & hip circumference (cm), fat and muscle mass (g) (clinical)(Changes from baseline at 36 months (1-year post-intervention))
- Quality of life (as measured by the health state utility values of EQ-5D3L questionnaire (patient-reported quality of life/economic))(Changes from baseline at 36 months (1-year post-intervention))
- Anxiety(Changes from baseline at 36 months (1-year post-intervention))
- Depression(Changes from baseline at 36 months (1-year post-intervention))
- Satisfaction With Life Scale(Changes from baseline at 36 months (1-year post-intervention))
- Health Care Utilization(Changes from baseline at 36 months (1-year post-intervention))
- Physical Activity (SenseWear)(Changes from baseline at 36 months (1-year post-intervention))
- Patient Self-Management(Changes from baseline at 36 months (1-year post-intervention))
研究者
Karim Miran-Khan
Principal Investigator
University of British Columbia