Clinical trial NCT02002143: GMVs in Primary Care: An RCT of Group-Based Versus Individual Appointments to Reduce HbA1c in Older People
Official title: Group Medical Visits (GMVs) in Primary Care: An RCT of Group-Based Versus Individual Appointments to Reduce HbA1c in Older People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Diabetes
Older People
Seniors
Group Appointments
Group Medical Visits
Shared Appointments
Quality of Life
Physical Activity
Health care Utilization
Depression
Anxiety
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Ministry of Health, British Columbia
First posted: 2013-12-05
Enrollment: 128
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

A recent Systematic Review of Group Appointments in T2DM performed by two current Co-Investigators (HOUSDEN, DAWES) highlighted the need for a Canadian Primary Care RCT that would extend previous research from Italy. The extension of research by this study is to have a Primary Care physician lead Group Appointments and for the RCT to include exclusively men and women aged 65 years and older.

The clinical and societal importance of T2DM in older people is not disputed. 'Diabetes mellitus is a serious condition with potentially devastating complications that affects all age groups worldwide'.

Diabetes epidemiology was reviewed in the 2013 Canadian Diabetes Practice Guidelines and Public Health Agency of Canada's 'Diabetes in Facts \& Figures'. To make this literature 'critical' the investigators will focus on 1) the accelerating rate of diagnosis of type 2 diabetes in older people; 2) the challenge of delivering quality diabetes care affordably in a traditional one-to-one primary care encounter 3) the equipoise that results from international evidence for testing GAs to improve patient self-management in the absence of Canadian Primary Care research in this field; 4) a brief review of the validity and limitations of HbA1C as a measure of T2DM self-management; and 5) the theoretical framework underpinning their Group Appointment intervention.

From the 2013 Canadian Clinical Practice Guidelines for Diabetes, as of 2009, 6.8% of Canadians (2.4 million people) had the condition. This represented a 230% increase compared to prevalence estimates 11 years earlier. A decade from now, an additional 1.3 million Canadians are expected to have T2DM. Diabetes and its complications increase costs and service pressures on Canada's publicly funded healthcare system. People with diabetes were three times more likely to require hospital admission in the preceding year with longer lengths of stay.

Good metabolic control of diabetes prevents complications. This requires lifestyle and behavioural modification. In Canada, the usual clinical care for diabetes is via individual patient consultations combined with 'ad hoc' educational advice during a family practice appointment or referral to an educational support program, if available. Although traditional primary care delivery addresses clinical problems, it fails to embrace the principles of behaviour change (compliance/ adherence) that are an essential part of chronic disease management.

The Canadian Practice Guidelines for T2DM call for psychological support, exercise promotion and nutritional advice. Traditional one-to-one clinical encounters in a fee-for-service setting do not encourage such coordinated care. There is a call to improve the scope of diabetes care currently offered in Canada. The quote 'if you keep doing what you've always done, you'll keep getting what you've always got' is relevant in this setting.

Traditional one-to-one clinical encounters will always have a place in health service delivery.

However, given the common needs across patients and the burgeoning costs to treat those with T2DM - the investigators address the question, 'Is there a more effective way to encourage successful patient self-management for older people with T2DM.

Two major resources on Group Appointments relate to various medical settings (i.e., not primary care alone). The 'Bible' of Group Appointments is Dr. Edward Noffsinger's 500-page book Running Group Visits in Your Practice (2009). He describes two main types of GAs -not limited to the primary care setting. A second foundational source for Canadians in particular, is The Group Medical Appointment Manual (First Edition 2007) published by the Northern Health Authority in British Columbia (developed after a visit by Dr. Noffsinger).

In clinical trials, the most compelling data for Group Appointments providing superior control of HemoglobinAA1C come from Drs. Trento and Porta, University of Turin, Italy. Patients who attended structured Group Appointments decreased their HbA1C by 0.9% (Effect size 0.56) compared with control group counterparts. There are a number of differences between these studies and what the investigators propose. First, studies in Turin and around Italy took place in 'hospital-based clinics', not regular primary care settings. Second, participants in the Turin studies were 64years, on average -younger than in our proposed study. Third, Turin studies did not include a generic quality of life measure (e.g. EQ-5D) and did not estimate health utilities. Fourth, health economic implications cannot be extrapolated from the Italian to the Canadian health system.

Considering all published RCTs, HOUSDEN and DAWES (co-investigators) found a significant 0.46% reduction in HbA1C across 10 RCTs that met their inclusion criteria. However, in a 12- month US Veteran Affairs Medical Centre trial, GA patients had only a 0.3% improvement over patients randomized to individual care (effect size 0.21). Other than study duration, the approach between the US and University of Turin studies appeared similar.

The aforementioned HOUSDEN and DAWES' systematic review highlighted that no RCT in the Primary Care setting examined Group Appointments as a vehicle to improve patient management as measured by HbAIC or another clinical measure. Previous published papers describing T2DM Group Appointments in the Primary Care setting focused on patient satisfaction and physician perception.

Such research provides valuable insight into barriers and facilitators to Group Appointments. However, no studies answered the question 'Do Primary Care-led Group Appointments improve metabolic control in diabetes?' HOUSDEN reported that duration of Group Appointments (i.e., 24-months) was significantly associated with outcome (approximately 0.25% lower HbA1C per year) but number of GAs was not. That informed the decision of the investigators to conduct an RCT across two years.

The rationale for Group Appointments builds on the social cognitive theory and transtheoretical stages of change at the individual level and brings to bear group dynamics that are unavailable in an Individual Appointment. The investigators emphasize that GAs combine three elements: 1) medical care; 2) disease-specific education (e.g. the significance of HbA1C, healthy food choices); and 3) life skills development such as goal setting, action planning, and problem-solving.

Patients who attend the Group Appointments are, by definition, in the 'post-intentional' phase (transtheoretical model) when they receive education. They know their diagnosis and recognize the need to do something about it. Thus, Group Appointments move beyond mere education of medical facts and are 'dynamic' in that the curriculum will focus on key challenges that surface in the process of turning goals into action.

Collectively, these components will help patients adopt healthier lifestyles (action) and also maintain these health behavior changes when they experience setbacks or failures (coping). This is consistent with the transtheoretical model and well as the health action process approach.

Note that the Group Appointments also reinforce self-efficacy and emotional support.

This contrasts with a traditional primary care individual appointment where 1) the clinician may or may not make time for counseling in a busy schedule or 2) gives generic verbal advice or referral without attention to specific nutrition or physical activity goals that may be most appropriate for the patient. The investigators propose elements for GAs that are consistent with best evidence and patient preference.

On the one hand, Group Appointments may at first seem a logical component of the diabetes continuum of care. A proportion of primary care practices, including those of our collaborators offer them. There is Provincial Government and British Columbia (BC) Medical Association (BCMA) (through the General Practice Services Committee) endorsement. Yet there remain no quantitative metabolic (HbA1C) or economic data (QALY/health care utilization) on the outcomes of Group Appointments specifically for elderly patients with T2DM in the Canadian Primary Care setting.

Therefore, this rigorous review of the literature suggests - there is as yet NO clear Canadian evidence that would convince policymakers to invest in Primary care-led Group Appointment for older people with T2DM unless further evidence was obtained to show they work. The investigators propose to address this gap. They will conduct measurements at 0 (baseline), 12 (mid-intervention) and 24 (end of-intervention), months. The investigators assess primary outcomes at 24 months but will follow-up to evaluate change at 36 months (12-month follow-up). In addition, the investigators will obtain three-monthly data for blood tests as part of routine patient management before each of the three-monthly Group Appointments (Intervention) and at individual patient appointments (usual care). At these three-monthly intervals a research assistant (RA#1) will administer the Health Resource Utilization (HUI3) collection instrument and the EQ-5D.

SIGNIFICANCE: Despite the clinical burden of T2DM among older Canadians, and the potential for the primary care system to deliver innovative multidisciplinary care and education, there have been no randomized controlled trials (RCTs) with that goal. The "GAP" study will apply conceptual clinical innovations in Group Appointments in the primary care setting to the health need of older adults with diabetes. There is a need for quantitative Canadian research in GAs broadly and the investigators target the substantial clinical problem - diabetes in older people. Do primary care led, Group Appointments reduce HbA1C, improve quality of life and do so at a reasonable price? If the answer is encouraging, there is potential to 'scale-up' the model via divisions, provinces and ultimately nationwide.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Patients' control (decreased levels) of HemoglobinA1C (clinical)
timeFrame: Changes from baseline at 24 months
Secondary outcomes:
measure: Resting systolic blood pressure (mmHg)) (clinical)
timeFrame: Changes from baseline at 12 months
measure: Resting systolic blood pressure (mmHg)) (clinical)
timeFrame: Changes from baseline at 24 months
measure: Resting systolic blood pressure (mmHg)) (clinical)
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: Resting diastolic blood pressure (mmHg)) (clinical)
timeFrame: Changes from baseline at 12 months
measure: Resting diastolic blood pressure (mmHg)) (clinical)
timeFrame: Changes from baseline at 24 months
measure: Resting diastolic blood pressure (mmHg)) (clinical)
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: Electrical activity of the heart (ECG) (clinical)
timeFrame: Changes from baseline at 12 months
measure: Electrical activity of the heart (ECG) (clinical)
timeFrame: Changes from baseline at 24 months
measure: Electrical activity of the heart (ECG) (clinical)
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: C-reactive protein (mg/L) (clinical)
timeFrame: Changes from baseline at 12 months
measure: C-reactive protein (mg/L) (clinical)
timeFrame: Changes from baseline at 24 months
measure: C-reactive protein (mg/L) (clinical)
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: plasma glucose (mmol/L) (clinical)
timeFrame: Changes from baseline at 12 months
measure: plasma glucose (mmol/L) (clinical)
timeFrame: Changes from baseline at 24 months
measure: plasma glucose (mmol/L) (clinical)
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: High-density lipoprotein - cholesterol (HDL-C; mmol/L) (clinical)
timeFrame: Changes from baseline at 12 months
measure: High-density lipoprotein - cholesterol (HDL-C; mmol/L) (clinical)
timeFrame: Changes from baseline at 24 months
measure: High-density lipoprotein - cholesterol (HDL-C; mmol/L) (clinical)
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: Fasting low-density lipoprotein (LDL; mmol/L) (clinical)
timeFrame: Changes from baseline at 12 months
measure: Fasting low-density lipoprotein (LDL; mmol/L) (clinical)
timeFrame: Changes from baseline at 24 months
measure: Fasting low-density lipoprotein (LDL; mmol/L) (clinical)
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: Triglycerides (mmol/L) (clinical)
timeFrame: Changes from baseline at 12 months
measure: Triglycerides (mmol/L) (clinical)
timeFrame: Changes from baseline at 24 months
measure: Triglycerides (mmol/L) (clinical)
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: Height (cm), weight (kg), waist & hip circumference (cm), fat and muscle mass (g) (clinical)
timeFrame: Changes from baseline at 12 months
measure: Height (cm), weight (kg), waist & hip circumference (cm), fat and muscle mass (g) (clinical)
timeFrame: Changes from baseline at 24 months
measure: Height (cm), weight (kg), waist & hip circumference (cm), fat and muscle mass (g) (clinical)
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: Quality of life (as measured by the health state utility values of EQ-5D3L questionnaire (patient-reported quality of life/economic))
timeFrame: Changes from baseline at 12 months
measure: Quality of life (as measured by the health state utility values of EQ-5D3L questionnaire (patient-reported quality of life/economic))
timeFrame: Changes from baseline at 24 months
measure: Quality of life (as measured by the health state utility values of EQ-5D3L questionnaire (patient-reported quality of life/economic))
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: Health Care Utilization
timeFrame: Changes from baseline at 12 months
measure: Health Care Utilization
timeFrame: Changes from baseline at 24 months
measure: Health Care Utilization
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: Anxiety
timeFrame: Changes from baseline at 12 months
measure: Anxiety
timeFrame: Changes from baseline at 24 months
measure: Anxiety
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: Depression
timeFrame: Changes from baseline at 12 months
measure: Depression
timeFrame: Changes from baseline at 24 months
measure: Depression
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: Satisfaction With Life Scale
timeFrame: Changes from baseline at 12 months
measure: Satisfaction With Life Scale
timeFrame: Changes from baseline at 24 months
measure: Satisfaction With Life Scale
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: Physical Activity (PASE)
timeFrame: Changes from baseline at 12 months
measure: Physical Activity (PASE)
timeFrame: Changes from baseline at 24 months
measure: Physical Activity (PASE)
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: Physical Activity (SenseWear)
timeFrame: Changes from baseline at 12 months
measure: Physical Activity (SenseWear)
timeFrame: Changes from baseline at 24 months
measure: Physical Activity (SenseWear)
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: Goal Setting and Action Planning
timeFrame: Baseline
measure: Goal Setting and Action Planning
timeFrame: Changes from baseline at 12 months
measure: Goal Setting and Action Planning
timeFrame: Changes from baseline at 24 months
measure: Goal Setting and Action Planning
timeFrame: Changes from baseline at 36 months
measure: Food Diary
timeFrame: Baseline
measure: Food Diary
timeFrame: Changes from baseline at 12 months
measure: Food Diary
timeFrame: Changes from baseline at 24 months
measure: Food Diary
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
measure: Patient Self-Management
timeFrame: Baseline
measure: Patient Self-Management
timeFrame: Changes from baseline at 12 months
measure: Patient Self-Management
timeFrame: Changes from baseline at 24 months
measure: Patient Self-Management
timeFrame: Changes from baseline at 36 months (1-year post-intervention)
Other outcomes:
Locations:
city: Abbotsford
country: Canada
facility: Gateway Clinic / Kent Place Clinic
state: British Columbia
city: Vancouver
country: Canada
facility: Centre for Hip Health and Mobility (Vancouver Coastal Health Research Institute/University of British Columbia)
state: British Columbia
Study officials:
affiliation: Centre for Hip Health and Mobility (University of British Columbia)
name: Karim Miran-Khan, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: UBC Department of Population & Public Health
name: Jennifer Davis, PhD
role: STUDY_DIRECTOR
affiliation: UBC Department of Family Practice
name: Martin Dawes, MB.BS, MD
role: STUDY_DIRECTOR
affiliation: UBC Psychology Department
name: Christiane Hoppmann, PhD
role: STUDY_DIRECTOR
affiliation: UBC Department of Physical Therapy
name: Teresa Liu-Ambrose, PhD, PT
role: STUDY_DIRECTOR
affiliation: UBC Department of Medicine (Geriatric Medicine)
name: Ken Madden, MD
role: STUDY_DIRECTOR
affiliation: UBC Faculty of Pharmaceutical Sciences
name: Carlo Marra, Pharm.D, PhD
role: STUDY_DIRECTOR
affiliation: UBC Department of Family Practice
name: Adriaan Windt, MD
role: STUDY_DIRECTOR
affiliation: UBC School of Nursing
name: Laura Housden, MN-NP(F)
role: STUDY_DIRECTOR
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