GMVs in Primary Care: An RCT of Group-Based Versus Individual Appointments to Reduce HbA1c in Older People

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.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

BEHAVIORAL

Group Appointments

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Ministry of Health, British Columbia

  collaborator OTHER_GOV

• University of British Columbia

  lead OTHER

Principal Investigators

• Karim Miran-Khan, MD, PhD, MBA · Centre for Hip Health and Mobility (University of British Columbia)

• Jennifer Davis, PhD · UBC Department of Population & Public Health

• Martin Dawes, MB.BS, MD · UBC Department of Family Practice

• Christiane Hoppmann, PhD · UBC Psychology Department

• Teresa Liu-Ambrose, PhD, PT · UBC Department of Physical Therapy

• Ken Madden, MD · UBC Department of Medicine (Geriatric Medicine)

• Carlo Marra, Pharm.D, PhD · UBC Faculty of Pharmaceutical Sciences

• Adriaan Windt, MD · UBC Department of Family Practice

• Laura Housden, MN-NP(F) · UBC School of Nursing

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2019-02-28

Completion

2020-02-29

Countries

• Canada

Study Locations