Type 2 Diabetes Mellitus (T2DM) Clinical Trial
Official title:
Group Medical Visits (GMVs) in Primary Care: An RCT of Group-Based Versus Individual Appointments to Reduce HbA1c in Older People
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.
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.
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