Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes

Background: Although efforts by VA providers and researchers have improved diabetes care
quality for Veterans, individuals with persistent poorly-controlled diabetes mellitus (type
1 or type 2 diabetes with hemoglobin A1c >9.0% for > 1 year despite receipt of medical care)
have proven refractory to these widespread improvements, and remain at high risk for
complications and accrued costs. Prior research has illustrated that medication regimen
complexity, suboptimal self-care, and comorbid depressive symptoms interact to perpetuate
suboptimal control among individuals with PPDM. Current models of clinic-based diabetes care
do not meet these Veterans' needs. Without the implementation of care delivery strategies
that target this population's unique barriers to improved diabetes control, these Veterans
will continue to be left behind by progress in diabetes management throughout VA, and will
remain at high risk for complications and high costs. We propose using existing local Home
Telehealth services to implement Advanced Comprehensive Diabetes Care, a patient-centered,
evidence-based intervention combining medication management, self-care behavior support, and
depressive symptom management to Veterans with PPDM.

Objectives: The specific aims of this RRP are to: 1) evaluate the effectiveness of the
Advanced Comprehensive Diabetes Care among Veterans with persistent poorly-controlled
diabetes; 2) utilize a mixed method formative evaluation to assess our main implementation
strategy, the use of existing Home Telehealth services to administer the intervention; and
3) generate data we will use to refine local intervention implementation and inform the
development of an SDP proposal evaluating broader implementation of the Advanced
Comprehensive Diabetes Care intervention.

Methods: We propose a pilot Effectiveness-Implementation Hybrid trial to study the Advanced
Comprehensive Diabetes Care intervention in Veterans with persistent poorly-controlled
diabetes. After baseline evaluation, 50 Veterans will be randomly assigned into intervention
(n = 25) or control groups (n = 25). Veterans randomized to the intervention will be
enrolled in the Home Telehealth program at Durham VAMC and will receive the study
intervention (telehealth-based medication management, self-care behavior support, and
depressive symptom management) for 6 months. Intervention-group Veterans with no depression
on baseline assessment will not initially receive the depressive symptom management
component, but will be monitored for new symptoms throughout the study. Veterans randomized
to the control arm will receive diabetes educational materials and management per their
primary provider. The primary effectiveness outcome for this study will be hemoglobin A1c.
Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported
medication adherence, and depressive symptoms. This RRP will also include a mixed method
formative evaluation to qualitatively and quantitatively assess patient-level,
provider-level, and organizational barriers and facilitators influencing intervention
implementation. Formative evaluation data will be analyzed during the study to consider
whether adjustments to the intervention or its implementation may be indicated, and findings
will also be used to inform future implementation efforts.

Inclusion Criteria:

- Veterans with type 2 diabetes managed for > 1 year at an eligible site (Durham,
Raleigh, Greenville, or Morehead City) will be eligible for enrollment.

- We will identify Veterans with PPDM (defined as the presence of at least 2 A1c values
of > 9.0% during the past year with no readings of < 9.0% despite ongoing medical
care) by reviewing electronic medical records and soliciting referrals from primary
physicians.

Exclusion Criteria:

- Exclusion criteria will include lack of telephone access or severe hearing/ speech
impairment that would limit:

- telephone interaction

- metastatic cancer

- active psychosis documented in medical record

- active alcohol or substance abuse

- diagnosis of dementia

- known pregnancy (patients becoming pregnant during the study will be withdrawn
and referred to appropriate services)

- documented seizure history

- documented history of severe complications of hypoglycemia (such as coma or
seizure)

- documented refusal or inability to perform self-monitoring of blood glucose

- ongoing use of warfarin with prior history of major bleeding event

- Due to challenges with dose adjustment by phone, Veterans on continuous subcutaneous
insulin infusion (insulin pumps) will not be eligible for this study.

- Due to challenges with regulations regarding testing supplies pts will need to
be taking insulin (a few patients had enrolled prior to this change.).