Background: Type 2 diabetes mellitus (T2D) affects almost one in five VA patients overall
and almost one in four VA patients who are racial and ethnic minorities. Adherence to
medication regimens and lifestyle factors (such as diet and exercise) is important to
improve outcomes in T2D. Adherence to these factors and subsequent achievement of
outcomes is related, at least in part, to effective communication in medical encounters.
Empowering and activating patients to use more effective communication behaviors with
their providers leads to better adherence to treatment and better biomedical outcomes.
However, interventions to improve communication have not been adopted in practice largely
due to the cost of trained personnel to deliver the training. Thus, there is a gap in
effective interventions that can improve communication related outcomes. In a recent VA
HSR&D funded trial the investigators showed efficacy of the Speak Up! video. Veterans
watching the video had significantly higher self-efficacy to communicate and lower
hemoglobin A1c at follow-up.
Significance: Type 2 diabetes (T2D) is common, expensive, and chronic. Estimates put the
prevalence of T2D at almost 20 percent. The proposed study is highly significant because
the condition under study, T2D, is highly prevalent and has negative impacts for Veterans
with the symptoms and sequelae of T2D. The objective to activate patients' communication
to achieve goals of care and to improve outcomes of T2D is responsive to VA priorities to
improve customer service, primary care practice, and care of complex chronic diseases.
Innovation: The proposal to engage patients in communication in medical visits is
innovative because addressing patients' communication as contrasted with providers'
communication is unique in the VA. It is also innovative because activating patients
facilitates patient-centered care and shared decision making which are key goals in the
VA/DOD guideline for the management of T2D and contributes to VA's commitment to the
Whole Health model. Also, the intervention could be a paradigm for encouraging patients
with other conditions to use active participatory communication. Specifically, the design
and communication content of Speak Up! Could serve as a model for the development of
activation interventions for Veterans with other conditions.
Specific Aims: The proposed Hybrid Type 2 study has two specific aims:
Aim 1. Implementation aim - In partnership with key clinical staff develop a strategy to
deliver the Speak Up! video in VA outpatient primary care clinics using a facilitated
Plan Do Study Act (PDSA) process.
Aim 2. Effectiveness aim - Examine the effectiveness of the Speak Up! video using the
RE-AIM framework to evaluate Reach into the patient population, Effectiveness to improve
outcomes (Hemoglobin A1c, communication self-efficacy, diabetes distress), Adoption by
providers and clinics, Implementation (completion, fidelity, and intensity), and
Maintenance after the end of external facilitation.
Hypothesis 1. Patients will have improvements in outcomes (A1c, diabetes distress,
communication self-efficacy) from before to after watching the video.
Exploratory Hypothesis 2. Patients that are at higher risk of having challenges
communicating with physicians (patients with low health literacy, African-American
patients, patients with depression) will also have improvements in outcomes.
Methodology: The proposed study is a Hybrid Type 2 effectiveness - implementation trial
of the intervention using a cluster-randomized stepped-wedge design in eight clinics. The
investigators will test the implementation strategies using a formative evaluation guided
by the Promoting Action on Research Implementation in Health Services (PARIHS) framework,
and the investigators will use the Reach, Effectiveness, Adoption, Implementation, and
Maintenance (RE-AIM) framework: to examine effectiveness of the Speak Up! Video; to
supplement the formative evaluation from PARIHS; and to conduct a summative evaluation to
evaluate success of the implementation strategies.
Implementation/Next Steps: This proposal will test the feasibility of implementing the
Speak Up! video in primary care and if successful will generate the evidence to justify
widespread dissemination of the video.