Transforming the Patient Role to Achieve Better Outcomes Through a Patient Empowerment Program: A Randomized Wait-List Control Trial Protocol

Abstract

Background: In the patient-centered medical home model of health care, both health care providers (HCPs) and patients must understand their respective roles and responsibilities, view the other as a partner, and use communication skills that promote shared decision making. This is particularly necessary in chronic conditions where outcomes depend on behavior change and in underserved populations where the burden of chronic disease is high.

Objective: The objectives of this study are to determine if a Patient Empowerment Program (PEP) (1) is acceptable to patients and feasible across multiple clinical sites; (2) will increase patient preference for control in medical decision making, improve patient perceptions of patient-HCP communication, and increase patient activation; (3) is associated with an increase in diabetes self-management behaviors; and (4) has an effect on hemoglobin A1c (HbA1c) level.

Methods: This study recruited English-speaking adult patients with type 2 diabetes mellitus from three urban clinical sites in New York City and randomized them to an immediate intervention group that completed the PEP intervention or a deferred intervention group that served as a wait-list control and completed the PEP intervention after 3-4 months. The PEP intervention consists of two facilitated small group sessions. Session 1 focuses on defining HCP and patient roles in the medical encounter by introducing ideal communication behaviors in each role and by providing both positive and negative examples of patient-HCP encounters. Session 2 focuses on practicing communication skills by role-playing with actors who serve as standardized health care providers. After the role play, participants set goals for their own health care and for future interactions with their HCPs. Outcome measures include the Patient Activation Measure; Ask, Understand, Remember Assessment; Krantz Health Opinion Survey; SF-12v2 Health Survey; Diabetes Self-Management Questionnaire; and HbA1c. These measures will be assessed at the time of enrollment, after the waiting period (deferred intervention only), and then postintervention at 1 week, 3 months, and 6 months.

Results: Study recruitment occurred from November 2014 to June 2015, with a total of 80 patients enrolled. To date, 45 participants have attended at least one session of the PEP intervention. Further intervention sessions and post-intervention follow-up are ongoing, with data collection set to be completed in April 2016 and results of data analysis available by June 2016.

Conclusions: From preliminary participant self-report data, our PEP intervention is acceptable to low-income, low-health literate patients and feasible to hold across multiple clinical sites. Participants have reported learning specific ways to change their behaviors at their next HCP visit (eg, stating their opinions, asking more questions). With the forthcoming quantitative data on participant attitudinal and behavior change, the PEP intervention may ultimately empower participants within the medical encounter and improve health outcomes.

Keywords: health literacy; patient activation; shared decision making.

Figure 1

CONSORT flow diagram. HbA1c: hemoglobin A1c; PEP: Patient Empowerment Program; T2DM: type 2 diabetes mellitus.

Figure 2

Framework for patient–health care provider interactions.