Self-efficacy, Beliefs and Adherence- Pilot and Feasibility Trial of a Pharmacist-led Intervention
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study uses an intervention mixed methods design. The overall purpose is to improve
      medication adherence and assess the clinical impact on diabetes outcomes among patients with
      uncontrolled diabetes. We will examine if usual care combined with a clinic-based health
      literacy/psychosocial support intervention improves medication adherence compared to usual
      care alone. A randomized controlled trial will be conducted at William S. Middleton Memorial
      Veterans Hospital in Madison, targeting individuals with uncontrolled diabetes. The
      patient-centered health literacy intervention will focus on enhancing patients' self-efficacy
      and addressing patients' negative beliefs in medicine and illness.
    

Detailed description: 
      The study will improve medication adherence for patients with diabetes using two strategies:
      1) addressing health literacy by reducing the complexity of diabetes content disseminated to
      patients during medication counseling and 2) addressing health literacy by enhancing
      patient-pharmacist communication. The second strategy aims to improve the psychosocial
      support offered to patients by building self-efficacy and addressing negative beliefs about
      medicines and diabetes. Together, the patient and the pharmacist can work together towards
      goal setting, problem solving, and negotiation of competing priorities.

      Currently, with usual care, the pharmacist confirms if patients understand how to take
      medications correctly, adjusts diabetes medications, and monitor patients' hemoglobin A1C
      levels periodically to make sure that patients are capable of managing their diabetes
      appropriately. With the proposed intervention, the pharmacist will identify patients'
      concerns and barriers to medication taking and self-care with diabetes with an emphasis on
      self-efficacy, negative beliefs in medicine and illness. Then the pharmacist will provide
      individualized plans and set specific goals with each patient by strengthening their
      confidence in medication use and health literacy skills in navigating health information for
      diabetes self-care. The methods described for the intervention are in line with the current
      clinic workflow and will not require a substantial change to the current system for
      counseling diabetes patients. Knowledge change often does not lead to behavior change. Hence,
      the intervention will innovatively focus on moving knowledge towards action as the clinical
      pharmacist works with patients in assessing health literacy, identifying their barriers to
      medication use, including lack of self-efficacy, addressing negative beliefs about diabetes
      and diabetes medications; towards problem solving, and developing goals and action plans that
      will improve medication adherence and glycemic control.
    

Intervention name(s): Health literacy-psychosocial support
Intervention type(s): Other
Intervention description(s): The intervention is based upon enhancing patient health literacy-related attributes by (1) addressing the barriers to patients' self-efficacy by working with the patient to minimize the barriers (2) clarifying the patient beliefs about diabetes and diabetes medications, and (3) developing personalized action plans. We will tailor the intervention to each patient, so, the details of the content of each session will depend on the individual's self-efficacy, beliefs in illness and medicines, and health literacy level obtained at baseline. In addition to the 45-minute scheduled sessions, patients will be able to call the clinical pharmacist on the phone during the 6-week session at their discretion, for patient-driven support for self-management of goals and skills.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Health literacy; Self-efficacy; Beliefs about diabetes; Beliefs in medicines