Medication Adherence Clinical Decision Support
Condition: Hyperlipidemia; Hypertension; Diabetes; Medication Nonadherence
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      More than 50% of adults treated for diabetes, hypertension, or lipid disorders have
      suboptimal medication adherence, a prominent barrier to continued improvement in chronic
      disease care in the United States. Primary care providers (PCPs) often fail to identify
      medication nonadherence and/or have insufficient time and training to address underlying
      reasons for it. In this project, we propose a patient-centered and technology-driven strategy
      to identify patients with adherence issues and apply a team approach to help them achieve
      evidence-based personalized goals for glucose, blood pressure, or lipids. This intervention
      extends the use of a widely available clinical decision support (CDS) infrastructure to
      support a model of care that, for the first time outside of a fully integrated care
      environment, will integrate pharmacists within the primary care team. The intervention relies
      on a continuous health informatics loop to do the following: (a) identify high-risk patients
      with adherence problems at the point of care by expanding the capability of an electronic
      medical record (EMR)-linked CDS to identify poor adherence to medications; (b) establish and
      maintain an auto-populating up-to-date registry of patients identified for proactive
      pharmacist outreach; (c) implement a pharmacist outreach strategy based on an
      information-motivation-behavioral (IMB) framework recommended by the World Health
      Organization (WHO) with demonstrated ability to influence adherence across a variety of
      clinical applications; and (d) coordinate care and adherence information by incorporating
      pharmacist assessment and action plans into CDS at subsequent office encounters.
    

Detailed description: 
      Patients are randomly allocated 1:1 through a computer-generated program to either control or
      intervention.

      Control: All control patients will continue to receive the basic Electronic Medical Record
      (EMR)-linked Clinical Decision Support (CDS) tool for cardiovascular (CV) risk factor
      management. This CDS includes algorithmically derived identification of high CV risk patients
      and prioritized treatment suggestions for lipids, Blood Pressure (BP), glycemic control,
      weight, tobacco, and aspirin use based on distance from goal, current medications, labs,
      allergies, and safety considerations. The basic CDS does not include any information on
      medication adherence. Patients will receive basic CDS plus usual care.

      Intervention: For intervention patients, the basic CDS system for CV risk-factor control is
      enhanced to support a team-based care model that identifies risk of non-adherence, computes
      adherence information and incorporates it in the CDS, creates a registry to direct proactive
      pharmacist outreach, and coordinates action plans. To do this, the CDS Web service will
      combine EMR-identified medications with Epic Medication Adherence score (e-PDC) data.
      Algorithms will identify poor adherence using e-PDC scores available within the Epic EMR at
      patient encounters. When medication adherence issues are identified, alert messages will
      appear on the CDS tools for patients and providers. Patients with index visits will be
      followed-up for 6 months as they continue to receive CDS at subsequent encounters. At 6
      months, patient e-PDC as well as clinical outcomes will be reevaluated. Patients with
      persistent adherence issues identified are added to a registry that is used by the
      pharmacists to conduct outreach. Pharmacist outreach will be conducted primarily by phone,
      but in-person arrangements are also an option. Pharmacists conducting outreach will identify
      themselves to patients as part of the care team working with the primary care provider (PCP).
      Examples of specific action plans that may be recommended includes education, recommending
      lower cost alternative medications or combination medications, addressing side effects, using
      pill boxes, modifying pill-taking schedules and/or using reminder systems, or referrals to
      medication therapy management (MTM) services or health educators. Pharmacists will be guided
      by a script template for the phone outreach that walks them through the IMB intervention and
      data collection. The pharmacists involved will have full read/write access to the EMR in full
      compliance with HIPAA regulations. They can make medication changes through established care
      protocols and/or communicate with the prescriber through secure messaging or phone
      consultation. The date of the pharmacist outreach and actions that result from the IMB
      intervention will be documented in the EMR and incorporated into subsequent CDS tools and
      registries to reflect the new patient state.
    

Intervention name(s): Adherence-enhanced clinical decision support; ReachOut Adherence intervention
Intervention type(s): Other; Behavioral
Intervention description(s): Clinical decision support system integrating electronic medication data with claims data on prescription fills; The pharmacist outreach intervention is based on the theoretically grounded and evidence-based Information-Motivation-Behavioral framework endorsed by the World Health Organization to improve adherence
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Decision Support Systems, Clinical; Cardiovascular Diseases; Cardiovascular Risk Factor; Medication Non-adherence