Electronic Medication Adherence Reporting and Feedback During Care Transitions

Mass General Brigham

Status: Completed

Conditions: Medication Adherence

Treatments: Other: pre-filled medication trays; Other: automated medication reminders

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03475030

2016P000241

1R21HS024587 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

Patients often have problems with their medications after leaving the hospital and going back home. The goals of this study are to provide a special electronic pill-box with pre-filled weekly medication trays that can alert patients when it is time to take their medications, alert family members (with patients' permission) if there is a problem, and produce a report of medication-taking habits for patients' primary care providers. The investigators will evaluate the effects of this technology on patients' ability to take their medications safely, on the control of chronic conditions like high blood pressure, and also ask patients about any barriers to using this technology in the real world. The investigators hypothesize that a smart pillbox (i) can be successfully implemented in the transitions setting, including engagement of patients, caregivers, and providers in electronically available medication adherence reports; (ii) will decrease medication discrepancies and increase medication adherence in the 6 months after hospital discharge; and (iii) among patients with hypertension, diabetes mellitus, and hyperlipidemia will improve routinely collected measures of disease control.

Full description

Adverse drug events are very common after hospitalization and are due to a variety of factors, including misunderstanding of the correct medication regimen and non-adherence with that regimen. The goals of this study are to implement and evaluate a novel "smart pillbox" using health information technology (HIT) to minimize discrepancies in prescribed regimens and improve adherence after hospital discharge. To the investigators' knowledge this type of technology has not been studied in the transitions setting, where there are unique challenges but also tremendous opportunities to engage patients, caregivers, and providers in medication safety and to improve care.

Specific Aims:

1. Implement a smart pillbox intervention for patients discharged from the hospital to the community

   a. Hypothesis 1: a smart pillbox can be successfully implemented in the transitions setting, including engagement of patients, caregivers, and providers in electronically available medication adherence reports

2. Evaluate the effects of the intervention on post-discharge medication discrepancies, medication adherence, and chronic disease management

   1. Hypothesis 2a: a smart pillbox intervention will decrease medication discrepancies and increase medication adherence in the 6 months after hospital discharge
   2. Hypothesis 2b: among patients with hypertension, diabetes mellitus, and hyperlipidemia, a smart pillbox intervention will improve routinely collected measures of disease control

3. Determine barriers and facilitators of implementation of the intervention

To achieve these aims, the investigators will conduct a cluster-randomized controlled trial. This research design will allow for rigorous measurement of medication safety outcomes while minimizing contamination and facilitating education of providers within each practice in the access and use of medication adherence reports created by the smart pillbox and available as a link within the Epic electronic health record (EHR).

This is a Pilot and Feasibility Study focused on several areas, most notably Implementation and Outcomes, although it also evaluates Use (e.g., differences in use and efficacy among in-network providers with access to adherence reports within the EHR and out-of-network providers who do not have access), and Measurement (i.e., a measure of real-time medication adherence that is automatically created by the HIT intervention). The study will generate new knowledge about the benefits of this type of intervention on medication safety and will pave the way for future studies to more precisely quantify the benefits on downstream patient outcomes.

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admitted to the medicine service of a large, urban hospital
• Taking 5 or more chronic medications

Exclusion criteria

• Plan to discharge patient to hospice, rehabilitation, or skilled nursing facility (i.e., not to the community)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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207 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Patients receive usual care and can continue using their existing pharmacy.

Smart Pillbox

Experimental group

Description:

Patients receive pre-filled medication trays from Curant Health Pharmacy or the Brigham and Women's Hospital Outpatient Pharmacy. The smart pillbox in which pre-filled medication trays are housed provide automated medication reminders.

Treatment:

Other: pre-filled medication trays

Other: automated medication reminders