Electronic Medication Adherence Reporting and Feedback During Care Transitions

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.

Study Overview

• Status: Completed
• Conditions: Medication Adherence
• Intervention / Treatment: Other: pre-filled medication trays; Other: automated medication reminders

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Usual Care; Patients receive usual care and can continue using their existing pharmacy.
EXPERIMENTAL: Smart Pillbox; 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.	Other: pre-filled medication trays; Other: automated medication reminders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Discrepancies	Number of discrepancies per patient (mean per month)	Monthly for the 6 months after discharge
Medication Adherence	Proportion of patients with Proportion of Days Covered (PDC) > 80% or Proportion of patients with Daily Polypharmacy Possession Ratio (DPPR) > 80%.	6 months after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of regimen in pill trays [intervention arm only]	Mean proportion of regimen in pill trays, averaged over all dispense episodes	Biweekly for the 6 months after discharge
Biweekly delivery of trays [intervention arm only]	Proportion of two-week periods for which delivery was made	Biweekly for the 6 months after discharge
Use of adherence reports by patients [intervention arm only]	Number of times accessed per patient	Cumulative during the 6 months after discharge
Use of adherence reports by caregivers [intervention arm only]	Number of times accessed by caregivers, per patient	Cumulative during the 6 months after discharge
Use of adherence reports by Partners HealthCare providers [intervention arm only]	Number of times accessed by providers, per patient	Cumulative during the 6 months after discharge
Actions taken by providers [intervention arm only]	Proportion of eligible patients where action taken by providers in response to adherence data when baseline adherence (PDC) is < 80%	Cumulative during the 6 months after discharge
Blood Pressure Control (in patients on antihypertensive medications)	Last value during 6-month post-discharge study period compared with last value prior to admission. If BP at goal at baseline: maintenance of goal. If BP not at goal at baseline: decrease in systolic and diastolic BP; achievement of goal.	Minimum of 6 months
LDL Cholesterol Control (in patients on statins)	Last value during 6-month post-discharge study period compared with last value prior to admission. If LDL at goal at baseline: maintenance of goal. If LDL not at goal at baseline: decrease in LDL; achievement of goal.	Minimum of 6 months
Diabetes Control (in patients on diabetes medications)	Last value during 6-month post-discharge study period compared with last value prior to admission. If A1c at goal at baseline: maintenance of goal. If A1c not at goal at baseline: decrease in A1c; achievement of goal.	Minimum of 6 months
14-day adherence [intervention arm only]	Proportion of doses opened on schedule from pillbox during any 14-day period	14 day-period

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Agency for Healthcare Research and Quality (AHRQ); TowerView Health

Publications and helpful links

General Publications

• Shahani A, Nieva HR, Czado K, Shannon E, Gaetani R, Gresham M, Garcia JC, Ganesan H, Cerciello E, Dave J, Jain R, Schnipper JL. An electronic pillbox intervention designed to improve medication safety during care transitions: challenges and lessons learned regarding implementation and evaluation. BMC Health Serv Res. 2022 Oct 30;22(1):1304. doi: 10.1186/s12913-022-08702-y.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (ACTUAL): March 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 16, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2016P000241; 1R21HS024587 (AHRQ)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No