Clinical trial NCT03475030: Electronic Medication Adherence Reporting and Feedback During Care Transitions
Official title: Electronic Medication Adherence Reporting and Feedback During Care Transitions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: TowerView Health
First posted: 2018-03-23
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Medication Discrepancies
timeFrame: Monthly for the 6 months after discharge
measure: Medication Adherence
timeFrame: 6 months after discharge
Secondary outcomes:
measure: Proportion of regimen in pill trays [intervention arm only]
timeFrame: Biweekly for the 6 months after discharge
measure: Biweekly delivery of trays [intervention arm only]
timeFrame: Biweekly for the 6 months after discharge
measure: Use of adherence reports by patients [intervention arm only]
timeFrame: Cumulative during the 6 months after discharge
measure: Use of adherence reports by caregivers [intervention arm only]
timeFrame: Cumulative during the 6 months after discharge
measure: Use of adherence reports by Partners HealthCare providers [intervention arm only]
timeFrame: Cumulative during the 6 months after discharge
measure: Actions taken by providers [intervention arm only]
timeFrame: Cumulative during the 6 months after discharge
measure: Blood Pressure Control (in patients on antihypertensive medications)
timeFrame: Minimum of 6 months
measure: LDL Cholesterol Control (in patients on statins)
timeFrame: Minimum of 6 months
measure: Diabetes Control (in patients on diabetes medications)
timeFrame: Minimum of 6 months
measure: 14-day adherence [intervention arm only]
timeFrame: 14 day-period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jeffrey L Schnipper, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.