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Clinical Trials/NCT03475030
NCT03475030CompletedNot Applicable

Electronic Medication Adherence Reporting and Feedback During Care Transitions

Brigham and Women's Hospital1 site in 1 country207 target enrollmentStarted: October 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
207
Locations
1
Primary Endpoint
Medication Adherence

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Usual Care

No Intervention

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

Smart Pillbox

Experimental

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.

Intervention: pre-filled medication trays (Other)

Smart Pillbox

Experimental

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.

Intervention: automated medication reminders (Other)

Outcomes

Primary Outcomes

Medication Adherence

Time Frame: 6 months after discharge

Proportion of patients with Proportion of Days Covered (PDC) \> 80% or Proportion of patients with Daily Polypharmacy Possession Ratio (DPPR) \> 80%.

Medication Discrepancies

Time Frame: Monthly for the 6 months after discharge

Number of discrepancies per patient (mean per month)

Secondary Outcomes

  • Blood Pressure Control (in patients on antihypertensive medications)(Minimum of 6 months)
  • Use of adherence reports by caregivers [intervention arm only](Cumulative during the 6 months after discharge)
  • Biweekly delivery of trays [intervention arm only](Biweekly for the 6 months after discharge)
  • Use of adherence reports by patients [intervention arm only](Cumulative during the 6 months after discharge)
  • 14-day adherence [intervention arm only](14 day-period)
  • Proportion of regimen in pill trays [intervention arm only](Biweekly for the 6 months after discharge)
  • Actions taken by providers [intervention arm only](Cumulative during the 6 months after discharge)
  • LDL Cholesterol Control (in patients on statins)(Minimum of 6 months)
  • Use of adherence reports by Partners HealthCare providers [intervention arm only](Cumulative during the 6 months after discharge)
  • Diabetes Control (in patients on diabetes medications)(Minimum of 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeffrey L. Schnipper, MD.,MPH.

Associate Professor of Medicine

Brigham and Women's Hospital

Study Sites (1)

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