NCT03475030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

2.2 years

First QC Date

March 14, 2018

Last Update Submit

February 16, 2019

Conditions

Medication Adherence

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Proportion of regimen in pill trays [intervention arm only]

    Biweekly for 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

  • Use of adherence reports by caregivers [intervention arm only]

    Cumulative during the 6 months after discharge

  • Use of adherence reports by Partners HealthCare providers [intervention arm only]

    Cumulative during the 6 months after discharge

  • +5 more secondary outcomes

Study Arms (2)

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.

Other: pre-filled medication traysOther: automated medication reminders

Interventions

pre-filled medication traysOTHER
Smart Pillbox
automated medication remindersOTHER
Smart Pillbox

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 36309744DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jeffrey L Schnipper, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

March 14, 2018

First Posted

March 23, 2018

Study Start

October 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 19, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)