An interventional study of pre-filled medication trays and automated medication reminders in Medication Adherence, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-19.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research
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.
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:
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
Evaluate the effects of the intervention on post-discharge medication discrepancies, medication adherence, and chronic disease management
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.
937 studies on the registry are indexed under Medication Adherence; 159 are open to participants now.
This study's enrollment of 207 is above the median of 120 across 768 interventional studies indexed under Medication Adherence.
Browse Medication Adherence studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients receive usual care and can continue using their existing pharmacy.
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
Medication Discrepancies
Number of discrepancies per patient (mean per month)
Time frame: 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%.
Time frame: 6 months after discharge
Proportion of regimen in pill trays [intervention arm only]
Mean proportion of regimen in pill trays, averaged over all dispense episodes
Time frame: Biweekly for the 6 months after discharge
Biweekly delivery of trays [intervention arm only]
Proportion of two-week periods for which delivery was made
Time frame: Biweekly for the 6 months after discharge
Use of adherence reports by patients [intervention arm only]
Number of times accessed per patient
Time frame: Cumulative during the 6 months after discharge
Use of adherence reports by caregivers [intervention arm only]
Number of times accessed by caregivers, per patient
Time frame: 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
Time frame: 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%
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Minimum of 6 months
14-day adherence [intervention arm only]
Proportion of doses opened on schedule from pillbox during any 14-day period
Time frame: 14 day-period
Plan to share: No
Ran from Oct 2016 to primary completion in Dec 2018, 26 months.
Of 425 non-industry interventional studies with no phase under Medication Adherence, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's 26 months is above that.
Counting every sponsor, half of 442 studies reached it within 21 months; a quarter within 11 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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