Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT03475030
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
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:
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
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Monthly for the 6 months after discharge
Number of discrepancies per patient (mean per month)
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%.
Time frame: Biweekly for the 6 months after discharge
Mean proportion of regimen in pill trays, averaged over all dispense episodes
Time frame: Biweekly for the 6 months after discharge
Proportion of two-week periods for which delivery was made
Time frame: Cumulative during the 6 months after discharge
Number of times accessed per patient
Time frame: Cumulative during the 6 months after discharge
Number of times accessed by caregivers, per patient
Time frame: Cumulative during the 6 months after discharge
Number of times accessed by providers, per patient
Time frame: Cumulative during the 6 months after discharge
Proportion of eligible patients where action taken by providers in response to adherence data when baseline adherence (PDC) is < 80%
Time frame: Minimum of 6 months
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
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
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: 14 day-period
Proportion of doses opened on schedule from pillbox during any 14-day period
Brigham and Women's Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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