Medication AdherenceNCT03475030
Electronic Medication Adherence Reporting and Feedback During Care Transitions
A study testing pre-filled medication trays and automated medication reminders in people with Medication Adherence, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- pre-filled medication trays and automated medication reminders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to the medicine service of a large, urban hospital
- Taking 5 or more chronic medications
Who cannot join
- Plan to discharge patient to hospice, rehabilitation, or skilled nursing facility (i.e., not to the community)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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:
- Implement a smart pillbox intervention for patients discharged from the hospital to the community
- 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
- Hypothesis 2a: a smart pillbox intervention will decrease medication discrepancies and increase medication adherence in the 6 months after hospital discharge
- Hypothesis 2b: among patients with hypertension, diabetes mellitus, and hyperlipidemia, a smart pillbox intervention will improve routinely collected measures of disease control
- 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.
- Conditions
- Medication Adherence
- Being tested
- pre-filled medication trays, automated medication reminders
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-filled medication traysOther
automated medication remindersOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: pre-filled medication trays; Other: automated medication reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Discrepancies
Number of discrepancies per patient (mean per month)
Measured: 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%.
Measured: 6 months after discharge
Secondary outcomes (10)
Proportion of regimen in pill trays [intervention arm only]
Mean proportion of regimen in pill trays, averaged over all dispense episodes
Measured: Biweekly for the 6 months after discharge
Biweekly delivery of trays [intervention arm only]
Proportion of two-week periods for which delivery was made
Measured: Biweekly for the 6 months after discharge
Use of adherence reports by patients [intervention arm only]
Number of times accessed per patient
Measured: Cumulative during the 6 months after discharge
Use of adherence reports by caregivers [intervention arm only]
Number of times accessed by caregivers, per patient
Measured: 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
Measured: 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%
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Minimum of 6 months
14-day adherence [intervention arm only]
Proportion of doses opened on schedule from pillbox during any 14-day period
Measured: 14 day-period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study startOct 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), TowerView Health
- Responsible party
- Principal investigator, Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital
- Investigators
- Jeffrey L Schnipper, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475030
- Sponsor's protocol ID
- 2016P000241
- Other IDs
- 1R21HS024587
- Status last verified
- Feb 2019
- First submitted
- 14 Mar 2018
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36309744
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Medication Adherence Reporting and Feedback During Care Transitions
- ClinicalTrials.gov ID
- NCT03475030
- Acronym / sponsor ID
- 2016P000241
- Conditions
- Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), TowerView Health
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Implement a smart pillbox intervention for patients discharged from the hospital to the community
- 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
- Hypothesis 2a: a smart pillbox intervention will decrease medication discrepancies and increase medication adherence in the 6 months after hospital discharge
- Hypothesis 2b: among patients with hypertension, diabetes mellitus, and hyperlipidemia, a smart pillbox intervention will improve routinely collected measures of disease control
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients receive usual care and can continue using their existing pharmacy. |
| Smart Pillbox | Experimental | Other: pre-filled medication trays, Other: automated medication remindersPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted to the medicine service of a large, urban hospital
- Taking 5 or more chronic medications
Key exclusion criteria (1 listed)
- Plan to discharge patient to hospice, rehabilitation, or skilled nursing facility (i.e., not to the community)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre-filled medication trays | Other | Smart Pillbox |
| automated medication reminders | Other | Smart Pillbox |
Primary outcome
Medication Discrepancies
Time frame: Monthly for the 6 months after discharge
Number of discrepancies per patient (mean per month)
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%.
10 secondary outcomes
Proportion of regimen in pill trays [intervention arm only]
Time frame: Biweekly for the 6 months after discharge
Biweekly delivery of trays [intervention arm only]
Time frame: Biweekly for the 6 months after discharge
Use of adherence reports by patients [intervention arm only]
Time frame: Cumulative during the 6 months after discharge
Use of adherence reports by caregivers [intervention arm only]
Time frame: Cumulative during the 6 months after discharge
Use of adherence reports by Partners HealthCare providers [intervention arm only]
Time frame: Cumulative during the 6 months after discharge
Actions taken by providers [intervention arm only]
Time frame: Cumulative during the 6 months after discharge
Blood Pressure Control (in patients on antihypertensive medications)
Time frame: Minimum of 6 months
LDL Cholesterol Control (in patients on statins)
Time frame: Minimum of 6 months
Diabetes Control (in patients on diabetes medications)
Time frame: Minimum of 6 months
14-day adherence [intervention arm only]
Time frame: 14 day-period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Derived from this study: PubMed 36309744Shahani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey L Schnipper, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-filled medication trays and automated medication reminders in people with Medication Adherence, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Discrepancies (time frame: Monthly for the 6 months after discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03475030, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.