- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04676165
Mobile Application to Enhance Medication Management (SAM)
Evaluation of a Mobile Application to Enhance Medication Management Following Hospital Discharge
Adverse drug events (ADEs) are a leading cause of death in North America, with over 2 million ADEs causing 100,000 deaths every year and millions in economic costs. The majority of ADEs that occur within 30 days of discharge from hospital are related to prescription medications and of these, more than 50% are preventable. Among the causes of ADEs are incomplete and unclear medication lists, and a lack of patient understanding and adherence. Patients are usually discharged from hospital on substantially difference medication regiments than those prior to admission. In the absence of supportive mechanisms that ensure patients' understanding of their medication list, adherence to prescribed medication changes is likely to be reduced and the subsequent risk of ADEs increased. Secondary analyses from a recently conducted randomized controlled trial (RCT) by our team suggest that more than 50% of study patient were non-adherent to at least one in-hospital medication change, and that this non-adherence significantly increased the risk of hospital re-admission and emergency department visits in the 30 days post-discharge. Furthermore, analyses of interview data suggest that non-adherence may be driven by unclear communication with patients about medication changes and the reasons for these changes, as well as difficulties in managing complex dosing schedules and drug regimen information. There is therefore a clear need to implement and evaluate patient support mechanisms that reduce non-adherence to essential changes in therapy following hospitalization.
The objective of this project is to conduct a pilot RCT that will evaluate the usability of a medication management mobile application and its efficacy in reducing non-adherence to in-hospital medication changes following discharge. We will randomize 100 patients from the internal medicine unit of the McGill University Health Centre (MUHC) Glen site to either the intervention or control arm. Patients in the control arm will receive usual care (i.e. no medication management support), whereas those in the intervention arm will receive a tablet with the installed mobile application. The application will integrate prescription claims data from the Régie de l'assurance maladie du Québec (RAMQ) for the 3-month period prior to hospital admission with the patient's discharge prescription to generate a patient-friendly medication list, along with details of in-hospital medication changes. The app will also offer a number of features designed to maximize patient understanding and adherence, including pill images, patient-friendly drug monographs, weekly dosing schedules, drug alerts, home refill services, and features that connect with the patient's caregiver and hospital pharmacist.
At 1 week post-discharge, study coordinators will conduct a usability assessment to obtain patient feedback on the app (via a technology acceptance questionnaire) and to document usability using the "think aloud" protocol, which is based on observing and recording patients as they use the application and verbalize any thoughts that might occur to them. Qualitative analysis of recorded and transcribed sessions will then be used to assess the technology's ease of use, user-friendliness, efficiency, and any features that may cause confusion, frustration, or user errors.
Non-adherence to in-hospital treatment changes will be assessed by comparing patients' discharge prescriptions with medications dispensed in the 30 days following hospital discharge (obtained from RAMQ pharmacy claims). We will compare, between intervention and control groups, the average number of in-hospital medication changes not adhered to in the 30-day follow-up period.
This project will assess a technological intervention that has the potential to improve patient adherence to in-hospital medication changes and may subsequently reduce the occurrence of ADEs. Given the high costs associated with ADEs, this small investment has the potential to incur significant cost savings for the Quebec healthcare system.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Quebec
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Montreal, Quebec, Canada
- McGill University Health Centre (MUHC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Discharged home from internal medicine units of the McGill University Health Center
- Have a mobile or tablet device with internet connection
- Have prescription drug insurance from the provincial health insurer
- Prescribed at least one medication at discharge from hospital
Exclusion Criteria:
- Discharged to a rehabilitation center
- Transferred to a non-study unit'
- Prognosis of less than 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: SAM Group
At discharge from hospital, patients (and/or caregivers) will receive access to Smart About Meds (SAM), a medication management mobile application that has been developed by the McGill Clinical and Health Informatics (MCHI) Research Group.
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SAM generates a patient-friendly list of prescribed and dispensed medications and offers several features:
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No Intervention: Usual Care Group
At discharge from hospital, patients will be provided with a written discharge prescription to be filled at their community pharmacy, and may or may not receive written or verbal instructions about changes made to therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Usability of the SAM app
Time Frame: 1 week post-discharge
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Users will be observed as they use the app, following the "think aloud protocol".
This involves users verbalizing their thoughts as they perform a standardized set of tasks, while being audio-recorded.
In this pilot, a field assistant familiar with the SAM app will observe and record users as they access SAM and complete the following standardized tasks: view medications lists and dosing schedule, peruse drug information, and examine alerts.
Each session will be transcribed and transcriptions will be qualitatively analyzed to assess the following usability concepts: (1) ease of use, (2) user-friendliness, (3) efficiency, and (4) features that may cause confusion, frustration, or user errors.
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1 week post-discharge
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User acceptance of and satisfaction with the SAM app
Time Frame: 1 week post-discharge
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Participants in the intervention arm will complete the Technology Acceptance Model (TAM) Questionnaire 1 week following discharge from hospital. The questionnaire was developed using the TAM 1, 2, and 3, which were developed by Davis (1989), Venkatesh & Davis (2000), and Venkatesh and Bala (2008), respectively. The questionnaire is self-administered and consists of 38 questions, each of which is on a Likert scale of 1 (strongly disagree) to 7 (strongly agree). The questionnaire assesses users' satisfaction with the application and its usability. TAM 1 - Davis (1989) Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology TAM 2 - Venkatesh & Davis (2000) A Theoretical Extension of the Technology Acceptance Model: Four Longitudinal Field Studies TAM 3 - Venkatesh & Bala (2008) Technology Acceptance Model 3 and a Research Agenda on Interventions |
1 week post-discharge
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Proportion of medication changes that are adhered to
Time Frame: 30 days post-discharge
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Pharmacy claims data from the public insurance provider will be used to identify community medications dispensed to participating patients in the 30 days following hospital discharge.
These data will be compared with the patient's hospital discharge prescription to identify non-adherence to in-hospital medication changes.
Non-adherence to in-hospital treatment changes in the 30-day post-discharge period will be defined as (1) failure to fill newly prescribed medications, (2) re-filling a previous prescription that was stopped at discharge, or (3) filling a previous prescription whose dosage was modified at discharge, but was dispensed post-discharge at the incorrect daily dose.
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30 days post-discharge
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2-53
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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