Mobile Application to Enhance Medication Management

NCT ID: NCT04676165

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-04
• Study Completion Date: 2020-04-17

Brief Summary

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.

Conditions

Medication Adherence; Mobile Application

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Smart About Meds (SAM)

Intervention Type: DEVICE

SAM generates a patient-friendly list of prescribed and dispensed medications and offers several features:

• Drug information: Patient-friendly monographs that describe treatment indications and the harms/benefits of medications.
• Adherence alerts: Alerts users to non-adherence, such as when they fill prescriptions that were stopped at hospital discharge, don't fill prescribed medications, or buy medications at the incorrect dose.
• Side-effect checker: Provides a list of side effects associated with individual medications and the patient's overall drug profile.
• Rate my med: Allows patients to rate medications and describe experiences with a medication. Patients can view ratings given by users.
• Caregiver connect: Provides patients' caregivers with access to the app.
• Pharmacy connect: Allows patients to connect with their hospital pharmacist to ask questions regarding their medications and adherence alerts.
• Other: pill images, daily pill reminders, weekly dosing schedule

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Smart About Meds (SAM)

SAM generates a patient-friendly list of prescribed and dispensed medications and offers several features:

• Drug information: Patient-friendly monographs that describe treatment indications and the harms/benefits of medications.
• Adherence alerts: Alerts users to non-adherence, such as when they fill prescriptions that were stopped at hospital discharge, don't fill prescribed medications, or buy medications at the incorrect dose.
• Side-effect checker: Provides a list of side effects associated with individual medications and the patient's overall drug profile.
• Rate my med: Allows patients to rate medications and describe experiences with a medication. Patients can view ratings given by users.
• Caregiver connect: Provides patients' caregivers with access to the app.
• Pharmacy connect: Allows patients to connect with their hospital pharmacist to ask questions regarding their medications and adherence alerts.
• Other: pill images, daily pill reminders, weekly dosing schedule

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: lead

Responsible Party

Robyn Tamblyn

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robyn Tamblyn, PhD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

McGill University Health Centre (MUHC)

Montreal, Quebec, Canada

Countries

Canada

References

Habib B, Buckeridge D, Bustillo M, Marquez SN, Thakur M, Tran T, Weir DL, Tamblyn R. Smart About Meds (SAM): a pilot randomized controlled trial of a mobile application to improve medication adherence following hospital discharge. JAMIA Open. 2021 Jul 31;4(3):ooab050. doi: 10.1093/jamiaopen/ooab050. eCollection 2021 Jul.

Reference Type: DERIVED

PMID: 34345805 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2-53

Identifier Type: -

Identifier Source: org_study_id