Smart About Meds (SAM) RCT

NCT05371548 | Recruiting DMC

• 1 other identifier: 2022-7858
• Study Type: interventional
• Target: 3,250
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Almost half of patients discharged from hospital are re-admitted or return to the emergency department (ED) within 90 days. Patient nonadherence to medication changes during hospitalization and the use of potentially inappropriate medications (PIMs) both contribute to the risk of adverse events post-discharge. Smart About Meds (SAM) is a patient-centered mobile application designed to target medication nonadherence and PIMs use. This protocol describes a randomized controlled trial (RCT) to evaluate the effectiveness of SAM. Methods \& Analysis: A pragmatic, stratified RCT will be conducted among 3,250 patients discharged from internal medicine, cardiac care, cardiac surgery, vascular surgery, and respiratory units of the Royal Victoria Hospital and the Montreal General Hospital. At discharge, patients will be randomized 1:1 to usual care or the SAM intervention. SAM integrates novel user-centered features (e.g. continuously updated medication list with pill images, side-effect checker, interaction checker) with pharmacist monitoring to tackle post-discharge nonadherence to new medication regimens. SAM also notifies patients of PIMS in their regimen, with advice to discuss with their physician. Following discharge, patients will be followed for 90 days, during which the occurrence of the composite outcome of ED visits, hospital readmissions, or death will be measured. Secondary outcomes will include the individual components of the composite outcome, nonadherence to medication changes, defined as failure to fill a new prescription, filling a modified prescription at the incorrect dose, or filling discontinued medications, secondary medication adherence, patient empowerment, and health-related quality of life. An intention-to-treat analysis will evaluate the effectiveness of SAM. Multivariable logistic regression will estimate differences between treatment groups in the proportion of patients nonadherent to at least one medication change. With a sample size of 3,250, there will be 80% power to detect a 5% absolute reduction in this outcome. Two-way interaction terms will test hypothesized modifiers of SAM's effectiveness, including hospital, unit, age, sex, gender and comorbidity burden. Binary and continuous secondary outcomes will be assessed using multivariable logistic and linear regression, respectively.

Conditions

Medication Adherence

Keywords

medication adherence; mobile application; medication management; patient empowerment; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• ED visits, hospital readmissions, and deaths (composite)

  This is a composite, binary outcome of having experienced an ED visit, hospital readmission, or death in the 90 days post-discharge. In Quebec, physicians must record the location of the services they provide to be remunerated on a fee-for-service basis. These medical services claims data are timely and accurate in measuring hospitalization occurrence and length of stay. The hospitalization database, which records admission and discharge diagnoses and procedures for all acute care hospitalizations in Quebec, will be used to collect additional descriptive information on the reasons for hospitalization and to re-validate the medical services data. Patients will be classified as having an ED visit or hospital readmission if they received a service whose location is recorded as an ED or inpatient hospital unit, respectively. Post-discharge deaths will be retrieved from the RAMQ beneficiary database.

  90 days post-discharge

Secondary Outcomes (5)

• Individual components of the primary composite outcome

  90 days post-discharge

• Nonadherence to medication changes

  90 days post-discharge

• Secondary adherence

  90 days post-discharge

• Patient and caregiver empowerment

  90 days post-discharge

• Patient health-related quality of life

  90 days post-discharge

Study Arms (2)

Intervention (SAM app)

EXPERIMENTAL

Patients will receive training in and access to the SAM app at discharge. SAM uses prescribed and dispensed medication data to display a continuously updated drug list and provides patients and caregivers with tools to address barriers to adherence. Drug information: Provides patient-friendly drug monographs. Interaction checker: Generates drug-drug interactions between the patient's medications and other OTC drugs. Adherence alerts: Uses decision algorithms to alert users to adherence problems with the new regimen. Side effect checker: Displays possible side effects for each medication and frequency of occurrence. PIMs alerts: Alerts patients to potentially inappropriate medications in their list. Pharmacist connect: Connects users with pharmacists through a secured messaging service. Social connect: Allows users to share medication experiences. Caregiver connect: Allows patients to enroll caregivers who can use the app. Weekly medication schedule \& pill reminders

Device: SAM mobile application

Control (usual care)

NO INTERVENTION

Patients will receive usual care at discharge. On study units, medication reconciliation is conducted for all patients. Patients have their community medication list obtained via fax from their community pharmacy. The list is validated by the unit pharmacist who then reconciles it with admission orders, and recommends changes as needed to the attending physician. At discharge, the community drug list is reconciled with medications administered in hospital and the discharge prescription is generated by the attending physician or resident, classifying each medication as new medication, dose modification, discontinued therapy, or continued community medication. The discharge prescription is provided to the patient. Patients fill their discharge prescription at their community pharmacy. If there are questions about changes to the community drug list, the pharmacist will ask the patient, and if not clear will contact the discharging physician.

Interventions

SAM mobile application DEVICE

See description of intervention group

Intervention (SAM app)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Covered by provincial (RAMQ) health insurance plan
• Covered by provincial (RAMQ) prescription drug insurance plan
• Owns a smartphone or tablet with internet connection
• At least one medication prescribed at discharge
• Speak and read English or French
• Age 18+

You may not qualify if:

• Discharged to rehabilitation center or to long-term care
• Transferred to a non-study unit

Sponsors & Collaborators

• Robyn Tamblyn: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, Canada

RECRUITING

Related Publications (1)

• Tamblyn R, Habib B, Buckeridge DL, Weir DL, Frolova E, Alattar R, Rogozinsky J, Beauchamp C, Pupo R, Bartlett SJ, McDonald E. Evaluating the effectiveness of the Smart About Meds (SAM) mobile application among patients discharged from hospital: protocol of a randomised controlled trial. BMJ Open. 2024 Nov 24;14(11):e084492. doi: 10.1136/bmjopen-2024-084492.

  PMID: 39581737 DERIVED

MeSH Terms

Conditions

Medication Adherence; Patient Participation

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Bettina Habib, MSc MScPH

CONTACT

514-396-1156; bettina.habib@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 12, 2022
• Study Start: February 1, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Following publication of the main trial results.

Locations

CA (1)