Smart About Meds (SAM) RCT

Medication Adherence Clinical Trial

Official title:

Evaluating the Effectiveness of the Smart About Meds (SAM) Medication Management Mobile Application: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05371548
• Other study ID #: 2022-7858
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: McGill University
• Contact: Bettina Habib, MSc MScPH
• Phone: 514-396-1156
• Email: bettina.habib[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 3,200 patients discharged from internal medicine, cardiac care, and hospitalist units of the Royal Victoria Hospital, Montreal General Hospital, and Lachine 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 nonadherence to medication changes, defined as failure to fill a new prescription, filling a modified prescription at the incorrect dose, or filling discontinued medications, as well as 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 3,200, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3200
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 change made at discharge

• Speak and read English or French

Exclusion Criteria:

• Discharged to rehab

• Transferred to a non-study unit

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Device:
• SAM mobile application
See description of intervention group

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Robyn Tamblyn	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Nonadherence to medication changes	This is a binary outcome of a patient having adhered or not to medication changes in the discharge prescription. Nonadherence to medication changes is defined as a failure to fill a new prescription within 90 days of discharge, filling a modified prescription at the incorrect dose, or filling any discontinued medication in 90 days.	90 days post-discharge
Secondary	Patient and caregiver empowerment	Patient and caregiver empowerment will be measured using the Patient Reported Outcome Measurement Information System (PROMIS) Self-Efficacy Measure for Managing Medication and Treatments (PROMIS-SE Meds). This 8-item measure assesses patient confidence in managing medication schedules of varying complexity and in challenging situations, such as when running out of supply or when adverse effects occur. Five-point ratings scales assess confidence levels. Scores are calibrated as T-scores (mean 50, SD 10), where higher scores indicate greater self efficacy.	90 days post-discharge
Secondary	Patient health-related quality of life	Patient health-related quality of life (HRQoL) will be measured using the Patient Reported Outcome Measurement Information System-29 (PROMIS-29), which measures quality of life in seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance). Five-point ratings scales assess HRQoL. Scores are calibrated as T-scores (mean 50, SD 10), where higher scores indicate greater self HRQoL.	90 days post-discharge