Clinical trial NCT05371548: Smart About Meds (SAM) RCT
Official title: Evaluating the Effectiveness of the Smart About Meds (SAM) Medication Management Mobile Application: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medication Adherence
Keywords: medication adherence
mobile application
medication management
patient empowerment
randomized controlled trial
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-05-12
Enrollment: 3250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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 prescribed at discharge
* Speak and read English or French
* Age 18+

Exclusion Criteria:

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

Primary outcomes:
measure: ED visits, hospital readmissions, and deaths (composite)
timeFrame: 90 days post-discharge
Secondary outcomes:
measure: Individual components of the primary composite outcome
timeFrame: 90 days post-discharge
measure: Nonadherence to medication changes
timeFrame: 90 days post-discharge
measure: Secondary adherence
timeFrame: 90 days post-discharge
measure: Patient and caregiver empowerment
timeFrame: 90 days post-discharge
measure: Patient health-related quality of life
timeFrame: 90 days post-discharge
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
References: