Smart About Meds (SAM) RCT

Официальное название

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

Обзор

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.

Вмешательства

• Устройство SAM mobile application
  See description of intervention group

Первичные конечные точки

• ED visits, hospital readmissions, and deaths (composite) [Срок оценки: 90 days post-discharge]

Вторичные конечные точки (5)

• Individual components of the primary composite outcome [Срок оценки: 90 days post-discharge]
• Nonadherence to medication changes [Срок оценки: 90 days post-discharge]
• Secondary adherence [Срок оценки: 90 days post-discharge]
• Patient and caregiver empowerment [Срок оценки: 90 days post-discharge]
• Patient health-related quality of life [Срок оценки: 90 days post-discharge]

Критерии участия

Критерии включения

• 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+

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Канада · 1 центр

• McGill University Health Centre — Montreal

Публикации

• 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

Идентификаторы

NCT: NCT05371548 · 2022-7858

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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