Mobile Application to Enhance Medication Management

Medication Adherence Clinical Trial

— SAM  

Official title:

Evaluation of a Mobile Application to Enhance Medication Management Following Hospital Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04676165
• Other study ID #: 2-53
• Status: Completed
• Phase: N/A
• Start date: June 4, 2019
• Est. completion date: April 17, 2020

Study information

• Verified date: December 2020
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 17, 2020
• Est. primary completion date: April 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Adherence
• Mobile Application

Intervention

Device:
• 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

Locations

Country	Name	City	State
Canada	McGill University Health Centre (MUHC)	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability of the SAM app	Users will be observed as they use the app, following the "think aloud protocol". This involves users verbalizing their thoughts as they perform a standardized set of tasks, while being audio-recorded. In this pilot, a field assistant familiar with the SAM app will observe and record users as they access SAM and complete the following standardized tasks: view medications lists and dosing schedule, peruse drug information, and examine alerts. Each session will be transcribed and transcriptions will be qualitatively analyzed to assess the following usability concepts: (1) ease of use, (2) user-friendliness, (3) efficiency, and (4) features that may cause confusion, frustration, or user errors.	1 week post-discharge
Primary	User acceptance of and satisfaction with the SAM app	Participants in the intervention arm will complete the Technology Acceptance Model (TAM) Questionnaire 1 week following discharge from hospital. The questionnaire was developed using the TAM 1, 2, and 3, which were developed by Davis (1989), Venkatesh & Davis (2000), and Venkatesh and Bala (2008), respectively. The questionnaire is self-administered and consists of 38 questions, each of which is on a Likert scale of 1 (strongly disagree) to 7 (strongly agree). The questionnaire assesses users' satisfaction with the application and its usability.; TAM 1 - Davis (1989) Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology; TAM 2 - Venkatesh & Davis (2000) A Theoretical Extension of the Technology Acceptance Model: Four Longitudinal Field Studies; TAM 3 - Venkatesh & Bala (2008) Technology Acceptance Model 3 and a Research Agenda on Interventions	1 week post-discharge
Primary	Proportion of medication changes that are adhered to	Pharmacy claims data from the public insurance provider will be used to identify community medications dispensed to participating patients in the 30 days following hospital discharge. These data will be compared with the patient's hospital discharge prescription to identify non-adherence to in-hospital medication changes. Non-adherence to in-hospital treatment changes in the 30-day post-discharge period will be defined as (1) failure to fill newly prescribed medications, (2) re-filling a previous prescription that was stopped at discharge, or (3) filling a previous prescription whose dosage was modified at discharge, but was dispensed post-discharge at the incorrect daily dose.	30 days post-discharge