Trial Outcomes & Findings for Mobile Application to Enhance Medication Management (NCT NCT04676165)

Last Updated: 2025-01-07

Results Overview

Users were observed as they used the app, following the "think aloud protocol". This involved users verbalizing their thoughts as they perform a standardized set of tasks, while being audio-recorded.A field assistant familiar with the SAM app observed and recorded users as they accessed SAM and completed the following standardized tasks: log in, peruse drug information, send the pharmacist a message, add a medication review, use the interaction checker, and use the side effect checker. User performance was observed and registered by a trained research assistant to establish if the user was able to complete the task and to determine the ease/difficulty with which the task was completed, rated in 1-to-4 scale as (1) user can do it perfectly, without any help, (2) user can do it with difficulty but without help, (3) user can do it with difficulty and help, and (4) user cannot do it.

Recruitment status

COMPLETED

Study phase

Target enrollment

66 participants

Primary outcome timeframe

At baseline, prior to hospital discharge

Results posted on

2025-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	SAM Intervention Group At discharge from hospital, patients (and/or caregivers) received access to Smart About Meds (SAM), a medication management mobile application that has been developed by the McGill Clinical and Health Informatics (MCHI) Research Group.	Usual Care Group At discharge from hospital, patients were provided with a written discharge prescription to be filled at their community pharmacy, and may or may not have received written or verbal instructions about changes made to therapy.
Overall Study STARTED	34	32
Overall Study COMPLETED	23	26
Overall Study NOT COMPLETED	11	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SAM Intervention Group n=23 Participants At discharge from hospital, patients (and/or caregivers) received access to Smart About Meds (SAM), a medication management mobile application that has been developed by the McGill Clinical and Health Informatics (MCHI) Research Group.	Usual Care Group n=26 Participants At discharge from hospital, patients were provided with a written discharge prescription to be filled at their community pharmacy, and may or may not have received written or verbal instructions about changes made to therapy.	Total n=49 Participants Total of all reporting groups
Age, Continuous	54.6 years n=23 Participants	68.6 years n=26 Participants	64.6 years n=49 Participants
Sex: Female, Male Female	11 Participants n=23 Participants	8 Participants n=26 Participants	19 Participants n=49 Participants
Sex: Female, Male Male	12 Participants n=23 Participants	18 Participants n=26 Participants	30 Participants n=49 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Participant has caregiver	1 Participants n=23 Participants	7 Participants n=26 Participants	8 Participants n=49 Participants
ED visit in 3 months prior to admission	15 Participants n=23 Participants	14 Participants n=26 Participants	29 Participants n=49 Participants
Hospitalization in 3 months prior to admission	5 Participants n=23 Participants	5 Participants n=26 Participants	10 Participants n=49 Participants
Number of medications prescribed at discharge	13.0 medications n=23 Participants	15.5 medications n=26 Participants	15.0 medications n=49 Participants
Number of medications continued at discharge	6.0 medications n=23 Participants	11.5 medications n=26 Participants	9.0 medications n=49 Participants
Number of medications changed at discharge	6.0 medications n=23 Participants	7.0 medications n=26 Participants	7.0 medications n=49 Participants
Number of new medications at discharge	3.0 medications n=23 Participants	3.0 medications n=26 Participants	3.0 medications n=49 Participants
Number of dose changes at discharge	1.0 medications n=23 Participants	1.0 medications n=26 Participants	1.0 medications n=49 Participants
Number of discontinued medications at discharge	2.0 medications n=23 Participants	2.0 medications n=26 Participants	2.0 medications n=49 Participants

PRIMARY outcome

Timeframe: At baseline, prior to hospital discharge

Population: This analysis population included 31 patients who consented to participate in the pilot and who were randomized to the intervention group and baseline and were successfully administered the questionnaire. It includes some individuals who were withdrawn from the study following randomization for various reasons (e.g. withdrew consent, discharged to a rehabilitation center, transferred to a non-study unit) and not included in other outcome analysis populations.

Outcome measures

Outcome measures
Measure	SAM Intervention Group n=31 Participants At discharge from hospital, patients (and/or caregivers) received access to Smart About Meds (SAM), a medication management mobile application that has been developed by the McGill Clinical and Health Informatics (MCHI) Research Group.	Usual Care Group At discharge from hospital, patients were provided with a written discharge prescription to be filled at their community pharmacy, and may or may not have received written or verbal instructions about changes made to therapy.
Usability of the SAM App Severity scale mean, send a message	1.35 score on a scale Standard Deviation 0.65	—
Usability of the SAM App Severity scale mean, review a medication	1.81 score on a scale Standard Deviation 1.09	—
Usability of the SAM App Severity scale mean, check side effects of a specific medication	1.13 score on a scale Standard Deviation 0.45	—
Usability of the SAM App Severity scale mean, check side effect profile of all medications (side effect checker)	1.71 score on a scale Standard Deviation 0.88	—
Usability of the SAM App Severity scale mean, use interaction checker	1.17 score on a scale Standard Deviation 0.37	—
Usability of the SAM App Severity scale mean, login	1.14 score on a scale Standard Deviation 0.51	—
Usability of the SAM App Severity scale mean, view drug information	1.32 score on a scale Standard Deviation 0.74	—

PRIMARY outcome

Timeframe: 2 weeks post-discharge

Population: This analysis population includes individuals who consented to participate in the pilot, were randomized to the intervention group at baseline, and who at 2 week post-discharge agreed to complete the TAM questionnaire. Only 12 of the 23 participants in the intervention group were reachable and agreed to complete the questionnaire at this point during follow-up.

Participants in the intervention arm completed the Technology Acceptance Model (TAM) Questionnaire 2 weeks following discharge from hospital. The questionnaire measures users' perceived ease of use and perceived usefulness of the SAM app and their intention to use the app. The TAM questionnaire is self-administered, and consists of 38 questions on a Likert scale of 1 to 7, with responses being strongly agree (7), moderately agree (6), somewhat agree (4), neutral (4), somewhat disagree (3), moderately disagree (2), and strongly disagree (1). Responses higher on the Likert scale typically reflected higher acceptance, usability, perceived usefulenss of the app, and intent to use the app from users' perspectives.

Outcome measures

Outcome measures
Measure	SAM Intervention Group n=12 Participants At discharge from hospital, patients (and/or caregivers) received access to Smart About Meds (SAM), a medication management mobile application that has been developed by the McGill Clinical and Health Informatics (MCHI) Research Group.	Usual Care Group At discharge from hospital, patients were provided with a written discharge prescription to be filled at their community pharmacy, and may or may not have received written or verbal instructions about changes made to therapy.
User Acceptance of and Satisfaction With the SAM App TAM domain: behavioral intention	5.17 score on a scale Standard Deviation 2.12	—
User Acceptance of and Satisfaction With the SAM App TAM domain: perceived usefulness	5.29 score on a scale Standard Deviation 2.11	—
User Acceptance of and Satisfaction With the SAM App TAM domain: subjective norm	3.81 score on a scale Standard Deviation 1.74	—
User Acceptance of and Satisfaction With the SAM App TAM domain: relevance	4.86 score on a scale Standard Deviation 1.78	—
User Acceptance of and Satisfaction With the SAM App TAM domain: output quality	5.44 score on a scale Standard Deviation 1.65	—
User Acceptance of and Satisfaction With the SAM App TAM domain: result demonstrability	5.06 score on a scale Standard Deviation 1.82	—
User Acceptance of and Satisfaction With the SAM App TAM domain: computer self-efficacy	5.60 score on a scale Standard Deviation 2.00	—
User Acceptance of and Satisfaction With the SAM App TAM domain: perceived ease of use	5.65 score on a scale Standard Deviation 2.02	—
User Acceptance of and Satisfaction With the SAM App TAM domain: perceived enjoyment	5.34 score on a scale Standard Deviation 1.97	—

PRIMARY outcome

Timeframe: 30 days post-discharge

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. For each type of medication change, the number of changes among all patients will be counted (e.g. number of newly prescribed medications among the patient population), and the number of those that were properly adhered to will then be used to calculate the proportion of medication changes that were adhered to.

Outcome measures

Outcome measures
Measure	SAM Intervention Group n=23 Participants At discharge from hospital, patients (and/or caregivers) received access to Smart About Meds (SAM), a medication management mobile application that has been developed by the McGill Clinical and Health Informatics (MCHI) Research Group.	Usual Care Group n=26 Participants At discharge from hospital, patients were provided with a written discharge prescription to be filled at their community pharmacy, and may or may not have received written or verbal instructions about changes made to therapy.
Proportion of Medication Changes That Are Adhered to Proportion of all medication changes adhered to	0.837 proportion of medication changes	0.778 proportion of medication changes
Proportion of Medication Changes That Are Adhered to Proportion of all new medications adhered to	0.727 proportion of medication changes	0.617 proportion of medication changes
Proportion of Medication Changes That Are Adhered to Proportion of all dose changes adhered to	0.909 proportion of medication changes	0.818 proportion of medication changes
Proportion of Medication Changes That Are Adhered to Proportion of all discontinued medications adhered to	0.935 proportion of medication changes	0.943 proportion of medication changes

Adverse Events

SAM Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bettina Habib, Research Project Manager

McGill University

Phone: 514-396-1156

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place