Medication AdherenceSAMNCT04676165
Mobile Application to Enhance Medication Management
A study testing Smart About Meds (SAM) in people with Medication Adherence and Mobile Application, run by McGill University at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Mobile Application
- What is being tested?
- Smart About Meds (SAM)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jun 2019to 17 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Discharged to a rehabilitation center
- Transferred to a non-study unit'
- Prognosis of less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Mobile Application to Enhance Medication Management Following Hospital Discharge
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.
Read more
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.
- Conditions
- Medication Adherence, Mobile Application
- Being tested
- Smart About Meds (SAM)
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart About Meds (SAM)Device
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
| Study group | Role | What they receive |
|---|---|---|
| SAM Group | Experimental | At discharge from hospital, patients (and/or caregivers) will receive 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. Receives: Device: Smart About Meds (SAM) |
| Usual Care Group | No intervention | At discharge from hospital, patients will be provided with a written discharge prescription to be filled at their community pharmacy, and may or may not receive written or verbal instructions about changes made to therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the SAM App
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.
Measured: At baseline, prior to hospital discharge
User Acceptance of and Satisfaction With the SAM App
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.
Measured: 2 weeks post-discharge
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. 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.
Measured: 30 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start4 Jun 2019
- Primary completion17 Apr 2020
- Study completion17 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Principal investigator, Robyn Tamblyn, McGill University
- Investigators
- Robyn Tamblyn, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676165
- Sponsor's protocol ID
- 2-53
- Acronym
- SAM
- Status last verified
- Nov 2024
- First submitted
- 9 Dec 2020
- Last updated
- 7 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Habib B, Buckeridge D, Bustillo M, Marquez SN, Thakur M, Tran T, Weir DL, Tamblyn R. Smart About Meds (SAM): a pilot randomized controlled trial of a mobile application to improve medication adherence following hospital discharge. JAMIA Open. 2021 Jul 31;4(3):ooab050. doi: 10.1093/jamiaopen/ooab050. eCollection 2021 Jul.
PubMed 34345805
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Mobile Application to Enhance Medication Management Following Hospital Discharge
- ClinicalTrials.gov ID
- NCT04676165
- Acronym / sponsor ID
- SAM / 2-53
- Conditions
- Medication Adherence, Mobile Application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 17 Apr 2020 (actual)
- Study completion
- 17 Apr 2020 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Posted 7 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAM Group | Experimental | Device: Smart About Meds (SAM)At discharge from hospital, patients (and/or caregivers) will receive 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 | No intervention | –At discharge from hospital, patients will be provided with a written discharge prescription to be filled at their community pharmacy, and may or may not receive written or verbal instructions about changes made to therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Discharged to a rehabilitation center
- Transferred to a non-study unit'
- Prognosis of less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | SAM Group |
Primary outcome
Usability of the SAM App
Time frame: At baseline, prior to hospital discharge
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.
User Acceptance of and Satisfaction With the SAM App
Time frame: 2 weeks post-discharge
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.
Proportion of Medication Changes That Are Adhered to
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34345805Habib B, Buckeridge D, Bustillo M, Marquez SN, Thakur M, Tran T, Weir DL, Tamblyn R. Smart About Meds (SAM): a pilot randomized controlled trial of a mobile application to improve medication adherence following hospital discharge. JAMIA Open. 2021 Jul 31;4(3):ooab050. doi: 10.1093/jamiaopen/ooab050. eCollection 2021 Jul.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn Tamblyn, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart About Meds (SAM) in people with Medication Adherence and Mobile Application, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the SAM App (time frame: At baseline, prior to hospital discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04676165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.