PAUSE: Sick Day Medication Management Mobile App Study

ConditionsChronic Condition Adverse Event

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-99

SponsorUniversity of Alberta

About this trial

Diabetes, heart disease and kidney disease have high morbidity and costs of care. Medications used to treat these conditions are effective. Yet, some have the risk of preventable adverse events when people are sick with the flu or stomach bug. These events include low blood sugar and acute kidney injury which can lead to extended hospital stays or death. Sick day medication guidance (SDMG) recommends stopping these medications temporarily when sick and restarted after symptoms subside. Unfortunately, many patients are not aware of these recommendations or find them hard to follow.

The investigator's previous research has shown that there is a lack of SDMG education and patient resources. Research on the development, implementation, usability and efficacy of these resources is also limited. In developing a SDMG tool, the investigators surveyed patients who expressed interest in an electronic health (eHealth) tool. As a result, the PAUSE App provides a timely and innovative way to provide continuity of care to patients that is linked to each patients' unique pharmacy record.

In the present pilot randomized control trial, the investigators will examine the outcomes of the PAUSE Initiative consisting of the PAUSE App and a SDMG educational handout. Approximately 16 Loblaw/Shoppers Drug Mart pharmacies across Alberta will take part. Patients of these pharmacies who take high-risk medications will be invited to participate. Each pharmacy will be randomized to provide their patients usual care (i.e. SDMG handout) or the intervention (i.e., PAUSE App + handout). Approximately 320 participants (20 per pharmacy) are expected to be recruited. The expected trial length is 9 months from recruitment to analysis.

A simulated 'sick day' survey will be used to assess the fidelity and efficacy of the PAUSE Initiative. Feasibility of the study processes (i.e., recruitment, onboarding) will be assessed to inform a full-scale trial. The usability and acceptability of the PAUSE App will also be investigated. Pharmacists and participants will complete questionnaires and qualitative interviews to assess these outcomes. Additionally, PAUSE App user metrics will be collected. All participants will receive an honorarium for their time.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years of age and able to provide informed consent

be able to communicate (read, write, and speak) in English

have access to a smartphone/tablet with an Internet connection

be willing and able to download and use the PC Health app for the duration of the study

Disqualifiers

fail to meet the inclusion criteria

have kidney failure requiring maintenance dialysis

have had an organ transplant

are pregnant

Trial design

Design model

Parallel

Treatments tested in this trial

PAUSE App
Other intervention
Participants receiving the intervention will receive access to the PAUSE App, a self-management tool for SDMG intended for patients to use during an acute illness. The app asks users a series of questions regarding signs and symptoms that identify a qualifying sick day illness, and screens for 'red flags' that would require emergency, or HCP or urgent care referral, and help patients identify which of their medications they should temporarily withhold or adjusted, tailored to a patients' current medication list. This aims to provide patients with interactive support for managing medication during a sick day event. As part of the intervention, patients will also receive a SDMG patient handout. The intervention addresses the previously identified challenges described above via an interactive and individualized electronic application designed to facilitate provision of SDMG.

Treatment groups

320 Participants

are divided into 2 treatment groups

Group A: Usual CareNo intervention 0 interventions

Group B: PAUSE App InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Recruitment rate

Two to three patient participants on average per pharmacy per week can be recruited (320 patients from 16 pharmacies over 8 weeks)

Time frame

3-month follow up

Time to randomization

≥90% of study participants receive the intervention (SDMG handout, PAUSE App onboarding) to which they are randomized within 1 week of giving informed consent

Time frame

3-month follow up

Adherence to SDMG

≥50% of study participants randomized to pharmacies using the PAUSE app follow SDMG error-free during the simulated sick day evaluation.

Time frame

3-month follow up

Secondary outcomes

Exploration of participant experiences of study design and intervention acceptability

Semi-structured participant interviews will be undertaken to explore themes related to study design elements, such as pharmacist onboarding and education, and barriers and facilitators to understanding and usability of the PAUSE App intervention/SDMG tools. Coded concepts will be synthesized into overall themes inductively to form a comprehensive description of the data.

Time frame

3-month follow-up

Exploration of pharmacist experiences of study design and intervention acceptability

Semi-structured pharmacist interviews will be undertaken to explore themes related to study design elements, such as onboarding procedures and education components, and experiences interacting with patients regarding the PAUSE App intervention and SDMG education. Coded concepts will be synthesized into overall themes inductively to form a comprehensive description of the data.

Time frame

3-month follow-up

Exploration of PAUSE App-generated user behaviours and usage patterns

Routinely collected, app-generated Google Analytics data will be captured over the data collection period to explore summary data trends, including but not limited to: total number of app visits, session duration, clicks on various pages within the app, time of day most frequently used, PDF (e.g., sick day guidance resources) downloads, and in-app engagement.

Time frame

Throughout the 3-month data collection period

Exploration of the efficacy of the intervention in managing a simulated sick day event

Pre- and post-intervention evaluation of paraticipant medication self-management using a 13-item Self-efficacy for Appropriate Medication Use Scale (SEAMS-13) survey.

Time frame

At baseline and 3-month follow-up

Other outcomes

Exploration of future health outcomes summary data resultant of adverse drug-related events

Utilization of future health summary and administrative data to determine the difference, if any, of the intervention on all-cause health outcomes. Proposed collected summary data may include: * Increases in serum creatinine (mg/dl) based on the 2012 Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guidelines for AKI and AKD (i.e., \>/= 0.3 mg/dl increase or 1.5-1.9x baseline serum creatinine) * Hospital admissions and emergency department data related to AKI and/or SDMG-related health outcomes * Vital statistics (e.g., death records) summary data related to AKI * Prescription medication history summary data related to AKI, worsening chronic conditions and/or SDMG

Time frame

Over an extended follow-up period of 5 years, or death (whichever comes first)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

University of Calgary

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: