PAUSE: Sick Day Medication Management Mobile App Study

NCT06433414 | Not Yet Recruiting

• 1 other identifier: Pro000140652
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Condition; Adverse Event

Keywords

chronic condition; medication safety; sick day medication guidance

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

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

  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

  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.

  3-month follow up

Secondary Outcomes (4)

• Exploration of participant experiences of study design and intervention acceptability

  3-month follow-up

• Exploration of pharmacist experiences of study design and intervention acceptability

  3-month follow-up

• Exploration of PAUSE App-generated user behaviours and usage patterns

  Throughout the 3-month data collection period

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

  At baseline and 3-month follow-up

Other Outcomes (1)

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

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

Study Arms (2)

Usual Care

NO INTERVENTION

Participants receiving usual care will only receive the SDMG patient handout from their community pharmacist. This handout has been adapted from the Diabetes Canada "How to Stay Safe When You Are Sick" SDMG patient resource as well as the results of a modified Delphi study conducted by the research team to achieve consensus among 25 international clinicians on recommendations for SDMG for people with diabetes, kidney, or cardiovascular disease. This handout will be reviewed and refined with input from people with lived experience with the chronic conditions of interest prior to the study and is intended to provide guidance on how to self-manage medications during a sick day event.

PAUSE App Intervention

EXPERIMENTAL

Participants will receive enhanced care through onboarding and accessing the PAUSE App via the PC Health app to provide continuity of care electronically through a personalized eHealth mobile application, as well as the SDMG patient resource handout. The PAUSE App provides the same guidance as the SDMG handout, but uses algorithms tailored to identify and provide guidance specific to users' symptoms and current medications.

Other: PAUSE App

Interventions

PAUSE App OTHER

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.

PAUSE App Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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
• currently be taking 2 or more medications from the following classes: renin-angiotensin-aldosterone system (RAAS) antagonists, diuretics, oral NSAIDs, metformin, or 1 or more medications from the following classes: insulin, sulfonylureas, meglitinides, SGLT2 inhibitors.

You may not qualify if:

• have kidney failure requiring maintenance dialysis
• have had an organ transplant
• are pregnant
• receive qualifying medications in a blister pack or sachet
• do not primarily manage their own medications and condition (i.e., receive home care, in a rehabilitation or medical respite facility)
• cannot use the PC Health app independently
• previously participated in studies that led to the development of the PAUSE App (including the PAUSE study usability testing or needs assessment focus groups)

Sponsors & Collaborators

• University of Alberta: lead
• University of Calgary: collaborator

Related Publications (4)

• Watson KE, Dhaliwal K, McMurtry E, Donald T, Lamont N, Benterud E, Kung JY, Robertshaw S, Verdin N, Drall KM, Donald M, Campbell DJT, McBrien K, Tsuyuki RT, Pannu N, James MT. Sick Day Medication Guidance for People With Diabetes, Kidney Disease, or Cardiovascular Disease: A Systematic Scoping Review. Kidney Med. 2022 May 28;4(9):100491. doi: 10.1016/j.xkme.2022.100491. eCollection 2022 Sep.

  PMID: 36046611 BACKGROUND

• Watson KE, Dhaliwal K, Robertshaw S, Verdin N, Benterud E, Lamont N, Drall KM, McBrien K, Donald M, Tsuyuki RT, Campbell DJT, Pannu N, James MT; PAUSE (Preventing Medication Complications During Acute Illness Through Symptom Evaluation and Sick Day Guidance) Medication Safety Advisory Panel. Consensus Recommendations for Sick Day Medication Guidance for People With Diabetes, Kidney, or Cardiovascular Disease: A Modified Delphi Process. Am J Kidney Dis. 2023 May;81(5):564-574. doi: 10.1053/j.ajkd.2022.10.012. Epub 2022 Dec 5.

  PMID: 36470530 BACKGROUND

• Dhaliwal KK, Watson KE, Lamont NC, Drall KM, Donald M, James MT, Robertshaw S, Verdin N, Benterud E, McBrien K, Gil S, Tsuyuki RT, Pannu N, Campbell DJT. Managing 'sick days' in patients with chronic conditions: An exploration of patient and healthcare provider experiences. Health Expect. 2023 Aug;26(4):1746-1756. doi: 10.1111/hex.13789. Epub 2023 Jun 8.

  PMID: 37291977 BACKGROUND

• Watson KE, Dhaliwal K, Benterud E, Robertshaw S, Verdin N, McMurtry E, Lamont N, Drall KM, Gill S, Campbell DJT, McBrien K, Tsuyuki RT, Pannu N, James MT, Donald M. Managing Medications During "Sick Days" in Patients With Diabetes, Kidney, and Cardiovascular Conditions: A Theory-informed Approach to Intervention Design and Implementation. Can J Diabetes. 2024 Jun;48(4):259-268.e4. doi: 10.1016/j.jcjd.2024.02.003. Epub 2024 Feb 21.

  PMID: 38395301 BACKGROUND

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ross T Tsuyuki, PharmD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• David JT Campbell, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shania Liu, PhD

CONTACT

825-965-3258; shania.liu@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized controlled trial

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 29, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share