Patient Centered Post-Op Pain Management Software Tool Interventional Study Verses Standard of Care
NCT Number: NCT06469177
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post-operative Pain, Acute|Opioid Use, Unspecified|Arthroplasty Complications|Knee Osteoarthritis|Shoulder Arthritis|Hip Arthritis
Interventions: DEVICE: Pain Coach App
Sponsor: Nova Scotia Health Authority
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-09

Summary:
The goal of this clinical trial is to learn if the Pain Coach App will result in less opioids being prescribed to and used by patients undergoing Shoulder/Hip/Knee Arthroplasty surgery while maintaining the same or better pain control versus standard of care. The main questions it aims to answer are:

1. Will elective shoulder, hip and knee arthroplasty patients using PainCoach App be prescribed and/or use less opioids, measured by total morphine milliequivalents (MME) after surgery when compared to those treated as standard of care while maintaining similar pain control?
2. Will arthroplasty surgeons using PainCoach App write more patient-specific prescriptions resulting in a reduction in opioids prescribed after surgery with no increase in further opioids prescribed in the months following surgery?
3. Will the use of Pain Coach App lead to equal or reduced healthcare system utilization after surgery?
4. Will patients and surgeons using PainCoach App find it helpful enough to use it again and recommend to colleagues, family and friends?

Researchers will compare participants assigned to use Pain Coach App vs participants assigned to standard of care arm to see if there are differences in opioid prescriptions and self reported use.

Participants will either use the Pain Coach App or follow standard of care instructions and be followed forward for the opioid prescriptions dispensed in community and self-reported opioids use at study end.

Primary Outcome Measures: Opioid Prescriptions Efficacy Information, Describe and compare immediate release opioids prescription quantities (in MME) filled by patients and surgeons using PainCoach App vs Standard of Care., At discharge, 2 weeks, 1 and 3 months after surgery.|Pain Related Adverse Effects, Assess for any Pain/Opioid related side effects by administering the QoR-15 questionnaire (see appendix to both groups and reviewing ED visits by patients in both treatment and control groups to ensure safety/efficacy of application use., Post Operative Day 2 and 30
Secondary Outcome Measures: Health Systems Usage, Describe patient reported interactions with the healthcare system including patient reported calls to surgeon's office, calls to the Orthopedic Assessment Clinic, calls to their primary care provider and calls to their pharmacy as a composite endpoint, From discharge to 90 days post-op|Self reported Opioid usage, Describe and compare patients' self-reported usage of opioids after surgery.

1. How many days after surgery did they use opioids?
2. Did the patient use all of the opioids they were prescribed? (Yes/no)

i. If no: How many opioid tablets did have left after surgery will be used to compare to amount originally filled to report absolute MME used after surgery for each treatment group., At Post Op Day 30|Surgeon Adoption, Describe satisfaction and compliance with PainCoach App prescribing tools.

1. Were surgeons satisfied with the prescriptions and progress notes provided by PainCoach App?
2. Frequency surgeon followed one of three pathways: if they used the full suggested prescription, made changes or used their default prescribing pathway ? Which will be identified via chart review., Study End