Patient Centered Post-Op Pain Management Software Tool Interventional Study Verses Standard of Care

Patient Centered Post-operative Pain Management Software Tool Vs Standard of Care: a Controlled Clinical Trial in Elective Shoulder, Hip and Knee Arthroplasty Patients.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Knee Osteoarthritis; Arthroplasty Complications; Hip Arthritis; Opioid Use, Unspecified; Shoulder Arthritis; Post-operative Pain, Acute
• Intervention / Treatment: Device: Pain Coach App

Detailed Description

This will be a randomized, parallel group prospective interventional study. Patient participants will be consented and then randomized using a tool built into RedCap to either the "treatment group" and a "control group". The treatment group will be sent an email with instructions to set up a Pain Coach Account and download the app onto their mobile device. (Phone or tablet)The control group will not be offered Pain Coach technology and will just follow the usual care pathway for arthroplasty patients. When a participant in the treatment arm completes the initial questionnaire within the app (known as the Pain Coach Profile) this information will be used by a pharmacist in the study to create a suggested prescription for that patient. This suggested prescription will be provided to the patients surgeon for them to review and either accept, edit or discard based on their own clinical judgement.- For the rest of the study the patients in the treatment arm will have access to the Pain Coach app functionalities and use them as they require/prefer. A survey will be sent to both treatment and control groups after their surgery on Post Op Day 2 and 30 to assess pain control. There will be an interim analysis once 281 participants have been recruited into each treatment arm. At this point a retrospective chart review will be used to identify ED related visits for surgical pain within 90 days will be compared between groups at 6 months, also the amount of opioids prescribed (and number of refills) up to 3 months after surgery will be recorded and compared between groups. If at this point there is a statistically significant difference between groups the study will end early. Otherwise it will control until 561 participants are assigned to each group. This will provide 80% power to detect a minimally clinically important difference of 10% reduction in opioid prescribing between groups.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Dartmouth, Nova Scotia, Canada, B2T4G8
      • Nova Scotia Health QEII and Dartmouth General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Elective total shoulder (day surgery only), hip or knee arthroplasty completed within NSH, starting at the HI or DGH
• OR date for surgery is known and booked
• Able to access the internet via mobile device (has access to smart phone)
• If expresses concern about low tech IQ, has a support person available
• Able to read and write in English

Exclusion Criteria:

• Non-elective arthroplasty surgery procedures (trauma, fractures)
• Bilateral knee or hip arthroplasty
• Unable to read or write in English
• Lacks capacity to provide consent due to cognitive impairment
• No access to internet or mobile device to use self-help pain management tools
• Inpatient Shoulder arthroplasty as residents write these discharge prescriptions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain Coach App Users; Participants enrolled in Pain Coach App software and directed to download on their mobile device	Device: Pain Coach App; Pain Coach App is a mobile application that offers patients undergoing shoulder, hip and knee arthroplasty surgery preoperative educational tools and questionnaires to provide patient specific details to their surgeons for prescribing purposes as well as post operative pain assessment and medication reminders/tracking, problem troubleshooting and a resource library for further pain management tools and education.
No Intervention: Standard of Care; Participants received traditional standard of care supports for joint arthroplasty surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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.; How many days after surgery did they use opioids?; 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.; Were surgeons satisfied with the prescriptions and progress notes provided by PainCoach App?; 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

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority

Publications and helpful links

Helpful Links

• Pain Coach Inc. Website

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Joint Diseases; Pain, Postoperative; Arthritis
• Other Study ID Numbers: 64876

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No