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

NCT06469177 | Enrolling By Invitation

• 1 other identifier: 64876
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.Will the use of Pain Coach App lead to equal or reduced healthcare system utilization after surgery?
4. 4.Will patients and surgeons using PainCoach App find it helpful enough to use it again and recommend to colleagues, family and friends?

Conditions

Post-operative Pain, Acute; Opioid Use, Unspecified; Arthroplasty Complications; Knee Osteoarthritis; Shoulder Arthritis; Hip Arthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Health Systems Usage

  From discharge to 90 days post-op

• Self reported Opioid usage

  At Post Op Day 30

• Surgeon Adoption

  Study End

Study Arms (2)

Pain Coach App Users

EXPERIMENTAL

Participants enrolled in Pain Coach App software and directed to download on their mobile device

Device: Pain Coach App

Standard of Care

NO INTERVENTION

Participants received traditional standard of care supports for joint arthroplasty surgery

Interventions

Pain Coach App DEVICE

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.

Pain Coach App Users

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health QEII and Dartmouth General Hospital

Dartmouth, Nova Scotia, B2T4G8, Canada

Location

Related Links

• Pain Coach Inc. Website

MeSH Terms

Conditions

Pain, Postoperative; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

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

Model Details: Randomized, parallel group prospective interventional study. Patient participants will be consented and then randomized to either the "treatment group" and a "control group".

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 21, 2024
• Study Start: January 7, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)