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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain Coach App Users | Experimental | Participants enrolled in Pain Coach App software and directed to download on their mobile device |
|
| Standard of Care | No Intervention | Participants received traditional standard of care supports for joint arthroplasty surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Scotia Health QEII and Dartmouth General Hospital | Dartmouth | Nova Scotia | B2T4G8 | Canada |
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| Label | URL |
|---|---|
| Pain Coach Inc. Website | View source |
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Randomized, parallel group prospective interventional study. Patient participants will be consented and then randomized to either the "treatment group" and a "control group".
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|
| Self reported Opioid usage |
Describe and compare patients' self-reported usage of opioids after surgery.
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.
| Study End |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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