Post-operative Pain, AcuteNCT06469177
Patient Centered Post-Op Pain Management Software Tool Interventional Study Verses Standard of Care
A study testing Pain Coach App in people with Post-operative Pain, Acute and Opioid Use, Unspecified, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Acute, Opioid Use, Unspecified, Arthroplasty Complications
- What is being tested?
- Pain Coach App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jan 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Nova Scotia Health QEII and Dartmouth General Hospital
Dartmouth, Nova Scotia, B2T4G8
About this study
Official title: 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:
- 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?
- 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?
- Will the use of Pain Coach App lead to equal or reduced healthcare system utilization after surgery?
- Will patients and surgeons using PainCoach App find it helpful enough to use it again and recommend to colleagues, family and friends?
Read more
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.
Read the 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.
- Conditions
- Post-operative Pain, Acute, Opioid Use, Unspecified, Arthroplasty Complications, Knee Osteoarthritis, Shoulder Arthritis, Hip Arthritis
- Being tested
- Pain Coach App
- Medical subject headings
- Pain, Postoperative, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Coach AppDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pain Coach App Users | Experimental | Participants enrolled in Pain Coach App software and directed to download on their mobile device Receives: Device: Pain Coach App |
| Standard of Care | No intervention | Participants received traditional standard of care supports for joint arthroplasty surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Post Operative Day 2 and 30
Secondary outcomes (3)
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
Measured: 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)
- 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.
Measured: 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.
Measured: Study End
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start7 Jan 2025
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel group prospective interventional study. Patient participants will be consented and then randomized to either the "treatment group" and a "control group".
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469177
- Sponsor's protocol ID
- 64876
- Status last verified
- Feb 2025
- First submitted
- 17 Jun 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centered Post-operative Pain Management Software Tool Vs Standard of Care: a Controlled Clinical Trial in Elective Shoulder, Hip and Knee Arthroplasty Patients.
- ClinicalTrials.gov ID
- NCT06469177
- Acronym / sponsor ID
- 64876
- Conditions
- Post-operative Pain, Acute, Opioid Use, Unspecified, Arthroplasty Complications, Knee Osteoarthritis, Shoulder Arthritis, Hip Arthritis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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?
- Will the use of Pain Coach App lead to equal or reduced healthcare system utilization after surgery?
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, parallel group prospective interventional study. Patient participants will be consented and then randomized to either the "treatment group" and a "control group".
| Arm | Type | Receives |
|---|---|---|
| Pain Coach App Users | Experimental | Device: Pain Coach AppParticipants 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Coach AppPain 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. | Device | Pain Coach App Users |
Primary outcome
Opioid Prescriptions Efficacy Information
Time frame: At discharge, 2 weeks, 1 and 3 months after surgery.
Describe and compare immediate release opioids prescription quantities (in MME) filled by patients and surgeons using PainCoach App vs Standard of Care.
Pain Related Adverse Effects
Time frame: Post Operative Day 2 and 30
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.
3 secondary outcomes
Health Systems Usage
Time frame: From discharge to 90 days post-op
Self reported Opioid usage
Time frame: At Post Op Day 30
Surgeon Adoption
Time frame: Study End
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Pain Coach Inc. WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Coach App in people with Post-operative Pain, Acute and Opioid Use, Unspecified, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Prescriptions Efficacy Information (time frame: At discharge, 2 weeks, 1 and 3 months after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.