Ignite Creation Date:
2024-07-17 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469177
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-17
Brief Title:
Patient Centered Post-Op Pain Management Software Tool Interventional Study Verses Standard of Care
Sponsor:
Nova Scotia Health Authority
Organization:
Nova Scotia Health Authority
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ShoulderHipKnee 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 andor 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
1 Will elective shoulder hip and knee arthroplasty patients using PainCoach App be prescribed andor 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
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 tabletThe 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 requireprefer 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None