Collecting Outcomes and Managing Pain After Surgery

Surgery Clinical Trial

— COMPAS  

Official title:

COMPAS Trial. Collecting Outcomes and Managing Pain After Surgery: Predicting Patients at High Risk for Chronic Opioid Use and Creating Algorithms to Responsibly Tailor Opioid Prescribing and Weaning After Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03834818
• Other study ID #: Pro00094157
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: April 2025

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: Ashley Burke
• Phone: +1 919 681 2849
• Email: ashley.burke[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to measure pain and psychosocial patient reported outcomes, objective functionality, and actual daily at home opioid usage in orthopedic patients. The study's goal following the data collection is to predict which patients are at high risk for chronic opioid use.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• aged 18-90 years old who are undergoing elective orthopedic surgery at Duke Health.

• Patients must have their own smartphone IOS or Android device.

• Patients must be able to read English.

Exclusion Criteria:

• Lacking capacity to provide consent.

• Cannot read English

• Under 18 years of age

• Older than 90 years of age

Related Conditions & MeSH terms

• Surgery

Intervention

Behavioral:
• COMPAS Participants
The schedule of events for this study are as follows: Day 1 Pre-Surgery: Download the Medable App Register to the study Validated Questionnaires Active Task Every Day 9:00 a.m. Daily Questions 9:00 p.m. Daily Questions Outcome Surveys and Active Task: Day 1 Pre-Surgery 1-Week Post Operation 2-Weeks Post Operation 1-Month Post Operation 3-Months Post Operation 6-Months Post Operation

Locations

Country	Name	City	State
United States	Duke Orthopaedics	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reported Pain of Participants measured via PROMIS-29	28 Questions regarding pain are ranked on a 5-point Likert Scale with 1 meaning "not at all" and 5 meaning "very much".	6 Months
Primary	Reported Pain of Participants measured via PROMIS-29	One question on an 11-point rating scale for pain intensity, with 0 meaning "no pain" and 10 meaning "worst imaginable pain".	6 Months
Primary	Reported Pain of Participants measured via Pain Catastrophizing pain scale.	Statements regarding pain are rated on a scale from 0 to 4 with 0 meaning "not at all" and 4 meaning "all the time"	6 Months
Primary	Opioid Use of Participants	Total number of patients with self reported use of opioids.	6 months
Primary	Practicality of Mobile Application	How long participants actively use the app to track their opined use and pain.	6 Months