Collecting Outcomes and Managing Pain After Surgery

Not Applicable

Not yet recruiting

• Conditions: Surgery
• Interventions: Behavioral: COMPAS Participants

• Registration Number: NCT03834818
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-06
• Study First Submitted QC: 2019-02-06
• Study First Posted: 2019-02-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27
• Study Start: 2025-01-01
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

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.

Read More

Exclusion Criteria

• Lacking capacity to provide consent.
• Cannot read English
• Under 18 years of age
• Older than 90 years of age

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COMPAS Participants	COMPAS Participants	Patents between the ages of 18 and 90 who are undergoing orthopedic surgery at Duke Health will be eligible for enrollment.

Primary Outcome Measures

Name	Time	Method
Opioid Use of Participants	6 months	Total number of patients with self reported use of opioids.
Reported Pain of Participants measured via PROMIS-29	6 Months	One question on an 11-point rating scale for pain intensity, with 0 meaning "no pain" and 10 meaning "worst imaginable pain".
Reported Pain of Participants measured via Pain Catastrophizing pain scale.	6 Months	Statements regarding pain are rated on a scale from 0 to 4 with 0 meaning "not at all" and 4 meaning "all the time"
Practicality of Mobile Application	6 Months	How long participants actively use the app to track their opined use and pain.

Trial Locations

Locations (1)

Duke Orthopaedics; 🇺🇸 Durham, North Carolina, United States