Collecting Outcomes and Managing Pain After Surgery (COMPAS)

June 26, 2024 updated by: Duke University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Orthopaedics
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COMPAS Participants
Patents between the ages of 18 and 90 who are undergoing orthopedic surgery at Duke Health will be eligible for enrollment.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reported Pain of Participants measured via PROMIS-29
Time Frame: 6 Months
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
Reported Pain of Participants measured via PROMIS-29
Time Frame: 6 Months
One question on an 11-point rating scale for pain intensity, with 0 meaning "no pain" and 10 meaning "worst imaginable pain".
6 Months
Reported Pain of Participants measured via Pain Catastrophizing pain scale.
Time Frame: 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"
6 Months
Opioid Use of Participants
Time Frame: 6 months
Total number of patients with self reported use of opioids.
6 months
Practicality of Mobile Application
Time Frame: 6 Months
How long participants actively use the app to track their opined use and pain.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Michael Bullock, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

February 6, 2019

First Submitted That Met QC Criteria

February 6, 2019

First Posted (Actual)

February 8, 2019

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00094157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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