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NCT Number: NCT03834818

Collecting Outcomes and Managing Pain 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.

Recruiting

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Key information

Conditions

Surgery Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Orthopaedics

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Neil D Ray, MD

CONTACT

[email protected]

919-681-1924

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COMPAS Participants

Behavioral

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

Primary outcomes

  1. 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".

  2. 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".

  3. 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"

  4. Opioid Use of Participants

    Time frame: 6 months

    Total number of patients with self reported use of opioids.

  5. Practicality of Mobile Application

    Time frame: 6 Months

    How long participants actively use the app to track their opined use and pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Burke

CONTACT

[email protected]

+1 919 681 2849

Michael Bullock, MD

CONTACT

[email protected]

+1 919 668 2024

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study 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

Acronym: COMPAS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 8, 2019
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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