Collecting Outcomes and Managing Pain After Surgery

NCT03834818 | Recruiting

• 1 other identifier: Pro00094157
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

opioid use; pain; surgery; orthopedic surgery; orthopedic

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• Opioid Use of Participants

  Total number of patients with self reported use of opioids.

  6 months

• Practicality of Mobile Application

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

  6 Months

Study Arms (1)

COMPAS Participants

EXPERIMENTAL

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

Behavioral: COMPAS Participants

Interventions

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

COMPAS Participants

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Orthopaedics

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Bullock, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Burke

CONTACT

+1 919 681 2849; ashley.burke@duke.edu

Michael Bullock, MD

CONTACT

+1 919 668 2024; william.bullock@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients undergoing orthopedic surgery at Duke Health will be eligible for enrollment. Additionally, all potential participants must be an adult at least 18 years of age, speak and read English, own a smartphone they are willing to use for the study, and live in the United States of America. All study assessments will take place on the app and other than baseline screening all assessments will take place after surgery until the patient stops taking opioids. Patients will be approached in the orthopedic clinic up to the day of surgery and asked if they are willing to be screened for inclusion. If they accept the screening request a link will be emailed to them or a QR code supplied that permits them to download the study app on their phone. Screening, consent, and all study data collection will occur from the app launch. All data will be collected after enrollment and consent through the Medable Research Application.

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 8, 2019
• Study Start: January 13, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)