Collecting Outcomes and Managing Pain After Surgery

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT03834818
Status
Recruiting

Conditions

  • Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jan 13, 2025
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
10,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: 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 Measure

Reported Pain of Participants measured via PROMIS-29 [ Time Frame: 6 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke OrthopaedicsDurhamNorth Carolina27710
Neil D Ray, MD
919-681-1924

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