Collecting Outcomes and Managing Pain After Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: COMPAS Participants.
- Who it may be relevant to
- Registry conditions: Surgery. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- 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
Primary outcome measures
- Reported Pain of Participants measured via PROMIS-29 [Time frame: 6 Months]
- Reported Pain of Participants measured via PROMIS-29 [Time frame: 6 Months]
- Reported Pain of Participants measured via Pain Catastrophizing pain scale. [Time frame: 6 Months]
- Opioid Use of Participants [Time frame: 6 months]
- Practicality of Mobile Application [Time frame: 6 Months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Duke Orthopaedics — Durham
Identifiers
NCT: NCT03834818 · Pro00094157