Collecting Outcomes and Managing Pain After Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-13

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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COMPAS Participants

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

Group Type EXPERIMENTAL

COMPAS Participants

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.