Surgery
Conditions
Keywords
opioid use, pain, surgery, orthopedic surgery, orthopedic
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.
Interventions
BEHAVIORALCOMPAS 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
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reported Pain of Participants measured via PROMIS-29 | 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". |
| Reported Pain of Participants measured via Pain Catastrophizing pain scale. | 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" |
| Opioid Use of Participants | 6 months | Total number of patients with self reported use of opioids. |
| Practicality of Mobile Application | 6 Months | How long participants actively use the app to track their opined use and pain. |
Countries
United States
Contacts
CONTACTAshley Burke
CONTACTMichael Bullock, MD
PRINCIPAL_INVESTIGATORMichael Bullock, MD
Duke University
Outcome results
None listed