Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT04394559
Eligibility Criteria:
Inclusion Criteria:
* Adult patients admitted to orthopedic or neuro-surgical spine services at Brigham and Women's Hospital during the 6 month enrollment period
* English or Spanish speakers
* Patients who are and are not opioid-naïve for 30 days prior to admission based on their verified preadmission medication list and state-wide opioid prescription information.
* Undergo one of several designated orthopedic or spine surgeries, including trauma and arthroplasty surgeries.
* Age 18 or older
* Clinical discharge plan to home or short-term rehabilitation facility.
Exclusion Criteria:
* Not pregnant women, prisoners or institutionalized individuals
* Under the age of 18
* Current illicit opioid use.
* Patient is unable to provide informed consent, and has no available proxy
* Plan to be discharged to an acute care facility.
* Patient requires a second surgery or has medical condition requiring opioid use during the 6-month follow-up period (data are censored at time of second surgery).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04394559
Study Brief:
Protocol Section:
NCT04394559