Perioperative Recovery of Moods, Opioids, and Pain Trial (PROMPT) (NCT02070003) | Clinical Trial Compass
CompletedNot Applicable
Perioperative Recovery of Moods, Opioids, and Pain Trial (PROMPT)
United States104 participantsStarted 2014-11-26
Plain-language summary
The investigators aim to characterize the relationship between changes in emotional distress, opioid use, and pain throughout surgery and recovery. Additionally, the investigators aim to compare the effectiveness of post-surgical motivational interviewing and physician-guided opioid weaning vs. usual care on reducing persistent opioid use. Overall, the proposed research will advance knowledge regarding the role of psychological factors contributing to persistent opioid use after surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18+
* Undergoing a scheduled surgery
* English speaking
* Ability and willingness to complete questionnaires and assessments.
Exclusion Criteria:
* Any conditions causing inability to complete baseline, telephone and internet assessments (e.g. education, cognitive ability, mental status, medical status)at the discretion of the investigator.
* Known Pregnancy
* Elevated Suicidality as assessed by an answer of 2 or greater on question 9 of the Beck Depression Inventory assessing suicidal thoughts.
* Coexisting Chronic Pain Disorder of moderate severity in area other than surgical target
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Trial Feasibility - The proportion of people consented who complete the study in the group to which they were randomized
Timeframe: Duration of the study - up to 2 years per participant