Perioperative Recovery of Moods, Opioids, and Pain Trial (PROMPT)

Not Applicable

Completed

• Conditions: Opioid Cessation
• Interventions: Behavioral: Motivational Interviewing and Physician Guided Opioid Weaning

• Registration Number: NCT02070003
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-20
• Study First Posted: 2014-02-24
• Study Start: 2014-11-26
• Primary Completion: 2018-07-26
• Study Completion: 2018-08-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Age 18+
• Undergoing a scheduled surgery
• English speaking
• Ability and willingness to complete questionnaires and assessments.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motivational Interviewing and Physician Guided Opioid Weaning	Motivational Interviewing and Physician Guided Opioid Weaning	Patients will go through motivational interviewing with the study physician via phone once a week for 7 weeks, and once a month up to a year as applicable, until patient completes the protocol.

Primary Outcome Measures

Name	Time	Method
Trial Feasibility - The proportion of people consented who complete the study in the group to which they were randomized	Duration of the study - up to 2 years per participant	Factors that contribute to non-completion of the study, measured at baseline for each patient, will be analyzed.

Secondary Outcome Measures

Name	Time	Method
Efficacy - time to opioid cessation	Duration of the trial - Up to 2 years per participant	Time to opioid cessation between the two groups will be analyzed using survival analysis

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States