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

NCT02070003 | Completed

• 1 other identifier: 26234
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Cessation

Outcome Measures

Primary Outcomes (1)

• Trial Feasibility - The proportion of people consented who complete the study in the group to which they were randomized

  Factors that contribute to non-completion of the study, measured at baseline for each patient, will be analyzed.

  Duration of the study - up to 2 years per participant

Secondary Outcomes (1)

• Efficacy - time to opioid cessation

  Duration of the trial - Up to 2 years per participant

Study Arms (2)

Motivational Interviewing and Physician Guided Opioid Weaning

EXPERIMENTAL

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.

Behavioral: Motivational Interviewing and Physician Guided Opioid Weaning

Usual Care

NO INTERVENTION

Interventions

Motivational Interviewing and Physician Guided Opioid Weaning BEHAVIORAL

Motivational Interviewing and Physician Guided Opioid Weaning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• Hah JM, Trafton JA, Narasimhan B, Krishnamurthy P, Hilmoe H, Sharifzadeh Y, Huddleston JI, Amanatullah D, Maloney WJ, Goodman S, Carroll I, Mackey SC. Efficacy of motivational-interviewing and guided opioid tapering support for patients undergoing orthopedic surgery (MI-Opioid Taper): A prospective, assessor-blind, randomized controlled pilot trial. EClinicalMedicine. 2020 Oct 16;28:100596. doi: 10.1016/j.eclinm.2020.100596. eCollection 2020 Nov.

  PMID: 33294812 DERIVED

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jennifer Hah, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 24, 2014
• Study Start: November 26, 2014
• Primary Completion: July 26, 2018
• Study Completion: August 15, 2018
• Last Updated: July 10, 2020

Record last verified: 2020-07

Locations

US (1)