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

July 8, 2020 updated by: Jennifer Hah, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: 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.
Behavioral: Motivational Interviewing and Physician Guided Opioid Weaning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trial Feasibility - The proportion of people consented who complete the study in the group to which they were randomized
Time Frame: 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.
Duration of the study - up to 2 years per participant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - time to opioid cessation
Time Frame: Duration of the trial - Up to 2 years per participant
Time to opioid cessation between the two groups will be analyzed using survival analysis
Duration of the trial - Up to 2 years per participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Jennifer Hah, MD, MS, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2014

Primary Completion (Actual)

July 26, 2018

Study Completion (Actual)

August 15, 2018

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 24, 2014

Study Record Updates

Last Update Posted (Actual)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Opioid Cessation

Clinical Trials on Motivational Interviewing and Physician Guided Opioid Weaning

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe