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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02070003
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 2
• Actual Duration (Months): 44.6
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Cessation	Behavioral: Motivational Interviewing and Physician Guided Opioid Weaning	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Nov 26, 2014
• Actual Primary Completion Date: Jul 26, 2018
• Actual Study Completion Date: Aug 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
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
No Intervention: Usual Care

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Palo Alto	California	United States	94304

Sponsors and Collaborators

• Stanford University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jennifer Hah, Assistant Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT02070003
• Other Study ID Numbers: 26234
• First Posted: Feb 24, 2014
• Last Update Posted: Jul 10, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Analgesics, Opioid

Study Results

No Results Posted as of Jul 10, 2020