Impact of Coaching Patients on Pain Control With and Without Financial Incentivization

The Economy of Pain: A Pilot Study of the Impact of an Opioid Buyback Program

Opioids are commonly prescribed pain medications, but they can lead to addiction. The study team is trying to determine if providing someone with an incentive (money in the form of a Visa gift card) to use less pain medications will result in study participants actually using fewer pain tablets than allowed by their health care provider. The study team also wants to know if providing the incentive (the Visa gift card alone) works the same as the incentive (the Visa gift card) plus providing additional information about addiction and alternative pain management.

Study Overview

• Status: Withdrawn
• Conditions: Opioid Use
• Intervention / Treatment: Other: Possible Incentive for Tablet Return; Other: Incentive for Completed Diary; Behavioral: Coaching

Detailed Description

Study participants will receive the standard of care for pain management at discharge. If study participants were not hospitalized at discharge, the study team will begin that standard of pain management at the participant's first outpatient clinic visit. Study participants will be randomized to 1 of 3 groups. All groups will receive a gift card if participants return the completed medication diary to the study team.

• Group 1 will complete a medication diary. Also, group 1 will be encouraged to return any unused tablets to the study clinic.
• Group 2 will be asked to complete a medication diary. Group 2 will also have a 50/50 chance of receiving money for each unused opioid tablet returned to the study clinic.
• Group 3 will be the same as group 2 except in addition, they will be given a coaching session about the use of pain medication and a simple way that may help participants use less opioid pain medication.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients suffering from a burn injury of one or both hands/upper extremities
• Patients staying less than 2 midnights after date of injury or presenting for first visit to the clinic 4 or less days after injury
• Patients able to self-administer their oxycodone.
• Aged 18-89 years old

Exclusion Criteria:

• No burns on either hand or upper extremity
• Patients suffering chemical or electrical burns
• Patients with other traumatic injuries for which they might require opioids/pain treatment
• Patients taking opioids prior to injury
• Patients who are discharged with prescriptions other than oxycodone with a dosage of 5 milligrams by mouth every six hours as needed

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1--Diary and Possible Opioid Return Incentive; Participants in this arm will be given incentives upon return of completed diary and will have the possibility to earn incentives for returning any leftover tablets to the study team.	Other: Possible Incentive for Tablet Return; Subjects who return completed diary will have the possibility to receive money for returned opioid tablets.; Other: Incentive for Completed Diary; Subjects who return completed diary will receive a gift card.
Experimental: Group 2--Diary, Coaching, Possible Opioid Return Incentive; Participants in this arm will be given coaching. They will also be given incentives upon return of completed diary and will have the possibility to earn incentives for returning any leftover tablets to the study team.	Other: Possible Incentive for Tablet Return; Subjects who return completed diary will have the possibility to receive money for returned opioid tablets.; Other: Incentive for Completed Diary; Subjects who return completed diary will receive a gift card.; Behavioral: Coaching; Subjects will receive coaching prior to starting pain medication.
Experimental: Group 3--Diary and coaching; Participants in this arm will be given coaching. They will also be given incentives upon return of completed diary.	Other: Incentive for Completed Diary; Subjects who return completed diary will receive a gift card.; Behavioral: Coaching; Subjects will receive coaching prior to starting pain medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean number of opioid tablets used daily	up through two weeks

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: John K Bailey, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: opioid buyback; opioid misuse prevention
• Other Study ID Numbers: IRB00058073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No