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

Not Applicable

Withdrawn

• Conditions: Opioid Use
• Interventions: Other: Possible Incentive for Tablet Return; Other: Incentive for Completed Diary; Behavioral: Coaching

• Registration Number: NCT04113252
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-02
• Status Verified: 2021-08
• Study Start: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-12
• Primary Completion: 2022-08
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2--Diary, Coaching, Possible Opioid Return Incentive	Incentive for Completed Diary	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.
Group 3--Diary and coaching	Incentive for Completed Diary	Participants in this arm will be given coaching. They will also be given incentives upon return of completed diary.
Group 2--Diary, Coaching, Possible Opioid Return Incentive	Coaching	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.
Group 2--Diary, Coaching, Possible Opioid Return Incentive	Possible Incentive for Tablet Return	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.
Group 3--Diary and coaching	Coaching	Participants in this arm will be given coaching. They will also be given incentives upon return of completed diary.
Group 1--Diary and Possible Opioid Return Incentive	Possible Incentive for Tablet Return	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.
Group 1--Diary and Possible Opioid Return Incentive	Incentive for Completed Diary	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.

Primary Outcome Measures

Name	Time	Method
Mean number of opioid tablets used daily	up through two weeks