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

NCT ID: NCT04113252

Last Updated: 2022-05-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2022-08-31

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.

Conditions

Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Possible Incentive for Tablet Return

Intervention Type: OTHER

Subjects who return completed diary will have the possibility to receive money for returned opioid tablets.

Incentive for Completed Diary

Intervention Type: OTHER

Subjects who return completed diary will receive a gift card.

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.

Group Type: EXPERIMENTAL

Possible Incentive for Tablet Return

Intervention Type: OTHER

Subjects who return completed diary will have the possibility to receive money for returned opioid tablets.

Incentive for Completed Diary

Intervention Type: OTHER

Subjects who return completed diary will receive a gift card.

Coaching

Intervention Type: BEHAVIORAL

Subjects will receive coaching prior to starting pain medication.

Group 3--Diary and coaching

Participants in this arm will be given coaching. They will also be given incentives upon return of completed diary.

Group Type: EXPERIMENTAL

Incentive for Completed Diary

Intervention Type: OTHER

Subjects who return completed diary will receive a gift card.

Coaching

Intervention Type: BEHAVIORAL

Subjects will receive coaching prior to starting pain medication.

Interventions

Possible Incentive for Tablet Return

Subjects who return completed diary will have the possibility to receive money for returned opioid tablets.

Intervention Type: OTHER

Incentive for Completed Diary

Subjects who return completed diary will receive a gift card.

Intervention Type: OTHER

Coaching

Subjects will receive coaching prior to starting pain medication.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John K Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Other Identifiers

IRB00058073

Identifier Type: -

Identifier Source: org_study_id