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

NCT04113252 | Withdrawn

• 1 other identifier: IRB00058073
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Opioid Use

Keywords

opioid buyback; opioid misuse prevention

Outcome Measures

Primary Outcomes (1)

• Mean number of opioid tablets used daily

  up through two weeks

Study Arms (3)

Group 1--Diary and Possible Opioid Return Incentive

EXPERIMENTAL

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; Other: Incentive for Completed Diary

Group 2--Diary, Coaching, Possible Opioid Return Incentive

EXPERIMENTAL

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; Other: Incentive for Completed Diary; Behavioral: Coaching

Group 3--Diary and coaching

EXPERIMENTAL

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

Other: Incentive for Completed Diary; Behavioral: Coaching

Interventions

Possible Incentive for Tablet Return OTHER

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

Group 1--Diary and Possible Opioid Return Incentive; Group 2--Diary, Coaching, Possible Opioid Return Incentive

Incentive for Completed Diary OTHER

Subjects who return completed diary will receive a gift card.

Group 1--Diary and Possible Opioid Return Incentive; Group 2--Diary, Coaching, Possible Opioid Return Incentive; Group 3--Diary and coaching

Coaching BEHAVIORAL

Subjects will receive coaching prior to starting pain medication.

Group 2--Diary, Coaching, Possible Opioid Return Incentive; Group 3--Diary and coaching

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Officials

• John K Bailey, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 2, 2019
• Study Start: May 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: May 12, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF