Recruitment and Behavioral Economic Strategies

Application of Behavioral Economic Strategies to Enhance Recruitment Into a Pediatric Randomized Clinical Trial

Sponsors

Lead Sponsor: Vanessa Olbrecht

Source Nationwide Children's Hospital
Brief Summary

To determine the impact of the application of behavioral economic strategies on recruitment of pediatric patients into a randomized clinical trial assessing the impact of technology-based interventions on postoperative pain management.

Detailed Description

Patients will be asked to watch one of two videos in either Phase 1 or Phase 2 relating to recruitment and fill out a survey to determine their likelihood to enroll in a research study. Patients 12-18 years of age presenting for surgery that requires postoperative admission and usually requires narcotic administration.

Overall Status Recruiting
Start Date 2022-05-17
Completion Date 2025-05-01
Primary Completion Date 2025-05-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
To determine the impact of the application of behavioral economic strategies on recruitment of pediatric patients into a randomized clinical trial assessing the impact of technology-based interventions on postoperative pain management. 1 hour
Enrollment 800
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Behavioral Economics (BE) recruitment strategies

Description: Behavioral economics (BE), a method of economic analysis that applies psychological insights into human behavior to explain economic decision-making, has broad applicability and its techniques offer a novel way that may be applied to try to help enhance study recruitment and enrollment.

Intervention Type: Other

Intervention Name: Biofeedback-based virtual reality (VR-BF)

Description: Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm.

Intervention Type: Other

Intervention Name: Manage My Pain

Description: Commercially available and free app to track, analyze and monitor pain.

Eligibility

Criteria:

Inclusion Criteria: - Patients between the ages of 12-18 years of age - Patients able to read, understand, and speak English - Patients undergoing surgery requiring postoperative admission - Patients undergoing surgery that requires narcotic administration Exclusion Criteria: - Patients outside of the age range - Patients with history of developmental delay, uncontrolled psychiatric conditions, or neurological conditions (i.e., epilepsy, motion sickness, nausea/vomiting) - History of severe vertigo or dizziness - History of chronic pain - Patients that use opioids or benzodiazepines chronically - Patients with conditions that would preclude placement of a VR headset, including craniofacial abnormalities or undergoing surgeries of the head and neck.

Gender:

All

Minimum Age:

12 Years

Maximum Age:

18 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: Catherine Roth, MPH

Phone: 614-722-2997

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Nationwide Children's Hospital Catherine Roth, MPH 614-722-2997 [email protected] Vanessa Olbrecht, MD Principal Investigator
Location Countries

United States

Verification Date

2022-06-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Nationwide Children's Hospital

Investigator Full Name: Vanessa Olbrecht

Investigator Title: MD, MBA

Has Expanded Access No
Number Of Arms 4
Arm Group

Label: Phase 1 - VR-BF BE

Type: Experimental

Description: We are applying Behavioral Economics (BE)-based messaging and presentation strategies to patient recruitment and determining whether these strategies may enhance patient recruitment into a pediatric randomized clinical trial. Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm.

Label: Phase 1 - VR-BF Biological

Type: Active Comparator

Description: A similar to BE-based recruitment video using a standard biological approach on teenagers' decision to enroll in a clinical study will be used as comparison. Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm.

Label: Phase 2 - Manage My Pain BE

Type: Experimental

Description: We are applying Behavioral Economics (BE)-based messaging and presentation strategies to patient recruitment and determining whether these strategies may enhance patient recruitment into a pediatric randomized clinical trial. Phase 2 will focus on patients that would be enrolled into the control arm of a clinical trial with a control intervention, Manage My Pain application.

Label: Phase 2 - Manage My Pain Biological

Type: Placebo Comparator

Description: A similar to BE-based recruitment video using a standard biological approach on teenagers' decision to enroll in a clinical study will be used as comparison. Phase 2 will focus on patients that would be enrolled into the control arm of a clinical trial with a control intervention, Manage My Pain application.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Sequential Assignment

Primary Purpose: Health Services Research

Masking: Single (Participant)

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Clinical Trials on Patients 12-18 Years of Age Presenting for Surgery That Requires Postoperative Admission and Usually Requires Narcotic Administration

Clinical Trials on Behavioral Economics (BE) recruitment strategies