Recruitment and Behavioral Economic Strategies

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

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.

Study Overview

• Status: Terminated
• Conditions: Surgery; Adolescent Behavior
• Intervention / Treatment: Behavioral: Behavioral Economics (BE) recruitment strategies; Other: Biofeedback-based virtual reality (VR-BF); Other: Manage My Pain

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1 - VR-BF BE; 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.	Behavioral: Behavioral Economics (BE) recruitment strategies; 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.; Other: Biofeedback-based virtual reality (VR-BF); Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm.
Active Comparator: Phase 1 - VR-BF Biological; 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.	Other: Biofeedback-based virtual reality (VR-BF); Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm.
Experimental: Phase 2 - Manage My Pain BE; 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.	Behavioral: Behavioral Economics (BE) recruitment strategies; 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.; Other: Manage My Pain; Commercially available and free app to track, analyze and monitor pain.
Placebo Comparator: Phase 2 - Manage My Pain Biological; 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.	Other: Manage My Pain; Commercially available and free app to track, analyze and monitor pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	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.	Survey to identify likelihood to participate in study using a 5-point Likert scale (1="Extremely Unlikely" to 5="Extremely Likely").	Baseline
Willingness to Participate in Clinical Trial	If given the opportunity, would you participate in the clinical trial?	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intention to Adhere to Therapy - Would Practice	Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would practice this technology at least once per day before surgery.	Baseline
Acceptability of Therapy - Excitement	Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would be excited to use this technology.	Baseline
Perception of Efficacy - Less Pain	Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I believe this technology would help me have less pain after surgery.	Baseline
Perception of Risk - Side Effects	Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I am worried that this technology would have a lot of side effects.	Baseline
Opinion of Treatment Burden - Ease of Use	Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I feel that this technology would be easy to use.	Baseline
Intention to Adhere to Therapy - Would Use	Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would use this technology at least once per day after surgery while I was still needing it.	Baseline
Acceptability of Therapy - Pain Medication	Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would like to use this technology to help me take less pain medication.	Baseline
Acceptability of Therapy - Recommend to Others	Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would recommend this therapy to other individuals undergoing surgery.	Baseline
Acceptability of Therapy - Preference	Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would prefer using this technology over taking pain medications.	Baseline
Perception of Efficacy - Less Pain Medication	Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I believe that this technology would help me use less pain medication after surgery.	Baseline
Perception of Risk - Amount	Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I believe that this technology would be too risky for me to use.	Baseline
Opinion of Treatment Burden - Independence	Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would feel comfortable using this technology independently without supervision.	Baseline
Opinion of Treatment Burden - Familiar	Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I am familiar with how to use this type of technology.	Baseline
Opinion of Treatment Burden - Pay for Technology	Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would pay for the opportunity to use this technology during my recovery. I am comfortably using technologies like this.	Baseline
Opinion of Treatment Burden - Technology Comfort	Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I am comfortably using technologies like this.	Baseline

Collaborators and Investigators

• Sponsor: Vanessa Olbrecht

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Actual): September 8, 2022
• Study Completion (Actual): September 8, 2022

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00002413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No