Recruitment and Behavioral Economic Strategies

Sponsor
Vanessa Olbrecht (Other)
Overall Status
Recruiting
CT.gov ID
NCT05441579
Collaborator
(none)
800
1
4
35.5
22.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral Economics (BE) recruitment strategies
  • Other: Biofeedback-based virtual reality (VR-BF)
  • Other: Manage My Pain
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
Application of Behavioral Economic Strategies to Enhance Recruitment Into a Pediatric Randomized Clinical Trial
Actual Study Start Date :
May 17, 2022
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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]

    Survey to identify likelihood to participate in study

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nationwide Children's Hospital Columbus Ohio United States 43205

Sponsors and Collaborators

  • Vanessa Olbrecht

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vanessa Olbrecht, MD, MBA, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT05441579
Other Study ID Numbers:
  • STUDY00002413
First Posted:
Jul 1, 2022
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 1, 2022