Recruitment and Behavioral Economic Strategies

NCT05441579 | Terminated Results

• 1 other identifier: STUDY00002413
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Adolescent Behavior

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• Intention to Adhere to Therapy - Would Practice

  Baseline

• Acceptability of Therapy - Excitement

  Baseline

• Perception of Efficacy - Less Pain

  Baseline

• Perception of Risk - Side Effects

  Baseline

• Opinion of Treatment Burden - Ease of Use

  Baseline

Study Arms (4)

Phase 1 - VR-BF BE

EXPERIMENTAL

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; Other: Biofeedback-based virtual reality (VR-BF)

Phase 1 - VR-BF Biological

ACTIVE COMPARATOR

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 2 - Manage My Pain BE

EXPERIMENTAL

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; Other: Manage My Pain

Phase 2 - Manage My Pain Biological

PLACEBO COMPARATOR

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

Interventions

Behavioral Economics (BE) recruitment strategies BEHAVIORAL

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.

Phase 1 - VR-BF BE; Phase 2 - Manage My Pain BE

Biofeedback-based virtual reality (VR-BF) OTHER

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

Phase 1 - VR-BF BE; Phase 1 - VR-BF Biological

Manage My Pain OTHER

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

Phase 2 - Manage My Pain BE; Phase 2 - Manage My Pain Biological

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanessa Olbrecht: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Adolescent Behavior

Interventions

Economics, Behavioral

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Psychology; Behavioral Sciences; Behavioral Disciplines and Activities; Economics; Health Care Economics and Organizations

Results Point of Contact

• Title: Dr. Vanessa Olbrecht
• Organization: Nationwide Children's Hospital

vanessa.olbrecht@nationwidechildrens.org

614-722-4200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: May 17, 2022
• Primary Completion: September 8, 2022
• Study Completion: September 8, 2022
• Last Updated: December 20, 2024
• Results First Posted: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)