Recruitment and Behavioral Economic Strategies

Vanessa Olbrecht

Status: Invitation-only

Conditions: Surgery; Adolescent Behavior

Treatments: Behavioral: Behavioral Economics (BE) recruitment strategies; Other: Manage My Pain; Other: Biofeedback-based virtual reality (VR-BF)

Study type: Interventional

Funder types: Other

Identifiers

NCT05441579

STUDY00002413

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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800 participants in 4 patient groups, including a placebo group

Phase 1 - VR-BF BE

Experimental group

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.

Treatment:

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

Behavioral: Behavioral Economics (BE) recruitment strategies

Phase 1 - VR-BF Biological

Active Comparator group

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.

Treatment:

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

Phase 2 - Manage My Pain BE

Experimental group

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.

Treatment:

Other: Manage My Pain

Behavioral: Behavioral Economics (BE) recruitment strategies

Phase 2 - Manage My Pain Biological

Placebo Comparator group

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.

Treatment:

Other: Manage My Pain