Recruitment and Behavioral Economic Strategies

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgery, Adolescent Behavior

Intervention / Treatment
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* Behavioral: Behavioral Economics (BE) recruitment strategies
* Other: Biofeedback-based virtual reality (VR-BF)
* Other: Manage My Pain


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | Baseline |