Recruitment and Behavioral Economic Strategies
Application of Behavioral Economic Strategies to Enhance Recruitment Into a Pediatric Randomized Clinical Trial
| Sponsors |
Lead Sponsor: Vanessa Olbrecht |
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| Source | Nationwide Children's Hospital |
| 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. |
| 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. |
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| Overall Status | Recruiting | ||||
| Start Date | 2022-05-17 | ||||
| Completion Date | 2025-05-01 | ||||
| Primary Completion Date | 2025-05-01 | ||||
| Phase | N/A | ||||
| Study Type | Interventional | ||||
| Primary Outcome |
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| Enrollment | 800 |
| Condition | |
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| Intervention |
Intervention Type: Behavioral Intervention Name: Behavioral Economics (BE) recruitment strategies Description: 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. Intervention Type: Other Intervention Name: Biofeedback-based virtual reality (VR-BF) Description: Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm. Intervention Type: Other Intervention Name: Manage My Pain Description: Commercially available and free app to track, analyze and monitor pain. |
| Eligibility |
Criteria:
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. Gender: All Minimum Age: 12 Years Maximum Age: 18 Years Healthy Volunteers: Accepts Healthy Volunteers |
| Overall Contact |
Last Name: Catherine Roth, MPH Phone: 614-722-2997 Email: [email protected] |
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| Location |
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| Location Countries |
United States |
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| Verification Date |
2022-06-01 |
| Responsible Party |
Type: Sponsor-Investigator Investigator Affiliation: Nationwide Children's Hospital Investigator Full Name: Vanessa Olbrecht Investigator Title: MD, MBA |
| Has Expanded Access | No |
| Number Of Arms | 4 |
| Arm Group |
Label: Phase 1 - VR-BF BE Type: Experimental 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. Label: Phase 1 - VR-BF Biological Type: Active Comparator 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. Label: Phase 2 - Manage My Pain BE Type: Experimental 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. Label: Phase 2 - Manage My Pain Biological Type: Placebo Comparator 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. |
| Patient Data | No |
| Study Design Info |
Allocation: Randomized Intervention Model: Sequential Assignment Primary Purpose: Health Services Research Masking: Single (Participant) |
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patients 12-18 Years of Age Presenting for Surgery That Requires Postoperative Admission and Usually Requires Narcotic Administration
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NCT05441579RecruitingConditions: Patients 12-18 Years of Age Presenting for Surgery That Requires Postoperative Admission and Usually Requires Narcotic Administration
Clinical Trials on Behavioral Economics (BE) recruitment strategies
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NCT05441579RecruitingConditions: Patients 12-18 Years of Age Presenting for Surgery That Requires Postoperative Admission and Usually Requires Narcotic Administration