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Interim analysis showed no difference between groups
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intention to Adhere to Therapy - Would Practice | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would practice this technology at least once per day before surgery. | Baseline |
| Acceptability of Therapy - Excitement |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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Phase 2 was not initiated and was discontinued due to statistical futility.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. 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. |
| FG001 | 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. 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. |
| FG002 | Phase 2 - Manage My Pain BE | Control arm of trial with the control intervention, Manage My Pain application with a script and film using a BE-informed recruitment video. |
| FG003 | Phase 2 - Manage My Pain Biological | Control arm of trial with the control intervention, Manage My Pain application with a script and film using a recruitment video using a standard biological approach. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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"). | Two participants from the standard recruitment video group did not respond to questions related to this outcome. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vanessa Olbrecht | Nationwide Children's Hospital | 614-722-4200 | vanessa.olbrecht@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 6, 2022 | Feb 6, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 8, 2021 | Aug 6, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D060909 | Economics, Behavioral |
| ID | Term |
|---|---|
| D011584 | Psychology |
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
| D004467 | Economics |
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|
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| 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. |
|
| Manage My Pain | Other | Commercially available and free app to track, analyze and monitor pain. |
|
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would be excited to use this technology. |
| Baseline |
| Perception of Efficacy - Less Pain | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I believe this technology would help me have less pain after surgery. | Baseline |
| Perception of Risk - Side Effects | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I am worried that this technology would have a lot of side effects. | Baseline |
| Opinion of Treatment Burden - Ease of Use | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I feel that this technology would be easy to use. | Baseline |
| Intention to Adhere to Therapy - Would Use | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would use this technology at least once per day after surgery while I was still needing it. | Baseline |
| Acceptability of Therapy - Pain Medication | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would like to use this technology to help me take less pain medication. | Baseline |
| Acceptability of Therapy - Recommend to Others | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would recommend this therapy to other individuals undergoing surgery. | Baseline |
| Acceptability of Therapy - Preference | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would prefer using this technology over taking pain medications. | Baseline |
| Perception of Efficacy - Less Pain Medication | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I believe that this technology would help me use less pain medication after surgery. | Baseline |
| Perception of Risk - Amount | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I believe that this technology would be too risky for me to use. | Baseline |
| Opinion of Treatment Burden - Independence | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would feel comfortable using this technology independently without supervision. | Baseline |
| Opinion of Treatment Burden - Familiar | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I am familiar with how to use this type of technology. | Baseline |
| Opinion of Treatment Burden - Pay for Technology | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would pay for the opportunity to use this technology during my recovery. I am comfortably using technologies like this. | Baseline |
| Opinion of Treatment Burden - Technology Comfort | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I am comfortably using technologies like this. | Baseline |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Previous pain management | Type of pain management used in the past. | Count of Participants | Participants |
|
| OG001 | 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. 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. |
|
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| Primary | Willingness to Participate in Clinical Trial | If given the opportunity, would you participate in the clinical trial? | Two participants from the standard recruitment video group did not respond to questions related to this outcome. | Posted | Count of Participants | Participants | Baseline |
|
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| Secondary | Intention to Adhere to Therapy - Would Practice | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would practice this technology at least once per day before surgery. | Posted | Median | Inter-Quartile Range | score on a Likert scale | Baseline |
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| Secondary | Acceptability of Therapy - Excitement | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would be excited to use this technology. | Posted | Median | Inter-Quartile Range | score on a Likert scale | Baseline |
|
|
|
| Secondary | Perception of Efficacy - Less Pain | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I believe this technology would help me have less pain after surgery. | Posted | Median | Inter-Quartile Range | score on a Likert scale | Baseline |
|
|
|
| Secondary | Perception of Risk - Side Effects | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I am worried that this technology would have a lot of side effects. | Posted | Median | Inter-Quartile Range | score on a Likert scale | Baseline |
|
|
|
| Secondary | Opinion of Treatment Burden - Ease of Use | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I feel that this technology would be easy to use. | Posted | Median | Inter-Quartile Range | score on a Likert scale | Baseline |
|
|
|
| Secondary | Intention to Adhere to Therapy - Would Use | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would use this technology at least once per day after surgery while I was still needing it. | Posted | Median | Inter-Quartile Range | score on a Likert scale | Baseline |
|
|
|
| Secondary | Acceptability of Therapy - Pain Medication | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would like to use this technology to help me take less pain medication. | Posted | Median | Inter-Quartile Range | score on a Likert scale | Baseline |
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| Secondary | Acceptability of Therapy - Recommend to Others | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would recommend this therapy to other individuals undergoing surgery. | Posted | Median | Inter-Quartile Range | score on a Likert scale | Baseline |
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| Secondary | Acceptability of Therapy - Preference | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would prefer using this technology over taking pain medications. | Posted | Median | Inter-Quartile Range | score on a Likert scale | Baseline |
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| Secondary | Perception of Efficacy - Less Pain Medication | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I believe that this technology would help me use less pain medication after surgery. | Posted | Median | Inter-Quartile Range | score on a Likert scale | Baseline |
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| Secondary | Perception of Risk - Amount | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I believe that this technology would be too risky for me to use. | Posted | Median | Inter-Quartile Range | score on a Likert scale | Baseline |
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| Secondary | Opinion of Treatment Burden - Independence | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would feel comfortable using this technology independently without supervision. | Posted | Median | Inter-Quartile Range | score on a Likert scale | Baseline |
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| Secondary | Opinion of Treatment Burden - Familiar | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I am familiar with how to use this type of technology. | Posted | Median | Inter-Quartile Range | score on a Likert scale | Baseline |
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| Secondary | Opinion of Treatment Burden - Pay for Technology | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I would pay for the opportunity to use this technology during my recovery. I am comfortably using technologies like this. | Posted | Median | Inter-Quartile Range | score on a Likert scale | Baseline |
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| Secondary | Opinion of Treatment Burden - Technology Comfort | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"): I am comfortably using technologies like this. | Posted | Median | Inter-Quartile Range | score on a Likert scale | Baseline |
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| 0 |
| 64 |
| 0 |
| 64 |
| 0 |
| 64 |
| EG001 | 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. 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. | 0 | 64 | 0 | 64 | 0 | 64 |
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| D004472 |
| Health Care Economics and Organizations |