Application of behavioral economic strategies to enhance recruitment into a pediatric randomized clinical trial for postoperative pain relief : A randomized clinical trial
© 2023 The Authors. Pediatric Anesthesia published by John Wiley & Sons Ltd..
INTRODUCTION: A major challenge in conducting clinical trials is recruitment. Trial under-enrollment leads to underpowered studies. Behavioral economics offers strategies that may enhance trial recruitment. This study assessed the impact of behavioral economic strategies versus a standard biological approach to recruit children into a randomized clinical trial assessing a biofeedback-based virtual reality intervention for postoperative pain management. We hypothesized the behavioral economics-informed approach would increase enrollment into the future trial, intention to adhere to therapy, acceptability of the intervention, and perceived efficacy while decreasing perception of treatment burden and risk.
METHODS: This single-center, prospective, randomized trial recruited patients 12-18 years old undergoing surgery requiring postoperative admission and narcotic administration. Patient-parent dyads were randomized to watch a behavioral economics-informed (n = 64) or standard biological (n = 66) recruitment video about a study designed to assess impact of a virtual reality pain management intervention.
RESULTS: There was no difference in rates of intention to enroll in the study between groups (behavioral economics: 75%, control: 79%, p = 0.744) or in median response scores to questions regarding intention to adhere to therapy (4.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p=0.084), acceptability of therapy (4.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p = 0.376), perceptions of treatment burden (3.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p=0.251), and efficacy (3.0 [3.0, 4.0] vs. 3.0 [3.0, 4.0], p = 0.914). Patients in the behavioral economics group were less likely to perceive risk associated with virtual reality versus the control group (behavioral economics: 2.0 [1.0, 2.0], control: 2.0 [2.0, 3.0], p = 0.023).
DISCUSSION: A behavioral economics-informed video did not increase patients' intentions to enroll into a clinical trial assessing the impact of virtual reality intervention for postoperative pain management.
CONCLUSION: Either approach would be sufficient for patient recruitment for this type of clinical trial since the overall intention to enroll rate was 77%.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:33 |
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| Enthalten in: |
Paediatric anaesthesia - 33(2023), 12 vom: 01. Dez., Seite 1091-1098 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Karthic, Anitra [VerfasserIn] |
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| Links: |
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| Themen: |
Behavioral |
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| Anmerkungen: |
Date Completed 03.11.2023 Date Revised 13.11.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/pan.14755 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM362096473 |
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| 520 | |a © 2023 The Authors. Pediatric Anesthesia published by John Wiley & Sons Ltd. | ||
| 520 | |a INTRODUCTION: A major challenge in conducting clinical trials is recruitment. Trial under-enrollment leads to underpowered studies. Behavioral economics offers strategies that may enhance trial recruitment. This study assessed the impact of behavioral economic strategies versus a standard biological approach to recruit children into a randomized clinical trial assessing a biofeedback-based virtual reality intervention for postoperative pain management. We hypothesized the behavioral economics-informed approach would increase enrollment into the future trial, intention to adhere to therapy, acceptability of the intervention, and perceived efficacy while decreasing perception of treatment burden and risk | ||
| 520 | |a METHODS: This single-center, prospective, randomized trial recruited patients 12-18 years old undergoing surgery requiring postoperative admission and narcotic administration. Patient-parent dyads were randomized to watch a behavioral economics-informed (n = 64) or standard biological (n = 66) recruitment video about a study designed to assess impact of a virtual reality pain management intervention | ||
| 520 | |a RESULTS: There was no difference in rates of intention to enroll in the study between groups (behavioral economics: 75%, control: 79%, p = 0.744) or in median response scores to questions regarding intention to adhere to therapy (4.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p=0.084), acceptability of therapy (4.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p = 0.376), perceptions of treatment burden (3.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p=0.251), and efficacy (3.0 [3.0, 4.0] vs. 3.0 [3.0, 4.0], p = 0.914). Patients in the behavioral economics group were less likely to perceive risk associated with virtual reality versus the control group (behavioral economics: 2.0 [1.0, 2.0], control: 2.0 [2.0, 3.0], p = 0.023) | ||
| 520 | |a DISCUSSION: A behavioral economics-informed video did not increase patients' intentions to enroll into a clinical trial assessing the impact of virtual reality intervention for postoperative pain management | ||
| 520 | |a CONCLUSION: Either approach would be sufficient for patient recruitment for this type of clinical trial since the overall intention to enroll rate was 77% | ||
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| 700 | 1 | |a Stevens, Jack |e verfasserin |4 aut | |
| 700 | 1 | |a Olbrecht, Vanessa A |e verfasserin |4 aut | |
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