Use of Nudges To Enhance Enrollment in Critical Care Research

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Behavioral: Pre-Consent Nudge Bundle

• Registration Number: NCT03284359
• Lead Sponsor: University of Pennsylvania

Brief Summary

Difficulties enrolling patients in randomized clinical trials (RCTs) have long been recognized as a major barrier to successful evaluation of medical interventions. This is particularly problematic among intensive care unit (ICU) trials, of which more than one-third do not reach target enrollment. Under-enrollment and selective enrollment reduce RCTs' abilities to answer the research questions, thereby degrading the trials' scientific value and ethics.

Current evidence suggests that financial incentives can ethically increase study enrollment, but this approach can pose large up-front costs to researchers. However, several nonmonetary behavioral interventions, or nudges, may offer novel and easily scalable approaches to increase enrollment in RCTs.

The investigation team propose a 2-arm RCT in 10 ICUs at Penn to test the relative effectiveness of nudges on enrollment rates. Investigators hypothesize that a bundle of nudges during recruitment will increase enrollment rates compared to usual recruitment procedures will increase enrollment.

Investigators will enroll 182 critically ill patients' surrogate decision makers(participants) to engage in recruitment procedures for a simulated RCT comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Investigators will also measure participants' assessment of risk of the simulated trial after the informed consent process. This work will provide the first empirical evidence regarding the efficacy of inexpensive, scalable nudges to potentially augment enrollment and reduce costs of future clinical trials.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-09-14
• Study First Posted: 2017-09-15
• Study Start: 2018-02-19
• Primary Completion: 2019-08-08
• Study Completion: 2019-08-08
• Status Verified: 2021-02
• Results First Submitted: 2021-02-11
• Results First Submitted QC: 2021-02-11
• Last Update Submitted: 2021-02-11
• Results First Posted: 2021-03-03
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

Surrogate decision-makers of patients who are:

1. Patient and surrogate is 18 years of age or older
2. Surrogate is English-proficient
3. Patient is mechanically ventilated
4. Patient is admitted to participating ICU

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Exclusion Criteria

Surrogate decision-makers of patients who are:

1. Patient is receiving comfort care only
2. Patient has anticipated extubation in the next 24 hours.
3. Patient with tracheostomy.
4. Bedside clinician declines patient participation.
5. Surrogate decision maker not available to approach prior to patient being extubated.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-Consent Nudge Bundle	Pre-Consent Nudge Bundle	Arm 1 will be administered a novel pre-consent nudge bundle which incorporates several behavioral economic interventions within a brief survey. Participants will subsequently be asked by the same research personnel to participate in a simulated randomized control trial (RCT) comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive the standard consent form followed by a risk assessment and demographic survey.

Primary Outcome Measures

Name	Time	Method
Consent Rate	Up to 96 hours	The primary outcome is consent rate for a simulated RCT. This is an easily measurable binary outcome that has the potential for significant impact on future trial recruitment.

Secondary Outcome Measures

Name	Time	Method
Risk Assessment	Up to 96 hours	Secondarily we will quantitatively assess the participant's assessment of the risk of participating in the simulated RCT. The risk assessment tool has been previously used in the assessment of risk perception of RCT participation in the setting of behavioral economic nudges. The risk assessment will be used to evaluate participants' impressions of the risk of participating in the RCT using a Likert scale ranging from 1 (Not risky at all) to 7 (very risky), as well as 9 comparative questions, each of which asks whether a study procedure was riskier than another risky activity, such as talking on one's cell phone while driving.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States