Use of Nudges To Enhance Enrollment in Critical Care Research

University of Pennsylvania

Status: Completed

Conditions: Critical Illness

Treatments: Behavioral: Pre-Consent Nudge Bundle

Study type: Interventional

Funder types: Other

Identifiers

NCT03284359

828046

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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182 participants in 2 patient groups

Pre-Consent Nudge Bundle

Experimental group

Description:

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.

Treatment:

Behavioral: Pre-Consent Nudge Bundle

Standard Consent

No Intervention group

Description:

Arm 2 will serve as the control arm. Participants will be approached by the research personnel to participate in a simulated RCT comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive a standard consent form as detailed in the Study Instruments section. Following the consent process participants will conduct the same risk assessment survey and demographic survey.