Use of Nudges To Enhance Enrollment in Critical Care Research

NCT03284359 | Completed Results DMC

• 1 other identifier: 828046
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

Critical Illness; Mechanical Ventilation; Economics, Behavioral; Surrogate decision maker

Outcome Measures

Primary Outcomes (1)

• Consent Rate

  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.

  Up to 96 hours

Secondary Outcomes (1)

• Risk Assessment

  Up to 96 hours

Study Arms (2)

Pre-Consent Nudge Bundle

EXPERIMENTAL

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.

Behavioral: Pre-Consent Nudge Bundle

Standard Consent

NO INTERVENTION

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.

Interventions

Pre-Consent Nudge Bundle BEHAVIORAL

The pre-consent nudge bundle survey was developed by the study team and incorporates several behavioral interventions into a bundle of 5 types of nudges: (i) injunctive norms; (ii) descriptive norms; (iii) duty of reciprocity; (iv) self-prophecy; and (v) foot-in-the-door. Injunctive norms involve the perception of what behavior is acceptable, while descriptive norms highlight what behaviors others are engaging in. The duty of reciprocity is the sense that one should repeat pro-social behavior for which they have benefited from. The foot-in-the-door nudge involves asking a participant to perform a small request which has a high consent rate followed by a larger request. The bundle consists of six questions and one statement.

Pre-Consent Nudge Bundle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surrogate decision-makers of patients who are:
• Patient and surrogate is 18 years of age or older
• Surrogate is English-proficient
• Patient is mechanically ventilated
• Patient is admitted to participating ICU

You may not qualify if:

• Surrogate decision-makers of patients who are:
• Patient is receiving comfort care only
• Patient has anticipated extubation in the next 24 hours.
• Patient with tracheostomy.
• Bedside clinician declines patient participation.
• Surrogate decision maker not available to approach prior to patient being extubated.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6006, United States

Location

Related Publications (1)

• Krutsinger DC, O'Leary KL, Ellenberg SS, Cotner CE, Halpern SD, Courtright KR. A Randomized Controlled Trial of Behavioral Nudges to Improve Enrollment in Critical Care Trials. Ann Am Thorac Soc. 2020 Sep;17(9):1117-1125. doi: 10.1513/AnnalsATS.202003-194OC.

  PMID: 32441987 DERIVED

MeSH Terms

Conditions

Critical Illness; Behavior

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Katherine Courtright
• Organization: University of Pennsylvania

Katherine.Courtright@pennmedicine.upenn.edu

267-978-5083

Study Officials

• Katherine Courtright, M.D., M.S.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: September 15, 2017
• Study Start: February 19, 2018
• Primary Completion: August 8, 2019
• Study Completion: August 8, 2019
• Last Updated: March 3, 2021
• Results First Posted: March 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)