Use of Nudges To Enhance Enrollment in Critical Care Research
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/17/2018 |
| Start Date: | October 9, 2017 |
| End Date: | January 2020 |
| Contact: | Dustin C Krutsinger, M.D. |
| Email: | dustin.krutsinger@uphs.upenn.edu |
| Phone: | 319-400-4964 |
A Randomized Trial of Nudges To Enhance Enrollment in Critical Care Research
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 3-arm RCT in 5 ICUs at Penn to test the relative
effectiveness of 2 different nudges on enrollment rates. Investigators hypothesize that a
bundle of nudges during recruitment will increase enrollment rates compared to usual
recruitment procedures, and that requiring participants to make a choice to participate or
not, with enhanced information about each option, will increase enrollment.
Investigators will enroll 273 critically ill patients' surrogate decision
makers(participants) to engage in recruitment procedures for a simulated RCT comparing two
oxygen saturation targets 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 two
inexpensive, scalable nudges to potentially augment enrollment and reduce costs of future
clinical trials.
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 3-arm RCT in 5 ICUs at Penn to test the relative
effectiveness of 2 different nudges on enrollment rates. Investigators hypothesize that a
bundle of nudges during recruitment will increase enrollment rates compared to usual
recruitment procedures, and that requiring participants to make a choice to participate or
not, with enhanced information about each option, will increase enrollment.
Investigators will enroll 273 critically ill patients' surrogate decision
makers(participants) to engage in recruitment procedures for a simulated RCT comparing two
oxygen saturation targets 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 two
inexpensive, scalable nudges to potentially augment enrollment and reduce costs of future
clinical trials.
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.
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