Critical Illness
Conditions
Keywords
Critical Illness, Mechanical Ventilation, Economics, Behavioral, Surrogate decision maker
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.
Interventions
BEHAVIORALPre-Consent Nudge Bundle
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.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Pre-Consent Nudge Bundle: 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. | 93 |
| Standard Consent 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. | 89 |
| Total | 182 |
Baseline characteristics
| Characteristic | Pre-Consent Nudge Bundle | Standard Consent | Total |
|---|---|---|---|
| Age, Continuous | 61.3 years STANDARD_DEVIATION 13.6 | 58.6 years STANDARD_DEVIATION 17.2 | 60 years STANDARD_DEVIATION 15.5 |
| Length of ICU stay at enrollment | 97.8 Hours STANDARD_DEVIATION 73.1 | 114.5 Hours STANDARD_DEVIATION 90.6 | 106.2 Hours STANDARD_DEVIATION 81.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 23 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 7 Participants | 11 Participants |
| Race (NIH/OMB) White | 74 Participants | 59 Participants | 133 Participants |
| Sex: Female, Male Female | 35 Participants | 36 Participants | 71 Participants |
| Sex: Female, Male Male | 58 Participants | 53 Participants | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 93 | 0 / 89 |
| other Total, other adverse events | 0 / 93 | 0 / 89 |
| serious Total, serious adverse events | 0 / 93 | 0 / 89 |
Outcome results
Primary
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.
Time frame: Up to 96 hours
Population: Intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-Consent Nudge Bundle | Consent Rate | 27 Participants |
| Standard Consent | Consent Rate | 30 Participants |
Secondary
Risk Assessment
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.
Time frame: Up to 96 hours
Population: Intention to treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-Consent Nudge Bundle | Risk Assessment | 2 units on a scale |
| Standard Consent | Risk Assessment | 2 units on a scale |