An interventional study of Pre-Consent Nudge Bundle in Critical Illness, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-03.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Health services 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 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.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's enrollment of 182 is above the median of 90 across 926 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
Compared within Critical Illness, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Surrogate decision-makers of patients who are:
Exclusion Criteria:
Surrogate decision-makers of patients who are:
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
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.
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.
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
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
| Milestone | Pre-Consent Nudge Bundle | Standard Consent |
|---|---|---|
| Started | 93 | 89 |
| Completed | 93 | 89 |
| Not completed | 0 | 0 |
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.
| Participants | Pre-Consent Nudge Bundle | Standard Consent |
|---|---|---|
| Consent Rate | 27 | 30 |
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.
| units on a scale | Pre-Consent Nudge Bundle | Standard Consent |
|---|---|---|
| Risk Assessment | 2 (0 to 5) | 2 (0 to 5.5) |
Collected over Adverse events were monitored during the interaction. Long term adverse events were not evaluated.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre-Consent Nudge Bundle | 0/93 (0%) | 0/93 (0%) | 0/93 (0%) |
| Standard Consent | 0/89 (0%) | 0/89 (0%) | 0/89 (0%) |
Intention to treat
| Age, Continuous(years) | Pre-Consent Nudge Bundle | Standard Consent | Total |
|---|---|---|---|
| Mean | 61.3 ± 13.6 | 58.6 ± 17.2 | 60 ± 15.5 |
| Sex: Female, Male(Participants) | Pre-Consent Nudge Bundle | Standard Consent | Total |
|---|---|---|---|
| Female | 35 | 36 | 71 |
| Male | 58 | 53 | 111 |
| Race (NIH/OMB)(Participants) | Pre-Consent Nudge Bundle | Standard Consent | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 15 | 23 | 38 |
| White | 74 | 59 | 133 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 7 | 11 |
| Length of ICU stay at enrollment(Hours) | Pre-Consent Nudge Bundle | Standard Consent | Total |
|---|---|---|---|
| Mean | 97.8 ± 73.1 | 114.5 ± 90.6 | 106.2 ± 81.9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2018 to primary completion in Aug 2019, 17 months.
Results were first posted in Mar 2021, 1 year 6 months after primary completion.
Of 399 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's 17 months is below that.
Counting every sponsor, half of 403 studies reached it within 21 months; a quarter within 12 and three quarters within 40.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.