| Registry | NCT01472458, acronym PremaTOR |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, single group, masking: single, health services research |
| Enrollment | 905 (Actual) |
| Sponsor | Sunnybrook Health Sciences Centre (Other); collaborators: Heart and Stroke Foundation of Canada, Canadian Institutes of Health Research (CIHR) |
| Conditions | Cardiac Arrest |
| Interventions | Quality improvement (Behavioral) |
| Dates | start 2011-11-01, primary completion 2014-06-01, completion 2014-06-01, first posted 2011-11-16, last updated 2017-02-06 |
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The study Premature Termination of Resuscitation in Survivors of Cardiac Arrest focuses on using innovative knowledge translation strategies to improve appropriate neuroprognostication for survivors of cardiac arrest and prevent premature termination of life sustaining therapies. This is important because any early gains achieved during resuscitation will be nullified if clinicians terminate life-sustaining therapies prematurely based on inadequate prognostic information. An effective translation strategy for neuroprognostication will result in improved physician adherence to evidence-based medicine and an increase in the proportion of patients surviving to achieve a good neurological outcome following cardiac arrest.
A stepped wedge cluster randomized trial design will be employed in order to properly evaluate the impact of this intervention. Each of the 18 participating hospitals will be randomized one of the four wedges according to a random schedule; each wedge will consist of 4 to 5 hospitals. With this design, the implementation of the intervention will be rolled out sequentially to the participating hospitals over a 5 month period for each wedge. All hospitals will have received the intervention by the end of the study.
Note that the study design fields provided by ClinicalTrials.gov do not allow for describing this type of study design; therefore, the investigators have listed the study as a single arm. In reality, this study will have 4 wedges, each containing randomized clusters of 4-5 hospitals.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Active Intervention | Active comparator | Behavioral: Quality improvement | This stepped-wedge cluster randomized evaluation will randomly allocate 18 hospitals into 4 groups to receive our active intervention at different sequential time points according to the randomly assigned stepped-wedge schedule. Hospitals will function as control hospitals until it is their turn to receive the active intervention, according to the stepped wedge schedule. Each wedge consists of 4-5 hospitals and will last 5 months. |
| Control Hospitals | No intervention | This stepped-wedge cluster randomized evaluation will randomly allocate 18 hospitals into 4 groups to receive our active intervention at different sequential time points according to the randomly assigned stepped-wedge schedule. Hospitals will function as control hospitals until it is their turn to receive the active intervention, according to the stepped wedge schedule. Each wedge consists of 4-5 hospitals and will last 5 months. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Patients =/> 18 years of age * Non-traumatic out of hospital cardiac arrest * Sustained return of spontaneous circulation (palpable pulse for > 20 minutes) * Comatose (i.e. without full neurological recovery; non-responsive to verbal commands) * Surviving to at least 6 hours after emergency department arrival Exclusion Criteria: * Patients who die within 6 hours of emergency department arrival