The Effect of SPecialty cAre on Recovery From Cardiac Arrest Trial (the SPARC Trial)

Overview

This randomized clinical trial will determine if adult participants who are in the emergency department after being resuscitated from a cardiac arrest outside of the hospital benefit from care delivered at specialized centers. The main question that it will answer is whether transferring participants to a hospital with a specialized cardiac arrest service improves recovery of function after 90 days. Participants will receive all usual medical care, but some participants will be offered transfer to a regional cardiac arrest center and others will be offered care at the closest appropriate hospital. Investigators will interview participants after 90 days to assess their recovery.

Detailed description

Cardiac arrest is a sudden stopping of the heart, which can sometimes be reversed by rapid cardiopulmonary resuscitation (CPR) and emergency medical care. Each year, over 150,000 Americans are admitted to the hospital after receiving CPR. However, many of these patients die in the hospital. There is wide variation in patient outcomes between hospitals. A key knowledge gap about systems of care is whether specific hospital or subsequent interventions or processes of care are associated with better patient outcomes. Specifically, it is unknown if patient outcomes are improved by specialized centers or by improved implementation of recommended interventions at all hospitals.

Observational data in our region and internationally suggest that out-of-hospital cardiac arrest outcomes are better when patients who survive CPR are hospitalized in specialty care or high-volume centers. It is unclear from these studies what are the minimal capabilities that distinguish specialty care from usual care and which aspects of specialty care are influencing outcomes.

This trial will take advantage of a regional system of care that includes 18 hospitals in southwestern Pennsylvania that treat over 1,000 patients resuscitated from out-of-hospital cardiac arrest annually. This region includes one high-volume specialty center with specific attention to recommended interventions for this patient population, as well as several secondary and tertiary care facilities with variable resources and approaches to patient care. This randomized trial will compare outcomes for patients assigned to care at the specialty center versus other centers and will leverage the heterogeneity of treatment between centers to understand the influence of specific treatments.

Interventions

• Other Transfer to specialty care
  Interfacility transport and treatment at the specialty care hospital
• Other Usual care
  Hospitalization and treatment at the closest appropriate facility

Primary outcome measures

• Modified Rankin Scale [Time frame: 90 Days post arrest]

Secondary outcome measures (3)

• Survival to ICU Admission [Time frame: 24 hours post arrest]
• 72 hour survival [Time frame: 72 hours post arrest]
• mRS at hospital discharge [Time frame: Up to 6 months post arrest]

Eligibility criteria

Inclusion criteria

• Out-of-hospital cardiac arrest
• Resuscitated from cardiac arrest with palpable pulse in the emergency department
• Treated at one of participating hospital emergency departments
• Age ≥18 years

Exclusion criteria

• Known prior advanced directives or decision to limit critical care
• Known pre-arrest dependent functional status (e.g., living in a skilled nursing facility, hospice or bedbound)
• Arrest in the emergency department >4 hours after arrival
• Traumatic etiology of arrest
• Known to have opted-out from the SPARC trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Pittsburgh Department of Emergency Medicine — Pittsburgh

Publications

• Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42. PMID 21513547
• Elmer J, Weisgerber AR, Wallace DJ, Horne E, Stuart SA, Shutterly K, Callaway CW. Between-hospital variability in organ donation after resuscitation from out-of-hospital cardiac arrest. Resuscitation. 2021 Oct;167:372-379. doi: 10.1016/j.resuscitation.2021.07.038. Epub 2021 Aug 4. PMID 34363855
• Elmer J, Molyneaux BJ, Shutterly K, Stuart SA, Callaway CW, Darby JM, Weisgerber AR. Organ donation after resuscitation from cardiac arrest. Resuscitation. 2019 Dec;145:63-69. doi: 10.1016/j.resuscitation.2019.10.013. Epub 2019 Oct 22. PMID 31654724
• Imai K, Keele L, Tingley D. A general approach to causal mediation analysis. Psychol Methods. 2010 Dec;15(4):309-34. doi: 10.1037/a0020761. PMID 20954780
• VanderWeele TJ. A unification of mediation and interaction: a 4-way decomposition. Epidemiology. 2014 Sep;25(5):749-61. doi: 10.1097/EDE.0000000000000121. PMID 25000145
• VanderWeele TJ. Bias formulas for sensitivity analysis for direct and indirect effects. Epidemiology. 2010 Jul;21(4):540-51. doi: 10.1097/EDE.0b013e3181df191c. PMID 20479643
• VanderWeele TJ. Commentary: On Causes, Causal Inference, and Potential Outcomes. Int J Epidemiol. 2016 Dec 1;45(6):1809-1816. doi: 10.1093/ije/dyw230. No abstract available. PMID 28130319
• Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173. PMID 3806354

Identifiers

NCT: NCT07002294 · STUDY25050152 · R61HL175113

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗