Study protocol for a two-center test of a nurse-implemented chronotherapeutic restoring bundle in critically ill children: RESTORE Resilience (R2)

Mallory A Perry; Onella S Dawkins-Henry; Ronke E Awojoodu; Jennifer Blumenthal; Lisa A Asaro; David Wypij; Sapna R Kudchadkar; Athena F Zuppa; Martha A Q Curley

doi:10.1016/j.conctc.2021.100840

Study protocol for a two-center test of a nurse-implemented chronotherapeutic restoring bundle in critically ill children: RESTORE Resilience (R²)

Contemp Clin Trials Commun. 2021 Aug 19:23:100840. doi: 10.1016/j.conctc.2021.100840. eCollection 2021 Sep.

Authors

Mallory A Perry¹, Onella S Dawkins-Henry², Ronke E Awojoodu^{3

4}, Jennifer Blumenthal^{1

5}, Lisa A Asaro², David Wypij^{2

6}, Sapna R Kudchadkar³, Athena F Zuppa^{5

7}, Martha A Q Curley^{1

7

8}

Affiliations

¹ Research Institute, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
² Department of Cardiology, Boston Children's Hospital, Boston, MA, USA.
³ Department of Anesthesiology and Critical Care Medicine, Charlotte R. Bloomberg Children's Center, Johns Hopkins Medicine, Baltimore, MD, USA.
⁴ University of Maryland Baltimore School of Nursing, Baltimore, MD, USA.
⁵ Department of Anesthesiology and Critical Care, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
⁶ Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
⁷ Department of Anesthesiology and Critical Care, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
⁸ Department of Family and Community Health, University of Pennsylvania School of Nursing, Philadelphia, PA, USA.

Abstract

Often, pediatric intensive care environments are not conducive to healing the sick. Critically ill children experience disruptions in their circadian rhythms, which can contribute to delayed recovery and poor outcomes. We aim to test the hypothesis that children managed via RESTORE Resilience (R²), a nurse-implemented chronotherapeutic bundle, will experience restorative circadian rhythms compared to children receiving usual care. In this two-phased, prospective cohort study, two separate pediatric intensive care units in the United Sates will enroll a total of 20 baseline subjects followed by 40 intervention subjects, 6 months to less than 18 years of age, requiring invasive mechanical ventilation. During the intervention phase, we will implement the R² bundle, which includes: (1) a focused effort to replicate the child's pre-hospitalization daily routine, (2) cycled day-night lighting and sound modulation, (3) minimal yet effective sedation (RESTORE), (4) nighttime fasting with bolus enteral daytime feedings, (5) early progressive mobility (PICU Up!), (6) continuity in nursing care, and (7) parent diaries. Our primary outcome is circadian activity ratio post-extubation. We hypothesize that children receiving R² will experience restored circadian rhythms as evidenced by decreased nighttime activity while in the PICU. Our exploratory outcomes include salivary melatonin levels; electroencephalogram (EEG) slow-wave activity; R² feasibility, adherence, and system barriers; levels of patient comfort; exposure to sedative medications; time to physiological stability; and parent perception of being well cared for. This paper describes the design, rationale, and implementation of R².

Clinicaltrialsgov identifier: NCT04695392.

Keywords: CINC, continuity in nursing care; Circadian rhythm; DARE, daytime activity ratio estimate; DCC, Data Coordinating Center; DMS, data management system; EEG, electroencephalography; FCCS, Family-Centered Care Scale; ICU, intensive care unit; Mechanical ventilation; Nurse-implemented interventions; PCPC, Pediatric Cerebral Performance Category; PICU, pediatric intensive care unit; POPC, Pediatric Overall Performance Category; PRISM III-12, Pediatric Risk of Mortality III score from first 12 h in the PICU; Pediatric critical care; WAT-1, Withdrawal Assessment Tool-1.

Associated data

ClinicalTrials.gov/NCT04695392

Abstract

Associated data

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