Deploying POKE Within Intermountain Healthcare

NCT03688607 | Unknown

• 1 other identifier: IHC IRB #1050915
• Study Type: observational
• Target: 2,600
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the impact of POKE on babies, the investigators will longitudinally track outcomes before and after implementation at Intermountain Healthcare's five NICUs. Process outcomes will include the number of total POKEs per baby and the number of painful POKEs per baby, each measured at both the patient-level and NICU-level. Clinical outcomes will include hospital acquired infections, length of stay, and mortality. Financial outcomes will include total variable costs and backfill rate. The effect of POKE on each of these outcomes will be measured using multivariable regression analysis with appropriate distributional families and interaction terms.

Conditions

Newborn; Infection

Keywords

NICU; POKE; Length of Stay; Infection; Neonates

Outcome Measures

Primary Outcomes (1)

• Number of POKEs per baby

  The primary outcomes will be the number of total POKEs per baby and the number of painful POKEs per baby. We will assess the impact of POKE on each of these outcomes modeled as counts (ie, generalized Poisson distributions) using multivariable regression adjusting for potential confounders including age, gestational age, interaction terms, and nominal indicators of NICU (to account for baseline heterogeneity across sites).

  1 October 2018 - 31 May 2019

Secondary Outcomes (5)

• Infection Rate

  1 October 2018 - 31 May 2019

• Length of Stay

  1 October 2018 - 31 May 2019

• Mortality

  1 October 2018 - 31 May 2019

• Total Variable Cost

  1 October 2018 - 31 May 2019

• Aggregate Backfill Rate

  1 October 2018 - 31 May 2019

Study Arms (1)

POKE

All babies in NICU at Intermountain Healthcare hospitals

Procedure: There will not be an intervention, rather the investigators will deploy best practices and track POKEs within the healthcare system to evaluate clinical and operational outcomes.

Interventions

There will not be an intervention, rather the investigators will deploy best practices and track POKEs within the healthcare system to evaluate clinical and operational outcomes. PROCEDURE

There will not be an intervention, rather the investigators will deploy best practices and track POKEs within the healthcare system to evaluate clinical and operational outcomes.

POKE

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Babies admitted to hospital

You may qualify if:

• All babies in Intermountain Healthcare NICU

You may not qualify if:

• None

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Dixie Regional Medical Center, Intermountain Healthcare

St. George, Utah, 84770, United States

Location

Related Publications (8)

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  PMID: 28554944 BACKGROUND

• Berwick DM, Hackbarth AD. Eliminating waste in US health care. JAMA. 2012 Apr 11;307(14):1513-6. doi: 10.1001/jama.2012.362. Epub 2012 Mar 14.

  PMID: 22419800 BACKGROUND

• Committee on the Learning Health Care System in America; Institute of Medicine; Smith M, Saunders R, Stuckhardt L, McGinnis JM, editors. Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. Washington (DC): National Academies Press (US); 2013 May 10. Available from http://www.ncbi.nlm.nih.gov/books/NBK207225/

  PMID: 24901184 BACKGROUND

• Special Care Nursery Admissions. (2011). National Perinatal Information Center Quality Analytic Services. Retrieved from https://www.marchofdimes.org/peristats/pdfdocs/nicu_summary_final.pdf

  BACKGROUND

• Critical Care Statistics. Retrieved from http://www.sccm.org/Communications/Pages/CriticalCareStats.aspx

  BACKGROUND

• Harrison W, Goodman D. Epidemiologic Trends in Neonatal Intensive Care, 2007-2012. JAMA Pediatr. 2015 Sep;169(9):855-62. doi: 10.1001/jamapediatrics.2015.1305.

  PMID: 26214387 BACKGROUND

• National Center for Health Statistics. (2018, January 31). Retrieved from https://www.cdc.gov/nchs/nvss/births.htm

  BACKGROUND

• Kornhauser M, Schneiderman R. How plans can improve outcomes and cut costs for preterm infant care. Manag Care. 2010 Jan;19(1):28-30. No abstract available.

  PMID: 20131638 BACKGROUND

MeSH Terms

Conditions

Infections

Study Officials

• R. Erick Ridout, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

• Terri Kane, RN, MBA

  Intermountain Health Care, Inc.

  STUDY DIRECTOR

• Brad Isaacson, PhD, MBA, MSF

  Intermountain Health Care, Inc.

  STUDY DIRECTOR

Central Study Contacts

R. Erick Ridout, MD

CONTACT

435-705-9208; Erick.Ridout@imail.org

Terri Kane, RN, MBA

CONTACT

435-251-2104; Terri.Kane@imail.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 28, 2018
• Study Start: October 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: May 31, 2019
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)