Clinical trial NCT03688607: Deploying POKE Within Intermountain Healthcare
Official title: Deploying POKE Within Intermountain Healthcare
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Newborn; Infection
Keywords: NICU
POKE
Length of Stay
Infection
Neonates
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 2600
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Babies admitted to hospital

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.

Detailed description: POKE was developed and implemented at Dixie Regional Medical Center's Neonatal Intensive Care Unit (NICU) over the past 10 years to eliminate waste and reduce harm in healthcare. POKE is a combination of a unique culture and process, with a supporting database, that is designed to guide and inform care decisions while minimizing POKEs. The program utilizes an implementation framework, educational materials, electronic health records (EHR), and decision support analytics. POKE's initial deployment showed extremely promising results for Intermountain, which included: (1) eliminating 11,000 POKEs per year (a 50% reduction in overall POKEs), (2) realizing $940,000 per year in cost savings (a 28% reduction of overall cost), (3) reducing length of stay by 2 weeks per average stay (a 21% reduction in length of stay), and (4) eliminating Hospital Acquired Infections (i.e., Central-line Associated Bloodstream Infection and Ventilator-associated Pneumonia), translating into 10 lives saved and a $5.2M savings over a decade. POKE will now be deployed and routinized within all Intermountain Healthcare NICUs and be developed as a commercial product for external customers. To assess the impact of POKE on babies, the investigators will longitudinally track several outcomes before and after implementation at Intermountain 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.

Eligibility criteria: Inclusion Criteria:

* All babies in Intermountain Healthcare NICU

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of POKEs per baby
timeFrame: 1 October 2018 - 31 May 2019
Secondary outcomes:
measure: Infection Rate
timeFrame: 1 October 2018 - 31 May 2019
measure: Length of Stay
timeFrame: 1 October 2018 - 31 May 2019
measure: Mortality
timeFrame: 1 October 2018 - 31 May 2019
measure: Total Variable Cost
timeFrame: 1 October 2018 - 31 May 2019
measure: Aggregate Backfill Rate
timeFrame: 1 October 2018 - 31 May 2019
Other outcomes:
Locations:
city: Saint George
country: United States
facility: Dixie Regional Medical Center, Intermountain Healthcare
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: R. Erick Ridout, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Intermountain Health Care, Inc.
name: Terri Kane, RN, MBA
role: STUDY_DIRECTOR
affiliation: Intermountain Health Care, Inc.
name: Brad Isaacson, PhD, MBA, MSF
role: STUDY_DIRECTOR
References:
citation: Ebell MH, Sokol R, Lee A, Simons C, Early J. How good is the evidence to support primary care practice? Evid Based Med. 2017 Jun;22(3):88-92. doi: 10.1136/ebmed-2017-110704. Epub 2017 May 29.
citation: 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.
citation: 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/
citation: Special Care Nursery Admissions. (2011). National Perinatal Information Center Quality Analytic Services. Retrieved from https://www.marchofdimes.org/peristats/pdfdocs/nicu_summary_final.pdf
citation: Critical Care Statistics. Retrieved from http://www.sccm.org/Communications/Pages/CriticalCareStats.aspx
citation: 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.
citation: National Center for Health Statistics. (2018, January 31). Retrieved from https://www.cdc.gov/nchs/nvss/births.htm
citation: 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.