Deploying POKE Within Intermountain Healthcare

• Conditions: Newborn; Infection
• Interventions: 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.

• Registration Number: NCT03688607
• Lead Sponsor: Intermountain Health Care, Inc.

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.

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-09-26
• Last Update Submitted: 2018-09-26
• Study First Posted: 2018-09-28
• Last Update Posted: 2018-09-28
• Study Start: 2018-10-01
• Primary Completion: 2019-04-30
• Study Completion: 2019-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2600

Inclusion Criteria

• All babies in Intermountain Healthcare NICU

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
POKE	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.	All babies in NICU at Intermountain Healthcare hospitals

Primary Outcome Measures

Name	Time	Method
Number of POKEs per baby	1 October 2018 - 31 May 2019	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).

Secondary Outcome Measures

Name	Time	Method
Infection Rate	1 October 2018 - 31 May 2019	Also using multivariable regression, the secondary outcomes will be patient-level indicators, including hospital acquired infection (logistic regression)
Total Variable Cost	1 October 2018 - 31 May 2019	Total variable costs (log-linear regression)
Aggregate Backfill Rate	1 October 2018 - 31 May 2019	aggregated backfill rate (quasibinomial regression)
Length of Stay	1 October 2018 - 31 May 2019	Length of stay (scaled beta regression)
Mortality	1 October 2018 - 31 May 2019	Mortality (logistic regression)

Trial Locations

Locations (1)

Dixie Regional Medical Center, Intermountain Healthcare; 🇺🇸 Saint George, Utah, United States