Deploying POKE Within Intermountain Healthcare

Sponsor
Intermountain Health Care, Inc. (Other)
Overall Status
Unknown status
CT.gov ID
NCT03688607
Collaborator
(none)
2,600
1
8
327

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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.

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 Design

Study Type:
Observational
Anticipated Enrollment :
2600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Deploying POKE Within Intermountain Healthcare
Anticipated Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Apr 30, 2019
Anticipated Study Completion Date :
May 31, 2019

Arms and Interventions

Arm Intervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. Length of Stay [1 October 2018 - 31 May 2019]

    Length of stay (scaled beta regression)

  3. Mortality [1 October 2018 - 31 May 2019]

    Mortality (logistic regression)

  4. Total Variable Cost [1 October 2018 - 31 May 2019]

    Total variable costs (log-linear regression)

  5. Aggregate Backfill Rate [1 October 2018 - 31 May 2019]

    aggregated backfill rate (quasibinomial regression)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 12 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All babies in Intermountain Healthcare NICU
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dixie Regional Medical Center, Intermountain Healthcare Saint George Utah United States 84770

Sponsors and Collaborators

  • Intermountain Health Care, Inc.

Investigators

  • Principal Investigator: R. Erick Ridout, MD, Intermountain Health Care, Inc.
  • Study Director: Terri Kane, RN, MBA, Intermountain Health Care, Inc.
  • Study Director: Brad Isaacson, PhD, MBA, MSF, Intermountain Health Care, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT03688607
Other Study ID Numbers:
  • IHC IRB #1050915
First Posted:
Sep 28, 2018
Last Update Posted:
Sep 28, 2018
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Intermountain Health Care, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2018