AzTrials
AzTrials

Newborn; InfectionPOKENCT03688607

Deploying POKE Within Intermountain Healthcare

An observational study of Newborn; Infection, run by Intermountain Health Care, Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages Up to 12 monthsHealthy volunteers can take part
Conditions the study is for
Newborn; Infection
What is being tested?
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.
Type of treatment
Surgery or procedure
How many people
2,600 participants
Where
1 siteUnited States
Study dates
1 Oct 2018to 31 May 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 12 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Babies admitted to hospital

Who may be able to join

  • All babies in Intermountain Healthcare NICU

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

R. Erick Ridout, MD contact

435-705-9208

Erick.Ridout@imail.org

Terri Kane, RN, MBA contact

435-251-2104

Terri.Kane@imail.org

United States1 site

  • Dixie Regional Medical Center, Intermountain Healthcare

    St. George, Utah, 84770

    R. Erick Ridout, MD, 435-705-9208, Erick.Ridout@imail.org

    Patrick Carroll, MD, 435-688-5440, Patrick.Carroll@imail.org

Other trials in United States

About this study

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.

Read the 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.

Being tested
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.
Keywords
NICU, POKE, Length of Stay, Infection, Neonates
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 or surgery

    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.

Study groups in NCT03688607
Study groupRoleWhat they receive
POKEAll babies in NICU at Intermountain Healthcare hospitals
Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 1 October 2018 - 31 May 2019

Secondary outcomes (5)

  1. Infection Rate

    Also using multivariable regression, the secondary outcomes will be patient-level indicators, including hospital acquired infection (logistic regression)

    Measured: 1 October 2018 - 31 May 2019

  2. Length of Stay

    Length of stay (scaled beta regression)

    Measured: 1 October 2018 - 31 May 2019

  3. Mortality

    Mortality (logistic regression)

    Measured: 1 October 2018 - 31 May 2019

  4. Total Variable Cost

    Total variable costs (log-linear regression)

    Measured: 1 October 2018 - 31 May 2019

  5. Aggregate Backfill Rate

    aggregated backfill rate (quasibinomial regression)

    Measured: 1 October 2018 - 31 May 2019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2018
  2. Study start1 Oct 2018 (estimated)
  3. Primary completion30 Apr 2019 (estimated)
  4. Study completion31 May 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03688607
Sponsor's protocol ID
IHC IRB #1050915
Acronym
POKE
Status last verified
Sep 2018
First submitted
25 Sep 2018
Last updated
28 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28554944

  • 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.

    PubMed 22419800

  • 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/

    PubMed 24901184

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

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

  • 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.

    PubMed 26214387

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

  • Kornhauser, M., & R. S. (2017, December 15). How Plans Can Improve Outcomes And Cut Costs for Preterm Infant Care. Retrieved from https://www.managedcaremag.com/archives/2010/1/how-plans-can-improveoutcomes-and-cut-costs-preterm-infant-care

Questions about this trial

What is this clinical trial studying?

An observational study of Newborn; Infection, run by Intermountain Health Care, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact R. Erick Ridout, MD (435-705-9208, Erick.Ridout@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of POKEs per baby (time frame: 1 October 2018 - 31 May 2019). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03688607, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in