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NCT Number: NCT06651645

Pre- vs Post-Pandemic Risk-adjusted Survival Rates in the US Hospitals

This study aims to perform a retrospective cohort study of administrative health data to understand how care delivery performance varies across US hospitals post-COVID-19 pandemic compared to the pre-pandemic performance. We also hope to identify which factors contribute to performance changes.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health

Bethesda, Maryland, 20892, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The study cohort will include one random encounter per patient for all adult (age ≥18years) encounters. All inpatients with the Premier healthcare database (PINC-AI) and those patients who were admitted under observation status and expired in the hospital or those who presented acutely to the emergency department and died in the emergency department will be considered as inpatients for the purpose of this study as per prior precedence in including such patients.

All pediatric inpatients, skilled nursing facilities inpatients, long term acute care inpatients, rehabilitation facility inpatients, psychiatric inpatients, hospice inpatients, chemical dependency unit inpatients and deceased organ donor inpatients are excluded after applying encounter level exclusion criteria from this inpatient cohort. Application of this encounter level exclusion will also preferentially exclude any children hospitals, skilled nursing facilities, acute long term care facilities, psychiatry hospitals, inpatient hospices and chemical dependency units.

Treatment and study plan

COVID-19 Surge

Other

Impact of COVID-19 pandemic on hospital care delivery

Primary outcomes

  1. Adjusted in-hospital mortality

    Time frame: During hospital admission

    Our primary outcome will be based on a composite measure of in-hospital mortality or discharge to hospice as determined by discharge status code. The primary outcome will itself be expressed as a modified standardized mortality ration (mSMR) calculated as mean-shrunken number of observed deaths or discharge to hospice divided by the expected number of deaths or discharge to hospice for a center in that post-pandemic month assuming the effects of a typical center in the pre-pandemic era.

Secondary outcomes

  1. Rates of potential inpatient complications (PICs)

    Time frame: During hospital admission

    PICs are complications developed during the hospital stay which may reflect the performance changes post pandemic due to circumstances observed during the pandemic. List of PICs will be curated as has been done previously using Premier Healthcare Database as reported in Korvink et al. Med Care, 2023. For each of the patient, we will calculate the cumulative number of PICs developed during their inpatient stay, which would be a sum of individual counts of PICs out of the list of 74 total possible PICs. Eventually, observed and expected rate of PICs normalized to the length of stay will be calculated with analysis restricted to within hospitals after adjusting for patient level covariates. Subsequently, risk factor model will include hospital level factors to assess association of these factors to aggregate rates of PICs in the cohort to identify factors associated with better or poor performance post pandemic

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Registry information

Official study title

Pre- vs Post-COVID-19 Pandemic Risk-adjusted Survival Rates in the US Hospitals: Retrospective Cohort Study of Hospital Performance

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2024
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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