- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06651645
Pre- vs Post-Pandemic Risk-adjusted Survival Rates in the US Hospitals
Pre- vs Post-COVID-19 Pandemic Risk-adjusted Survival Rates in the US Hospitals: Retrospective Cohort Study of Hospital Performance
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pre-pandemic admissions
Patients admitted between January 1, 2018 - February 29, 2020 with one of the following five primary diagnoses of acute myocardial infarction, stroke, heart failure, pneumonia, and chronic obstructive pulmonary disease in alignment with the Centers for Medicare and Medicaid Service's (CMS's) condition-specific mortality measures reporting
|
|
|
Post-pandemic admissions
Patients admitted between May 1, 2022 and May 31, 2023 without a diagnosis for COVID-19 and with one of the following five primary diagnoses of acute myocardial infarction, stroke, heart failure, pneumonia, and chronic obstructive pulmonary disease in alignment with the Centers for Medicare and Medicaid Service's (CMS's) condition-specific mortality measures reporting.
|
Impact of COVID-19 pandemic on hospital care delivery
|
|
Pandemic admissions
Patients admitted between March 1, 2020 and April 30, 2022 without a diagnosis for COVID-19 and with one of the following five primary diagnoses of acute myocardial infarction, stroke, heart failure, pneumonia, and chronic obstructive pulmonary disease in alignment with the Centers for Medicare and Medicaid Service's (CMS's) condition-specific mortality measures reporting
|
Impact of COVID-19 pandemic on hospital care delivery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During hospital admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
During hospital admission
|
Collaborators and Investigators
Investigators
- Principal Investigator: Maniraj Neupane, MD, Ph.D., Grand Island Regional Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BD022390
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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