- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01536340
Identifying Adverse Events After Discharge From a Community Hospital
The purpose of this study is to:
-Determine the incidence of adverse events, preventable adverse events, and ameliorable adverse events, and the timeliness of post-discharge ambulatory appointments, affecting urban and rural patients approximately 3-4 weeks after discharge from a hospitalist-run medical service of a large community hospital to home.
H1: The incidence of post-discharge adverse events will be higher in rural patients compared with urban patients discharged from a hospitalist-run medical service of a large community hospital.
-Identify and classify the types of post-discharge adverse events (e.g., adverse drug events, procedure-related events, hospital acquired (nosocomial) infections, falls, and other) affecting urban and rural patients approximately 3-4 weeks after discharge from a hospitalist-run medical service of a large community hospital to home.
H2: All patients will be at higher risk for adverse drug events than other types of adverse events.
-Examine the relationships between the population at risk, characteristics of the health care delivery system, and the utilization of post-discharge health services, and how these relationships help us understand the incidence of post-discharge adverse events.
H3: Several factors will be independently associated with the incidence of post-discharge adverse events in rural and urban patients, including patient comorbidity, severity of acute illness, presence of a primary care physician prior to hospitalization, and a scheduled timely post-discharge ambulatory follow-up appointment.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Florida
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Tallahassee, Florida, United States, 32301
- Tallahassee Memorial HealthCare
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Our study population includes patients 21 and older living in Florida, who are discharged home from the TMH hospitalist service. Patients must have a phone number where they can be reached. They must also speak English or Spanish. Surrogates are permitted to complete an interview in the event that a patient is unable to complete it.
Rural patients are those who live in counties where the population density is 100 people per square mile or less. Patients with diminished mental capacity are at increased risk of adverse events. These patients (or their surrogates) are included in the sample.
Description
Inclusion Criteria:
- age over 21 years
- discharged home from TMH general medical service
- patients must have a telephone number where they can be reached for an interview
- patient or surrogate must be able to interview in Spanish or English
Exclusion Criteria:
- age less than 21 years
- patient or surrogate non-English or Spanish speaking
- patients being discharged to an institutionalized care (assisted living facilities, prisons, etc.)
- patients not discharged from general medical service
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
post discharge adverse event
Time Frame: six weeks after discharge from the hospital
|
Patients are contacted 3-6 weeks after discharge for a phone interview.
They are questioned about potential adverse events following their discharge from the hospital.
Interviewers/nurses conduct a review of systems to determine if the patient experienced an adverse event.
Potential cases are flagged on the basis of unexpected health care utilization, new/exacerbated symptoms and/or abnormal lab test results.
Cases are reviewed by two independent physician reviewers to determine whether the adverse event was preventable, using their implicit judgment.
|
six weeks after discharge from the hospital
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dennis Tsilimingras, MD, MPH, Wayne State University
- Study Director: Ashley Duke, Florida State University, College of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R01HS018694 (U.S. AHRQ Grant/Contract)
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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