Identifying Adverse Events After Discharge From a Community Hospital

Sponsor
Florida State University (Other)
Overall Status
Completed
CT.gov ID
NCT01536340
Collaborator
Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
684
1
37
18.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This 24-month prospective cohort study will examine the frequency and types of adverse events experienced by patients 3-4 weeks after discharge from the Tallahassee Memorial Hospital (TMH), the timeliness of post-discharge ambulatory appointments, and identify the associations, if any, of readily available patient, system, and patient care factors with the occurrence of these post-discharge adverse events. Data collection will involve telephone interviews with patients, and review of inpatient and outpatient health records for services received, as necessary, within 3-4 weeks after discharge from the hospital. These data sources will allow study physicians to implicitly (with some explicit guidance) determine whether an adverse event has occurred, distinguish preventable from ameliorable adverse events, and determine the types of adverse events. In addition, the study will determine the timeliness of post-discharge ambulatory appointments by conducting post-discharge telephone interviews with patients and reviewing health records.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    684 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Identifying Adverse Events After Discharge From a Community Hospital
    Study Start Date :
    Sep 1, 2011
    Actual Primary Completion Date :
    Oct 1, 2012
    Actual Study Completion Date :
    Oct 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. post discharge adverse event [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tallahassee Memorial Healthcare Tallahassee Florida United States 32301

    Sponsors and Collaborators

    • Florida State University
    • Agency for Healthcare Research and Quality (AHRQ)

    Investigators

    • Principal Investigator: Dennis Tsilimingras, MD, MPH, Wayne State University
    • Study Director: Ashley Duke, Florida State University, College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Dennis Tsilimingras, MD, MPH, School of Medicine, Wayne State University
    ClinicalTrials.gov Identifier:
    NCT01536340
    Other Study ID Numbers:
    • R01HS018694
    First Posted:
    Feb 22, 2012
    Last Update Posted:
    May 25, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by Dennis Tsilimingras, MD, MPH, School of Medicine, Wayne State University

    Study Results

    No Results Posted as of May 25, 2015