Identifying Adverse Events After Discharge From a Community Hospital

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dennis Tsilimingras, MD, MPH, Wayne State University
ClinicalTrials.gov Identifier:
NCT01536340
First received: February 16, 2012
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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
Iatrogenic Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identifying Adverse Events After Discharge From a Community Hospital

Resource links provided by NLM:


Further study details as provided by Florida State University:

Primary Outcome Measures:
  • post discharge adverse event [ Time Frame: six weeks after discharge from the hospital ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 684
Study Start Date: September 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536340

Locations
United States, Florida
Tallahassee Memorial Healthcare
Tallahassee, Florida, United States, 32301
Sponsors and Collaborators
Florida State University
Investigators
Principal Investigator: Dennis Tsilimingras, MD, MPH Wayne State University
Study Director: Ashley Duke Florida State University College of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Dennis Tsilimingras, MD, MPH, School of Medicine, Wayne State University
ClinicalTrials.gov Identifier: NCT01536340     History of Changes
Other Study ID Numbers: R01HS018694
Study First Received: February 16, 2012
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Florida State University:
post discharge adverse events
discontinuities in care
medical injury

ClinicalTrials.gov processed this record on September 30, 2014