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Completed

NCT Number: 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.

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Key information

Conditions

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tallahassee Memorial Healthcare

Tallahassee, Florida, 32301, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
Feb 22, 2012
Registry last updated
May 25, 2015

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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