Clinical trial NCT01536340: Identifying Adverse Events After Discharge From a Community Hospital
Official title: Identifying Adverse Events After Discharge From a Community Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iatrogenic Injury
Keywords: post discharge adverse events
discontinuities in care
medical injury
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2012-02-22
Enrollment: 684
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: post discharge adverse event
timeFrame: six weeks after discharge from the hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Memorial Healthcare
state: Florida
Study officials:
affiliation: Wayne State University
name: Dennis Tsilimingras, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida State University, College of Medicine
name: Ashley Duke
role: STUDY_DIRECTOR
References:
citation: Tsilimingras D, Schnipper J, Duke A, Agens J, Quintero S, Bellamy G, Janisse J, Helmkamp L, Bates DW. Post-Discharge Adverse Events Among Urban and Rural Patients of an Urban Community Hospital: A Prospective Cohort Study. J Gen Intern Med. 2015 Aug;30(8):1164-71. doi: 10.1007/s11606-015-3260-3. Epub 2015 Mar 31.