NCT01536340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
684

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

May 25, 2015

Status Verified

May 1, 2015

Enrollment Period

1.1 years

First QC Date

February 16, 2012

Last Update Submit

May 22, 2015

Conditions

Keywords

post discharge adverse eventsdiscontinuities in caremedical injury

Outcome Measures

Primary Outcomes (1)

  • post discharge adverse event

    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

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tallahassee Memorial Healthcare

Tallahassee, Florida, 32301, United States

Location

Related Publications (1)

  • 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.

    PMID: 25822112BACKGROUND

Study Officials

  • Dennis Tsilimingras, MD, MPH

    Wayne State University

    PRINCIPAL INVESTIGATOR
  • Ashley Duke

    Florida State University, College of Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
School of Medicine

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 22, 2012

Study Start

September 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2014

Last Updated

May 25, 2015

Record last verified: 2015-05

Locations