Iatrogenic InjuryNCT01536340
Identifying Adverse Events After Discharge From a Community Hospital
An observational study of Iatrogenic Injury, run by Florida State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Iatrogenic Injury
- How many people
- 684 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Tallahassee Memorial Healthcare
Tallahassee, Florida, 32301
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Iatrogenic Injury
- Keywords
- post discharge adverse events, discontinuities in care, medical injury
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six weeks after discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iatrogenic InjuryStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 684 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Dennis Tsilimingras, MD, MPH, Wayne State University
- Investigators
- Dennis Tsilimingras, MD, MPH, Principal investigator, Wayne State UniversityAshley Duke, Study director, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536340
- Sponsor's protocol ID
- R01HS018694
- Status last verified
- May 2015
- First submitted
- 16 Feb 2012
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25822112
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Adverse Events After Discharge From a Community Hospital
- ClinicalTrials.gov ID
- NCT01536340
- Acronym / sponsor ID
- R01HS018694
- Conditions
- Iatrogenic Injury
- Keywords
- post discharge adverse events, discontinuities in care, medical injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 684 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
- Background: PubMed 25822112Tsilimingras 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Tsilimingras, MD, MPH principal investigator
Wayne State University
Ashley Duke study director
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iatrogenic Injury, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post discharge adverse event (time frame: six weeks after discharge from the hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01536340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2015.