HospitalizationNCT02117804
Early Screen for Discharge Planning in Community Hospitals
An observational study of Hospitalization, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the predictive performance of the Early Screen for Discharge Planning (ESDP) tool in a regional community hospital. The central hypothesis is that the ESDP differentiates between patients in a regional community hospital who would benefit from those who would not benefit from… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hospitalization
- What is being tested?
- Early Screen for Discharge Planning
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to May 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study targets adults hospitalized for a variety of medical and surgical conditions in a rural regional community hospital that is part of a large health system in the Midwest. The sample will be limited to adults who are returning home in the community, because the investigators are primarily interested in the problems and unmet needs encountered after discharge during the recovery period at home. To enhance the generalizability of the results, the sample will be stratified based on 2010 national estimates of age categories for hospitalized adults.
Who may be able to join
- 18 years or older
- Able to read and speak English
- Returning home in the community after discharge
Who cannot join
- Discharged to facility care
- Pregnant females
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Health System - Eau Claire
Eau Claire, Wisconsin, 54703
About this study
Official title: Validating Discharge Planning Decision Support in a Regional Community Hospital
The purpose of this study is to determine the predictive performance of the Early Screen for Discharge Planning (ESDP) tool in a regional community hospital. The central hypothesis is that the ESDP differentiates between patients in a regional community hospital who would benefit from those who would not benefit from early discharge-planning intervention as measured by problems and unmet continuing care needs, quality of life, length of stay, and referrals to post-acute services.
Read the detailed description
Patients who are hospitalized for medical or surgical reasons who consent to the study will be screened within 24 hours of hospital admission using the Early Screen for Discharge Planning (ESDP). The ESDP is a four-item screening tool used to determine on admission which patients are likely to have complex discharge plans and could benefit from early engagement of discharge planning personnel. The ESDP yields a total score, and those with a score of 10 or greater are considered to have a "high score" and likely to have a complex discharge plan. Those with a score of 9 or below have a "low score". The ESDP screen has been proven to be valid in large academic medical centers. This study will determine if the screen performs with the same validity in a small community hospital.
- Conditions
- Hospitalization
- Being tested
- Early Screen for Discharge Planning
- Keywords
- Discharge Planning, Decision Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Screen for Discharge PlanningOther
This screen is completed by a study coordinator within 24 hours of patient admission to the hospital. The screen measures four variables available from routine hospital admission clinical data (walking limitation, age, living alone prior to admission, and level of disability) that exhibit high sensitivity and specificity (AUC's were .82 and.84) in identifying patients who should receive targeted attention from a DP expert.
| Study group | Role | What they receive |
|---|---|---|
| High ESDP Score | Patients with 10 or greater score on the Early Screen for Discharge Planning at the time of admission. Receives: Other: Early Screen for Discharge Planning | |
| Low ESDP Score | Patients with 9 or lower score on the Early Screen for Discharge Planning at the time of admission. Receives: Other: Early Screen for Discharge Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of problems reported after discharge, measured by the Problems After Discharge Questionnaire - English Version (PADQ-E)
A problem is defined as any worry, limitation, concern, or difficulty reported by the patient. The Problems After Discharge Questionnaire - English Version measures important patient factors often overlooked that contribute to poor post-acute recovery experience which are recognized as important factors likely to impact readmission.
Measured: 1 week after hospital discharge
Secondary outcomes (2)
Number of unmet needs reported after discharge, measured by the Problems After Discharge Questionnaire - English Version (PADQ-E)
An unmet need is a need for help identified by the patient that is reported to be inadequately met. The Problems After Discharge Questionnaire - English Version measures important patient factors often overlooked that contribute to poor post-acute recovery experience which are recognized as important factors likely to impact readmission.
Measured: 1 week after hospital discharge
Quality of life, measured by the EuroQoL-5D
The EuroQoL-5D (EQ-5D) is a standardized instrument for use as a measure of health out-come. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care.
Measured: 1 week after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HospitalizationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Diane Holland, Mayo Clinic
- Investigators
- Diane E. Holland, PhD, RN, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117804
- Sponsor's protocol ID
- 14-002495
- Status last verified
- May 2015
- First submitted
- 16 Apr 2014
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating Discharge Planning Decision Support in a Regional Community Hospital
- ClinicalTrials.gov ID
- NCT02117804
- Acronym / sponsor ID
- 14-002495
- Conditions
- Hospitalization
- Keywords
- Discharge Planning, Decision Support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 21 Apr 2014 (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 predictive performance of the Early Screen for Discharge Planning (ESDP) tool in a regional community hospital. The central hypothesis is that the ESDP differentiates between patients in a regional community hospital who would benefit from those who would not benefit from early discharge-planning intervention as measured by problems and unmet continuing care needs, quality of life, length of stay, and referrals to post-acute services.
Detailed description
Patients who are hospitalized for medical or surgical reasons who consent to the study will be screened within 24 hours of hospital admission using the Early Screen for Discharge Planning (ESDP). The ESDP is a four-item screening tool used to determine on admission which patients are likely to have complex discharge plans and could benefit from early engagement of discharge planning personnel. The ESDP yields a total score, and those with a score of 10 or greater are considered to have a "high score" and likely to have a complex discharge plan. Those with a score of 9 or below have a "low score". The ESDP screen has been proven to be valid in large academic medical centers. This study will determine if the screen performs with the same validity in a small community hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High ESDP Score | – | Other: Early Screen for Discharge PlanningPatients with 10 or greater score on the Early Screen for Discharge Planning at the time of admission. |
| Low ESDP Score | – | Other: Early Screen for Discharge PlanningPatients with 9 or lower score on the Early Screen for Discharge Planning at the time of admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study targets adults hospitalized for a variety of medical and surgical conditions in a rural regional community hospital that is part of a large health system in the Midwest. The sample will be limited to adults who are returning home in the community, because the investigators are primarily interested in the problems and unmet needs encountered after discharge during the recovery period at home. To enhance the generalizability of the results, the sample will be stratified based on 2010 national estimates of age categories for hospitalized adults.
Key inclusion criteria (3 listed)
- 18 years or older
- Able to read and speak English
- Returning home in the community after discharge
Key exclusion criteria (2 listed)
- Discharged to facility care
- Pregnant females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Screen for Discharge PlanningThis screen is completed by a study coordinator within 24 hours of patient admission to the hospital. The screen measures four variables available from routine hospital admission clinical data (walking limitation, age, living alone prior to admission, and level of disability) that exhibit high sensitivity and specificity (AUC's were .82 and.84) in identifying patients who should receive targeted attention from a DP expert. | Other | High ESDP Score, Low ESDP Score |
Primary outcome
Number of problems reported after discharge, measured by the Problems After Discharge Questionnaire - English Version (PADQ-E)
Time frame: 1 week after hospital discharge
A problem is defined as any worry, limitation, concern, or difficulty reported by the patient. The Problems After Discharge Questionnaire - English Version measures important patient factors often overlooked that contribute to poor post-acute recovery experience which are recognized as important factors likely to impact readmission.
2 secondary outcomes
Number of unmet needs reported after discharge, measured by the Problems After Discharge Questionnaire - English Version (PADQ-E)
Time frame: 1 week after hospital discharge
Quality of life, measured by the EuroQoL-5D
Time frame: 1 week after hospital discharge
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 21 May 2015.
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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.
Diane E. Holland, PhD, RN principal investigator
Mayo Clinic
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 Hospitalization, run by Mayo Clinic 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 3 inclusion and 2 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 21 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?
Number of problems reported after discharge, measured by the Problems After Discharge Questionnaire - English Version (PADQ-E) (time frame: 1 week after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2015.