HospitalizationTEPIDNCT02942524
Checklist Tool in Engaging Patients in the Discharge Planning Process
A study testing Communication Intervention, Questionnaire Administration and Survey Administration in people with Hospitalization and Malignant Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies how well a checklist tool works in engaging patients in the discharge planning process. Engaging patients in the discharge process may increase participation in the discharge process and improve discharge outcomes, understanding of care after hospitalization, and decrease complications. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hospitalization, Malignant Neoplasm, Transitional Care Planning
- What is being tested?
- Communication Intervention, Questionnaire Administration and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 4 Aug 2017
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fluent in English, conscious, coherent, and alert or have an adult caregiver present that is fluent in English will be identified for the TEPID research project
Who cannot join
- Patients discharged to another inpatient facility (hospice, skilled nursing facility, long term acute care hospital [LTACH], or acute rehab) or patients discharged home with hospice will be excluded
- Any patients that are transferred to another unit prior to discharge will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Tool to Engage Patients in Discharge (TEPID)
This clinical trial studies how well a checklist tool works in engaging patients in the discharge planning process. Engaging patients in the discharge process may increase participation in the discharge process and improve discharge outcomes, understanding of care after hospitalization, and decrease complications.
Read the detailed description
PRIMARY OBJECTIVES:
- Measure the impact on discharge and transition satisfaction of utilizing questions from the Consumer Assessment of Healthcare Providers and Systems (CHAPS) patient satisfaction survey.
II. Measure the impact of the Tool to Engage Patients in Discharge (TEPID) on patient's Readiness for Hospital Discharge and Problems After Discharge Questionnaire-English (PADQ-E) results.
III. Measure the impact on decreasing healthcare utilization measures: readmission rates within 30 days from hospital discharge, hospital length of stay of admission in hospital, and emergency department visits within 30 days of hospital discharge.
OUTLINE:
Patients complete the TEPID checklist of items during hospital stay.
After completion of the study, patients are followed up for 35 days.
- Being tested
- Communication Intervention, Questionnaire Administration, Survey Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication InterventionOther
Complete TEPID
Questionnaire AdministrationOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (TEPID) | Experimental | Patients complete the TEPID checklist of items during hospital stay. Receives: Other: Communication Intervention; Other: Questionnaire Administration; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average score from the PADQ-E
A simple analysis of variance (ANOVA) model with floor as a fixed blocking factor treatment (TEPID or no TEPID) as a fixed factor. Unit appears in the model as a nested factor within treatment, and statistical tests will be adjusted for this nesting structure. The main test of interest in each model is the overall effect of treatment, which quantifies the effect of TEPID on the average score for the response. P-values below 0.05 for this effect will be considered statistically significant.
Measured: Up to 12 months
Average score from the Readiness for Hospital Discharge Scale
A simple ANOVA model with floor as a fixed blocking factor treatment (TEPID or no TEPID) as a fixed factor. Unit appears in the model as a nested factor within treatment, and statistical tests will be adjusted for this nesting structure. The main test of interest in each model is the overall effect of treatment, which quantifies the effect of TEPID on the average score for the response. P-values below 0.05 for this effect will be considered statistically significant.
Measured: Up to 12 months
Emergency department visits
A generalized linear model will be used for the binary responses (readmission and ED visit).
Measured: Up to 12 months
Patient satisfaction as measured by the Press Ganey Consumer Assessment of Healthcare Providers and Systems Survey
A simple ANOVA model with floor as a fixed blocking factor treatment (TEPID or no TEPID) as a fixed factor. Unit appears in the model as a nested factor within treatment, and statistical tests will be adjusted for this nesting structure. The main test of interest in each model is the overall effect of treatment, which quantifies the effect of TEPID on the average score for the response. P-values below 0.05 for this effect will be considered statistically significant.
Measured: Up to 12 months
Readmission rates
A generalized linear model will be used for the binary responses (readmission and ED visit).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startApr 2016
- Primary completion4 Aug 2017
- Study completion4 Aug 2017
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 Ohio State University Comprehensive Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Graham, Ohio State University Comprehensive Cancer Center
- Investigators
- Lisa Graham, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942524
- Sponsor's protocol ID
- OSU-14237
- Other IDs
- NCI-2016-01308
- Acronym
- TEPID
- Status last verified
- Jul 2020
- First submitted
- 21 Oct 2016
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tool to Engage Patients in Discharge (TEPID)
- ClinicalTrials.gov ID
- NCT02942524
- Acronym / sponsor ID
- TEPID / OSU-14237
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 4 Aug 2017 (actual)
- Study completion
- 4 Aug 2017 (actual)
- First posted
- 24 Oct 2016 (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.
This clinical trial studies how well a checklist tool works in engaging patients in the discharge planning process. Engaging patients in the discharge process may increase participation in the discharge process and improve discharge outcomes, understanding of care after hospitalization, and decrease complications.
Detailed description
PRIMARY OBJECTIVES:
- Measure the impact on discharge and transition satisfaction of utilizing questions from the Consumer Assessment of Healthcare Providers and Systems (CHAPS) patient satisfaction survey.
II. Measure the impact of the Tool to Engage Patients in Discharge (TEPID) on patient's Readiness for Hospital Discharge and Problems After Discharge Questionnaire-English (PADQ-E) results.
III. Measure the impact on decreasing healthcare utilization measures: readmission rates within 30 days from hospital discharge, hospital length of stay of admission in hospital, and emergency department visits within 30 days of hospital discharge.
OUTLINE:
Patients complete the TEPID checklist of items during hospital stay.
After completion of the study, patients are followed up for 35 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (TEPID) | Experimental | Other: Communication Intervention, Other: Questionnaire Administration, Other: Survey AdministrationPatients complete the TEPID checklist of items during hospital stay. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients fluent in English, conscious, coherent, and alert or have an adult caregiver present that is fluent in English will be identified for the TEPID research project
Key exclusion criteria (2 listed)
- Patients discharged to another inpatient facility (hospice, skilled nursing facility, long term acute care hospital [LTACH], or acute rehab) or patients discharged home with hospice will be excluded
- Any patients that are transferred to another unit prior to discharge will be excluded
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 |
|---|---|---|
| Communication InterventionComplete TEPID | Other | Supportive care (TEPID) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (TEPID) |
| Survey AdministrationAncillary studies | Other | Supportive care (TEPID) |
Primary outcome
Average score from the PADQ-E
Time frame: Up to 12 months
A simple analysis of variance (ANOVA) model with floor as a fixed blocking factor treatment (TEPID or no TEPID) as a fixed factor. Unit appears in the model as a nested factor within treatment, and statistical tests will be adjusted for this nesting structure. The main test of interest in each model is the overall effect of treatment, which quantifies the effect of TEPID on the average score for the response. P-values below 0.05 for this effect will be considered statistically significant.
Average score from the Readiness for Hospital Discharge Scale
Time frame: Up to 12 months
A simple ANOVA model with floor as a fixed blocking factor treatment (TEPID or no TEPID) as a fixed factor. Unit appears in the model as a nested factor within treatment, and statistical tests will be adjusted for this nesting structure. The main test of interest in each model is the overall effect of treatment, which quantifies the effect of TEPID on the average score for the response. P-values below 0.05 for this effect will be considered statistically significant.
Emergency department visits
Time frame: Up to 12 months
A generalized linear model will be used for the binary responses (readmission and ED visit).
Patient satisfaction as measured by the Press Ganey Consumer Assessment of Healthcare Providers and Systems Survey
Time frame: Up to 12 months
A simple ANOVA model with floor as a fixed blocking factor treatment (TEPID or no TEPID) as a fixed factor. Unit appears in the model as a nested factor within treatment, and statistical tests will be adjusted for this nesting structure. The main test of interest in each model is the overall effect of treatment, which quantifies the effect of TEPID on the average score for the response. P-values below 0.05 for this effect will be considered statistically significant.
Readmission rates
Time frame: Up to 12 months
A generalized linear model will be used for the binary responses (readmission and ED visit).
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 29 Jul 2020.
- jameslineLink provided by the sponsor.
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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.
Lisa Graham principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Intervention, Questionnaire Administration and Survey Administration in people with Hospitalization and Malignant Neoplasm, run by Ohio State University Comprehensive Cancer Center 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 1 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 29 Jul 2020. 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?
Average score from the PADQ-E (time frame: Up to 12 months). The study lists 5 primary outcomes in all. 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 29 Jul 2020.