NCT02942524

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

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

April 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2017

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

1.3 years

First QC Date

October 21, 2016

Last Update Submit

July 27, 2020

Conditions

HospitalizationMalignant NeoplasmTransitional Care Planning

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    Up to 12 months

  • Emergency department visits

    A generalized linear model will be used for the binary responses (readmission and ED visit).

    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.

    Up to 12 months

  • Readmission rates

    A generalized linear model will be used for the binary responses (readmission and ED visit).

    Up to 12 months

Study Arms (1)

Supportive care (TEPID)

EXPERIMENTAL

Patients complete the TEPID checklist of items during hospital stay.

Other: Communication InterventionOther: Questionnaire AdministrationOther: Survey Administration

Interventions

Communication InterventionOTHER

Complete TEPID

Supportive care (TEPID)
Questionnaire AdministrationOTHER

Ancillary studies

Supportive care (TEPID)
Survey AdministrationOTHER

Ancillary studies

Supportive care (TEPID)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Lisa Graham

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 21, 2016

First Posted

October 24, 2016

Study Start

April 1, 2016

Primary Completion

August 4, 2017

Study Completion

August 4, 2017

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

US(1)