Stroke Transitions of Care to Reduce Hospital Length of Stay (TOCC)

June 13, 2020 updated by: Georgetown University

The purpose of this prospective pilot study is to access the feasibility of Transitions of Care Coordinator (TOCC) program, to determine if the use of a TOCC will decrease hospital length of stay (LOS), and determine if utilization of a TOCC will improve patient and family satisfaction. Patients are admitted to MedStar Georgetown University Hospital (MGUH) for primary diagnosis of acute ischemic stroke.

  1. Access the feasibility of TOCC program
  2. Determine if the use of a TOCC will decrease hospital length of stay (LOS) in patients admitted to MGUH for primary diagnosis of acute ischemic stroke
  3. Determine if utilization of a TOCC will improve the satisfaction for family and patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Goals and Objectives

The primary objective of this study is to access the feasibility of TOCC program and to determine if the use of a TOCC will decrease length of stay (LOS) in patients admitted to MedStar Georgetown University Hospital (MGU) for primary diagnosis of acute ischemic stroke and discharged to an acute rehabilitation facility. Secondary objectives for this study include determining if utilization of a TOCC will improve patient and family satisfaction.

Study Design/Setting

This will be a single-center, prospective, randomized pilot study. It will involve patients admitted to the MGUH Department of Neurology stroke service for primary diagnosis of acute ischemic stroke and discharged to an acute rehabilitation facility or home. The study will start after IRB approval. It will end once all required data has been obtained and analyzed. It is estimated that this pilot study will be finished over a three-month period.

Transition of Care Coordinator (TOCC) Program and Usual Care Group

The TOCC will be a registered nurse who will help facilitate the process of care transition from the day of admission. The TOCC's intervention will include meeting the patient and family within 48 hours of admission, identifying their home location and insurance status, following up the echocardiogram results, following up with physical, occupational, and speech therapy recommendations for rehabilitation after acute care hospitalization, attending daily multi-disciplinary rounds, attending bedside rounds with the physician team, facilitating referrals to rehab facilities, providing tailored discharge education to patients, and arranging stroke clinic follow-up assignments. The usual care group will receive care coordination by the primary stroke service of the Georgetown Neurology Department, which is the current method.

Both groups will receive the same content of care, which includes initial and supportive diagnostic studies as well as evidenced-based treatment of ischemic stroke, physical, occupational, and speech therapy, and case management for referral and transportation to an acute rehabilitation facility. The major difference between the two groups will be the method of care delivery.

Patient Population and Procedure

Participants in this study will be derived from the pool of patients admitted for ischemic stroke to MGUH. Patients admitted for a primary diagnosis of ischemic stroke with discharge plan for acute rehab or home will be included in this study.

Upon admission, patients will be randomized to receive the standard diagnostic studies and treatment for ischemic stroke under the care of either a TOCC (TOCC group) or the usual care/standard evidenced-based protocol of transitioning from acute care hospital to acute rehab setting (Control group). Due to the prospective nature of the study protocol, randomization will be performed based on the order in which the patients are enrolled in the trial. Every other patient admitted to the stroke service (i.e. those enrolled first, third, fifth, seventh, etc.) will be allocated to receive the intervention whereas patients falling between those admissions will be allocated to the usual care group (control) Length of stay for patients in TOCC group and control group will be recorded for comparison at the end of the study period. Patient and family satisfaction in each group will also be measured using HCAHPS scores for comparison at the end of the study period.

Study Sample Size

Based on the volumes of patients admitted for ischemic stroke to MGUH, it is estimated that at least 20 patients can be enrolled for each group, and at least 40 patients in total can be enrolled over a three-month period.

Data Analysis Plan

Descriptive statistics will be used to describe the baseline characteristics of all enrolled patients; mean and standard deviation will be reported for continuous variables; frequency and percentage will be reported for categorical variables.

The data analysis for this pilot study will be descriptive due to the small sample size. The proportion of patients who are in the TOCC group receive the complete transition of care intervention will be the primary feasibility metric. We will calculate the mean (SD) of the LOS at the end of study for patients of TOCC group and control group, respectively. Difference in mean of LOS between two groups will be calculated. Student's T-test or Wilcoxon Rank Sum test will be performed to test the difference in mean of LOS between TOCC group and control group, where appropriate. One-day decrease in hospital LOS is considered of clinical relevance. Generalized linear model will be utilized for the correlative analysis of LOS and TOCC program, adjusted for age, NHISS and other possible confounders.

For the patients and family satisfaction, measured by HCAHPS score, the percentage of satisfaction for each question will be reported, and the difference in percentage of satisfaction between TOCC group and control group will be summarized.

Safety Considerations

The treatment of patients with acute ischemic stroke will not be altered by this study protocol. Participants will receive the current evidenced-supported standard treatment for ischemic stroke and post-discharge recommendations will be made by the physical, occupational, and speech therapists of MGUH based on the patient's capabilities. As a quality improvement study, the intervention proposed would only serve improve the efficacy in transitioning patients back to living in the community.

The only possible perceived risk to participants is loss of confidentiality since personal health information (PHI) from the Electronic Medical Record (EMR) system will be used for eventual data analyses. To decrease this risk, this information will be distributed only amongst study investigators with the use of limited patient identifiers. In addition, any stored information will be in a password-secured database only accessible by the study investigators.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary diagnosis of acute ischemic stroke
  • patients admitted to the MGUH Stroke service
  • 18 years or older

Exclusion Criteria:

  • Diagnosis of subarachnoid hemorrhage
  • Diagnosis of intracerebral hemorrhage
  • Diagnosis of transient ischemic attack
  • Diagnosis of stroke mimic
  • admitted under observational status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Transitions of Care Coordinator Group
We developed the Transition of Care Coordinator (TOCC) program to aid in the completion of the diagnostic evaluations as well as in the transition out of the acute care hospital setting. In the TOCC intervention, the stroke nurse navigator completed eight specific tasks: (1) met the patient and family within 48 hours of admission, (2) identified patient home location and insurance status, (3) coordinated communication between treating providers (neurologists, cardiologists, etc.) regarding pending diagnostic tests, (4) followed up physical, occupational, and speech therapy teams' recommendations for rehabilitation, (5) attended daily multi-disciplinary rounds, (6) facilitated referrals to acute and subacute rehabilitation facilities with case managers, (7) assisted beside nurses in providing tailored stroke education and discharge instructions to patients and families, and (8) arranged stroke clinic follow-up appointments.
Other: Transitions of Care Coordinator
We developed the Transition of Care Coordinator (TOCC) program to aid in the completion of the diagnostic evaluations as well as in the transition out of the acute care hospital setting. In the TOCC intervention, the stroke nurse navigator completed eight specific tasks: (1) met the patient and family within 48 hours of admission, (2) identified patient home location and insurance status, (3) coordinated communication between treating providers (neurologists, cardiologists, etc.) regarding pending diagnostic tests, (4) followed up physical, occupational, and speech therapy teams' recommendations for rehabilitation, (5) attended daily multi-disciplinary rounds, (6) facilitated referrals to acute and subacute rehabilitation facilities with case managers, (7) assisted beside nurses in providing tailored stroke education and discharge instructions to patients and families, and (8) arranged stroke clinic follow-up appointments.
ACTIVE_COMPARATOR: Usual Care Group
Patients in the usual care group, which served as the control, received the current, ongoing method of care coordination by members of the multi-disciplinary stroke team. The current practice is that members of this multi-disciplinary team meet with each other every weekday morning to discuss the discharge plan of care for each stroke patient on the inpatient stroke service. Physicians, nurses, rehabilitation therapists and case managers are then individually responsible for talking to patients and their families/caregivers about the different aspects of the plan of care.
Other: Usual Care
Patients received the current, ongoing method of care coordination by members of the multi-disciplinary stroke team. The current practice is that members of this multi-disciplinary team meet with each other every weekday morning to discuss the discharge plan of care for each stroke patient on the inpatient stroke service. Physicians, nurses, rehabilitation therapists and case managers are then individually responsible for talking to patients and their families/caregivers about the different aspects of the plan of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Feasibility
Time Frame: Through length of study, an average of 1 year
The primary outcome was feasibility of implementing a TOCC program, which was defined as completion of all eight TOCC program tasks by the stroke nurse navigator in at least 75% of the intervention group patients.
Through length of study, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Length of Stay
Time Frame: Through length of study, an average of 1 year
Measured as number of days from admission to time of discharge from hospital
Through length of study, an average of 1 year
Patient Satisfaction
Time Frame: Through length of study, an average of 1 year
Patient satisfaction was determined using a questionnaire that assesses multiple facets of inpatient care and discharge logistics, including key variables such as: overall care, secondary stroke prevention education, blood pressure management, and follow up arrangements. Scores in the individual categories ranged from 1-5, with 1 representative of unsatisfied, and 5, representative of very satisfied.
Through length of study, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Investigators

  • Principal Investigator: Mary C Denny, MD, Georgetown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2018

Primary Completion (ACTUAL)

February 28, 2019

Study Completion (ACTUAL)

February 28, 2019

Study Registration Dates

First Submitted

June 6, 2020

First Submitted That Met QC Criteria

June 13, 2020

First Posted (ACTUAL)

June 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 13, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-0621

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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