Clinical trial NCT04434638: Stroke Transitions of Care to Reduce Hospital Length of Stay
Official title: Stroke Transitions of Care to Reduce Hospital Length of Stay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Nurse Navigator
Transitions of care
Length of Stay
Patient Satisfaction
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants in this study will be derived from the pool of patients admitted for ischemic stroke to Georgetown University Medical Center. 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 transitions of care coordinatory (TOCC group) or the 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Study Feasibility
timeFrame: Through length of study, an average of 1 year
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: Through length of study, an average of 1 year
measure: Patient Satisfaction
timeFrame: Through length of study, an average of 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Mary C Denny, MD
role: PRINCIPAL_INVESTIGATOR
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