NCT04434638

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. 1.Access the feasibility of TOCC program
  2. 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. 3.Determine if utilization of a TOCC will improve the satisfaction for family and patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable stroke

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, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

June 6, 2020

Last Update Submit

June 13, 2020

Conditions

Stroke

Keywords

StrokeNurse NavigatorTransitions of careLength of StayPatient Satisfaction

Outcome Measures

Primary Outcomes (1)

  • Study Feasibility

    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 Outcomes (2)

  • Hospital Length of Stay

    Through length of study, an average of 1 year

  • Patient Satisfaction

    Through length of study, an average of 1 year

Study Arms (2)

Transitions of Care Coordinator Group

EXPERIMENTAL

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

Usual Care Group

ACTIVE COMPARATOR

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

Interventions

Transitions of Care CoordinatorOTHER

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.

Transitions of Care Coordinator Group
Usual CareOTHER

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.

Usual Care Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (10)

  • Agency for Healthcare Research and Quality. "The Six Domains of Health Care Quality". Reviewed March 2016: Rockville, MD. http://www.ahrq.gov/professionals/quality-patient-safety/talkingquality/create/sixdomains.html

    BACKGROUND

  • Coleman EA, Rosenbek SA, Roman SP. Disseminating evidence-based care into practice. Popul Health Manag. 2013 Aug;16(4):227-34. doi: 10.1089/pop.2012.0069. Epub 2013 Mar 28.

    PMID: 23537156BACKGROUND

  • Institute of Medicine (IOM). "To Err Is Human: Building A Safer Health System". National Academy of Sciences; 2000. Web Access: May 1 2017. http://www.nationalacademies.org/hmd/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf

    BACKGROUND

  • Frelick R, Strusowski P, Petrelli N, and Grusenmeyer P. "Oncology Nurse Care Coordinators as 'Navigators': Improving cancer disease management and the patient experience". Oncology Issues. (2006); 26-30.

    BACKGROUND

  • Kwan JL, Morgan MW, Stewart TE, Bell CM. Impact of an innovative inpatient patient navigator program on length of stay and 30-day readmission. J Hosp Med. 2015 Dec;10(12):799-803. doi: 10.1002/jhm.2442. Epub 2015 Aug 10.

    PMID: 26259201BACKGROUND

  • Raines, D,

    BACKGROUND

  • Hall MJ, Levant S, DeFrances CJ. Hospitalization for stroke in U.S. hospitals, 1989-2009. NCHS Data Brief. 2012 May;(95):1-8.

    PMID: 22617404BACKGROUND

  • Mayo NE, Wood-Dauphinee S, Cote R, Gayton D, Carlton J, Buttery J, Tamblyn R. There's no place like home : an evaluation of early supported discharge for stroke. Stroke. 2000 May;31(5):1016-23. doi: 10.1161/01.str.31.5.1016.

    PMID: 10797160BACKGROUND

  • Bushnell C, Arnan M, Han S. A new model for secondary prevention of stroke: transition coaching for stroke. Front Neurol. 2014 Oct 27;5:219. doi: 10.3389/fneur.2014.00219. eCollection 2014.

    PMID: 25386161BACKGROUND

  • Condon C, Lycan S, Duncan P, Bushnell C. Reducing Readmissions After Stroke With a Structured Nurse Practitioner/Registered Nurse Transitional Stroke Program. Stroke. 2016 Jun;47(6):1599-604. doi: 10.1161/STROKEAHA.115.012524. Epub 2016 Apr 28.

    PMID: 27125528BACKGROUND

MeSH Terms

Conditions

StrokePatient Satisfaction

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Mary C Denny, MD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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 control group.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2020

First Posted

June 17, 2020

Study Start

April 1, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

June 17, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)