NCT05182060

Brief Summary

Care transitions are the movement of a person from one healthcare setting to another. Older adults who require skilled home health care ("home health") services (e.g., home-based nursing) after hospital discharge are at high risk of experiencing early re-hospitalization. Home health agencies need strategies to ensure safe transitions, yet there is relatively little research to guide improvement efforts. The goal of the study is to develop and test tools to allow home health agencies to identify and act upon threats to older adults' safety in real time. The investigators first analyzed threats to older adult safety during hospital-to-home health transitions and refined a bundle of interventions through stakeholder engagement. This prospective pilot will implement and measure the bundle of interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
761

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

April 7, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

December 20, 2021

Last Update Submit

August 22, 2023

Conditions

Keywords

Transitional CareHome Health CareFrail ElderlyStakeholder ParticipationQuality ImprovementMedication Management

Outcome Measures

Primary Outcomes (1)

  • ED visit use or re-hospitalization

    Whether or not the older adult experiences an ED visit use or re-hospitalization within 30 days of hospital discharge. This is a composite endpoint.

    Within 30 days after hospital discharge

Secondary Outcomes (2)

  • Mortality within 30 days of hospital discharge

    Within 30 days after hospital discharge

  • Existence of Unresolved Medication Issues

    Within 30 days after hospital discharge

Study Arms (2)

Transition Intervention

EXPERIMENTAL

We will implement a bundle of care transition safety resources with the assistance of home health coordinators at the study site. These resources include a link to a video about home health services, a caregiver assessment, a care task role assignment sheet, and a shopping list.

Behavioral: Transition Intervention

Control

NO INTERVENTION

We will select other home health provider teams that provide care to similar populations to serve as concurrent controls. No interventions will be administered.

Interventions

We will implement a bundle of care transition safety strategies with the assistance of home care coordinators at the study site and corresponding home health provider teams (nurses, rehabilitation therapists). Home care coordinators will approach patients at the study site being referred for home health and provide resources to assist them with preparing for their transition home. These resources include a link to a video about home health services, a caregiver assessment, a care task role assignment sheet, and a shopping list. The study team will contact the older adult and caregiver by telephone within 48 hours of the home visit to confirm eligibility, explain the study, obtain consent for participation, and ask them to complete the the Hospital-to-Home Health Transition Quality Index (H3TQ) over the phone. Home health providers in the home will also complete the H3TQ.

Transition Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Older Adults
  • Aged ≥ 65 years
  • Can speak English or Spanish
  • Is capable of assent
  • Hospitalized on a medical or surgical service
  • Referred for skilled home healthcare services (home health) after hospital discharge or skilled nursing facility (SNF) discharge
  • Family Caregivers
  • Unpaid
  • Assist the older adult with at least one healthcare task. Healthcare tasks include the following activities: managing health care bills, scheduling medical appointments, getting to and from medical appointments, getting medical equipment, getting services, getting information, following a diet, obtaining medication, planning a medication schedule, taking medication, and deciding to stop or change medication.
  • Home Health Providers
  • Employed by participating sites
  • Directly provide care to, or arrange services for, an eligible older adult

You may not qualify if:

  • Community referrals to home health: Older adults referred to home health from the ambulatory setting (e.g., outpatient clinic) and without a recent hospitalization or SNF stay.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

Location

Study Officials

  • Alicia Arbaje, MD, MPH, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 10, 2022

Study Start

April 7, 2022

Primary Completion

June 20, 2023

Study Completion

July 31, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Locations