Making Health Care Safer for Older Adults Receiving Skilled Home Health Care Services After Hospital Discharge

Frail Elderly Clinical Trial

Official title:

Making Health Care Safer for Older Adults Receiving Skilled Home Health Care Services After Hospital Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05182060
• Other study ID #: IRB00236941
• Secondary ID: 1R01HS026599-013
• Status: Completed
• Phase: N/A
• Start date: April 7, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Using a participatory ergonomics process, the investigators will pilot a bundle of interventions developed by stakeholders in a prospective cohort study to test feasibility. The study settings and inclusion criteria will be the same as used in the investigators' initial trial: cohort study of older adults (aged ≥ 65 years) experiencing a hospital-to-home health transition to the study sites, regardless of diagnosis. The investigators will implement the bundle with the assistance of home health provider teams at the study sites. The investigators will select other home health provider teams that provide care to similar populations to serve as concurrent controls. To provide historical control data, the investigators will also collect data on patient outcomes for the past year prior to the implementation of the bundle. Intervention refinement teams (IRTs) will meet to assess the impact of the bundle.

The investigators will retrospectively extract the dependent variables going back one year before implementation of the bundle (baseline) up until one year after implementation for both intervention and control groups. Outcome measures will include 30-day emergency department (ED) visit use or re-hospitalization, and mortality. The investigators will collect independent variables (Hospital-to-Home Health Transition Quality Index (H3TQ)) and measures of bundle impact from the intervention group. The investigators developed measures of bundle impact after a review of related existing measures. The investigators will collect measures of bundle impact in two ways: (1) through online surveys sent to all home health providers and older adults involved in the bundle at the end of the study period (30 days) using a Likert-type response scale; and (2) focus groups of home health providers and older adults.

The investigators will conduct two focus groups at the study site of: (1) the home health providers implementing the bundle (approximately 5 at each site, 10 total), and (2) a subset of the older adults/caregivers receiving the bundle. The investigators will randomly select approximately 10 older adults/caregivers at each site (20 total) and call these older adults/caregivers for an invitation to participate. Focus groups will discuss on key outcomes important in implementation research, which are distinct from system and clinical treatment outcomes and serve as indicators of implementation success: (1) acceptability, (2) appropriateness, (3) identification of barriers to implementation, and (4) analysis of impact on workflow. Focus groups will last 1.5 hours and will be audio-taped and transcribed. At least two researchers will independently review each focus group transcript and identify themes and sub-themes related to each of the four measures of bundle impact.

The investigators will compare dependent variables as follows: (1) pre-post comparison of dependent variables with historical controls for intervention and control groups separately; and (2) concurrent comparison of dependent variables between intervention and control groups.

For this feasibility study, the investigators anticipate having approximately 100 patients in the intervention group over the one-year pilot period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 761
• Est. completion date: July 31, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Frail Elderly
• Transitional Care

Intervention

Behavioral:
• Transition Intervention
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.

Locations

Country	Name	City	State
United States	Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality within 30 days of hospital discharge	Whether or not the older adult passes away within 30-days of hospital discharge.	Within 30 days after hospital discharge
Secondary	Existence of Unresolved Medication Issues	Existence of any medication issues (incorrect medication list, incorrect prescription, unfilled prescription, etc.) within 30 days of hospital discharge.	Within 30 days after hospital discharge