Transitional CareNCT05182060
Making Health Care Safer for Older Adults Receiving Skilled Home Health Care Services After Hospital Discharge
A study testing Transition Intervention in people with Transitional Care and Frail Elderly, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transitional Care, Frail Elderly, Home Health Care
- What is being tested?
- Transition Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 761 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
About this study
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.
Read the detailed 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.
- Conditions
- Transitional Care, Frail Elderly, Home Health Care
- Being tested
- Transition Intervention
- Keywords
- Transitional Care, Home Health Care, Frail Elderly, Stakeholder Participation, Quality Improvement, Medication Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days after hospital discharge
Secondary outcomes (2)
Mortality within 30 days of hospital discharge
Whether or not the older adult passes away within 30-days of hospital discharge.
Measured: Within 30 days after hospital discharge
Existence of Unresolved Medication Issues
Existence of any medication issues (incorrect medication list, incorrect prescription, unfilled prescription, etc.) within 30 days of hospital discharge.
Measured: Within 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start7 Apr 2022
- Primary completion20 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transitional CareStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Alicia Arbaje, MD, MPH, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182060
- Sponsor's protocol ID
- IRB00236941
- Other IDs
- 1R01HS026599-01, 3R01HS026599-02S1
- Status last verified
- Aug 2023
- First submitted
- 20 Dec 2021
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making Health Care Safer for Older Adults Receiving Skilled Home Health Care Services After Hospital Discharge
- ClinicalTrials.gov ID
- NCT05182060
- Acronym / sponsor ID
- IRB00236941
- Conditions
- Transitional Care, Frail Elderly, Home Health Care
- Keywords
- Transitional Care, Home Health Care, Frail Elderly, Stakeholder Participation, Quality Improvement, Medication Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 761 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transition Intervention | Experimental | Behavioral: Transition InterventionWe 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Older Adults
- Aged ≥ 65 years
- Can speak English or Spanish
- Is capable of assent
- Hospitalized on a medical or surgical service
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transition InterventionWe 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. | Behavioural | Transition Intervention |
Primary outcome
ED visit use or re-hospitalization
Time frame: Within 30 days after hospital discharge
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.
2 secondary outcomes
Mortality within 30 days of hospital discharge
Time frame: Within 30 days after hospital discharge
Existence of Unresolved Medication Issues
Time frame: Within 30 days after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Arbaje, MD, MPH, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transition Intervention in people with Transitional Care and Frail Elderly, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED visit use or re-hospitalization (time frame: Within 30 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.