Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
Study NCT ID:
NCT05182060
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2021-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Making Health Care Safer for Older Adults Receiving Skilled Home Health Care Services After Hospital Discharge
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Making Health Care Safer for Older Adults Receiving Skilled Home Health Care Services After Hospital Discharge
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01HS026599-01 | AHRQ | None | https://reporter.nih.gov/quic… | View |
| 3R01HS026599-02S1 | AHRQ | None | https://reporter.nih.gov/quic… | View |