- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02354482
Achieving Patient-Centered Care and Optimized Health In Care Transitions by Evaluating the Value of Evidence (ACHIEVE)
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Patient Communication and Care Management
- Behavioral: Home-Based Trust, Plain Language, and Coordination
- Behavioral: Hospital-Based Trust, Plain Language, and Coordination
- Behavioral: Patient/Caregiver Assessment and Provider Information Exchange
- Behavioral: Assessment and Teach Back
- Other: Standard of Care (Reference)
Detailed Description
Patients in the U.S. suffer harm too often as they move between sites of health care, and their caregivers experience significant burden. Unfortunately, the usual approach to health care does not support continuity and coordination during such "care transitions" between hospitals, clinics, home or nursing homes. Poorly managed patient care transitions can lead to worsening symptoms, adverse effects from medications, unaddressed test results, failed follow-up testing, and excess rehospitalizations and ER visits.
Specific Aims:
- Identify the transitional care outcomes and components that matter most to patients and caregivers.
- Determine which evidence-based transitional care components (TCCs) or clusters most effectively yield patient and caregiver desired outcomes overall and among diverse patient and caregiver populations in different types of care settings and communities.
- Identify barriers and facilitators to the implementation of specific TCCs or clusters of TCCs for different types of care settings and communities.
- Develop recommendations for dissemination and implementation of the findings on the best evidence regarding how to achieve optimal TC services and outcomes for patients, caregivers and providers.
Study Design:
Capitalizing on the opportunity for a natural experiment observational study, the research team will conduct qualitative and quantitative studies. This 52-month study is divided into two distinct phases. During the first phase, Project ACHIEVE will use focus groups, with patients, caregivers, providers, and site visits to identify the transitional care outcomes and service components that matter most to patients. In this first phase, based on this information and an extensive evidence-based review of the research literature, the ACHIEVE team will develop surveys to be administrated in Phase II. The project team will conduct mail and phone surveys of patients and caregivers recruited from approximately 45 hospitals across the U.S. to assess what transitional care services patients and caregivers experience and how they are associated with outcomes. Additionally, the project team will conduct healthcare provider surveys and site visits to assess the facilitators and barriers to implementing transitional care strategies, organizational contexts (leadership and physician engagement, change culture, etc.), and community collaboration.
Outcomes and Impact:
Through rigorous study and evaluation, Project ACHIEVE will:
- Identify best practices in care transitions that matter most to patients and their caregivers, and reduce excess emergency department and hospital utilization.
- Develop a toolkit to guide informed decisions and spread these best practices across the U.S.
- Develop Care Transitions Surveys that can standardize evaluation of patients' and caregivers' experience with care transitions.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- UK HealthCare
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
diverse high risk patient populations, including those with:
- multiple chronic conditions
- mental health issues
- rural area domicile
- limited English proficiency or low health literacy
- low socioeconomic status
- Medicare and Medicaid dual eligible
- disabled and younger than 65.
Exclusion Criteria:
- children
- non-Medicare patients
- Under police custody
- Under suicide watch
- In-hospital death
- Transferred (not discharged) to another acute care hospital
- Discharged against medical advice
- Admission for primary diagnosis of psychiatric conditions
- Admission for rehabilitation
- Admission for medical treatment of cancer
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Diverse, high-risk patient populations
|
Received the following Transitional Care strategies:
Received the following Transitional Care Strategies:
Received the following Transitional Care Strategies:
Received the following Transitional Care Strategies:
Received the following Transitional Care Strategies:
No specific Transitional Care Strategy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Readmission
Time Frame: 30 days post hospital discharge
|
Readmission to the hospital within 30 days of discharge.
|
30 days post hospital discharge
|
Emergency Department (ED) Visit
Time Frame: 30 days post hospital discharge
|
Visit to the ED within 30 days of hospital discharge.
|
30 days post hospital discharge
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark V Williams, MD, University of Kentucky
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 3048112229
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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