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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02354482
Other study ID # 3048112229
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2015
Est. completion date June 30, 2019

Study information

Verified date November 2019
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Funded by the Patient Centered Outcome Research Institute (PCORI), nationally recognized leaders in health care and research methods are partnering with patients and caregivers to evaluate the effectiveness of current efforts at improving care transitions and develop recommendations on best practices for patient-centered care transitions and guidance for spreading them across the U.S.


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:

1. Identify the transitional care outcomes and components that matter most to patients and caregivers.

2. 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.

3. Identify barriers and facilitators to the implementation of specific TCCs or clusters of TCCs for different types of care settings and communities.

4. 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:

1. Identify best practices in care transitions that matter most to patients and their caregivers, and reduce excess emergency department and hospital utilization.

2. Develop a toolkit to guide informed decisions and spread these best practices across the U.S.

3. Develop Care Transitions Surveys that can standardize evaluation of patients' and caregivers' experience with care transitions.


Recruitment information / eligibility

Status Completed
Enrollment 7939
Est. completion date June 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- diverse high risk patient populations, including those with:

1. multiple chronic conditions

2. mental health issues

3. rural area domicile

4. limited English proficiency or low health literacy

5. low socioeconomic status

6. Medicare and Medicaid dual eligible

7. 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Patient Communication and Care Management
Received the following Transitional Care strategies: Helpful Health Care Contact OR Symptom Management Post-discharge Care Consultation Patient Goal/Preference Assessment Plain Language Communication in Hospital Plain Language Communication at Home Transition Summary for Patients and Family Caregivers
Home-Based Trust, Plain Language, and Coordination
Received the following Transitional Care Strategies: Transition Team Home visits Plain Language Communication at Home Promote Trust at Home Referral to Community Services Follow-up Appointment
Hospital-Based Trust, Plain Language, and Coordination
Received the following Transitional Care Strategies: Post-discharge care consultation Identify High-Risk Patients and Intervene Medication Reconciliation Plain Language Communication in Hospital Promote Trust in the Hospital Transition Summary for Patients and Family Caregivers
Patient/Caregiver Assessment and Provider Information Exchange
Received the following Transitional Care Strategies: Patient Goal/Preference Assessment Identify High-Risk Patients and Intervene Timely Exchange of Critical Patient Information among Providers Patient/Family Caregiver Transitional Care Needs Assessment
Assessment and Teach Back
Received the following Transitional Care Strategies: Post-discharge care consultation Language Assessment Teach Back for Information and Skills
Other:
Standard of Care (Reference)
No specific Transitional Care Strategy

Locations

Country Name City State
United States UK Healthcare Lexington Kentucky

Sponsors (14)

Lead Sponsor Collaborator
Mark Williams America's Essential Hospitals, Boston Medical Center, Caregiver Action Network, Hospital Research & Education Trust, American Hospital Association, Joint Commission Resources, Kaiser Permanente, Louisiana State University Health Sciences Center Shreveport, National Association of Area Agencies on Aging, Telligen, Inc., United Hospital Fund, University of Illinois at Chicago, University of Pennsylvania, Westat

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital Readmission Readmission to the hospital within 30 days of discharge. 30 days post hospital discharge
Primary Emergency Department (ED) Visit Visit to the ED within 30 days of hospital discharge. 30 days post hospital discharge
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