Clinical trial NCT02354482: Achieving Patient-Centered Care and Optimized Health In Care Transitions by Evaluating the Value of Evidence
Official title: Achieving Patient-Centered Care and Optimized Health In Care Transitions by Evaluating the Value of Evidence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Care Transitions
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Boston Medical Center
name: Westat
name: Kaiser Permanente
name: Telligen, Inc.
name: University of Illinois at Chicago
name: Hospital Research & Education Trust, American Hospital Association
name: Joint Commission Resources
name: America's Essential Hospitals
name: Louisiana State University Health Sciences Center Shreveport
name: United Hospital Fund
name: Caregiver Action Network
name: National Association of Area Agencies on Aging
First posted: 2015-02-03
Enrollment: 7939
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Project ACHIEVE will focus on Medicare fee-for-services beneficiaries and study 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.

Brief 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.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital Readmission
timeFrame: 30 days post hospital discharge
measure: Emergency Department (ED) Visit
timeFrame: 30 days post hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: UK Healthcare
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Mark V Williams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li J, Brock J, Jack B, Mittman B, Naylor M, Sorra J, Mays G, Williams MV; Project ACHIEVE Team. Project ACHIEVE - using implementation research to guide the evaluation of transitional care effectiveness. BMC Health Serv Res. 2016 Feb 19;16:70. doi: 10.1186/s12913-016-1312-y.