Care TransitionsACHIEVENCT02354482
Achieving Patient-Centered Care and Optimized Health In Care Transitions by Evaluating the Value of Evidence
An observational study of Care Transitions, run by Mark Williams at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Care Transitions
- What is being tested?
- Patient Communication and Care Management, Home-Based Trust, Plain Language, and Coordination and Hospital-Based Trust, Plain Language, and Coordination
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 7,939 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 30 Jun 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- children
- non-Medicare patients
- Under police custody
- Under suicide watch
- In-hospital death
- Transferred (not discharged) to another acute care hospital
Show all 10Show fewer
- Discharged against medical advice
- Admission for primary diagnosis of psychiatric conditions
- Admission for rehabilitation
- Admission for medical treatment of cancer
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Care Transitions
- Being tested
- Patient Communication and Care Management, Home-Based Trust, Plain Language, and Coordination, Hospital-Based Trust, Plain Language, and Coordination, Patient/Caregiver Assessment and Provider Information Exchange, Assessment and Teach Back
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Communication and Care ManagementBehavioural
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 CoordinationBehavioural
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 CoordinationBehavioural
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 ExchangeBehavioural
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 BackBehavioural
Received the following Transitional Care Strategies:
- Post-discharge care consultation
- Language Assessment
- Teach Back for Information and Skills
Standard of Care (Reference)Other
No specific Transitional Care Strategy
| Study group | Role | What they receive |
|---|---|---|
| Diverse, high-risk patient populations | Not described Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Readmission
Readmission to the hospital within 30 days of discharge.
Measured: 30 days post hospital discharge
Emergency Department (ED) Visit
Visit to the ED within 30 days of hospital discharge.
Measured: 30 days post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startMar 2015
- Primary completion30 Apr 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Care TransitionsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,939 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Williams
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Boston Medical Center, Westat, Kaiser Permanente, Telligen, Inc., University of Illinois Chicago, Hospital Research & Education Trust, American Hospital Association, Joint Commission Resources, America's Essential Hospitals, Louisiana State University Health Sciences Center Shreveport, United Hospital Fund, Caregiver Action Network, National Association of Area Agencies on Aging
- Responsible party
- Sponsor-investigator, Mark Williams, University of Kentucky
- Investigators
- Mark V Williams, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354482
- Sponsor's protocol ID
- 3048112229
- Acronym
- ACHIEVE
- Status last verified
- Nov 2019
- First submitted
- 29 Jan 2015
- Last updated
- 26 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26896024
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Patient-Centered Care and Optimized Health In Care Transitions by Evaluating the Value of Evidence
- ClinicalTrials.gov ID
- NCT02354482
- Acronym / sponsor ID
- ACHIEVE / 3048112229
- Conditions
- Care Transitions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,939 participants (actual)
- Lead sponsor
- Mark WilliamsUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Boston Medical Center, Westat, Kaiser Permanente, Telligen, Inc., University of Illinois Chicago, Hospital Research & Education Trust, American Hospital Association, Joint Commission Resources, America's Essential Hospitals, Louisiana State University Health Sciences Center Shreveport, United Hospital Fund, Caregiver Action Network, National Association of Area Agencies on Aging
- Study start
- Mar 2015 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Posted 26 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diverse, high-risk patient populations | – | 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- diverse high risk patient populations, including those with:
Key exclusion criteria (10 listed)
- children
- non-Medicare patients
- Under police custody
- Under suicide watch
- In-hospital death
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 |
|---|---|---|
| Patient Communication and Care ManagementReceived the following Transitional Care strategies: 1. Helpful Health Care Contact OR Symptom Management 2. Post-discharge Care Consultation 3. Patient Goal/Preference Assessment 4. Plain Language Communication in Hospital 5. Plain Language Communication at Home 6. Transition Summary for Patients and Family Caregivers | Behavioural | Diverse, high-risk patient populations |
| Home-Based Trust, Plain Language, and CoordinationReceived the following Transitional Care Strategies: 1. Transition Team 2. Home visits 3. Plain Language Communication at Home 4. Promote Trust at Home 5. Referral to Community Services 6. Follow-up Appointment | Behavioural | Diverse, high-risk patient populations |
| Hospital-Based Trust, Plain Language, and CoordinationReceived the following Transitional Care Strategies: 1. Post-discharge care consultation 2. Identify High-Risk Patients and Intervene 3. Medication Reconciliation 4. Plain Language Communication in Hospital 5. Promote Trust in the Hospital 6. Transition Summary for Patients and Family Caregivers | Behavioural | Diverse, high-risk patient populations |
| Patient/Caregiver Assessment and Provider Information ExchangeReceived the following Transitional Care Strategies: 1. Patient Goal/Preference Assessment 2. Identify High-Risk Patients and Intervene 3. Timely Exchange of Critical Patient Information among Providers 4. Patient/Family Caregiver Transitional Care Needs Assessment | Behavioural | Diverse, high-risk patient populations |
| Assessment and Teach BackReceived the following Transitional Care Strategies: 1. Post-discharge care consultation 2. Language Assessment 3. Teach Back for Information and Skills | Behavioural | Diverse, high-risk patient populations |
| Standard of Care (Reference)No specific Transitional Care Strategy | Other | Diverse, high-risk patient populations |
Primary outcome
Hospital Readmission
Time frame: 30 days post hospital discharge
Readmission to the hospital within 30 days of discharge.
Emergency Department (ED) Visit
Time frame: 30 days post hospital discharge
Visit to the ED within 30 days of hospital discharge.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26896024Li 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.
- Individual participant dataSharing planned: No
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Optimizing Care Transitions in CHD
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I-SLEPT: Integrated Sleep and Life Engagement Program for Transitions
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Diabetes Toolkit at Discharge
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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.
Mark V Williams, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Care Transitions, run by Mark Williams 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 8 inclusion and 10 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 26 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 26 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hospital Readmission (time frame: 30 days post hospital discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02354482, which also lists 1 linked publication.
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 26 Nov 2019.