ACHIEVE: Achieving Patient-Centered Care and Optimized Health In Care Transitions by Evaluating the Value of Evidence

• Sponsor: Mark Williams (Other)
• Overall Status: Completed
• CT.gov ID: NCT02354482
• Collaborator: University of Pennsylvania (Other), Boston Medical Center (Other), Westat (Other), Kaiser Permanente (Other), Telligen, Inc. (Industry), University of Illinois at Chicago (Other), Hospital Research & Education Trust, American Hospital Association (Other), Joint Commission Resources (Other), America's Essential Hospitals (Other), Louisiana State University Health Sciences Center Shreveport (Other), United Hospital Fund (Other), Caregiver Action Network (Other), National Association of Area Agencies on Aging (Other)
• Enrollment: 7,939
• Location: 1
• Actual Duration (Months): 52
• Patients Per Site Per Month: 152.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Care Transitions	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:

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 7939 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Achieving Patient-Centered Care and Optimized Health In Care Transitions by Evaluating the Value of Evidence
• Actual Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Apr 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

Arm

Intervention/Treatment

Diverse, high-risk patient populations

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; Behavioral: 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; Behavioral: 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; Behavioral: 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; Behavioral: 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

Outcome Measures

Primary Outcome Measures

1. Hospital Readmission [30 days post hospital discharge]

   Readmission to the hospital within 30 days of discharge.

2. Emergency Department (ED) Visit [30 days post hospital discharge]

   Visit to the ED within 30 days of hospital discharge.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UK Healthcare	Lexington	Kentucky	United States	40536

Sponsors and Collaborators

• Mark Williams
• University of Pennsylvania
• Boston Medical Center
• Westat
• Kaiser Permanente
• Telligen, Inc.
• University of Illinois at 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

Investigators

• Principal Investigator: Mark V Williams, MD, University of Kentucky

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 20, 2017

More Information

Publications

None provided.

• Responsible Party: Mark Williams, Principal Investigator, University of Kentucky
• ClinicalTrials.gov Identifier: NCT02354482
• Other Study ID Numbers: 3048112229
• First Posted: Feb 3, 2015
• Last Update Posted: Nov 26, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Pre-assignment Detail	Any individual participant may have experienced more than one intervention.

Arm/Group Title	Participants Receiving Transitional Care Strategies
Arm/Group Description	Participants were exposed to one or more of five different transitional care strategies, or were part of a reference group that did not receive a specific transitional care strategy.
Period Title: Patient Communication and Care
STARTED	2158
COMPLETED	2158
NOT COMPLETED	0
Period Title: Patient Communication and Care
STARTED	1979
COMPLETED	1979
NOT COMPLETED	0
Period Title: Patient Communication and Care
STARTED	2090
COMPLETED	2090
NOT COMPLETED	0
Period Title: Patient Communication and Care
STARTED	3093
COMPLETED	3093
NOT COMPLETED	0
Period Title: Patient Communication and Care
STARTED	508
COMPLETED	508
NOT COMPLETED	0
Period Title: Patient Communication and Care
STARTED	2042
COMPLETED	2042
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Participants Recieving Transitional Care Strategies
Arm/Group Description	Participants received one or more of 5 transitional care strategies, or were part of a reference group that received no specific transitional care strategy.
Overall Participants	7939
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	337 4.2%
>=65 years	1821 22.9%
<=18 years	0 0%
Between 18 and 65 years	200 2.5%
>=65 years	1779 22.4%
<=18 years	0 0%
Between 18 and 65 years	172 2.2%
>=65 years	1918 24.2%
<=18 years	0 0%
Between 18 and 65 years	208 2.6%
>=65 years	2885 36.3%
<=18 years	0 0%
Between 18 and 65 years	47 0.6%
>=65 years	461 5.8%
<=18 years	0 0%
Between 18 and 65 years	336 4.2%
>=65 years	1706 21.5%
Age (years) [Mean (Standard Deviation) ]
Patient Communication	70.50 (10.38)
Home-Based Trust	72.04 (9.64)
Hospital-Based Trust	72.62 (9.34)
Patient/Family Caregiver Assessment	73.55 (9.04)
Assessment and Teach Back	72.42 (8.91)
Reference	71.69 (11.17)
Sex: Female, Male (Count of Participants)
Female	1093 13.8%
Male	1065 13.4%
Female	1102 13.9%
Male	877 11%
Female	1082 13.6%
Male	1008 12.7%
Female	1636 20.6%
Male	1457 18.4%
Female	268 3.4%
Male	240 3%
Female	1093 13.8%
Male	949 12%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	243 3.1%
Not Hispanic or Latino	1809 22.8%
Unknown or Not Reported	106 1.3%
Hispanic or Latino	250 3.1%
Not Hispanic or Latino	1627 20.5%
Unknown or Not Reported	102 1.3%
Hispanic or Latino	445 5.6%
Not Hispanic or Latino	1539 19.4%
Unknown or Not Reported	106 1.3%
Hispanic or Latino	580 7.3%
Not Hispanic or Latino	2345 29.5%
Unknown or Not Reported	168 2.1%
Hispanic or Latino	83 1%
Not Hispanic or Latino	394 5%
Unknown or Not Reported	31 0.4%
Hispanic or Latino	229 2.9%
Not Hispanic or Latino	1643 20.7%
Unknown or Not Reported	170 2.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	21 0.3%
Asian	46 0.6%
Native Hawaiian or Other Pacific Islander	8 0.1%
Black or African American	141 1.8%
White	1702 21.4%
More than one race	41 0.5%
Unknown or Not Reported	199 2.5%
American Indian or Alaska Native	12 0.2%
Asian	58 0.7%
Native Hawaiian or Other Pacific Islander	5 0.1%
Black or African American	234 2.9%
White	1449 18.3%
More than one race	38 0.5%
Unknown or Not Reported	183 2.3%
American Indian or Alaska Native	21 0.3%
Asian	87 1.1%
Native Hawaiian or Other Pacific Islander	9 0.1%
Black or African American	155 2%
White	1504 18.9%
More than one race	28 0.4%
Unknown or Not Reported	286 3.6%
American Indian or Alaska Native	28 0.4%
Asian	122 1.5%
Native Hawaiian or Other Pacific Islander	19 0.2%
Black or African American	296 3.7%
White	2144 27%
More than one race	49 0.6%
Unknown or Not Reported	435 5.5%
American Indian or Alaska Native	1 0%
Asian	13 0.2%
Native Hawaiian or Other Pacific Islander	1 0%
Black or African American	60 0.8%
White	362 4.6%
More than one race	12 0.2%
Unknown or Not Reported	59 0.7%
American Indian or Alaska Native	15 0.2%
Asian	37 0.5%
Native Hawaiian or Other Pacific Islander	9 0.1%
Black or African American	177 2.2%
White	1577 19.9%
More than one race	28 0.4%
Unknown or Not Reported	199 2.5%

Outcome Measures

1. Primary Outcome

Title	Hospital Readmission
Description	Readmission to the hospital within 30 days of discharge.
Time Frame	30 days post hospital discharge

Outcome Measure Data

Analysis Population Description

Any individual participant may have experienced more than one group; therefore, the sum of participants across the arms exceeds the total sample size. Results data are shown for the entire arm (overall) and are also broken down into subgroups.

Arm/Group Title	Patient Communication and Care Management	Home-Based Trust, Plain Language, and Coordination	Hospital-Based Trust, Plain Language, and Coordination	Patient/Family Caregiver Assessment and Information Exchange a	Assessment and Teach Back	Reference
Arm/Group Description	Participants received one more transitional care strategies. 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	Participants received one more transitional care strategies. 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	Participants received one more transitional care strategies. 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	Participants received one more transitional care strategies. Patient/Family Caregiver Assessment and Information Exchange among Providers: 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	Participants received one more transitional care strategies. Assessment and Teach Back: Received the following Transitional Care Strategies: Post-discharge care consultation Language Assessment Teach Back for Information and Skills	Participants were not involved in a specific transitional care strategy. Standard of Care: No specific Transitional Care Strategy
Measure Participants	2158	1979	2090	3093	508	2042
Overall	.956	.949	.698	.972	1.56	.964
Multiple Chronic Conditions	.894	.977	.848	1.009	1.137	.85
Mental Health Issues	1.075	.787	.63	.736	1.421	.636
Rural Area Domicile	.885	.776	.777	1.021	.122	.665
Low Health Literacy	1.113	1.129	.681	.916	1.057	.927
Medicare/Medicaid Dual Eligible	1.133	.687	.706	.889	1.357	.59
Disabled, <65	1.066	.855	.960	1.639	1.192	1.031

2. Primary Outcome

Title	Emergency Department (ED) Visit
Description	Visit to the ED within 30 days of hospital discharge.
Time Frame	30 days post hospital discharge

Outcome Measure Data

Analysis Population Description

Any individual participant may have experienced more than one group; therefore, the sum of participants across the arms exceeds the total sample size. Results data are shown for the entire arm (overall) and are also broken down into subgroups.

Arm/Group Title	Patient Communication and Care Management	Home-Based Trust, Plain Language, and Coordination	Hospital-Based Trust, Plain Language, and Coordination	Patient/Family Caregiver Assessment and Information Exchange a	Assessment and Teach Back	Reference
Arm/Group Description	Participants received one more transitional care strategies. 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	Participants received one more transitional care strategies. 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	Participants received one more transitional care strategies. 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	Participants received one more transitional care strategies. Patient/Family Caregiver Assessment and Information Exchange among Providers: 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	Participants received one more transitional care strategies. Assessment and Teach Back: Received the following Transitional Care Strategies: Post-discharge care consultation Language Assessment Teach Back for Information and Skills	Participants were not involved in a specific transitional care strategy. Standard of Care: No specific Transitional Care Strategy
Measure Participants	2158	1979	2090	3093	508	2042
Overall	.946	1.031	.803	1.091	1.524	.983
Multiple Chronic Conditions	.95	1.057	.927	1.035	.988	.931
Mental Health Issues	1.006	.879	.727	1.115	1.36	.909
Rural Area Domicile	1.013	.756	1.392	1.082	.246	.798
Low Health Literacy	1.125	1.097	.867	1.099	1.086	.939
Medicare/Medicaid Dual Eligible	.747	.621	.746	.85	.85	.5
Disabled, <65	.909	.63	.685	.761	1.024	.564

Adverse Events

Time Frame	30 days post hospital discharge
Adverse Event Reporting Description	Adverse events, serious adverse events, and all-cause mortality were not assessed as part of this study.
Arm/Group Title	Patient Communication and Care Management		Home-Based Trust, Plain Language, and Coordination		Hospital-Based Trust, Plain Language, and Coordination		Patient/Family Caregiver Assessment and Information Exchange a		Assessment and Teach Back		Reference
Arm/Group Description	Participants received one more transitional care strategies. 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		Participants received one more transitional care strategies. 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		Participants received one more transitional care strategies. 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		Participants received one more transitional care strategies. Patient/Family Caregiver Assessment and Information Exchange among Providers: 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		Participants received one more transitional care strategies. Assessment and Teach Back: Received the following Transitional Care Strategies: Post-discharge care consultation Language Assessment Teach Back for Information and Skills		Participants were not involved in a specific transitional care strategy. Standard of Care: No specific Transitional Care Strategy
All Cause Mortality
	Patient Communication and Care Management		Home-Based Trust, Plain Language, and Coordination		Hospital-Based Trust, Plain Language, and Coordination		Patient/Family Caregiver Assessment and Information Exchange a		Assessment and Teach Back		Reference
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Patient Communication and Care Management		Home-Based Trust, Plain Language, and Coordination		Hospital-Based Trust, Plain Language, and Coordination		Patient/Family Caregiver Assessment and Information Exchange a		Assessment and Teach Back		Reference
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Patient Communication and Care Management		Home-Based Trust, Plain Language, and Coordination		Hospital-Based Trust, Plain Language, and Coordination		Patient/Family Caregiver Assessment and Information Exchange a		Assessment and Teach Back		Reference
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.