Integrated Care (IC) Models for Patient-Centered Outcomes
IC
Leveraging Integrated Models of Care to Improve Patient-Centered Outcomes for Publicly-Insured Adults With Complex Health Care Needs
2 other identifiers
interventional
1,400
1 country
1
Brief Summary
Multiple chronic conditions (MCC) are widely recognized as the U.S. public health challenge of the 21st century. These physical and behavioral health conditions take a large toll on those living with chronic diseases, including many who are publicly insured, as well as caregivers and society. While evidence-based integrated care models can improve outcomes for individuals with MCC, such models have not yet been widely implemented. Insurance providers/payers have innovative system features that can be used to deploy these models; however, the investigators do not yet know which of these features can best help to improve outcomes for individuals with MCC in general or high-need subgroups in particular. As a result, patients lack information to make important decisions about their health and health care, and system-level decision makers face ongoing challenges in effectively and efficiently supporting those with MCC. This real-world study will provide useful information about available options for supporting individuals with MCC. Building on existing integrated care efforts, the investigators will enroll N=1,400 (a modified total N) adults with MCC at risk for repeated hospitalizations and assess the impact of three payer-led options (e.g. High-Touch, High-Tech, Standard Care/Optimal Discharge Planning (ODP)) on patient-centered outcomes, namely patient activation in health care, health status, and subsequent re-hospitalization. The investigators will also determine which option works best for whom under what circumstances by gathering information directly from individuals with MCC through self-report questionnaires, health care use data, and interviews.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Sep 2018
Longer than P75 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2018
CompletedFirst Posted
Study publicly available on registry
March 2, 2018
CompletedStudy Start
First participant enrolled
September 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedResults Posted
Study results publicly available
December 9, 2024
CompletedDecember 9, 2024
October 1, 2024
4.2 years
January 30, 2018
October 30, 2023
December 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Patient Activation
Assessed using the Patient Activation Measure (PAM), a 13-item scale that gauges individual knowledge, skills, and confidence essential to managing one's own health. We assess a global score of the PAM measure, with scores ranging from 0 to 100; lower values represent a poor outcome while higher values represent a better outcome.
Baseline, 3-, 6-, and 12-months.
Change in Health Status
Assessed using the RAND 36-Item Short Form Survey 1.0 (SF-36). The SF-36 is a set of 36 health status and quality-of-life measures that are patient self-reported and measure functional health and well-being within eight domains, including physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Values are recoded per the scoring key relating each item to the appropriate subscale. All items are scored so that a high score defines a more favorable health state. We assess a global scale with a 0 to 100 range with 0 being worst possible health status and 100 being the best possible health status.
Baseline, 3-, 6-, and 12-months.
90-Day Hospital Readmission Rate
90-Day Readmissions will be measured using an all-cause readmission rate from inpatient claims for physical and behavioral health service use within 90 days following discharge from the qualifying inpatient admission prior to enrollment in the study.
1 to 90 days
Secondary Outcomes (15)
30-Day Hospital Readmission Rate
1 to 30 days
Functional Status
Baseline, 3-, 6-, and 12-months.
Quality of Life
Baseline, 3-, 6-, and 12-months.
Care Satisfaction
Baseline, 3-, 6-, and 12-months.
Emergent Care Use
Assessed at baseline, 6- and 12-Months.
- +10 more secondary outcomes
Study Arms (3)
High-Touch
ACTIVE COMPARATORDelivered primarily via face-to-face interactions, with telephonic interactions and information sharing that does not require access to mobile devices or the Internet. In-person support and/or telephonic interactions to occur at least four times over at least a four-month period.
High-Tech
ACTIVE COMPARATORDelivered via a remote care management platform and digital health tools. Remote care support interactions to occur for at least a four-month period.
Optimal Discharge Planning
ACTIVE COMPARATORDelivered via Health Plan support and resources within 14-30 days of an initial home or telephonic visit.
Interventions
Transition to other Health Plan disease management programs and/or community resources.
Eligibility Criteria
You may qualify if:
- Medicaid or dual-eligible (Medicare-Medicaid) adults, ages 21 years and older with Multiple Chronic Conditions (MCC).
- Have at least one physical health condition (e.g., cardiovascular disease, hypertension, COPD, diabetes).
- Have at least one additional physical or behavioral health condition (e.g., depression, serious mental illness, substance abuse disorder).
- Reside in Western, Central, or Eastern Pennsylvania.
- Be insured through physical and/or behavioral health payers within the UPMC ISD.
- Individuals will have several comorbidities, will have been prescribed several medications, and/or will be predicted future high health care utilizers.
- Must have at least one hospital discharge within 30 days of enrollment.
- Speak and read English or Spanish at a 4th grade level.
You may not qualify if:
- Individuals receiving advanced levels of care, including:
- Individuals who are pregnant.
- Individuals in skilled nursing facilities or receiving hospice or palliative care.
- Individuals on hemodialysis for kidney disease.
- Individuals whose inpatient admission was related to active cancer treatment.
- Individuals currently enrolled in an RPM program.
- Individuals who have participated in High-Touch or High-Tech within the previous 12 months.
- Individuals who are unable to operate a smart phone due to limitations in literacy, vision, or dexterity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UPMC
Pittsburgh, Pennsylvania, 15219, United States
Related Publications (2)
Kearney SM, Williams K, Nikolajski C, Park MJ, Kraemer KL, Landsittel D, Kang C, Malito A, Schuster J. Stakeholder impact on the implementation of integrated care: Opportunities to consider for patient-centered outcomes research. Contemp Clin Trials. 2021 Feb;101:106256. doi: 10.1016/j.cct.2020.106256. Epub 2020 Dec 29.
PMID: 33383229BACKGROUNDWilliams K, Markwardt S, Kearney SM, Karp JF, Kraemer KL, Park MJ, Freund P, Watson A, Schuster J, Beckjord E. Addressing Implementation Challenges to Digital Care Delivery for Adults With Multiple Chronic Conditions: Stakeholder Feedback in a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Feb 1;9(2):e23498. doi: 10.2196/23498.
PMID: 33522981BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Approximately 10% of our total sample was eligible for the gaps in care analysis using Healthcare Effectiveness Data and Information Set (HEDIS) data, and therefore, several HEDIS based outcomes were not adequately powered to demonstrate statistical significance. Due to privacy and data sharing policies, we recognize not all claims related substance use diagnoses or behavioral health were obtained for analysis.
Results Point of Contact
- Title
- Kelly Williams, PhD, MPH
- Organization
- UPMC Center for High-Value Health Care
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Swayze, DrPH, MBA
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice President, Community Services for UPMC Health Plan
Study Record Dates
First Submitted
January 30, 2018
First Posted
March 2, 2018
Study Start
September 4, 2018
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
December 9, 2024
Results First Posted
December 9, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
Due to the sensitive nature of the questions asked in this study, survey respondents were assured raw data would remain confidential and would not be shared.