Leveraging Integrated Models of Care to Improve Patient-Centered Outcomes for Publicly-Insured Adults With Complex Health Care Needs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 1,400
- Locations
- 1
- Primary Endpoint
- Patient Activation
Study Overview
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.
Detailed Description
Study aims. Given the documented need for valuable information about system-level features that can be used to effectively and efficiently support adults in living well with MCC, this study is designed to achieve the following aims:
Aim 1: Compare the effectiveness of High-Touch, High-Tech, and ODP on primary outcomes including hospital readmission, health status, and patient activation, and on several secondary outcomes including functional status, quality of life, care satisfaction, emergent care use, engagement in primary, specialty, and mental health care, and gaps in care.
Aim 2: Examine the differential effects of the interventions for patient subgroups, based on age, race, illness complexity, and comorbid behavioral health conditions to evaluate heterogeneity of treatment effects (HTE) and determine for whom and in what circumstances the interventions are most effective.
Aim 3: Examine perceived barriers and facilitators to efficient and effective implementation of High-Touch and High-Tech interventions for delivering evidence-based integrated care.
An individual-level randomized design along with a pragmatic, mixed-methods approach to compare system-level features for delivering evidence-based components of integrated care for Medicaid or dual-eligible adult members with MCC who reside in in Western, Central, or Eastern PA and are at high risk for rehospitalization has been selected for this study. This design, based on significant input from patient stakeholders and Drs. Kevin Kraemer (Scientific Co-I; health services researcher) and Doug Landsittel (Co-I; biostatistician/CER expert), accords fully with the PCORI Methodology Standards. Intervention effectiveness will be determined by examining the differential impact on outcomes that are most meaningful to patients in our target population and those delivering their care. The scope and duration of the study interventions and evaluation are sufficient to measure change in patient-centered outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
High-Touch
Delivered 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.
Intervention: High-Touch (Behavioral)
High-Tech
Delivered via a remote care management platform and digital health tools. Remote care support interactions to occur for at least a four-month period.
Intervention: High-Tech (Behavioral)
Optimal Discharge Planning
Delivered via Health Plan support and resources within 14-30 days of an initial home or telephonic visit.
Intervention: Optimal Discharge Planning (Behavioral)
Outcomes
Primary Outcomes
Patient Activation
Time Frame: Baseline, 3-, 6-, and 12-months.
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.
Change in Health Status
Time Frame: Baseline, 3-, 6-, and 12-months.
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.
90-Day Hospital Readmission Rate
Time Frame: 1 to 90 days
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.
Secondary Outcomes
- 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.)
- Engagement in Primary Care(Assessed at baseline, 6- and 12-Months.)
- Engagement in Specialty Care(Assessed at baseline, 6- and 12-Months.)
- Inpatient Readmissions Over 12-Months(Assessed at baseline, 6- and 12-Months.)
- Mental Health Care Visits(Assessed at baseline, 6- and 12-Months.)
- Gaps in Care: Asthma(Assessed at baseline, 6- and 12-Months)
- Gaps in Care: Chronic Obstructive Pulmonary Disease (COPD)(Assessed at baseline, 6- and 12-Months)
- Gaps in Care: Congestive Heart Failure (CHF)(Assessed at 30-days from an index admission discharge.)
- Gaps in Care: Cardiovascular Disease (CVD)(Assessed at baseline, 6- and 12-Months)
- Gaps in Care: Diabetes(Assessed at baseline, 6- and 12-Months)
- Gaps in Care: Depression(Assessed at baseline, 6- and 12-Months)
Investigators
Daniel Swayze
Vice President, Community Services for UPMC Health Plan
University of Pittsburgh