PCORI Integrated Care (IC) Models for Patient-Centered Outcomes

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 Usual Care 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. Kraemer (Scientific
Co-I; health services researcher) and Landsittel (Co-I; biostatistician/CER expert), accords
fully with the PCORI Methodology Standards.91. 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.
Upon receipt of an award, the evaluation and analytics plan described within this section
will be translated into a formal study protocol to be vetted again for content and process
with patient partners and other stakeholders and approved by the Human Research Protection
Office (HRPO).

High-Touch, High-Tech, and Usual Care will serve as the comparators for this study. Usual
Care follows standardized procedures for patient engagement including when a patient is
either hospitalized or transitioning from the hospital setting into ambulatory care for
follow-up and condition management. Due to resources and other limitations, not all patients
who are eligible for High-Touch/High-Tech enroll in these programs. Thus, the addition of the
Usual Care arm will allow for a less intensive model to be examined and targeted to
appropriate patient populations.

For Aims 1 and 2, an individual, stratified randomized trial design was selected to randomly
assign each enrollee to one of the three interventions arms, minimizing and balancing for
confounding variables. Individual-level randomization was selected as opposed to cluster
randomization at a system level (e.g., practice-, hospital-level) because the interventions
are delivered by a single payer and are not subject to within-practice contamination. Based
on valuable system-level stakeholder feedback, an unequal randomization ratio of 2:2:1 for
High-Touch, High-Tech, and Usual Care, respectively, was utilized. While the less resource
intensive Usual Care may, in fact, improve meaningful outcomes for certain patient subgroups,
the health care system has invested heavily in High-Touch and High-Tech as evidence-based
solutions for chronic disease care. Additionally, stakeholders have indicated that they would
like as many participants as possible to have a fully integrated care experience offered by
High-Touch/High-Tech and would like to limit enrollment into Usual Care. The investigators
will use a mixed-methods approach that incorporates both qualitative and quantitative data.
The addition of qualitative data collection and analyses in Aim 3 will permit more
comprehensive understanding of patient and staff experiences with the interventions and
results will aide in dissemination of study findings in a manner that is most consistent with
patient and other stakeholder perceptions and experiences. The overall, four-year study
timeline includes three phases: Pre-Intervention (months 1-6), Intervention and Data
Collection (months 7-40), and Data Analysis and Reporting (months 41-48).

The study population includes Medicaid or dual-eligible (Medicare-Medicaid) adults age 21
years and older with MCC, including at least one physical health condition (e.g.,
cardiovascular disease, hypertension, COPD, diabetes) and at least one additional physical or
behavioral health condition (e.g., depression, serious mental illness, substance abuse
disorder) and at least one hospital discharge in the previous 30 days. These individuals will
reside in PA and will be insured through physical and/or behavioral health payers within the
UPMC Insurance Services Division (ISD). In addition, these individuals will have several
comorbidities, will have been prescribed several medications, and/or will be predicted future
high health care utilizers. Assuming a 75% enrollment rate, 1,662 individuals will be
randomized to either High-Tech (n=667), High-Touch (n=667) or Usual Care (n=328).

The study will use web-based randomization to one of the three interventions for those
individuals who consent to participate in the study. Once a member of the interdisciplinary
care team (ICT) determines eligibility, he or she will enter key identification information,
and the system will then generate a Study ID (numeric identification number) along with
assignment to an intervention arm. Randomization will be stratified by gender, type of
insurance (Medicaid or Medicare-Medicaid), and technology/digital literacy, which will be
assessed at time of enrollment and before randomization, to ensure that intervention arms are
balanced with respect to these important variables. Within each stratum, random block sizes
of 5 and 10 will be used to maximize balance between intervention groups while minimizing the
ability to unmask investigators to the next treatment assignment, triggering an automated
alert to ICT staff regarding which intervention to implement for each participant and
documented accordingly in HealthPlaNET, UPMC ISD's integrated health management software
program. If a participant is unwilling to be randomized, they will be excluded from the
study.

Each patient is assigned a nurse Clinical Care Manager (CCM) or a licensed social worker, and
a pharmacist who provide comprehensive services for the duration of intervention
implementation. Bilingual ICT staff will be available to support native Spanish speaking
participants. CCMs are currently employed to develop and implement care plans with patients,
coordinate healthcare services, work with the pharmacist to manage patient's medications,
make home visits, and deliver telehealth care and remote monitoring. Social workers are
responsible for each patient's biopsychosocial needs assessment, meeting with patients in
their homes, hospitals and provider offices, and conducting psychosocial status reviews.
Pharmacists conduct medication reconciliations for all patients and share findings about
potential drug interactions or medication adjustments with CCMs, patients, and providers as
indicated. Each ICT has a caseload of up to fifty patients and all staff members meet monthly
to review progress for all individuals participating in the interventions.

Staff members undergo extensive in-person and web-based module training to increase
uniformity in patient engagement and intervention implementation. The work of Peggy Swarbrick
of Rutgers and the Collaborative Support Programs of New Jersey, Inc. provides the basis of
the wellness coaching and health navigation training that teaches all ICT staff how to
utilize motivational interviewing to identify and address barriers and facilitators related
to disease self-management and holistic health. Additional training includes modules related
to: medication reconciliations, common physical/behavioral health conditions, strategies to
engage eligible patients, documentation protocols, trauma-informed care, substance use, and
harm reduction. SAMHSA's 8 Dimensions of Wellness (physical, emotional, environmental,
social, financial, occupational, spiritual, and intellectual) are considered with all
intervention-related activities to ensure that whole health and wellness are taken into
account when assessing each patient's unique needs.

Patients in both High-Touch and High-Tech will experience similar procedures at the start of
their participation. A CCM or social worker engages patients in a face-to-face assessment in
the hospital or in a community setting to dialogue about the social determinants affecting
continued hospital readmissions and emergency department use. At the completion of the
assessment, the initial home visit is scheduled and medication reconciliation is ordered.
Individuals randomized to Usual Care will be provided with the transitional care services.
High-Touch and High-Tech interventions are provided for approximately four months following
hospitalization, and Usual Care is approximately one month.

Inclusion Criteria:

Enrollment Phase I Inclusion Criteria:

1. Medicaid or dual-eligible (Medicare-Medicaid) adults age 21 years and older with
Multiple Chronic Conditions (MCC).

2. Have at least one physical health condition (e.g., cardiovascular disease,
hypertension, COPD, diabetes).

3. Have at least one additional physical or behavioral health condition (e.g.,
depression, serious mental illness, substance abuse disorder).

4. Reside in Western, Central, or Eastern Pennsylvania.

5. Be insured through physical and/or behavioral health payers within the UPMC ISD.

6. Are identified as members with consistently high or rising resource utilization (which
takes into account avoidable hospital readmissions, emergency department usage, and
high cost, among other utilization-related variables).

Enrollment Phase II Inclusion Criteria:

1. Medicaid or dual-eligible (Medicare-Medicaid) adults age 21 years and older with
Multiple Chronic Conditions (MCC).

2. Have at least one physical health condition (e.g., cardiovascular disease,
hypertension, COPD, diabetes).

3. Have at least one additional physical or behavioral health condition (e.g.,
depression, serious mental illness, substance abuse disorder).

4. Reside in Western, Central, or Eastern Pennsylvania.

5. Be insured through physical and/or behavioral health payers within the UPMC ISD.

6. ) Individuals will have several comorbidities, will have been prescribed several
medications, and/or will be predicted future high health care utilizers.

7. Must have at least one hospital discharge within 30 days of enrollment.

Exclusion Criteria:

Individuals who are pregnant, in skilled nursing facilities, on hemodialysis for kidney
disease, in active cancer treatment, or unable to operate a smart phone due to reasons of
literacy, vision or dexterity will be excluded from the study.