Clinical trial NCT03451630: Integrated Care (IC) Models for Patient-Centered Outcomes
Official title: Leveraging Integrated Models of Care to Improve Patient-Centered Outcomes for Publicly-Insured Adults With Complex Health Care Needs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Asthma
Chronic Obstructive Pulmonary Disease
Hypertension
Anxiety
Atrial Fibrillation
Congestive Heart Failure
Depression
Bipolar Disorder
Schizophrenia
Keywords: chronic conditions
care management
digital tools
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2018-03-02
Enrollment: 1400
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: We chose an individual, stratified randomized trial design to randomly assign each enrollee to one of the three interventions arms, minimizing and balancing confounding variables. We will utilize an unequal randomization ratio of 2:2:1 for High-Touch, High-Tech, and ODP, respectively. While the less resource intensive ODP, in fact, improve meaningful outcomes for certain patient subgroups, our health care system has invested heavily in High-Touch and High-Tech as evidence-based solutions for chronic disease care. We will use a mixed-methods approach that incorporates both qualitative and quantitative data.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

High-Touch, High-Tech, and ODP will serve as the comparators for this study. ODP 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 ODP 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 ODP, respectively, was utilized. While the less resource intensive ODP 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 ODP. 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). Note: a 19-month no cost extension was granted to the study team to complete enrollment and data collection, especially during workflow adaptations related to COVID-19 restrictions.

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. Based on a 75% enrollment rate, we initially expected1,662 individuals to be randomized to either High-Tech (n=667), High-Touch (n=667) or ODP (n=328). However, our funder approved a sample size recalculation for an 90% retention rate for 1,400 consented individuals randomized to either High-Tech (n=448), High-Touch (n=448) or ODP (n=224).

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 Community Team (CT), multidisciplinary community-based team of nurses, licensed social workers, and licensed professional counselors, determines eligibility, CT personnel 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 CT 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 care manager (CM) who provides comprehensive services for the duration of intervention implementation. Bilingual staff will be available to support native Spanish speaking participants. CMs 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.

Patients in both High-Touch and High-Tech will experience similar procedures at the start of their participation. A CM engages patients in a face-to-face assessment in-home or telephonically to dialogue about the social determinants affecting continued hospital readmissions and emergency department use. At the completion of the assessment, the study is presented to the member and if agreeable informed consent occurs. Individuals randomized to ODP will be provided with the transitional care services. High-Touch and High-Tech interventions are provided for four to twelve months following hospitalization, based on need, and ODP participants are transitioned to appropriate Health Plan or community resources within 14 to 30 days.

Eligibility criteria: Inclusion Criteria:

1. Medicaid or dual-eligible (Medicare-Medicaid) adults, ages 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.
8. Speak and read English or Spanish at a 4th grade level.

Exclusion Criteria:

1. 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.
2. Individuals currently enrolled in an RPM program.
3. Individuals who have participated in High-Touch or High-Tech within the previous 12 months.
4. Individuals who are unable to operate a smart phone due to limitations in literacy, vision, or dexterity.

Primary outcomes:
measure: Patient Activation
timeFrame: Baseline, 3-, 6-, and 12-months.
measure: Change in Health Status
timeFrame: Baseline, 3-, 6-, and 12-months.
measure: 90-Day Hospital Readmission Rate
timeFrame: 1 to 90 days
Secondary outcomes:
measure: 30-Day Hospital Readmission Rate
timeFrame: 1 to 30 days
measure: Functional Status
timeFrame: Baseline, 3-, 6-, and 12-months.
measure: Quality of Life
timeFrame: Baseline, 3-, 6-, and 12-months.
measure: Care Satisfaction
timeFrame: Baseline, 3-, 6-, and 12-months.
measure: Emergent Care Use
timeFrame: Assessed at baseline, 6- and 12-Months.
measure: Engagement in Primary Care
timeFrame: Assessed at baseline, 6- and 12-Months.
measure: Engagement in Specialty Care
timeFrame: Assessed at baseline, 6- and 12-Months.
measure: Inpatient Readmissions Over 12-Months
timeFrame: Assessed at baseline, 6- and 12-Months.
measure: Mental Health Care Visits
timeFrame: Assessed at baseline, 6- and 12-Months.
measure: Gaps in Care: Asthma
timeFrame: Assessed at baseline, 6- and 12-Months
measure: Gaps in Care: Chronic Obstructive Pulmonary Disease (COPD)
timeFrame: Assessed at baseline, 6- and 12-Months
measure: Gaps in Care: Congestive Heart Failure (CHF)
timeFrame: Assessed at 30-days from an index admission discharge.
measure: Gaps in Care: Cardiovascular Disease (CVD)
timeFrame: Assessed at baseline, 6- and 12-Months
measure: Gaps in Care: Diabetes
timeFrame: Assessed at baseline, 6- and 12-Months
measure: Gaps in Care: Depression
timeFrame: Assessed at baseline, 6- and 12-Months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Dan Swayze, DrPH, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Williams 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.