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

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ClinicalTrials.gov Identifier: NCT03451630
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : March 11, 2021
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
James Schuster, University of Pittsburgh

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 suffering from the 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=1,927 (N=265 Phase I and N=1,662 Phase II) adults with MCC at risk for repeated hospitalizations and assess the impact of three payer-led options (e.g. High-Touch, High-Tech, Usual Care) 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.


Condition or disease Intervention/treatment Phase
Diabetes Arthritis Asthma Chronic Obstructive Pulmonary Disease Hypertension Anxiety Atrial Fibrillation Congestive Heart Failure Depression Bipolar Disorder Schizophrenia Behavioral: High-Touch Behavioral: High-Tech Behavioral: Usual Care/Optimal Discharge Planning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1927 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
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 Usual Care, respectively. While the less resource intensive Usual Care may, 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Leveraging Integrated Models of Care to Improve Patient-Centered Outcomes for Publicly-Insured Adults With Complex Health Care Needs
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Behavioral: High-Touch
Intensive, in-person support.

Active Comparator: 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.
Behavioral: High-Tech
Remote care management and self-directed digital tools.

Active Comparator: Usual Care
Delivered via Health Plan support and resources within 14 days of an initial home or telephonic visit.
Behavioral: Usual Care/Optimal Discharge Planning
Transition to other Health Plan disease management programs.




Primary Outcome Measures :
  1. Patient activation [ Time Frame: Baseline and every three months for a 12 month intervention period. ]

    Patient activation will be 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. The PAM identifies where an individual falls within four different levels of activation.

    • Level 1 - Disengaged and overwhelmed
    • Level 2 - Becoming aware, but still struggling
    • Level 3 - Taking action
    • Level 4 - Maintaining behaviors and pushing further

  2. Change in Health Status [ Time Frame: Baseline and every three months for a 12 month intervention period. ]
    Health Status will be measured using the 36-Item Short Form Survey (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, physical ability to complete tasks, bodily pain, general health, vitality, social functioning, emotional ability to complete tasks, and mental health.. Patients are asked to reply to questions based on how they have felt over the previous week. There are eight scaled scores and each scale is translated into a 0-100 scale with each question carrying equal weight. Lower scores represent more disability and higher scores less disability. The items use Likert-type scales, some with 5 or 6 points and others with 2 or 3 points.

  3. Change in Hospital Readmission Rate [ Time Frame: Updated every six months for the active three year intervention period. ]
    Rehospitalization will be measured using an all-cause readmission rate existing in UPMC ISD inpatient claims for physical and behavioral health service use within 30 and 90 days following the index inpatient admission that triggered enrollment in the study.


Secondary Outcome Measures :
  1. Functional status [ Time Frame: Baseline and every three months for a 12 month intervention period. ]
    Functional status will be measured using the PROMIS Physical Function - Short Form 6b which is a brief self-report tool that consists of 6 self-reported physical function measures that assess current function including the functioning of upper extremities, lower extremities, central regions, as well as activities of daily living. Each question has five response options (a 5 point Likert scale) ranging in value from one to five. The instrument is scored using item-level calibrations using responses to each item for each participant. A single Physical Function capability score is generated from the short form.

  2. Quality of life, enjoyment and satisfaction [ Time Frame: Baseline and every three months for a 12 month intervention period. ]

    Quality of Life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF): which is a self-report measure consisting of 16 questions designed to enable investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning during the past week. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70. The raw total score is transformed into a percentage maximum possible score using the following formula:

    (raw total score - minimum score)/(maximum possible raw score - minimum score) The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Thus the formula for % maximum can also be written as (raw score - 14)/56.


  3. Care satisfaction [ Time Frame: Baseline and every three months for a 12 month intervention period. ]

    Care satisfaction will be assessed using the Patient Assessment of Care for Chronic Conditions (PACIC) Survey. The PACIC Survey consists of 20-items that measures specific actions or qualities of care that patients report they have experienced in the care of their chronic conditions over the past 6 months. There is an additional item that is not part of the PACIC Survey and is used to track the patient's hopefulness over time. The PACIC Survey is grouped into five scales where each scale is scored by averaging the items completed within the scale, and the overall PACIC is cored by averaging scores across all 20 items. The five scales are:

    • Patient Activation (items 1-3)
    • Delivery System Design/Decision Support (items 4-6)
    • Goal Setting (items 7-11)
    • Problem-solving/Contextual Counseling (items 12-15)
    • Follow-up/Coordination (items 16-20)

  4. Emergent care [ Time Frame: Updated every six months for the active three year intervention period. ]
    Emergent care use will be measured using existing behavioral and physical health claims data from the UPMC Insurance Services Division (ISD) data warehouse to determine the frequency of ED/inpatient admits in the 12 months following randomization.

  5. Engagement in primary, specialty, mental health care [ Time Frame: Updated every six months for the active three year intervention period. ]
    Engagement in primary, specialty, mental health care will be measured using existing behavioral and physical health claims data from the UPMC ISD data warehouse to determining participant frequency of non-acute visits for participants in the 12 months following randomization.

  6. Gaps in care [ Time Frame: Updated every six months for the active three year intervention period. ]
    Gaps in care will be assessed using HEDIS quality metrics that will be compiled using existing behavioral and physical health claims data from the UPMC ISD data warehouse. Gaps in care will be assessed for six of the most common chronic diseases present among our target population, including: asthma, chronic obstructive pulmonary disease, congestive heart failure, coronary artery disease, diabetes, and depression.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  1. Individuals who are pregnant.
  2. Individuals in skilled nursing facilities.
  3. Individuals on hemodialysis for kidney disease.
  4. Individuals who are in active cancer treatment.
  5. Individuals who have participated in High-Touch or High-Tech within the previous 12 months.
  6. Individuals who are unable to operate a smart phone due to reasons of literacy, vision or dexterity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451630


Contacts
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Contact: Kelly R Williams, PhD, MPH 412-454-1198 williamsk17@upmc.edu
Contact: Sarah Markwardt, MID 412-216-4620 markwardtsa@upmc.edu

Locations
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United States, Pennsylvania
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15219
Contact: Kelly R Williams, PhD, MPH    412-454-1198    williamsk17@upmc.edu   
Contact: Sarah M Markwardt, MID    412-454-9427    markwardtsa@upmc.edu   
Sub-Investigator: Kevin Kraemer, MD, MSc         
Sub-Investigator: Doug Landsittel, PhD         
Sub-Investigator: Megan Hamm, PhD         
Sub-Investigator: Chaeryon Kang, PhD         
Sub-Investigator: Jordan Karp, MD         
Sub-Investigator: Jonathan Encarnacion, MBA         
Sub-Investigator: Ellen Beckjord, PhD, MPH         
Sub-Investigator: Meg Park, M.Div.         
Sponsors and Collaborators
University of Pittsburgh
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: James Schuster, MD, MBA University of Pittsburgh
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: James Schuster, Clinical Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03451630    
Other Study ID Numbers: 1609-36670
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Heart Failure
Atrial Fibrillation
Schizophrenia
Bipolar Disorder
Cardiovascular Diseases
Heart Diseases
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Arrhythmias, Cardiac
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Bipolar and Related Disorders