Ignite Creation Date:
2024-05-06 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03451630
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-01-18
First Post:
2018-01-30
Brief Title:
PCORI Integrated Care IC Models for Patient-Centered Outcomes
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Leveraging Integrated Models of Care to Improve Patient-Centered Outcomes for Publicly-Insured Adults With Complex Health Care Needs
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IC
Brief Summary:
Multiple chronic conditions MCC are widely recognized as the US 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 providerspayers 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 N1927 N265 Phase I and N1662 Phase II adults with MCC at risk for repeated hospitalizations and assess the impact of three payer-led options eg 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
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 N1927 N265 Phase I and N1662 Phase II adults with MCC at risk for repeated hospitalizations and assess the impact of three payer-led options eg 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
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 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 Kevin Kraemer Scientific Co-I health services researcher and Doug Landsittel Co-I biostatisticianCER 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 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-TouchHigh-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 eg 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 221 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-TouchHigh-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 eg cardiovascular disease hypertension COPD diabetes and at least one additional physical or behavioral health condition eg 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 andor behavioral health payers within the UPMC Insurance Services Division ISD In addition these individuals will have several comorbidities will have been prescribed several medications andor will be predicted future high health care utilizers Assuming a 75 enrollment rate 1662 individuals will be randomized to either High-Tech n667 High-Touch n667 or Usual Care n328
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 technologydigital 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 ISDs 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 CMs 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 patients 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 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 participants are transitioned to Health Plan telephonic care management with in 14 days
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 Kevin Kraemer Scientific Co-I health services researcher and Doug Landsittel Co-I biostatisticianCER 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 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-TouchHigh-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 eg 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 221 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-TouchHigh-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 eg cardiovascular disease hypertension COPD diabetes and at least one additional physical or behavioral health condition eg 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 andor behavioral health payers within the UPMC Insurance Services Division ISD In addition these individuals will have several comorbidities will have been prescribed several medications andor will be predicted future high health care utilizers Assuming a 75 enrollment rate 1662 individuals will be randomized to either High-Tech n667 High-Touch n667 or Usual Care n328
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 technologydigital 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 ISDs 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 CMs 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 patients 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 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 participants are transitioned to Health Plan telephonic care management with in 14 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None