DiabetesICNCT03451630
Integrated Care (IC) Models for Patient-Centered Outcomes
A study testing High-Touch, High-Tech and Optimal Discharge Planning in people with Diabetes and Asthma, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Asthma, Chronic Obstructive Pulmonary Disease
- What is being tested?
- High-Touch, High-Tech and Optimal Discharge Planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2018to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leveraging Integrated Models of Care to Improve Patient-Centered Outcomes for Publicly-Insured Adults With Complex Health Care Needs
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.
Read the 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.
- Conditions
- Diabetes, Asthma, Chronic Obstructive Pulmonary Disease, Hypertension, Anxiety, Atrial Fibrillation
- Being tested
- High-Touch, High-Tech, Optimal Discharge Planning
- Keywords
- chronic conditions, care management, digital tools
- Medical subject headings
- Diabetes Mellitus, Asthma, Pulmonary Disease, Chronic Obstructive, Hypertension, Anxiety Disorders, Atrial Fibrillation, Heart Failure, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-TouchBehavioural
Intensive, in-person and/or telephonic support.
High-TechBehavioural
Remote care management and self-directed digital tools.
Optimal Discharge PlanningBehavioural
Transition to other Health Plan disease management programs and/or community resources.
| Study group | Role | What they receive |
|---|---|---|
| High-Touch | Active comparator | 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. Receives: Behavioral: High-Touch |
| High-Tech | Active comparator | Delivered via a remote care management platform and digital health tools. Remote care support interactions to occur for at least a four-month period. Receives: Behavioral: High-Tech |
| Optimal Discharge Planning | Active comparator | Delivered via Health Plan support and resources within 14-30 days of an initial home or telephonic visit. Receives: Behavioral: Optimal Discharge Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Activation
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.
Measured: Baseline, 3-, 6-, and 12-months.
Change in Health Status
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.
Measured: Baseline, 3-, 6-, and 12-months.
90-Day Hospital Readmission Rate
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.
Measured: 1 to 90 days
Secondary outcomes (15)
30-Day Hospital Readmission Rate
30-Day Readmissions will be measured using an all-cause readmission rate in claims for physical and behavioral health service use within 30 days following discharge from the qualifying inpatient admission prior to enrollment in the study.
Measured: 1 to 30 days
Functional Status
Assessed using the PROMIS Physical Function - Short Form 6b with six self-reported physical function measures to assess current function, including activities of daily living. Each question has five response options (a 5-point Likert scale) ranging from one to five with 5 being the highest level of physical function and 1 being the lowest. Per best practices, the instrument is scored by Health Measures Scoring Service, using item-level calibrations using responses to each item for each participant, producing a T-score. The highest possible T-score score is 59, indicating the highest level of physical function, and the lowest is 21, indicating the lowest level of physical function.
Measured: Baseline, 3-, 6-, and 12-months.
Quality of Life
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, ranging from 14 to 70. The raw total score is calculated into a 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 score can also be written as: (raw score - 14)/56.
Measured: Baseline, 3-, 6-, and 12-months.
Care Satisfaction
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. Each item is measured on a scale from 1-5 with 5 signifying higher patient satisfaction and 1 being the lowest. Scoring requires obtaining the mean of all 20 items.
Measured: Baseline, 3-, 6-, and 12-months.
Emergent Care Use
Emergent care use will be measured using existing behavioral and physical health claims data to determine the frequency of emergency department visits within 12-months from enrollment.
Measured: Assessed at baseline, 6- and 12-Months.
Engagement in Primary Care
Engagement in primary care will be measured using existing behavioral and physical health claims determining participant frequency of non-acute visits for participants in the 12 months following enrollment. Because clinical standards of care are 1 primary care (PCP) visit every 12 months, PCP visits are assessed as a Y/N variable at 12-Months.
Measured: Assessed at baseline, 6- and 12-Months.
Engagement in Specialty Care
Engagement in specialty care will be measured using existing behavioral and physical health claims data determining participant frequency of specialty provider visits for participants in the 12 months following enrollment. Specialty care is inclusive of any care provided outside of primary care, physical therapy, or occupational therapy.
Measured: Assessed at baseline, 6- and 12-Months.
Inpatient Readmissions Over 12-Months
Readmissions over 12 months will be measured using an all-cause readmission rate from inpatient claims for physical and behavioral health service use within one year following discharge from the qualifying inpatient admission prior to enrollment in the study. Inpatient readmissions were lower than hypothesized for the population. As such, we assessed a Y/N variable for inpatient readmissions at 12-Months.
Measured: Assessed at baseline, 6- and 12-Months.
Mental Health Care Visits
Assessed using existing behavioral health claims data determining frequency of mental health care visits for participants in the 12 months following enrollment. Because of the low frequency, we assess mental health care visits as a Y/N variable.
Measured: Assessed at baseline, 6- and 12-Months.
Gaps in Care: Asthma
Gaps in care will be assessed using Healthcare Effectiveness Data and Information Set (HEDIS) quality metrics. For asthma, we assess the percentage of members 21-64 years of age during the measurement year who were identified as having persistent asthma and were dispensed appropriate medications that they remained on during the treatment period. Two rates are reported:
- The percentage of members who remained on an asthma controller medication for at least 50% of their treatment period (MMA-1a).
- The percentage of members who remained on an asthma controller medication for at least 75% of their treatment period (MMA-1b).
Measured: Assessed at baseline, 6- and 12-Months
Gaps in Care: Chronic Obstructive Pulmonary Disease (COPD)
Gaps in care will be assessed using Healthcare Effectiveness Data and Information Set (HEDIS) quality metrics. For COPD, we assess the percentage of COPD exacerbations for members 40 years of age and older who had an acute inpatient discharge or ED encounter and who were dispensed appropriate medications. Two rates reported:
- Dispensed a systemic corticosteroid within 14 days of the event (PCE-1)
- Dispensed a bronchodilator within 30 days of the event (PCE-2)
Measured: Assessed at baseline, 6- and 12-Months
Gaps in Care: Congestive Heart Failure (CHF)
For Gaps in care related to CHF, we assess readmission rate within 30 days after discharge from inpatient stay for members with a diagnosis of CHF prior index hospitalization.
Measured: Assessed at 30-days from an index admission discharge.
Gaps in Care: Cardiovascular Disease (CVD)
Gaps in care will be assessed using Healthcare Effectiveness Data and Information Set (HEDIS) quality metrics. For CVD, we assess the percentage of males 21-75 years of age and females 40-75 years of age during the measurement year, who were identified as having clinical atherosclerotic cardiovascular disease (ASCVD) and met the following criteria. The following rates are reported:
- Received Statin Therapy. Members who were dispensed at least one high-intensity or moderate-intensity statin medication during the measurement year (SPC-1).
- Statin Adherence 80%. Members who remained on a high-intensity or moderate-intensity statin medication for at least 80% of the treatment period (SPC-2).
Measured: Assessed at baseline, 6- and 12-Months
Gaps in Care: Diabetes
Gaps in care will be assessed using Healthcare Effectiveness Data and Information Set (HEDIS) quality metrics. For diabetes, we assess the percentage of members 40-75 years of age during the measurement year with diabetes who do not have clinical atherosclerotic cardiovascular disease (ASCVD) who met the following criteria. Two rates are reported:
- Received Statin Therapy. Members who were dispensed at least one statin medication of any intensity during the measurement year (SPD-1).
- Statin Adherence 80%. Members who remained on a statin medication of any intensity for at least 80% of the treatment period (SPD-2).
Measured: Assessed at baseline, 6- and 12-Months
Gaps in Care: Depression
Gaps in care will be assessed using Healthcare Effectiveness Data and Information Set (HEDIS) quality metrics. For depression, we assess the percentage of members diagnosed with a new episode of major depression, treated with antidepressant medication, and who remained on an antidepressant medication for:
- Effective Acute Phase Treatment - 84 days of continuous treatment during 114-day period following the Index Prescription Start Date (AMM-1).
- Effective Continuation Phase Treatment - 180 days of continuous treatment during 231-day period following the Index Prescription Start Date (AMM-2).
Measured: Assessed at baseline, 6- and 12-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start4 Sep 2018
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- None (open label)
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Daniel Swayze, University of Pittsburgh
- Investigators
- Dan Swayze, DrPH, MBA, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451630
- Sponsor's protocol ID
- STUDY19030130
- Other IDs
- IHS-1609-36670
- Acronym
- IC
- Status last verified
- Oct 2024
- First submitted
- 30 Jan 2018
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 33383229Williams 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.
PubMed 33522981
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Integrated Models of Care to Improve Patient-Centered Outcomes for Publicly-Insured Adults With Complex Health Care Needs
- ClinicalTrials.gov ID
- NCT03451630
- Acronym / sponsor ID
- IC / STUDY19030130
- Conditions
- Diabetes, Asthma, Chronic Obstructive Pulmonary Disease, Hypertension, Anxiety, Atrial Fibrillation
- Keywords
- chronic conditions, care management, digital tools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| High-Touch | Active comparator | Behavioral: High-TouchDelivered 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. |
| High-Tech | Active comparator | Behavioral: High-TechDelivered via a remote care management platform and digital health tools. Remote care support interactions to occur for at least a four-month period. |
| Optimal Discharge Planning | Active comparator | Behavioral: Optimal Discharge PlanningDelivered via Health Plan support and resources within 14-30 days of an initial home or telephonic visit. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- Individuals receiving advanced levels of care, including:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-TouchIntensive, in-person and/or telephonic support. | Behavioural | High-Touch |
| High-TechRemote care management and self-directed digital tools. | Behavioural | High-Tech |
| Optimal Discharge PlanningTransition to other Health Plan disease management programs and/or community resources. | Behavioural | Optimal Discharge Planning |
Primary outcome
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.
15 secondary outcomes
30-Day Hospital Readmission Rate
Time frame: 1 to 30 days
Functional Status
Time frame: Baseline, 3-, 6-, and 12-months.
Quality of Life
Time frame: Baseline, 3-, 6-, and 12-months.
Care Satisfaction
Time frame: Baseline, 3-, 6-, and 12-months.
Emergent Care Use
Time frame: Assessed at baseline, 6- and 12-Months.
Engagement in Primary Care
Time frame: Assessed at baseline, 6- and 12-Months.
Engagement in Specialty Care
Time frame: Assessed at baseline, 6- and 12-Months.
Inpatient Readmissions Over 12-Months
Time frame: Assessed at baseline, 6- and 12-Months.
Mental Health Care Visits
Time frame: Assessed at baseline, 6- and 12-Months.
Gaps in Care: Asthma
Time frame: Assessed at baseline, 6- and 12-Months
Gaps in Care: Chronic Obstructive Pulmonary Disease (COPD)
Time frame: Assessed at baseline, 6- and 12-Months
Gaps in Care: Congestive Heart Failure (CHF)
Time frame: Assessed at 30-days from an index admission discharge.
Gaps in Care: Cardiovascular Disease (CVD)
Time frame: Assessed at baseline, 6- and 12-Months
Gaps in Care: Diabetes
Time frame: Assessed at baseline, 6- and 12-Months
Gaps in Care: Depression
Time frame: Assessed at baseline, 6- and 12-Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33383229Kearney 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.
- Background: PubMed 33522981Williams 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Swayze, DrPH, MBA principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Touch, High-Tech and Optimal Discharge Planning in people with Diabetes and Asthma, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Activation (time frame: Baseline, 3-, 6-, and 12-months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03451630, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.