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High-Touch, High-Tech Care for Chronic Conditions (IC Trial)
N/A
Waitlist Available
Led By Dan Swayze, DrPH, MBA
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Enrollment Phase I: Medicaid or dual-eligible (Medicare-Medicaid) adults age 21 years and older with Multiple Chronic Conditions (MCC)
Enrollment Phase II: Be insured through physical and/or behavioral health payers within the UPMC ISD
Must not have
Individuals who are unable to operate a smart phone due to reasons of literacy, vision or dexterity
Individuals on hemodialysis for kidney disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up updated every six months for the active three year intervention period.
Awards & highlights
No Placebo-Only Group
Summary
This trial will enroll 1,927 adults with multiple chronic conditions who are at risk for repeated hospitalizations. The investigators will 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.
Who is the study for?
Adults over 21 in Pennsylvania with multiple chronic conditions like heart disease, high blood pressure, COPD, or diabetes. They must be insured through UPMC ISD and not pregnant, in active cancer treatment, in nursing facilities, on hemodialysis for kidney disease or unable to use a smartphone.
What is being tested?
The study tests three care options for people with multiple health issues: usual care with optimal discharge planning; High-Touch (personalized support); and High-Tech (technology-based assistance). It aims to see which improves patient involvement and health while reducing re-hospitalizations.
What are the potential side effects?
This trial does not involve medication so typical drug side effects are not expected. However, participants may experience stress or discomfort from changes in their healthcare routine or the burden of additional monitoring.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 21, have Medicaid or Medicare-Medicaid, and multiple chronic conditions.
Select...
I am insured by UPMC for health services.
Select...
I have a physical health condition like heart disease or diabetes.
Select...
I am over 21, on Medicaid or Medicare-Medicaid, and have multiple chronic conditions.
Select...
I am over 21, on Medicaid or Medicare-Medicaid, and have multiple chronic conditions.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot use a smartphone because of issues with reading, seeing, or using my hands.
Select...
I am on hemodialysis for kidney disease.
Select...
I am currently receiving treatment for cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and every three months for a 12 month intervention period.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and every three months for a 12 month intervention period.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Health Status
Change in Hospital Readmission Rate
Patient activation
Secondary study objectives
Care satisfaction
Emergent care
Engagement in primary, specialty, mental health care
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: High-TouchActive Control1 Intervention
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.
Group II: High-TechActive Control1 Intervention
Delivered via a remote care management platform and digital health tools. Remote care support interactions to occur for at least a four-month period.
Group III: Usual CareActive Control1 Intervention
Delivered via Health Plan support and resources within 14 days of an initial home or telephonic visit.
Find a Location
Who is running the clinical trial?
Patient-Centered Outcomes Research InstituteOTHER
572 Previous Clinical Trials
27,076,201 Total Patients Enrolled
6 Trials studying Diabetes
2,663,176 Patients Enrolled for Diabetes
University of PittsburghLead Sponsor
1,776 Previous Clinical Trials
16,352,000 Total Patients Enrolled
20 Trials studying Diabetes
107,547 Patients Enrolled for Diabetes
Dan Swayze, DrPH, MBAPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You live in certain areas of Pennsylvania, including the west, center, or east.You have a history of frequently using a lot of healthcare resources, like going to the emergency room often or being admitted to the hospital multiple times.I am over 21, have Medicaid or Medicare-Medicaid, and multiple chronic conditions.I have a physical health condition like heart disease or diabetes.I am insured by UPMC for health services.I cannot use a smartphone because of issues with reading, seeing, or using my hands.I have multiple health issues, take many medications, and may need a lot of future healthcare.You have another physical or mental health condition like depression, serious mental illness, or substance abuse disorder.I have a chronic health condition like heart disease or diabetes.I am on hemodialysis for kidney disease.I have a physical health condition like heart disease or diabetes.I am over 21, on Medicaid or Medicare-Medicaid, and have multiple chronic conditions.You must have health insurance through UPMC ISD for both physical and mental health.I am over 21, on Medicaid or Medicare-Medicaid, and have multiple chronic conditions.You have been involved in a similar program called High-Touch or High-Tech in the past year.I am insured by UPMC for physical or mental health.People who live in nursing homes.I was discharged from the hospital within the last 30 days.I have another health condition like depression or substance abuse.I am currently receiving treatment for cancer.
Research Study Groups:
This trial has the following groups:- Group 1: High-Touch
- Group 2: High-Tech
- Group 3: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Diabetes Patient Testimony for trial: Trial Name: NCT03451630 — N/A
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