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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 below

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I am over 21, have Medicaid or Medicare-Medicaid, and multiple chronic conditions.

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I am insured by UPMC for health services.

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I have a physical health condition like heart disease or diabetes.

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I am over 21, on Medicaid or Medicare-Medicaid, and have multiple chronic conditions.

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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:

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I cannot use a smartphone because of issues with reading, seeing, or using my hands.

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I am on hemodialysis for kidney disease.

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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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every three months for a 12 month intervention period. for reporting.

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 more

Awards & 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.

0 / 8Eligibility criteria met