Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation

The overarching aim of the proposed project is to conduct a pragmatic, quality improvement evaluation of the IntelliCare Platform for improving processes of care in the Rush Collaborative Care program, and improving patient population depression outcomes, to determine the long-term utility of IntelliCare for Rush.

Study Overview

• Status: Terminated
• Conditions: Depression
• Intervention / Treatment: Behavioral: Treatment as Usual (TAU); Device: IntelliCare

Detailed Description

This study is a pragmatic, system-wide rollout quality improvement evaluation design displayed in Figure 1. The Rush IRB has waived consent for this quality improvement trial. Data from the EHR will be used beginning December 1, 2019. The first care manager (CM) will begin enrolling patients into IntelliCare in September, 2020. Additional CMs will begin using IntelliCare at approximately 3 month intervals. In September 2021, support for IntelliCare from the evaluation team will be withdrawn, to examine the sustainability of the IntelliCare Platform.

Patients Data from all patients, aged 18 or older, enrolled collaborative care from December 1, 2019 through August 31, 2022 will be used to evaluate the IntelliCare service. All CCT patients who are 18 or older, and have a smartphone will be offered enrollment.

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Enrolled in Rush Collaborative Care service
• Owns a personal smartphone

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment as Usual (TAU); TAU will be the treatment that is provided through the Rush Collaborative Care program as part of their service	Behavioral: Treatment as Usual (TAU); Treatment as usual in the Rush Collaborative Care service
Experimental: IntelliCare; Patients will be offered IntelliCare as part of their care in the Rush Collaborative Care service. Patients who agree will download the IntelliCare app, which provides self management and collects symptom self-report data. Symptom severity scores are displayed to the care manager, allowing them to manage the patient's care. The app also provides a secure messaging service for communication between the care manager and the patient.	Device: IntelliCare; IntelliCare provides self management and collects symptom self-report data. Symptom severity scores are displayed to the care manager, allowing them to manage the patient's care. The app also provides a secure messaging service for communication between the care manager and the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Patient Health Questionnaire-9 (PHQ-9) assessment for depression	Up to 20 Months
Number of assessments	Number of Patient Health Questionnaire (PHQ-9) assessments acquired in the EHR	Up to 20 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First to last assessment	Time from first to last PHQ-9	Up to 20 Months

Collaborators and Investigators

• Sponsor: Adaptive Health, Inc
• Collaborators: Rush University Medical Center
• Investigators: Principal Investigator: Carolyn MacIver, Adaptive Health

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: R44MH114725 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There is not current plan to share IPD outside the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No