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Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation

Primary Purpose

Depression

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IntelliCare
Treatment as Usual (TAU)
Sponsored by
Adaptive Health, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment as Usual (TAU)

IntelliCare

Arm Description

TAU will be the treatment that is provided through the Rush Collaborative Care program as part of their service

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.

Outcomes

Primary Outcome Measures

Depression
Patient Health Questionnaire-9 (PHQ-9) assessment for depression
Number of assessments
Number of Patient Health Questionnaire (PHQ-9) assessments acquired in the EHR

Secondary Outcome Measures

First to last assessment
Time from first to last PHQ-9

Full Information

First Posted
July 27, 2020
Last Updated
November 22, 2021
Sponsor
Adaptive Health, Inc
Collaborators
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04499729
Brief Title
Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation
Official Title
Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
The recruitment site (Rush University Medical Center Collaborative Care Program) redefined their service objectives such that IntelliCare was no longer a good fit.
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adaptive Health, Inc
Collaborators
Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will utilize a pragmatic, system-wide rollout quality improvement evaluation design. Data from patients in the Rush Collaborative Care service will be used beginning Dec 1, 2019. The first care manager will begin offering IntelliCare as part of the collaborative care service in September, 2020, and one additional care manager will begin offering IntelliCare to patients every 3 months
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
318 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
TAU will be the treatment that is provided through the Rush Collaborative Care program as part of their service
Arm Title
IntelliCare
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
IntelliCare
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual (TAU)
Intervention Description
Treatment as usual in the Rush Collaborative Care service
Primary Outcome Measure Information:
Title
Depression
Description
Patient Health Questionnaire-9 (PHQ-9) assessment for depression
Time Frame
Up to 20 Months
Title
Number of assessments
Description
Number of Patient Health Questionnaire (PHQ-9) assessments acquired in the EHR
Time Frame
Up to 20 Months
Secondary Outcome Measure Information:
Title
First to last assessment
Description
Time from first to last PHQ-9
Time Frame
Up to 20 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Enrolled in Rush Collaborative Care service Owns a personal smartphone Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn MacIver
Organizational Affiliation
Adaptive Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
There is not current plan to share IPD outside the research team.

Learn more about this trial

Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation

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