Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation

Depression Clinical Trial

Official title:

Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04499729
• Other study ID #: R44MH114725
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: November 2021
• Source: Adaptive Health, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 In September 2021, support for IntelliCare from the evaluation team will be withdrawn, to examine the sustainability of the IntelliCare Platform.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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 318
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Depression

Intervention

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.

Behavioral:
• Treatment as Usual (TAU)
Treatment as usual in the Rush Collaborative Care service

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Adaptive Health, Inc	Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	Patient Health Questionnaire-9 (PHQ-9) assessment for depression	Up to 20 Months
Primary	Number of assessments	Number of Patient Health Questionnaire (PHQ-9) assessments acquired in the EHR	Up to 20 Months
Secondary	First to last assessment	Time from first to last PHQ-9	Up to 20 Months