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Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation

Sponsor
Adaptive Health, Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT04499729
Collaborator
Rush University Medical Center (Other)
318
Enrollment
1
Location
2
Arms
17
Actual Duration (Months)
18.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: IntelliCare
  • Behavioral: Treatment as Usual (TAU)
 N/A

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 In September 2021, support for IntelliCare from the evaluation team will be withdrawn, to examine the sustainability of the IntelliCare Platform.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

Study Type:
Interventional
Actual Enrollment :
318 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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 monthsWe 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)
Primary Purpose:
Health Services Research
Official Title:
Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation
Actual Study Start Date :
Dec 1, 2019
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Depression [Up to 20 Months]

    Patient Health Questionnaire-9 (PHQ-9) assessment for depression

  2. Number of assessments [Up to 20 Months]

    Number of Patient Health Questionnaire (PHQ-9) assessments acquired in the EHR

Secondary Outcome Measures

  1. First to last assessment [Up to 20 Months]

    Time from first to last PHQ-9

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Enrolled in Rush Collaborative Care service

  • Owns a personal smartphone

Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rush University Medical Center Chicago Illinois United States 60612

Sponsors and Collaborators

  • Adaptive Health, Inc
  • Rush University Medical Center

Investigators

  • Principal Investigator: Carolyn MacIver, Adaptive Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adaptive Health, Inc
ClinicalTrials.gov Identifier:
NCT04499729
Other Study ID Numbers:
  • R44MH114725
First Posted:
Aug 5, 2020
Last Update Posted:
Dec 3, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Depression

Study Results

No Results Posted as of Dec 3, 2021