Recruiting

Collaborative Care

Sponsor:

Kaiser Permanente

Code:

NCT06556589

Conditions

Depression

Anxiety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Collaborative Care

Study Details

Brief summary:

The goal of this project is to evaluate the effectiveness of a collaborative care model for primary care patients at Kaiser Permanente Colorado (KPCO) with depression and/or anxiety. Collaborative care uses evidence-based short-term treatments delivered to patients over the phone. We will explore the use of cost-efficient automated processes for patient outreach and follow-up, such as care pools of patients and using patient portal messaging, risk-based results routing to providers, and electronic health record (EHR) tools for patient tracking and outcome assessment. Using a cluster randomized design, we will compare results between clinics that are offering collaborative care to those that are not.

Conditions

Depression

Anxiety

Study ID

NCT06556589

Start date

Mar 1, 2023

Status verified date

Aug, 2024

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Sep 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18+
  • Current membership and active on patient portal
  • Depression Diagnosis in the prior year
  • Overdue for PHQ9 Screening based on the following criteria:

  • High Risk: Last PHQ9 screener was completed greater than 4 months ago AND total Score is greater than or equal 10 or item 9 is greater than 0.
  • Low Risk: Last PHQ9 screener was completed greater than 12 months ago AND Last PHQ9 Total Score is less than 10 and item 9 is equal to 0.
  • Anxiety diagnoses in the prior year
  • Has a baseline GAD7 in the same prior year; score = 10+ (\*Note: Provider referrals could be GAD7 score of 7 or higher)
  • No Behavioral Health (BH) engagement in the prior year
  • Patient is not in a Skilled Nursing Facility or Hospice
  • Patient has no record of psychiatric hospitalization in the last year
  • Patient does not need an interpreter (i.e., English speaking)
  • Primary care location is one of the intervention clinics

Exclusion Criteria:

• Exclude individuals with any of the following diagnoses:

  • Psychosis
  • Dementia
  • Bipolar
  • Personality Disorders
  • Post Traumatic Stress Disorder (PTSD)
  • Obsessive Compulsive Disorder (OCD)
  • Panic Disorder
  • Cognitive Disorder

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Collaborative Care offered

Implement collaborative care in at least 2 clinic locations for patients with depression and/or anxiety using population-based outreach using electronic health record tools and provider referral, and tracking outcomes in the medical record.

No Collaborative Care offered

Provide care as usual for patients with depression and/or anxiety at all other KPCO clinics.

Interventions

Collaborative Care

Collaborative care components include patient-centered team care, population-based care, measurement-based treatment to target, evidence-based care, and accountable care.

Primary outcome measure

  • Patient Health Questionnaire 9-item (PHQ-9) score [ Time Frame: Baseline and up to 24 weeks ]
  • Generalized Anxiety Disorder 7-item (GAD-7) [ Time Frame: Baseline and up to 24 weeks ]

Central Contacts and Locations

Central contacts

Locations

Kaiser Permanente Colorado

Recruiting

Aurora, Colorado, United States, 80011

Contacts

More Information

Sponsor

Kaiser Permanente

Last update posted

Aug 16, 2024

Last verified

Aug, 2024

Keywords

  • Collaborative Care
  • Depression
  • Anxiety
  • Evaluation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2024-08-16.