Collaborative Care for Treatment of Depression and Anxiety

NCT06556589 | Recruiting

• 2 other identifiers: 2066851RNG212361
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Collaborative Care; Depression; Anxiety; Evaluation

Outcome Measures

Primary Outcomes (2)

• Patient Health Questionnaire 9-item (PHQ-9) score

  Change in Patient Health Questionnaire 9-item (PHQ-9) scores before and after Collaborative Care intervention. The score ranges from 0 to 27, with lower numbers indicating improvement in depression symptoms.

  Baseline and up to 24 weeks

• Generalized Anxiety Disorder 7-item (GAD-7)

  Generalized Anxiety Disorder 7-item (GAD-7) questionnaire scores before and after Collaborative Care intervention. The score ranges from 0 to 21, with lower numbers indicating improvement in anxiety symptoms.

  Baseline and up to 24 weeks

Study Arms (2)

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.

Behavioral: Collaborative Care

No Collaborative Care offered

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

Interventions

Collaborative Care BEHAVIORAL

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

Collaborative Care offered

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with depression and/or anxiety.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Garfield Memorial Fund: collaborator

Study Sites (1)

Kaiser Permanente Colorado

Aurora, Colorado, 80011, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Arne Beck, PhD

CONTACT

720-989-5181; Arne.Beck@kp.org

Erica Morse, MA

CONTACT

720-978-5214; Erica.F.Morse@kp.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: August 16, 2024
• Study Start: March 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: March 31, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)