- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04839718
Evaluation of the Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Program (ADAPT)
February 28, 2023 updated by: Kaiser Permanente
Evaluating the Implementation and Outcomes of the Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Collaborative Care Program in A Large, Integrated Healthcare System: A Mixed Methods Observational Study Protocol
Depression and anxiety are increasingly common conditions for which primary care providers (PCPs) serve as the initial healthcare contact for most patients.
Comorbid depression and anxiety result in higher costs, and treatment as usual, which is referrals to specialty psychiatric care, often contribute to delays in care.
Collaborative psychiatric care is an evidence-based strategy to increase mental healthcare access while reducing costs.
ADAPT is a novel collaborative care model.
By using technology-driven appointments with providers, ADAPT increases access to mental healthcare, and reduces member wait times.
This mixed methods study will assess implementation measures of the ADAPT program and the components of ADAPT related to patient mental health improvement compared to specialty mental health care.
The hypothesis is that: ADAPT program will have good program reach and efficacy.
We will examine program implementation and maintenance.
Further, the study looks to uncover member and program characteristics that are associated with depression and anxiety remission and care utilization.
Study Overview
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Oakland, California, United States, 94612
- Kaiser Permanente Northern California Division of Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Kaiser Permanente Northern California adult members who screen positive for depression or anxiety in primary care and are referred to treatment.
Description
Inclusion Criteria:
- Adult Outcomes Questionnaire (AOQ) score between 10-30
- English-Speaking
Exclusion Criteria:
- High risk for suicide defined by answer to question 9 on PHQ-9 of 1 or more
- Diagnosis of bipolar disorder
- Diagnosis of a psychotic disorder
- Dementia diagnosis
- Active substance use disorder diagnosis
- Current hospice
- Current home-based palliative care
- Residing in a skilled nursing facility
- Residing in an assisted living facility
- Non-Kaiser Permanente Member
- Established psychiatric care outside of Kaiser Permanente
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control
Patients receiving referral to specialty mental healthcare
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ADAPT
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The Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Program is a novel collaborative psychiatric care model that is designed to unburden PCPs and psychiatrists, increase access to quality specialty mental healthcare for Kaiser Permanente members, and improve patient depression and anxiety treatment outcomes by utilizing technology-driven appointments.
This program uses principles of collaborative care, including patient-centered care, population-based care, evidence-based care, measurement-based treatment to target, and accountable care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient reach
Time Frame: through study completion, 2 years
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Examine and compare patients eligible and enrolled in ADAPT versus those eligible but not enrolled in ADAPT
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through study completion, 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Member characteristics associated with depression remission
Time Frame: baseline, 3 and 6 months
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Clinical variables important to predicting intervention response: Patient demographics (age, sex, race/ethnicity, socioeconomic status), behavioral characteristics (exercise, sleep), and other individual characteristics (comorbidities, adverse childhood experiences, social supports, resilience).
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baseline, 3 and 6 months
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Member characteristics associated with anxiety remission
Time Frame: baseline, 3 and 6 months
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Clinical variables important to predicting intervention response: Patient demographics (age, sex, race/ethnicity, socioeconomic status), behavioral characteristics (exercise, sleep), and other individual characteristics (comorbidities, adverse childhood experiences, social supports, resilience).
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baseline, 3 and 6 months
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Efficacy: Patient therapy engagement
Time Frame: baseline, 3 and 6 months
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number of therapy contacts (individual, group and combined)
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baseline, 3 and 6 months
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Efficacy: Patient medication provider engagement
Time Frame: baseline, 3 and 6 months
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number of clinical pharmacy contacts
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baseline, 3 and 6 months
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Efficacy: Patient medication engagement
Time Frame: baseline, 3 and 6 months
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medication length of treatment
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baseline, 3 and 6 months
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Efficacy: Patient psychiatry engagement
Time Frame: baseline, 3 and 6 months
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number of contact with psychiatrist
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baseline, 3 and 6 months
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Efficacy: Patient time to care
Time Frame: baseline, 3 and 6 months
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average time from ADAPT referral to first appointment with therapist or pharmacist
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baseline, 3 and 6 months
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Efficacy: Depression outcomes
Time Frame: baseline, 3 and 6 months
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Examine if patients enrolled in ADAPT demonstrate non-inferior depression outcomes defined by change in the patient health questionnaire (PHQ-9) score compared to treatment as usual.
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baseline, 3 and 6 months
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Efficacy: Anxiety outcomes
Time Frame: baseline, 3 and 6 months
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Examine if patients enrolled in ADAPT demonstrate non-inferior anxiety outcomes defined by generalized anxiety disorder (GAD-2) score compared to treatment as usual.
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baseline, 3 and 6 months
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Efficacy: Time to clinical improvement
Time Frame: baseline, 3 and 6 months
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Compare time to clinical improvement as defined by change in Adult Outcomes Questionnaire (AOQ score) from baseline to 3, and 6 months for members in ADAPT compared to treatment as usual.
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baseline, 3 and 6 months
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Implementation: measurement-based care
Time Frame: through study completion, 2 years
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Examine provider use of measurement-based care
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through study completion, 2 years
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Implementation: Diagnosis
Time Frame: through study completion, 2 years
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Examine provider use of a specific depression or anxiety diagnosis
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through study completion, 2 years
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Maintenance: Measurement-based care
Time Frame: through study completion, 2 years
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Examine provider use of measurement-based care over time
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through study completion, 2 years
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Maintenance: Diagnosis
Time Frame: through study completion, 2 years
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Examine provider use of a specific depression or anxiety diagnosis over time
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through study completion, 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kathryn K Erickson-Ridout, MD PhD, Kaiser Permanente
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
March 29, 2021
First Submitted That Met QC Criteria
April 7, 2021
First Posted (Actual)
April 9, 2021
Study Record Updates
Last Update Posted (Actual)
March 2, 2023
Last Update Submitted That Met QC Criteria
February 28, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1421043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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