Evaluation of the Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Program

Depression Clinical Trial

— ADAPT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04839718
• Other study ID #: 1421043
• Status: Withdrawn
• Start date: April 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

Behavioral:
• ADAPT
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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Northern California Division of Research	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reach	Examine and compare patients eligible and enrolled in ADAPT versus those eligible but not enrolled in ADAPT	through study completion, 2 years
Secondary	Member characteristics associated with depression remission	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).	baseline, 3 and 6 months
Secondary	Member characteristics associated with anxiety remission	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).	baseline, 3 and 6 months
Secondary	Efficacy: Patient therapy engagement	number of therapy contacts (individual, group and combined)	baseline, 3 and 6 months
Secondary	Efficacy: Patient medication provider engagement	number of clinical pharmacy contacts	baseline, 3 and 6 months
Secondary	Efficacy: Patient medication engagement	medication length of treatment	baseline, 3 and 6 months
Secondary	Efficacy: Patient psychiatry engagement	number of contact with psychiatrist	baseline, 3 and 6 months
Secondary	Efficacy: Patient time to care	average time from ADAPT referral to first appointment with therapist or pharmacist	baseline, 3 and 6 months
Secondary	Efficacy: Depression outcomes	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.	baseline, 3 and 6 months
Secondary	Efficacy: Anxiety outcomes	Examine if patients enrolled in ADAPT demonstrate non-inferior anxiety outcomes defined by generalized anxiety disorder (GAD-2) score compared to treatment as usual.	baseline, 3 and 6 months
Secondary	Efficacy: Time to clinical improvement	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.	baseline, 3 and 6 months
Secondary	Implementation: measurement-based care	Examine provider use of measurement-based care	through study completion, 2 years
Secondary	Implementation: Diagnosis	Examine provider use of a specific depression or anxiety diagnosis	through study completion, 2 years
Secondary	Maintenance: Measurement-based care	Examine provider use of measurement-based care over time	through study completion, 2 years
Secondary	Maintenance: Diagnosis	Examine provider use of a specific depression or anxiety diagnosis over time	through study completion, 2 years