Effective Date: 5/28/2014 Version: 2.0 (Revised: 10/12/2015) Approval By: CCC Clinical Delivery Steering Planned Review Date: (04/47/2017)
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1 Protocol Title: Depression & Generalized Anxiety Disorder Effective Date: 5/28/2014 Version: 2.0 (Revised: 10/12/2015) Approval By: CCC Clinical Delivery Steering Planned Review Date: (04/47/2017) Group 1 Purpose & Objective The purpose is to identify, screen, and treat individuals in the CCC population with depression and generalized anxiety. This protocol provides evidence-based care recommendations in the screening and treatment of patients with Depression and/or Generalized Anxiety Disorder in the primary care setting. 2 Scope of Protocol 2.1 Target Population This protocol was derived from clinical guidelines for individuals in the CCC population diagnosed with Depression and/or Generalized Anxiety Disorder, 18 years of age or older. 2.2 Target Users This protocol is developed for use in primary care settings. 2.3 Excluded Topics This protocol was not designed for use with individuals diagnosed with Depression and/or Generalized Anxiety Disorder under the care of a primary Behavioral Health Provider/Prescriber. 2.4 Related Guidelines Gilbody S, Bower P, Fletcher J, et al. Collaborative Care for Depression: A Cumulative Meta-analysis and Review of Longer-term Outcomes. Arch Intern Med. 2006; 166: Rush, A. J. The Impact of Nonclinical Factors on Care Use For Patients with Depression: A STAR*D Report. CNS neuroscience & therapeutics. Hegel M, et al. Problem-Solving Treatment for Primary Care: A Treatment Manual for Project IMPACT. Dartmouth University
2 3 Protocol Development & Review Process Protocol Development & Review Process This protocol originated in the CCC Clinical Protocol Subcommittee, led by a Psychiatrist specializing in behavioral health. A group of clinical staff met and converged on the items in this document via a Rapid Design Session. In this session, a facilitator guided the group through the process to extract evidence-based elements to adequately care for the CCC population impacted by Depression and/or Generalized Anxiety Disorder. The above depiction describes the approval and subsequent review process for this protocol. 2
3 Group Name Approval Date CCC Depression Protocol Subcommittee 2/10/2014 (10/12/2015) CCC Clinical Protocols Workgroup 4/23/2014 (10/12/2015) CCC Clinical Delivery System Steering Group 10/28/2015 (12/2015; 01/2016 EV) (4/47/2016) CCC Advisory Committee 5/27/2014 CCC Board of Directors 5/13/ Screening Criteria & Tools All CCC patients who are not currently being treated for depression by a behavioral health provider will be screened at each provider visit using the PHQ-2 question set. For those who screen positive on the PHQ-2, advanced screening is recommended using the following table. 4.1 Initial Screening & Diagnosis Screening & Tool General Guidance Purpose for Screen Level of Screening Tools Use Criteria Frequency Practitioner Level Depression General PHQ-2 During V/S Every Visit Medical Assistant Depression Advanced Modified PHQ-9 PHQ-2 (+), Newly Dx patients, Chronic Disease Patients When indicated Care Manager, RN, LCSW Suicidial Ideation Advanced Suicide/Psychosis Assessment Modified PHQ-9 (+) When indicated Primary Care Physician GAD General GAD-2 All patients Annually, New Dx (Asthma, COPD, any chronic pulmonary disease) Quarterly, Post follow-up from inpatient Medical Assistant GAD Advanced GAD-7 GAD-2 (+) When indicated Care Manager, RN, LCSW 4.2 General and Advanced Screening Algorithms The following algorithms are applicable to patients that have not been previously diagnosed with depression. 3
4 Depression Screening Algorithm *PCP Reviews treatment options related to score range & activates appropriate treatment 4
5 Generalized Anxiety Disorder Screening Algorithm *PCP Reviews treatment options related to score range & activates appropriate treatment 5
6 4.3 Treatment Options PCP Score-Based Treatment Options Modified PHQ-9 Score 0 to 4 Depression Category Late Onset of Depressive Symptoms 5 to 9 Mild Depression PCP & Behaviorist Tx Options Prevention & Education Medication, MNT, Exercise, Psychotherapy, Education PCP Manages with Behavioral Health Professional No Yes 10 to 14 Moderate Depression Medication and/or Psychotherapy, (Add if applicable MNT, Exercise) Yes 15 to 19 Moderately Severe Depression Medication +/- Psychotherapy, IOP, (Add if applicable MNT, Exercise) Yes 20 to 27 Severe Depression Medication +/- Psychotherapy, IOP, or Partial Hospital Program Yes 6
7 5 Impact Model Based Options When considering treatment of patients, the Provider should discuss treatment options with the patient for the best outcomes. Some of the available treatment options include: Medication Therapy Psychotherapy Peer Support Medical Nutrition Therapy (MNT) Exercise Outpatient Psychosocial Rehabilitation Specialized Mental Health Services (Intensive Outpatient Psychotherapy) 7
8 5.1 Depression Medication Therapy Depression Medication Chart for Primary Care Prescriber Class SSRI SNRI Other Antidepressant Medication Citalopram Escitalopram Fluoxetine Paroxetine Sertraline Duloxetine Venlafaxine Bupropion Mirtazapine Starting Dose (SD) Maximum Dose (MD) SD-20mg MD-40mg SD-10mg MD-20mg SD-20mg MD-80mg SD-20mg MD-50mg SD-50mg MD-200mg SD-30mg MD-60mg SD mg (Target mg) MD-300mg SD-150mg (Target 300mg) MD-450mg SD-15mg MD-45mg Augmentation/ Combination Options Bupropion, Buspirone, Cognitive Therapy, Mirtazapine Buspirone, Cognitive Therapy, Mirtazapine, SNRI, SSRI Buspirone, Bupropion, Cognitive Therapy, SNRI, SSRI Time to reach maximum titrated dose 4 to 6 weeks 4 to 6 weeks 4 to 6 weeks Anxioltyic/ Augmentation Agent Buspirone SD-7.5mg BID MD-30mg BID N/A 4 to 6 weeks May consider any SSRI as initial treatment (Escitalopram has the least drug interactions) Patients should return for follow-up within a week of starting level 1 and reassessed every 3 weeks (mid-treatment) via Modified PHQ-9 and Lethality Screen to determine treatment effectiveness. Patients should be titrated up to the maximum dose over a 6 week period. Please see the Supplemental Medication Therapy Instructions for guidance on how to use the Medication Therapy Algorithm 8
9 5.2 Supplemental Medication Therapy Instructions 9
10 5.3 Generalized Anxiety Disorder Medication Therapy Anxiety Medication Chart for Primary Care Prescriber Class SSRI SNRI Medication Citalopram Escitalopram Fluoxetine Paroxetine Sertraline Duloxetine Venlafaxine Supplemental Medication Therapy Instructions: Starting Dose (SD) Maximum Dose (MD) SD-10mg MD-40mg SD-5mg MD-20mg SD-10mg MD-80mg SD-10mg MD-50mg SD-25mg MD-200mg SD-20mg MD-60mg SD-37.5mg (Target mg) MD-300mg Augmentation/ Combination Options Bupropion, Buspirone, Cognitive Therapy, Mirtazapine Time to reach maximum titrated dose 4 to 6 weeks Anxioltyic/ SD-7.5mg BID Buspirone N/A 4 to 6 weeks Augmentation Agent MD-30mg BID May consider any SSRI as initial treatment (Escitalopram has the least drug interactions) Patients should return for follow-up within a week of starting level 1 and reassessed every 3 weeks (mid-treatment) via Level 1: Initial Treatment: Buspirone, SSRI, SNRI Consider counseling at any stage of treatment Level 2: Switch to (treatment different from Level 1): Buspirone, SNRI, SSRI Or augment with: Buspirone Consider referral to Behavioral Health Prescriber after failure of 2 trials of maximally dosed antidepressants utilized for at least 4 weeks on maximum dose 10
11 Notes: For GAD For SSRI s (level 1), & SNRI s (level 2) start with lower doses and slow on tapering; May augment with Benzos while waiting for SSRI/Venlafaxine ER to be effective o Patient s should NOT remain on Benzo s long-term After level 2 treatment failure refer to Behavioral Health Prescriber 5.4 Generalized Anxiety Disorder Psychotherapy Methods 1. Mindful Based Stress Reduction(MBSR), 2. Cognitive Behaviorial Therapy (CBT), 3. Dialectical Behaviorial Therapy (DBT), 4. Solution Focused Therapy, 5. Behavorial Activation Therapy, 6. Cognitive Processing Therapy, 7. Prolonged Exposure to Therapy Attention: These methods should only be performed by individuals who are trained and/or licensed to do so. 11
12 5.5 Standing Orders Standing orders Standing Order Frequency Purpose Care/Case Management Follow up Post PCP appointment Ensure adherence to treatment protocol Provider monitoring of B/P for Patients prescribed Venlafaxine Each subsequent visit Venlafaxine may increase B/P Provider monitoring of Weight for Patients prescribed Mirtazapine Each subsequent visit Mirtazapine may cause weight gain Providers should conduct psychosis screen for all Modified PHQ-9 (+) screens When applicable To ensure suicidal ideation is screened and treated Providers should conduct lethality screen for all Modified PHQ-9 (+) screens When applicable To ensure suicidal ideation is screened and treated 12
13 5.6 Treatment Monitoring Monitoring Reassessment/ Monitoring Tool 1 week after beginning level 1 treatment Check up for medication toleration Every 3 weeks & before titration Modified PHQ-9 Before moving to a higher drug treatment level Modified PHQ-9 13
14 5.7 Referrals Referrals Patients Criteria When to Refer To Whom Homicidal/ Suicidal Lethality Screen (+) Immediately Behavioral Health Professional, Mental Health Officer Psychotic Symptoms (+) Within 24hrs (may use Telepsychiatry) Primary Care Provider Level 2A Treatment Failure Seen within 2 weeks of Treatment Failure PHQ-9 (+) after level 2 treatment Behavioral Health Prescriber Behavioral Health Professional will use their discretion as to if a higher level of care is needed. 14
15 6 Protocol Development Team Name Mark Hernandez MD *Chief Medical Officer Kari Wolf MD *Clinical Champion James Baker MD Phillip Lai PharmD Smitha Murthy MD Lloyd Berg PhD Curk McFall, MSN, RN Veronica Buitron-Camacho, MSN, RN Affiliation Community Care Collaborative (CCC) & Seton Healthcare Family Interim Chief Medical Officer, CommUnityCare Seton Healthcare Family Austin Travis County Integral Care CommUnityCare Seton Healthcare Family Seton Healthcare Family Community Care Collaborative Community Care Collaborative 7 References Gilbody S, Bower P, Fletcher J, et al. Collaborative Care for Depression: A Cumulative Meta-analysis and Review of Longer-term Outcomes. Arch Intern Med. 2006; 166: Rush, A. J. The Impact of Nonclinical Factors on Care Use For Patients with Depression: A STAR*D Report. CNS Neuroscience & Therapeutics. Hegel M, et al. Problem-Solving Treatment for Primary Care: A Treatment Manual for Project IMPACT. Dartmouth University
16 8 Glossary of Abbreviations Abbreviation Term B/P Blood Pressure Benzo Benzodiazepine BH Behavioral Health CBT Cognitive Behavioral Therapy CCC Community Care Collaborative DBT Dialectical Behavioral Therapy Dx Diagnosis EHR Electronic Health Record ER Extended Release GAD Generalized Anxiety Disorder GAD-2 Generalized Anxiety Disorder - 2 GAD-7 Generalized Anxiety Disorder 7 Hrs Hours IOP Intensive Outpatient LCSW Licensed Clinical Social Worker MBSR Mindfulness-Based Stress Reduction MD Maximum Dose MNT Medical Nutrition Therapy PCP Primary Care Provider PHQ-2 Patient Health Questionnaire - 2 PHQ-9 Patient Health Questionnaire - 9 RN Registered Nurse SD Starting Dose SNRI Serotonin-Norepinephrine Reuptake Inhibitor SR Sustained Release SSRI Selective Serotonin Reuptake Inhibitor Tx Treatment V/S Vital Signs XL Extended Release 16
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