Stepped Enhancement of PTSD Services Using Primary Care (STEPS UP): A Randomized Effectiveness Trial
NCT ID: NCT01492348
Last Updated: 2017-03-14
Study Results
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Basic Information
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COMPLETED
NA
666 participants
INTERVENTIONAL
2012-01-31
2016-02-29
Brief Summary
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Primary Hypothesis 1: Active duty primary care patients with PTSD, depression, or both who are randomly assigned to STEPS UP will report significantly greater reductions in PTSD and depression symptom severity compared to participants assigned to OUC over 12-months of follow-up.
Hypothesis 2: Active duty primary care patients with either PTSD, depression, or both who are randomly assigned to STEPS UP will report significantly greater improvements in somatic symptom severity, alcohol use, mental health functioning, and work functioning compared to participants assigned to OUC over 12-months of follow-up.
Hypothesis 3: The STEPS UP program will be both more costly and more effective compared to OUC over the 12-months of follow-up, and will have a favorable cost-effectiveness ratio in terms of dollars per quality adjusted life years saved.
Hypothesis 4: Active duty primary care patients participating in STEPS UP, their clinicians, care managers, and family members will report that STEPS UP is acceptable, effective, satisfying, and appropriate PTSD and depression care.
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Detailed Description
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The purpose of the STEPS UP (STepped Enhancement of PTSD Services Using Primary Care) trial is to compare centralized telephonic care management with preference-based stepped PTSD and depression care to optimized usual care. We hypothesize that the STEPS UP intervention will lead to improvements in (1) PTSD and depression symptom severity (primary hypothesis); (2) somatic symptom severity, alcohol use, mental health functioning, work functioning; (3) costs and cost-effectiveness. We further hypothesize that qualitative data obtained from interviews will show that (4) patients, their family members, and participating clinicians find the STEPS-UP intervention to be an acceptable, effective, and satisfying approach to deliver and receive PTSD and depression care.
STEPS-UP is a six-site, two-parallel arm (N = 666) randomized controlled effectiveness trial with 3-month, 6-month, and 12-month follow-up comparing centralized telephonic stepped-care management to optimized usual PTSD and depression care. In addition to the existing PTSD and depression treatment options, STEPS UP includes web-based cognitive behavioral self-management, telephone cognitive-behavioral therapy, continuous RN nurse care management, and computer-automated care management support. Both arms can refer patients for mental health specialty care as needed, preferred and available. The study uses sites currently running RESPECT-Mil, the existing military primary care-mental health services practice network, to access site health care leaders and potential study participants at the 6 study sites.
If effective, we expect that STEPS UP will increase the percentage of military personnel with unmet PTSD- and depression-related health care needs who get timely, effective, and efficient PTSD and depression care. Our real-world primary care effectiveness emphasis will prevent the Institute of Medicine's so called "15 year science to service gap." If successful, STEPS UP could roll out immediately, reinforcing and facilitating pathways to PTSD and depression recovery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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STEPS UP Intervention
STEPS UP is a centrally assisted stepped collaborative telecare management program within primary care. The STEPS UP intervention added to Optimized Usual Care (PCMH-BH; formerly RESPECT-Mil) in 4 ways: (1) care management enhancements; (2) stepped psychosocial treatment options (web, phone, in person); (3) electronic symptom registry for measurement-based treatment planning (symptoms are measured at regular intervals and care is intensified for patients with recurrent or persistent PTSD and/or depressive) and for telecare manager caseload and site performance monitoring; and (4) routine assisted review of patient, telecare manager, and site performance by a central psychiatrist and psychologist.
STEPS UP
The STEPS UP intervention enhances RESPECT-Mil in several ways:
1. Adds care manager training in motivational enhancement, problem solving, and behavioral activation strategies to improve patient engagement.
2. Adds preference-based stepped care (i.e., order of steps determined by symptom severity, patient preference, \& primary care recommendation) to existing options of pharmacotherapy that includes web-based self-management programs; flexible, modularized telephone-delivered CBT; and individual face to face psychotherapy by specialist.
3. Adds option for centralized, telephone-based care management to improve fidelity of intervention delivery, continuity of care, and access to care during off-hours.
4. Adds a centralized care team using an electronic symptom registry to provide staffing to care managers, track patients longitudinally, develop stepped-based treatment recommendations, and monitor intervention components.
Optimized Usual Care (OUC)
Service members randomized to Optimized Usual Care (OUC) will get usual treatment at the site. OUC is RESPECT-Mil, a voluntary, primary care-based implementation program where, with the assistance and collaboration of a psychiatrist and an on-site nurse-level care manager, service members with symptoms of PTSD and depression are screened, tracked, and treated within the primary care system.
OUC
Service members randomized to Optimized Usual Care (OUC) will get usual treatment at the site. OUC is RESPECT-Mil, a voluntary, primary care-based implementation program based on the "three-component model" where, with the assistance and collaboration of a psychiatrist and an on-site nurse-level care manager, service members with symptoms of PTSD and depression are screened, tracked, and treated within the primary care system. Components of the RESPECT-Mil program include (1) equipping and training primary care clinics to screen each visit and use symptom severity tools for diagnosis and assessment; (2) using nurse care managers to assist patients and primary care clinicians; and (3) increasing access to a mental health specialist, often using a clinic specialist.
Interventions
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STEPS UP
The STEPS UP intervention enhances RESPECT-Mil in several ways:
1. Adds care manager training in motivational enhancement, problem solving, and behavioral activation strategies to improve patient engagement.
2. Adds preference-based stepped care (i.e., order of steps determined by symptom severity, patient preference, \& primary care recommendation) to existing options of pharmacotherapy that includes web-based self-management programs; flexible, modularized telephone-delivered CBT; and individual face to face psychotherapy by specialist.
3. Adds option for centralized, telephone-based care management to improve fidelity of intervention delivery, continuity of care, and access to care during off-hours.
4. Adds a centralized care team using an electronic symptom registry to provide staffing to care managers, track patients longitudinally, develop stepped-based treatment recommendations, and monitor intervention components.
OUC
Service members randomized to Optimized Usual Care (OUC) will get usual treatment at the site. OUC is RESPECT-Mil, a voluntary, primary care-based implementation program based on the "three-component model" where, with the assistance and collaboration of a psychiatrist and an on-site nurse-level care manager, service members with symptoms of PTSD and depression are screened, tracked, and treated within the primary care system. Components of the RESPECT-Mil program include (1) equipping and training primary care clinics to screen each visit and use symptom severity tools for diagnosis and assessment; (2) using nurse care managers to assist patients and primary care clinicians; and (3) increasing access to a mental health specialist, often using a clinic specialist.
Eligibility Criteria
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Inclusion Criteria
* Positive PTSD screen (2 or more yes responses on PC-PTSD), per routine primary care screening.
* DSM-IV-TR criteria for A) PTSD using the PCL-C (i.e.., a "moderate" or greater severity level on 1 re-experiencing, 3 avoidance, and 2 hyperarousal symptoms) and/or B) Depression, using the PHQ-9 (i.e., endorsement of at least 5 of the 9 symptoms experienced "more than half the days" and at least one of those symptoms must include either "little interest or pleasure in doing things" or "feeling down, depressed or hopeless")
* Report of routine computer, Internet, and e-mail access
* Capacity to consent to participation and provide research informed consent using local IRB-approved form
Exclusion Criteria
* Acute psychosis, psychotic episode, or psychotic disorder diagnosis by history within the past 2 years
* Bipolar I disorder by history or medical record review within last 2 years.
* Active substance dependence disorder in the past year by history within the past 12 months.
* Active suicidal ideation within the past 2 months by history.
* Patients on psychoactive medication, unless that medication dosing and administration has been stable and regular for at least 1 month.
* Acute or unstable physical illness.
* Anticipated deployment, demobilization, or separation during the next six months.
* Personnel who work in participating clinics.
18 Years
65 Years
ALL
No
Sponsors
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United States Department of Defense
FED
RAND
OTHER
RTI International
OTHER
University of Washington
OTHER
VA Boston Healthcare System
FED
Henry M. Jackson Foundation for the Advancement of Military Medicine
OTHER
Responsible Party
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Principal Investigators
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Robert M Bray, PhD
Role: PRINCIPAL_INVESTIGATOR
RTI International
Lisa Jaycox, PhD
Role: PRINCIPAL_INVESTIGATOR
RAND
Bradley E Belsher, PhD
Role: PRINCIPAL_INVESTIGATOR
United States Department of Defense
Locations
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Evans Army Community Hospital
Fort Carson, Colorado, United States
Winn Army Community Hospital
Fort Stewart, Georgia, United States
Blanchfield Army Community Hospital
Fort Campbell, Kentucky, United States
Womack Army Medical Center
Fort Bragg, North Carolina, United States
William Beaumont Army Medical Center
Fort Bliss, Texas, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Countries
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References
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Engel CC. Improving primary care for military personnel and veterans with posttraumatic stress disorder--the road ahead. Gen Hosp Psychiatry. 2005 May-Jun;27(3):158-60. doi: 10.1016/j.genhosppsych.2005.01.001. No abstract available.
Engel CC, Hyams KC, Scott K. Managing future Gulf War Syndromes: international lessons and new models of care. Philos Trans R Soc Lond B Biol Sci. 2006 Apr 29;361(1468):707-20. doi: 10.1098/rstb.2006.1829.
Spira, J.L., Pyne, J.M., & Wiederhold, B. (2006). Chapter 10: Experiential Methods in the Treatment of Combat PTSD. In Figley, C.R. and Nash, W.P. In For Those Who Bore the Battle: Combat Stress Injury Theory, Research, and Management. For the Routledge Psychosocial Stress Book Series
Tanielian, T. & Jaycox, L., Eds. "Invisible Wounds of War: Psychological and Cognitive Injuries, Their Consequences, and Services to Assist Recovery." RAND/MG-720- CCF (available at http://veterans.rand.org)
Jaycox LH, Stein BD, Kataoka SH, Wong M, Fink A, Escudero P, Zaragoza C. Violence exposure, posttraumatic stress disorder, and depressive symptoms among recent immigrant schoolchildren. J Am Acad Child Adolesc Psychiatry. 2002 Sep;41(9):1104-10. doi: 10.1097/00004583-200209000-00011.
Lisa S. Meredith, Terri L. Tanielian, Michael D. Greenberg, Ana Suárez, Elizabeth Eiseman. "Expanding Access to Mental Health Counselors: Evaluation of the Tricare Demonstration" RAND/DRR-3458-1-OSD (available at www.rand.org)
Stein BD, Tanielian TL, Ryan GW, Rhodes HJ, Young SD, Blanchard JC. A bitter pill to swallow: nonadherence with prophylactic antibiotics during the anthrax attacks and the role of private physicians. Biosecur Bioterror. 2004;2(3):175-85. doi: 10.1089/bsp.2004.2.175.
Meredith LS, Mendel P, Pearson M, Wu SY, Joyce G, Straus JB, Ryan G, Keeler E, Unutzer J. Implementation and maintenance of quality improvement for treating depression in primary care. Psychiatr Serv. 2006 Jan;57(1):48-55. doi: 10.1176/appi.ps.57.1.48.
Litz BT, Engel CC, Bryant RA, Papa A. A randomized, controlled proof-of-concept trial of an Internet-based, therapist-assisted self-management treatment for posttraumatic stress disorder. Am J Psychiatry. 2007 Nov;164(11):1676-83. doi: 10.1176/appi.ajp.2007.06122057.
Williams JW Jr, Gerrity M, Holsinger T, Dobscha S, Gaynes B, Dietrich A. Systematic review of multifaceted interventions to improve depression care. Gen Hosp Psychiatry. 2007 Mar-Apr;29(2):91-116. doi: 10.1016/j.genhosppsych.2006.12.003.
Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. doi: 10.1056/NEJMoa040603.
Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32. doi: 10.1001/jama.295.9.1023.
Engel CC, Oxman T, Yamamoto C, Gould D, Barry S, Stewart P, Kroenke K, Williams JW Jr, Dietrich AJ. RESPECT-Mil: feasibility of a systems-level collaborative care approach to depression and post-traumatic stress disorder in military primary care. Mil Med. 2008 Oct;173(10):935-40. doi: 10.7205/milmed.173.10.935.
Engel CC, Bray RM, Jaycox LH, Freed MC, Zatzick D, Lane ME, Brambilla D, Rae Olmsted K, Vandermaas-Peeler R, Litz B, Tanielian T, Belsher BE, Evatt DP, Novak LA, Unutzer J, Katon WJ. Implementing collaborative primary care for depression and posttraumatic stress disorder: design and sample for a randomized trial in the U.S. military health system. Contemp Clin Trials. 2014 Nov;39(2):310-9. doi: 10.1016/j.cct.2014.10.002. Epub 2014 Oct 12.
Belsher BE, Jaycox LH, Freed MC, Evatt DP, Liu X, Novak LA, Zatzick D, Bray RM, Engel CC. Mental Health Utilization Patterns During a Stepped, Collaborative Care Effectiveness Trial for PTSD and Depression in the Military Health System. Med Care. 2016 Jul;54(7):706-13. doi: 10.1097/MLR.0000000000000545.
Engel CC, Jaycox LH, Freed MC, Bray RM, Brambilla D, Zatzick D, Litz B, Tanielian T, Novak LA, Lane ME, Belsher BE, Olmsted KL, Evatt DP, Vandermaas-Peeler R, Unutzer J, Katon WJ. Centrally Assisted Collaborative Telecare for Posttraumatic Stress Disorder and Depression Among Military Personnel Attending Primary Care: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jul 1;176(7):948-56. doi: 10.1001/jamainternmed.2016.2402.
Tanielian T, Woldetsadik MA, Jaycox LH, Batka C, Moen S, Farmer C, Engel CC. Barriers to Engaging Service Members in Mental Health Care Within the U.S. Military Health System. Psychiatr Serv. 2016 Jul 1;67(7):718-27. doi: 10.1176/appi.ps.201500237. Epub 2016 Mar 15.
Batka C, Tanielian T, Woldetsadik MA, Farmer C, Jaycox LH. Stakeholder Experiences in a Stepped Collaborative Care Study Within U.S. Army Clinics. Psychosomatics. 2016 Nov-Dec;57(6):586-597. doi: 10.1016/j.psym.2016.05.008. Epub 2016 May 31.
Bray RM, Engel CC, Williams J, Jaycox LH, Lane ME, Morgan JK, Unutzer J. Posttraumatic Stress Disorder in U.S. Military Primary Care: Trajectories and Predictors of One-Year Prognosis. J Trauma Stress. 2016 Aug;29(4):340-8. doi: 10.1002/jts.22119. Epub 2016 Jul 22.
Belsher BE, Evatt DP, Liu X, Freed MC, Engel CC, Beech EH, Jaycox LH. Collaborative Care for Depression and Posttraumatic Stress Disorder: Evaluation of Collaborative Care Fidelity on Symptom Trajectories and Outcomes. J Gen Intern Med. 2018 Jul;33(7):1124-1130. doi: 10.1007/s11606-018-4451-5. Epub 2018 Apr 27.
Other Identifiers
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W81XWH-09-2-0077
Identifier Type: -
Identifier Source: org_study_id
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