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Item A Patient-Centered Nurse-Supported Primary care-based Collaborative Care Program to Treat Opioid Use Disorder and Depression: Design and Protocol for the MI-CARE Randomized Controlled Trial(Elsevier, 2023) DeBar, Lynn L.; Bushey, Michael A.; Kroenke, Kurt; Bobb, Jennifer F.; Schoenbaum, Michael; Thompson, Ella E.; Justice, Morgan; Zatzick, Douglas; Hamilton, Leah K.; McMullen, Carmit K.; Hallgren, Kevin A.; Benes, Lindsay L.; Forman, David P.; Caldeiro, Ryan M.; Brown, Ryan P.; Campbell, Noll L.; Anderson, Melissa L.; Son, Sungtaek; Haggstrom, David A.; Whiteside, Lauren; Schleyer, Titus K. L.; Bradley, Katharine A.; Psychiatry, School of MedicineBackground: Opioid use disorder (OUD) contributes to rising morbidity and mortality. Life-saving OUD treatments can be provided in primary care but most patients with OUD don't receive treatment. Comorbid depression and other conditions complicate OUD management, especially in primary care. The MI-CARE trial is a pragmatic randomized encouragement (Zelen) trial testing whether offering collaborative care (CC) to patients with OUD and clinically-significant depressive symptoms increases OUD medication treatment with buprenorphine and improves depression outcomes compared to usual care. Methods: Adult primary care patients with OUD and depressive symptoms (n ≥ 800) from two statewide health systems: Kaiser Permanente Washington and Indiana University Health are identified with computer algorithms from electronic Health record (EHR) data and automatically enrolled. A random sub-sample (50%) of eligible patients is offered the MI-CARE intervention: a 12-month nurse-driven CC intervention that includes motivational interviewing and behavioral activation. The remaining 50% of the study cohort comprise the usual care comparison group and is never contacted. The primary outcome is days of buprenorphine treatment provided during the intervention period. The powered secondary outcome is change in Patient Health Questionnaire (PHQ)-9 depression scores. Both outcomes are obtained from secondary electronic healthcare sources and compared in "intent-to-treat" analyses. Conclusion: MI-CARE addresses the need for rigorous encouragement trials to evaluate benefits of offering CC to generalizable samples of patients with OUD and mental health conditions identified from EHRs, as they would be in practice, and comparing outcomes to usual primary care. We describe the design and implementation of the trial, currently underway.Item Canons of Collaborative Care(Springer, 2022) Kroenke, Kurt; Cheville, Andrea; Medicine, School of MedicineItem Collaborative Care for Depression and Anxiety in the Bone Marrow Transplant Population: A Pilot Feasibility Study(Wiley, 2021) Copeland, Anureet C.; Tan, Xianming; Nash, Rebekah P.; Holmes, Emily G.; Markey, Janell; Shea, Thomas C.; Wood, William A.; Park, Eliza M.; Psychology, School of ScienceItem Depression treatment and diabetes risk: a 9-year follow-up study of the impact trial(2015) Khambaty, Tasneem; Stewart, Jesse C.; Hirsh, Adam T.; Mosher, Catherine E.; Callahan, Christopher M.Objectives: To examine the effect of a collaborative care program for late-life depression on risk of diabetes among depressed, older adults. Method: We conducted a 9-year follow-up study of 160 older, primary care patients with a depressive disorder but without diabetes enrolled at the Indiana sites of the Improving Mood-Promoting Access to Collaborative Treatment (IMPACT) trial. Results: Surprisingly, the rate of incident diabetes in the collaborative care group (22/80 = 27.5%) was twice the rate observed in the usual care group (11/80 = 13.7%). Cox proportional hazards models adjusted for randomization status (HR = 1.94, p = .076), demographic factors (HR = 1.94, p = .075), and additionally for diabetes risk factors (HR = 1.73, p = .157) indicated that the risk of incident diabetes did not differ between the collaborative care and usual care groups, with collaborative care patients remaining at a nonsignificant increased risk. Conclusions: Our novel findings suggest that depression may not be a casual risk factor for diabetes and that depression treatment may be insufficient to reduce the excess diabetes risk of depressed, older adults.Item Effect of Modernized Collaborative Care for Depression on Depressive Symptoms and Cardiovascular Disease Risk Biomarkers: eIMPACT Randomized Controlled Trial(Elsevier, 2023) Stewart, Jesse C.; Patel, Jay S.; Polanka, Brittanny M.; Gao, Sujuan; Nurnberger, John I., Jr.; MacDonald, Krysha L.; Gupta, Samir K.; Considine, Robert V.; Kovacs, Richard J.; Vrany, Elizabeth A.; Berntson, Jessica; Hsueh, Loretta; Shell, Aubrey L.; Rollman, Bruce L.; Callahan, Christopher M.; Psychology, School of ScienceAlthough depression is a risk and prognostic factor for cardiovascular disease (CVD), clinical trials treating depression in patients with CVD have not demonstrated cardiovascular benefits. We proposed a novel explanation for the null results for CVD-related outcomes: the late timing of depression treatment in the natural history of CVD. Our objective was to determine whether successful depression treatment before, versus after, clinical CVD onset reduces CVD risk in depression. We conducted a single-center, parallel-group, assessor-blinded randomized controlled trial. Primary care patients with depression and elevated CVD risk from a safety net healthcare system (N = 216, Mage = 59 years, 78% female, 50% Black, 46% with income <$10,000/year) were randomized to 12 months of the eIMPACT intervention (modernized collaborative care involving internet cognitive-behavioral therapy [CBT], telephonic CBT, and/or select antidepressants) or usual primary care for depression (primary care providers supported by embedded behavioral health clinicians and psychiatrists). Outcomes were depressive symptoms and CVD risk biomarkers at 12 months. Intervention participants, versus usual care participants, exhibited moderate-to-large (Hedges' g = -0.65, p < 0.01) improvements in depressive symptoms. Clinical response data yielded similar results - 43% of intervention participants, versus 17% of usual care participants, had a ≥ 50% reduction in depressive symptoms (OR = 3.73, 95% CI: 1.93-7.21, p < 0.01). However, no treatment group differences were observed for the CVD risk biomarkers - i.e., brachial flow-mediated dilation, high-frequency heart rate variability, interleukin-6, high-sensitivity C-reactive protein, β-thromboglobulin, and platelet factor 4 (Hedges' gs = -0.23 to 0.02, ps ≥ 0.09). Our modernized collaborative care intervention - which harnessed technology to maximize access and minimize resources - produced clinically meaningful improvements in depressive symptoms. However, successful depression treatment did not lower CVD risk biomarkers. Our findings indicate that depression treatment alone may not be sufficient to reduce the excess CVD risk of people with depression and that alternative approaches are needed. In addition, our effective intervention highlights the utility of eHealth interventions and centralized, remote treatment delivery in safety net clinical settings and could inform contemporary integrated care approaches.Item Supporting caregivers of veterans with Alzheimer’s disease and traumatic brain injury: study protocol for a randomized controlled trial(BMC, 2020) Carnahan, Jennifer L.; Judge, Katherine S.; Daggy, Joanne K.; Slaven, James E.; Coleman, Nicki; Fortier, Emily L.; Suelzer, Christopher; Fowler, Nicole R.; Medicine, School of MedicineBackground: Patients with Alzheimer's disease and related dementias (ADRD) and traumatic brain injury (TBI) and their caregivers require cognitive and behavioral symptom management, interdisciplinary care, support for caregivers, and seamless care coordination between providers. Caring for someone with ADRD or TBI is associated with higher rates of psychological morbidity and burden, social isolation, financial hardship, and deterioration of physical health. Tremendous need exists for primary care-based interventions that concurrently address the care needs of dyads and aim to improve care and outcomes for both individuals with ADRD and TBI and their family caregivers. Methods: The Aging Brain Care Acquiring New Skills While Enhancing Remaining Strengths (ABC ANSWERS) study is a randomized controlled trial that tests the effectiveness of an intervention based on two evidence-based programs that have been developed for and previously tested in populations with ADRD, TBI, stroke, and late-life depression and/or who have survived an intensive care unit stay. This study includes 200 dyads comprised of a veteran with a diagnosis of ADRD or TBI and the veteran's primary informal caregiver. Dyads are randomized to receive the ABC ANSWERS intervention or routine Veterans Health Administration (VHA) primary care with a standardized educational and resource information packet. Data collection occurs at baseline and three follow-up time points (3 months, 6 months, and 12 months). The primary outcome is caregiver quality of life (QoL). A secondary measure for the caregiver is caregiver burden. Secondary measures for both the veteran and caregiver include symptoms of depression and anxiety. Discussion: The ABC ANSWERS intervention integrates common features of an evidence-based collaborative care model for brain health while concurrently attending to the implementation barriers of delivering care and skills to dyads. We hypothesize that caregivers in dyads randomized to the ABC ANSWERS program will experience higher levels of QoL and lower levels of depression, anxiety, dyadic strain, and caregiver burden at 12 months than those receiving usual VHA primary care.Item A trauma medical home, evaluating collaborative care for the older injured patient: study protocol for a randomized controlled trial(BMC, 2020-07-16) Ortiz, Damaris; Meagher, Ashley D.; Lindroth, Heidi; Holler, Emma; Gao, Sujuan; Khan, Babar; Lasiter, Sue; Boustani, Malaz; Zarzaur, Ben; Surgery, School of MedicineBackground It is estimated that 55 million adults will be 65 years and older in the USA by 2020. These older adults are at increased risk for injury and their recovery is multi-faceted. A collaborative care model may improve psychological and functional outcomes of the non-neurologically impaired older trauma patient and reduce health care costs. Methods This is a randomized controlled trial of 430 patients aged 50 and older who have suffered a non-neurologic injury and are admitted to a level one trauma center in Indianapolis, IN, or Madison, WI. Participants will be assigned to either the Trauma Medical Home (TMH) intervention or usual care. The TMH intervention is a collaborative care model that includes validated protocols addressing the multi-faceted needs of this population, with the help of care coordination software and a mobile office concept. The primary outcome is self-reported physical recovery at 6- and 12-month follow-up. Secondary outcomes include self-reported psychological recovery, acute health care utilization, and cost-effectiveness of the intervention at 6 and 12 months. The TMH collaborative care model will be delivered by a registered nurse care coordinator. The assessments will be completed by trained blinded research assistants. Discussion The proposed study will evaluate a collaborative care model to help maximize psychological and functional recovery for non-neurologically injured older patients at four level one trauma centers in the Midwest.