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Browsing by Author "Bushey, Michael A."
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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 Assessing Depression Improvement with the Remission Evaluation and Mood Inventory Tool (REMIT)(Elsevier, 2019-09) Bushey, Michael A.; Kroenke, Kurt; Baye, Fitsum; Lourens, Spencer; Psychiatry, School of MedicineObjective The Remission Evaluation and Mood Inventory Tool (REMIT) was developed as a brief complementary measure to provide a more robust assessment of depression improvement than tracking DSM-V symptom improvement alone. This study provides further validation of the REMIT tool and examines its utility in predicting depression improvement. Methods The sample comprised 294 primary care patients enrolled in a telecare trial of pain plus depression and/or anxiety. Assessments collected included: REMIT, PHQ-9 and measures assessing anxiety, pain, sleep, fatigue, somatization, health-related quality of life and disability. Data was analyzed to assess the REMIT's validity, its minimally important difference (MID), and its utility in predicting 6-month depression improvement. Results Convergent and construct validity of REMIT was supported by moderate correlations with mental health measures and weaker correlation with physical health measures. MID of approximately 2 points for REMIT was estimated by two metrics: 0.5 standard deviation and 1 standard error of measurement. Both baseline and 3-month change in REMIT scores predicted depression improvement at 6 months. Indeed, REMIT was as good or better predictor than the PHQ-9. Conclusion The REMIT measure is a brief 5-item tool that augments core DSM-V symptom-oriented metrics in assessing and predicting recovery from major depression.Item Composite measures of pain, anxiety, and depressive (PAD) symptoms: Construct and predictive validity(Elsevier, 2021-09) Bushey, Michael A.; Kroenke, Kurt; Baye, Fitsum; Lourens, Spencer; Psychiatry, School of MedicineObjective Pain, anxiety, and depression (PAD) are common, co-occurring symptoms that adversely affect one another and may respond to common treatments. PAD composite measures would be useful for tracking treatment response in patients with PAD symptoms. The goal of this study is to compare 3 different PAD composite scales in terms of construct validity, responsiveness, and utility in predicting global improvement. Method The sample consisted of 294 primary care patients enrolled in a telecare trial for treating pain, anxiety, and depression. Assessments at baseline and 3 months included the Brief Pain Inventory, PHQ-9 depression scale, GAD-7 anxiety scale, PROMIS measures, Medical Outcomes Study Short-Form items, disability measures, and patient-reported global improvement. Construct validity of the PAD composite measures, their responsiveness, and their ability to predict global improvement was analyzed using Pearson correlations, standardized response means, and receiver operating characteristics analysis. Results PAD composite measures correlated strongly with one another, and moderately with measures of function, vitality, and disability. Each PAD composite measure demonstrated similar responsiveness in detecting improvement at 3 months as assessed by standardized response means (SRMs) and area under the curve (AUC analyses).The SRMs for partial and substantial global improvement corresponded to moderate (Cohen's d of 0.58 to 0.69) and large (0.81 to 0.93) effect sizes, respectively. Conclusions Three different PAD composite measures demonstrate good construct validity as well as responsiveness in detecting global improvement of pain, anxiety and depression at 3 months.Item Design and methods of the Care Management for the Effective Use of Opioids (CAMEO) trial(Elsevier, 2021-07) Bushey, Michael A.; Slaven, James; Outcalt, Samantha D.; Kroenke, Kurt; Kempf, Carol; Froman, Amanda; Sargent, Christy; Baecher, Brad; Zillich, Alan; Damush, Teresa M.; Saha, Chandan; French, Dustin D.; Bair, Matthew J.; Medicine, School of MedicineLow back pain is the most common pain condition seen in primary care, with the most common treatment being analgesic medications, including opioids. A dramatic increase in opioid prescriptions for low back pain over the past few decades has led to increased non-medical use and opioid overdose deaths. Cognitive behavioral therapy (CBT) for chronic pain is an evidence-based non-pharmacological treatment for pain with demonstrated efficacy when delivered using collaborative care models. No previous studies have tested CBT compared to analgesic optimization that includes opioid management in primary care. This paper describes the study design and methods of the CAre Management for the Effective use of Opioids (CAMEO) trial, a 2-arm, randomized comparative effectiveness trial in seven primary care clinics. CAMEO enrolled 261 primary care veterans with chronic (6 months or longer) low back pain of at least moderate severity who were receiving long-term opioid therapy and randomized them to either nurse care management focused on analgesic treatment and optimization (MED) or cognitive behavioral therapy (CBT). All subjects undergo comprehensive outcome assessments at baseline, 3, 6, 9, and 12 months by interviewers blinded to treatment assignment. The primary outcome is pain severity and interference, measured by the Brief Pain Inventory (BPI) total score. Secondary outcomes include health-related quality of life, fatigue, sleep, functional improvement, pain disability, pain beliefs, alcohol and opioid problems, depression, anxiety, and stress.Item Effect of Medication Optimization vs Cognitive Behavioral Therapy Among US Veterans With Chronic Low Back Pain Receiving Long-term Opioid Therapy: A Randomized Clinical Trial(American Medical Association, 2022-11-01) Bushey, Michael A.; Slaven, James E.; Outcalt, Samantha D.; Kroenke, Kurt; Kempf, Carol; Froman, Amanda; Sargent, Christy; Baecher, Brad; Zillich, Alan J.; Damush, Teresa M.; Saha, Chandan; French, Dustin D.; Bair, Matthew J.; Psychiatry, School of MedicineImportance: Medication management and cognitive behavioral therapy (CBT) are commonly used treatments for chronic low back pain (CLBP). However, little evidence is available comparing the effectiveness of these approaches. Objective: To compare collaborative care medication optimization vs CBT on pain intensity, interference, and other pain-related outcomes. Design, setting, and participants: The Care Management for the Effective Use of Opioids (CAMEO) trial was a 12-month, comparative effectiveness randomized clinical trial with blinded outcome assessment. Recruitment of veterans with CLBP prescribed long-term opioids occurred at 7 Veterans Affairs primary care clinics from September 1, 2011, to December 31, 2014, and follow-up was completed December 31, 2015. Analyses were based on intention to treat in all randomized participants and were performed from March 22, 2015, to November 1, 2021. Interventions: Patients were randomized to receive either collaborative care with nurse care manager-delivered medication optimization (MED group) (n = 131) or psychologist-delivered CBT (CBT group) (n = 130) for 6 months, with check-in visits at 9 months and final outcome assessment at 12 months. Main outcomes and measures: The primary outcome was change in Brief Pain Inventory (BPI) total score, a composite of the pain intensity and interference subscales at 6 (treatment completion) and 12 (follow-up completion) months. Scores on the BPI range from 0 to 10, with higher scores representing greater pain impact and a 30% improvement considered a clinically meaningful treatment response. Secondary outcomes included pain-related disability, pain catastrophizing, self-reported substance misuse, health-related quality of life, depression, and anxiety. Results: A total of 261 patients (241 [92.3%] men; mean [SD] age, 57.9 [9.5] years) were randomized and included in the analysis. Baseline mean (SD) BPI scores in the MED and CBT groups were 6.45 (1.79) and 6.49 (1.67), respectively. Improvements in BPI scores were significantly greater in the MED group at 12 months (between-group difference, -0.54 [95% CI, -1.18 to -0.31]; P = .04) but not at 6 months (between-group difference, -0.46 [95% CI, -0.94 to 0.11]; P = .07). Secondary outcomes did not differ significantly between treatment groups. Conclusions and relevance: In this randomized clinical trial among US veterans with CLBP who were prescribed long-term opioid therapy, collaborative care medication optimization was modestly more effective than CBT in reducing pain impact during the 12-month study. However, this difference may not be clinically meaningful or generalize to nonveteran populations.Item Opioid Use as a Predictor of Pain Outcomes in Iraq and Afghanistan Veterans with Chronic Pain: Analysis of a Randomized Controlled Trial(Oxford Academic, 2021) Bushey, Michael A.; Wu, Jingwei; Outcalt, Samantha D.; Krebs, Erin E.; Ang, Dennis; Kline, Matthew; Yu, Zhangsheng; Bair, Matthew J.; Psychiatry, School of MedicineOBJECTIVE: Our objectives were to: 1) assess the relationship between self-reported opioid use and baseline demographics, clinical characteristics and pain outcomes; and 2) examine whether baseline opioid use moderated the intervention effect on outcomes at 9 months. DESIGN: We conducted a secondary analysis of data from the Evaluation of Stepped Care for Chronic Pain (ESCAPE) trial, which found stepped-care to be effective for chronic pain in military veterans. SETTING: A post-deployment clinic and five general medicine clinics at a Veteran Affairs Medical Center. SUBJECTS: In total 241 veterans with chronic musculoskeletal pain; 220 with complete data at 9 months. METHODS: Examination of baseline relationships and multivariable linear regression to examine baseline opioid use as a moderator of pain-related outcomes including Roland Morris Disability Questionnaire (RMDQ), Brief Pain Inventory (BPI) Interference scale, and Graded Chronic Pain Scale (GCPS) at 9 months. RESULTS: Veterans reporting baseline opioid use (n = 80) had significantly worse RMDQ (16.0 ± 4.9 vs. 13.4 ± 4.2, P < .0001), GCPS (68.7 ± 12.0 vs. 65.0 ± 14.4, P = .049), BPI Interference (6.2 ± 2.2 vs. 5.0 ± 2.1, P < .0001), and depression (PHQ-9 12.5 ± 6.2 vs. 10.6 ± 5.7, P = .016) compared to veterans not reporting baseline opioid use. Using multivariable modeling we found that baseline opioid use moderated the intervention effect on pain-related disability (RMDQ) at 9 months (interaction Beta = -3.88, P = .0064) but not pain intensity or interference. CONCLUSIONS: In a stepped-care trial for pain, patients reporting baseline opioid use had greater improvement in pain disability at 9 months compared to patients not reporting opioid use.Item Patient and health service factors associated with enrollment in a multidisciplinary pain rehabilitation program: a retrospective cohort study(Frontiers Media, 2025-04-10) Bushey, Michael A.; Flegge, Lindsay G.; Melendez, Melissa; Harris, Elizabeth K.; Hammond, Flora M.; Psychiatry, School of MedicineIntroduction: Despite multidisciplinary pain rehabilitation programs (PRPs) being well-established as an effective treatment for chronic pain, the existence of such programs has been declining across the United States over recent decades. Objective: This study aims to identify factors associated with enrollment in a three-week, intensive outpatient PRP. Methods: This is a retrospective cohort study of all patient visits to a multidisciplinary pain evaluation clinic in 2023. The cohort was divided into those who did and did not subsequently enroll in a PRP program. Health service, demographic, and patient-reported outcome measures were compared between groups; continuous variables by independent samples Student's T-tests and categorical variables by chi-squared tests. Results: Of the 335 patients who had an evaluation in 2023, 48 went on to enroll in PRP (PRP-Yes group), and 287 did not (PRP-No group). Compared to PRP non-enrollers, the PRP-enrollers were more likely to have had a mental health (94% vs. 52%, p < .001) and physical therapy (94% vs. 48%, p < .001) assessment as part of their evaluation, had shorter lag times between their initial referral and medical evaluation [mean (SD) 43.5 (28.9) vs. 57.7 (41.7), p = .024], and had significantly greater anxiety, PTSD symptoms, somatic symptoms, and insomnia. Additionally, referral source, medical provider, and physical therapy provider seen differed significantly between PRP-enrollers and non-enrollers. PRP enrollment was not predicted by demographic variables including race, payer-type, or distance from the clinic. Discussion: Both personal and systemic factors were identified to be associated with enrollment in a three-week multidisciplinary PRP. These findings highlight variables worth considering for clinical and research programs looking to increase PRP enrollment.Item Symptomatic joint hypermobility is not a barrier to attendance, graduation, or satisfaction for adults participating in a multidisciplinary pain rehabilitation program(Frontiers Media, 2025-03-20) Flegge, Lindsay G.; Estrella, Emma; Harris, Elizabeth K.; Hirsh, Adam T.; Bushey, Michael A.; Psychiatry, School of MedicineIntroduction: Symptomatic joint hypermobility, as found in conditions like hypermobile Ehlers-Danlos syndrome (hEDS), presents unique challenges in pain management due to associated symptoms such as chronic pain, joint instability, and dysautonomia. Despite the high prevalence of hypermobility and associated healthcare costs, there is a lack of research on effective treatments for these patients, particularly in the context of multidisciplinary pain rehabilitation programs. Objective: This study aims to compare the baseline characteristics, attendance, graduation rates, and patient satisfaction of hypermobile and non-hypermobile adult outpatients participating in a multidisciplinary pain rehabilitation program (PRP). Methods: This retrospective cohort study analyzed clinical data from 335 patients at the Indiana University Health Pain Navigation Service between January 1, 2023, and December 31, 2023. Baseline characteristics were assessed using patient-reported outcome measures, and attendance and graduation rates were tracked. Hypermobile and non-hypermobile groups were compared with independent samples t-tests and chi-squared tests. A multiple linear regression model was used to assess the impact of hypermobility diagnosis on PRP attendance, with pertinent demographic and baseline clinical scores entered as covariates. Results: Hypermobile patients differed significantly from non-hypermobile patients in demographics, including age, gender, race, education, and employment status. Despite these differences, hypermobile patients did not differ from non-hypermobile patients in PRP attendance or graduation rates. Baseline pain, depression, and pain catastrophizing scores were lower in the hypermobile group. Exit surveys indicated similar levels of overall satisfaction with the program, though hypermobile patients were less likely to report that their needs were fully met than were non-hypermobile patients. Discussion: Despite the potential for joint hypermobility to pose a barrier to participation in multidisciplinary pain rehabilitation programs, we found no evidence that patients with a hypermobile diagnosis had less participation in an intensive outpatient pain rehabilitation program. After accounting for group differences in key demographic and clinical variables, there were no significant differences in PRP attendance between hypermobile and non-hypermobile patients. Our results are encouraging regarding the potential for multidisciplinary pain rehabilitation programs to serve the needs of these patients.