Browsing by Author "Outcalt, Samantha D."
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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 Does comorbid chronic pain affect posttraumatic stress disorder diagnosis and treatment? Outcomes of posttraumatic stress disorder screening in Department of Veterans Affairs primary care(2016) Outcalt, Samantha D.; Hoen, Helena Maria; Yu, Zhangsheng; Franks, Tenesha Marie; Krebs, Erin E.; Department of Psychiatry, IU School of MedicineBecause posttraumatic stress disorder (PTSD) is both prevalent and underrecognized, routine primary care-based screening for PTSD has been implemented across the Veterans Health Administration. PTSD is frequently complicated by the presence of comorbid chronic pain, and patients with both conditions have increased symptom severity and poorer prognosis. Our objective was to determine whether the presence of pain affects diagnosis and treatment of PTSD among Department of Veterans Affairs (VA) patients who have a positive PTSD screening test. This retrospective cohort study used clinical and administrative data from six Midwestern VA medical centers. We identified 4,244 VA primary care patients with a positive PTSD screen and compared outcomes for those with and without a coexisting pain diagnosis. Outcomes were three clinically appropriate responses to positive PTSD screening: (1) mental health visit, (2) PTSD diagnosis, and (3) new selective serotonin reuptake inhibitor (SSRI) prescription. We found that patients with coexisting pain had a lower rate of mental health visits than those without pain (hazard ratio: 0.889, 95% confidence interval: 0.821–0.962). There were no significant differences in the rate of PTSD diagnosis or new SSRI prescription between patients with and without coexisting pain.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 Evaluation of Stepped Care for Chronic Pain (ESCAPE) in Veterans of the Iraq and Afghanistan Conflicts A Randomized Clinical Trial(AMA, 2015-05) Bair, Matthew J.; Ang, Dennis; Wu, Jingwei; Outcalt, Samantha D.; Sargent, Christy; Kempf, Carol; Froman, Amanda; Schmid, Arlena A.; Damush, Teresa M.; Yu, Zhangsheng; Davis, Louanne W.; Kroenke, Kurt; Department of Medicine, IU School of MedicineIMPORTANCE: Despite the prevalence and the functional, psychological, and economic impact of chronic pain, few intervention studies of treatment of chronic pain in veterans have been performed. OBJECTIVE: To determine whether a stepped-care intervention is more effective than usual care, as hypothesized, in reducing pain-related disability, pain interference, and pain severity. DESIGN, SETTING, AND PARTICIPANTS: We performed a randomized clinical trial comparing stepped care with usual care for chronic pain. We enrolled 241 veterans from Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn with chronic (>3 months) and disabling (Roland Morris Disability Scale score, ≥7) musculoskeletal pain of the cervical or lumbar spine or extremities (shoulders, knees, and hips) in the Evaluation of Stepped Care for Chronic Pain (ESCAPE) trial from December 20, 2007, through June 30, 2011. The 9-month follow-up was completed by April 2012. Patients received treatment at a postdeployment clinic and 5 general medicine clinics at a Veterans Affairs medical center. INTERVENTIONS: Step 1 included 12 weeks of analgesic treatment and optimization according to an algorithm coupled with pain self-management strategies; step 2, 12 weeks of cognitive behavioral therapy. All intervention aspects were delivered by nurse care managers. MAIN OUTCOMES AND MEASURES: Pain-related disability (Roland Morris Disability Scale), pain interference (Brief Pain Inventory), and pain severity (Graded Chronic Pain Scale). RESULTS: The primary analysis included 121 patients receiving the stepped-care intervention and 120 patients receiving usual care. At 9 months, the mean decrease from baseline in the Roland Morris Disability Scale score was 1.7 (95% CI, -2.6 to -0.9) points in the usual care group and 3.7 (95% CI, -4.5 to -2.8) points in the intervention group (between-group difference, -1.9 [95% CI, -3.2 to -0.7] points; P=.002). The mean decrease from baseline in the Pain Interference subscale score of the Brief Pain Inventory was 0.9 points in the usual care group and 1.7 points in the intervention group (between-group difference, -0.8 [95% CI, -1.3 to -0.3] points; P=.003). The Graded Chronic Pain Scale severity score was reduced by 4.5 points in the usual care group and 11.1 points in the intervention group (between-group difference, -6.6 [95% CI, -10.5 to -2.7] points; P=.001). CONCLUSIONS AND RELEVANCE: A stepped-care intervention that combined analgesics, self-management strategies, and brief cognitive behavioral therapy resulted in statistically significant reductions in pain-related disability, pain interference, and pain severity in veterans with chronic musculoskeletal pain.Item Factors underlying metastatic breast cancer patients' perceptions of symptom importance: a qualitative analysis(Wiley, 2018-01) Mosher, Catherine E.; Daily, Susan; Tometich, Danielle; Matthias, Marianne S.; Outcalt, Samantha D.; Hirsh, Adam; Johns, Shelley A.; Rand, Kevin; Schneider, Bryan; Mina, Lida; Storniolo, Anna Maria; Newton, Erin; Miller, Kathy; Psychology, School of ScienceThe symptom literature in cancer has primarily examined symptom severity, frequency and distress. Assessing cancer patients' perceptions of symptom importance-how important it is for them to see improvement in a symptom following an intervention-and factors influencing these judgments would also inform patient-centred care, but this analysis has not been undertaken. This qualitative study aimed to identify factors underlying perceptions of symptom importance among 25 symptomatic metastatic breast cancer (MBC) patients. Participants were recruited from a cancer centre in the Midwestern USA. Semi-structured interviews focused on patients' rationale for considering common symptoms (i.e., anxiety, sadness, sleep problems, pain or fatigue) to be important. Thematic analyses revealed five interrelated factors underlying MBC patients' perceptions of symptom importance: activity restriction, concentration difficulties, exacerbation of other physical symptoms, symptom-related long-term health concerns and negative impact on their relationships with others. Patients most frequently stated that a physical or psychological symptom was important because of the resulting activity restriction. Additionally, some patients considered pain to be important because it signalled potential long-term health concerns, such as worsening metastatic disease. Findings suggest that clinicians should take into account MBC patients' perceptions of symptom importance and factors underlying these judgments when making shared treatment decisions.Item Metastatic breast cancer patients' expectations and priorities for symptom improvement(Springer Nature, 2018-11) Tometich, Danielle B.; Mosher, Catherine E.; Hirsh, Adam T.; Rand, Kevin L.; Johns, Shelley A.; Matthias, Marianne S.; Outcalt, Samantha D.; Schneider, Bryan P.; Mina, Lida; Storniolo, Anna Maria V.; Newton, Erin V.; Miller, Kathy D.; Psychology, School of SciencePURPOSE: Little research has examined cancer patients' expectations, goals, and priorities for symptom improvement. Thus, we examined these outcomes in metastatic breast cancer patients to provide patients' perspectives on clinically meaningful symptom improvement and priorities for symptom management. METHODS: Eighty women with metastatic breast cancer participated in a survey with measures of comorbidity, functional status, engagement in roles and activities, distress, quality of life, and the modified Patient-Centered Outcomes Questionnaire that focused on 10 common symptoms in cancer patients. RESULTS: On average, patients reported low to moderate severity across the 10 symptoms and expected symptom treatment to be successful. Patients indicated that a 49% reduction in fatigue, 48% reduction in thinking problems, and 43% reduction in sleep problems would represent successful symptom treatment. Cluster analysis based on ratings of the importance of symptom improvement yielded three clusters of patients: (1) those who rated thinking problems, sleep problems, and fatigue as highly important, (2) those who rated pain as moderately important, and (3) those who rated all symptoms as highly important. The first patient cluster differed from other subgroups in severity of thinking problems and education. CONCLUSIONS: Metastatic breast cancer patients report differing symptom treatment priorities and criteria for treatment success across symptoms. Considering cancer patients' perspectives on clinically meaningful symptom improvement and priorities for symptom management will ensure that treatment is consistent with their values and goals.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 A Qualitative Examination of Pain Centrality Among Veterans of Iraq and Afghanistan Conflicts(Oxford, 2017-02) Outcalt, Samantha D.; Nicolaidis, Christina; Bair, Matthew J.; Myers, Laura J.; Miech, Edward J.; Matthias, Marianne S.; Psychology, School of ScienceObjective. Centrality of pain refers to the degree to which a patient views chronic pain as integral to his or her life or identity. The purpose of this study was to gain a richer understanding of pain centrality from the perspective of patients who live with chronic pain. Methods. Face-to-face interviews were conducted with 26 Veterans with chronic and disabling musculoskeletal pain after completing a stepped care intervention within a randomized controlled trial. Qualitative data were analyzed using an immersion/crystallization approach. We evaluated the role centrality plays in Veterans’ lives and examined whether and how their narratives differ when centrality either significantly decreases or increases after participation in a stepped care intervention for chronic pain. Results. Our data identified three emergent themes that characterized pain centrality: 1) control, 2) acceptance, and 3) preoccupation. We identified five characteristics that distinguished patients’ changes in centrality from baseline: 1) biopsychosocial viewpoint, 2) activity level, 3) pain communication, 4) participation in managing own pain, and 5) social support. Conclusions. This study highlights centrality of pain as an important construct to consider within the overall patient experience of chronic pain.Item Symptom experiences in metastatic breast cancer patients: relationships to activity engagement, value-based living, and psychological inflexibility(Wiley, 2017-11) Mosher, Catherine E.; Tometich, Danielle B.; Hirsh, Adam; Rand, Kevin L.; Johns, Shelley A.; Matthias, Marianne S.; Outcalt, Samantha D.; Bricker, Jonathan; Schneider, Bryan; Mina, Lida; Storniolo, Anna Maria; Newton, Erin; Miller, Kathy; Psychology, School of ScienceOBJECTIVE: This study examined symptom-based subgroups of metastatic breast cancer (MBC) patients and the extent to which they differed across key constructs of acceptance and commitment therapy (ACT). METHODS: Eighty women with MBC completed self-report surveys assessing 10 common symptoms and several ACT variables (ie, activity engagement, psychological inflexibility, value obstruction, and value progress) during a single time point. RESULTS: A cluster analysis yielded 3 patient subgroups: low symptoms, low-moderate symptoms, and moderate-high symptoms. Relative to the subgroup with low symptoms, the other subgroups reported less activity engagement. In addition, compared with patients with low symptoms, the subgroup with moderate-high symptoms reported greater psychological inflexibility (ie, avoidance of unwanted internal experiences) and greater difficulty living consistently with their values. CONCLUSIONS: Women with MBC show heterogeneity in their symptom profiles, and those with higher symptom burden are more likely to disengage from valued activities and avoid unwanted experiences (eg, thoughts, feelings, and bodily sensations). Findings are largely consistent with the ACT model and provide strong justification for testing ACT to address symptom interference in MBC patients.