Browsing by Author "Strauss, Jennifer L"

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    A Combined Patient and Provider Intervention for Management of Osteoarthritis in Veterans: A Randomized Clinical Trial.
    (Annals of internal medicine, 2016-01) Allen, Kelli D; Yancy, William S; Bosworth, Hayden B; Coffman, Cynthia J; Jeffreys, Amy S; Datta, Santanu K; McDuffie, Jennifer; Strauss, Jennifer L; Oddone, Eugene Z

    Background

    Management of osteoarthritis requires both medical and behavioral strategies, but some recommended therapies are underused.

    Objective

    To examine the effectiveness of a combined patient and provider intervention for improving osteoarthritis outcomes.

    Design

    Cluster randomized clinical trial with assignment to osteoarthritis intervention and usual care groups. (ClinicalTrials.gov: NCT01130740).

    Setting

    Department of Veterans Affairs Medical Center in Durham, North Carolina.

    Participants

    30 providers (clusters) and 300 outpatients with symptomatic hip or knee osteoarthritis.

    Intervention

    The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved delivery of patient-specific osteoarthritis treatment recommendations to primary care providers through the electronic medical record.

    Measurements

    The primary outcome was total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months. Secondary outcomes were WOMAC function and pain subscale scores, physical performance (Short Physical Performance Battery), and depressive symptoms (Patient Health Questionnaire-8). Linear mixed models that were adjusted for clustering of providers assessed between-group differences in improvement in outcomes.

    Results

    At 12 months, WOMAC scores were 4.1 points lower (indicating improvement) in the osteoarthritis intervention group versus usual care (95% CI, -7.2 to -1.1 points; P = 0.009). WOMAC function subscale scores were 3.3 points lower in the intervention group (CI, -5.7 to -1.0 points; P = 0.005). WOMAC pain subscale scores (P = 0.126), physical performance, and depressive symptoms did not differ between groups. Although more patients in the osteoarthritis intervention group received provider referral for recommended osteoarthritis treatments, the numbers who received them did not differ.

    Limitation

    The study was conducted in a single Veterans Affairs medical center.

    Conclusion

    The combined patient and provider intervention resulted in modest improvement in self-reported physical function in patients with hip and knee osteoarthritis.

    Primary funding source

    Department of Veterans Affairs, Health Services Research and Development Service.
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    A pilot randomized controlled trial with paroxetine for subthreshold PTSD in Operation Enduring Freedom/Operation Iraqi Freedom era veterans
    (Psychiatry Research, 2012-12-31) Naylor, Jennifer C; Dolber, Trygve R; Strauss, Jennifer L; Kilts, Jason D; Strauman, Timothy J; Bradford, Daniel W; Szabo, Steven T; Youssef, Nagy A; Connor, Kathryn M; Davidson, Jonathan RT; Marx, Christine E
    Subthreshold posttraumatic stress disorder (PTSD) is associated with increased risk for suicidality, depression, and functional impairment. We thus conducted a small (N=12) pilot randomized controlled trial (RCT) with paroxetine for subthreshold PTSD in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) era veterans. Hospital Anxiety and Depression Scale (HADS) scores improved by 30.4% in the paroxetine group. Paroxetine may have promise for subthreshold PTSD.
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    Acute effects of trauma-focused research procedures on participant safety and distress
    (Psychiatry Research, 2014-01-30) Brown, Vanessa M; Strauss, Jennifer L; LaBar, Kevin S; Gold, Andrea L; McCarthy, Gregory; Morey, Rajendra A
    The ethical conduct of research on posttraumatic stress disorder (PTSD) requires assessing the risks to study participants. Some previous findings suggest that patients with PTSD report higher distress compared to non-PTSD participants after trauma-focused research. However, the impact of study participation on participant risk, such as suicidal/homicidal ideation and increased desire to use drugs or alcohol, has not been adequately investigated. Furthermore, systematic evaluation of distress using pre- and post-study assessments, and the effects of study procedures involving exposure to aversive stimuli, are lacking. Individuals with a history of PTSD (n=68) and trauma-exposed non-PTSD controls (n=68) responded to five questions about risk and distress before and after participating in research procedures including a PTSD diagnostic interview and a behavioral task with aversive stimuli consisting of mild electrical shock. The desire to use alcohol or drugs increased modestly with study participation among the subgroup (n=48) of participants with current PTSD. Participation in these research procedures was not associated with increased distress or participant risk, nor did study participation interact with lifetime PTSD diagnosis. These results suggest some increase in distress with active PTSD but a participant risk profile that supports a favorable risk-benefit ratio for conducting research in individuals with PTSD. © 2013.
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    Allopregnanolone Levels Are Inversely Associated with Self-Reported Pain Symptoms in U.S. Iraq and Afghanistan-Era Veterans: Implications for Biomarkers and Therapeutics.
    (Pain Med, 2016-01) Naylor, Jennifer C; Kilts, Jason D; Szabo, Steven T; Dunn, Charlotte E; Keefe, Francis J; Tupler, Larry A; Shampine, Lawrence J; Morey, Rajendra A; Strauss, Jennifer L; Hamer, Robert M; Wagner, H Ryan; MIRECC Workgroup; Marx, Christine E
    BACKGROUND AND OBJECTIVES: Pain symptoms are common among Iraq/Afghanistan-era veterans, many of whom continue to experience persistent pain symptoms despite multiple pharmacological interventions. Preclinical data suggest that neurosteroids such as allopregnanolone demonstrate pronounced analgesic properties, and thus represent logical biomarker candidates and therapeutic targets for pain. Allopregnanolone is also a positive GABAA receptor modulator with anxiolytic, anticonvulsant, and neuroprotective actions in rodent models. We previously reported inverse associations between serum allopregnanolone levels and self-reported pain symptom severity in a pilot study of 82 male veterans. METHODS: The current study investigates allopregnanolone levels in a larger cohort of 485 male Iraq/Afghanistan-era veterans to attempt to replicate these initial findings. Pain symptoms were assessed by items from the Symptom Checklist-90-R (SCL-90-R) querying headache, chest pain, muscle soreness, and low back pain over the past 7 days. Allopregnanolone levels were quantified by gas chromatography/mass spectrometry. RESULTS: Associations between pain ratings and allopregnanolone levels were examined with Poisson regression analyses, controlling for age and smoking. Bivariate nonparametric Mann–Whitney analyses examining allopregnanolone levels across high and low levels of pain were also conducted. Allopregnanolone levels were inversely associated with muscle soreness [P = 0.0028], chest pain [P = 0.032], and aggregate total pain (sum of all four pain items) [P = 0.0001]. In the bivariate analyses, allopregnanolone levels were lower in the group reporting high levels of muscle soreness [P = 0.001]. CONCLUSIONS: These findings are generally consistent with our prior pilot study and suggest that allopregnanolone may function as an endogenous analgesic. Thus, exogenous supplementation with allopregnanolone could have therapeutic potential. The characterization of neurosteroid profiles may also have biomarker utility.
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    Patient and provider interventions for managing osteoarthritis in primary care: protocols for two randomized controlled trials.
    (BMC musculoskeletal disorders, 2012-04) Allen, Kelli D; Bosworth, Hayden B; Brock, Dorothea S; Chapman, Jennifer G; Chatterjee, Ranee; Coffman, Cynthia J; Datta, Santanu K; Dolor, Rowena J; Jeffreys, Amy S; Juntilla, Karen A; Kruszewski, Jennifer; Marbrey, Laurie E; McDuffie, Jennifer; Oddone, Eugene Z; Sperber, Nina; Sochacki, Mary P; Stanwyck, Catherine; Strauss, Jennifer L; Yancy, William S

    Background

    Osteoarthritis (OA) of the hip and knee are among the most common chronic conditions, resulting in substantial pain and functional limitations. Adequate management of OA requires a combination of medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and the majority of patients with hip and knee OA are overweight and physically inactive. Consequently, interventions at the provider-level and patient-level both have potential for improving outcomes. This manuscript describes two ongoing randomized clinical trials being conducted in two different health care systems, examining patient-based and provider-based interventions for managing hip and knee OA in primary care.

    Methods / design

    One study is being conducted within the Department of Veterans Affairs (VA) health care system and will compare a Combined Patient and Provider intervention relative to usual care among n = 300 patients (10 from each of 30 primary care providers). Another study is being conducted within the Duke Primary Care Research Consortium and will compare Patient Only, Provider Only, and Combined (Patient + Provider) interventions relative to usual care among n = 560 patients across 10 clinics. Participants in these studies have clinical and / or radiographic evidence of hip or knee osteoarthritis, are overweight, and do not meet current physical activity guidelines. The 12-month, telephone-based patient intervention focuses on physical activity, weight management, and cognitive behavioral pain management. The provider intervention involves provision of patient-specific recommendations for care (e.g., referral to physical therapy, knee brace, joint injection), based on evidence-based guidelines. Outcomes are collected at baseline, 6-months, and 12-months. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and secondary outcomes are the Short Physical Performance Test Protocol (objective physical function) and the Patient Health Questionnaire-8 (depressive symptoms). Cost effectiveness of the interventions will also be assessed.

    Discussion

    Results of these two studies will further our understanding of the most effective strategies for improving hip and knee OA outcomes in primary care settings.

    Trial registration

    NCT01130740 (VA); NCT 01435109 (NIH).
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    Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.
    (Annals of internal medicine, 2017-03) Allen, Kelli D; Oddone, Eugene Z; Coffman, Cynthia J; Jeffreys, Amy S; Bosworth, Hayden B; Chatterjee, Ranee; McDuffie, Jennifer; Strauss, Jennifer L; Yancy, William S; Datta, Santanu K; Corsino, Leonor; Dolor, Rowena J

    Background

    A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions.

    Objective

    To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes.

    Design

    Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109).

    Setting

    10 Duke University Health System community-based primary care clinics.

    Participants

    537 outpatients with symptomatic hip or knee osteoarthritis.

    Intervention

    The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers.

    Measurements

    The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups.

    Results

    No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care.

    Limitations

    The study involved 1 health care network. Data on provider referrals were not collected.

    Conclusion

    Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically significant improvements in the osteoarthritis intervention groups compared with usual care.

    Primary funding source

    National Institute of Arthritis and Musculoskeletal and Skin Diseases.