Browsing by Author "Weinberger, Morris"

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    Brief Educational Video plus Telecare to Enhance Recovery for Older Emergency Department Patients with Acute Musculoskeletal Pain: an update to the study protocol for a randomized controlled trial
    (Springer, 2022-05-12) Hurka-Richardson, Karen; Platts-Mills, Timothy F.; McLean, Samuel A.; Weinberger, Morris; Stearns, Sally C.; Bush, Montika; Quackenbush, Eugenia; Chari, Srihari; Aylward, Aileen; Kroenke, Kurt; Kerns, Robert D.; Weaver , Mark A.; Keefe, Francis J.; Berkoff, David; Meyer, Michelle L.; Medicine, School of Medicine
    Background This update describes changes to the Brief Educational Tool to Enhance Recovery (BETTER) trial in response to the COVID-19 pandemic. Methods/design The original protocol was published in Trials. Due to the COVID-19 pandemic, the BETTER trial converted to remote recruitment in April 2020. All recruitment, consent, enrollment, and randomization now occur by phone within 24 h of the acute care visit. Other changes to the original protocol include an expansion of inclusion criteria and addition of new recruitment sites. To increase recruitment numbers, eligibility criteria were expanded to include individuals with chronic pain, non-daily opioid use within 2 weeks of enrollment, presenting musculoskeletal pain (MSP) symptoms for more than 1 week, hospitalization in past 30 days, and not the first time seeking medical treatment for presenting MSP pain. In addition, recruitment sites were expanded to other emergency departments and an orthopedic urgent care clinic. Conclusions Recruiting from an orthopedic urgent care clinic and transitioning to remote operations not only allowed for continued participant enrollment during the pandemic but also resulted in some favorable outcomes, including operational efficiencies, increased enrollment, and broader generalizability.
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    Brief Educational Video plus Telecare to Enhance Recovery for Older Emergency Department Patients with Acute Musculoskeletal Pain: an update to the study protocol for a randomized controlled trial
    (Springer Nature, 2022-05-12) Hurka‑Richardson, Karen; Platts‑Mills, Timothy F.; McLean, Samuel A.; Weinberger, Morris; Stearns, Sally C.; Bush, Montika; Quackenbush, Eugenia; Chari, Srihari; Aylward, Aileen; Kroenke, Kurt; Kerns, Robert D.; Weaver, Mark A.; Keefe, Francis J.; Berkoff, David; Meyer, Michelle L.; Medicine, School of Medicine
    Background: This update describes changes to the Brief Educational Tool to Enhance Recovery (BETTER) trial in response to the COVID-19 pandemic. Methods/design: The original protocol was published in Trials. Due to the COVID-19 pandemic, the BETTER trial converted to remote recruitment in April 2020. All recruitment, consent, enrollment, and randomization now occur by phone within 24 h of the acute care visit. Other changes to the original protocol include an expansion of inclusion criteria and addition of new recruitment sites. To increase recruitment numbers, eligibility criteria were expanded to include individuals with chronic pain, non-daily opioid use within 2 weeks of enrollment, presenting musculoskeletal pain (MSP) symptoms for more than 1 week, hospitalization in past 30 days, and not the first time seeking medical treatment for presenting MSP pain. In addition, recruitment sites were expanded to other emergency departments and an orthopedic urgent care clinic. Conclusions: Recruiting from an orthopedic urgent care clinic and transitioning to remote operations not only allowed for continued participant enrollment during the pandemic but also resulted in some favorable outcomes, including operational efficiencies, increased enrollment, and broader generalizability.
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    Comparative Effectiveness of Anti-TNF in Combination With Low-Dose Methotrexate vs Anti-TNF Monotherapy in Pediatric Crohn's Disease: A Pragmatic Randomized Trial
    (Elsevier, 2023-07) Kappelman, Michael D.; Wohl, David A.; Herfarth, Hans H.; Firestine, Ann M.; Adler, Jeremy; Ammoury, Rana F.; Aronow, Jeanine E.; Bass, Dorsey M.; Bass, Julie A.; Benkov, Keith; Berenblum Tobi, Catalina; Boccieri, Margie E.; Boyle, Brendan M.; Brinkman, William B.; Cabera, Jose M.; Chun, Kelly; Colletti, Richard B.; Dodds, Cassandra M.; Dorsey, Jill M.; Ebach, Dawn R.; Entrena, Edurne; Forrest, Christopher B.; Galanko, Joseph A.; Grunow, John E.; Gulati, Ajay S.; Ivanova, Anastasia; Jester, Traci W.; Kaplan, Jess L.; Kugathasan, Subra; Kusek, Mark E.; Leibowitz, Ian H.; Linville, Tiffany M.; Lipstein, Ellen A.; Margolis, Peter A.; Minar, Phillip; Molle-Rios, Zarela; Moses, Jonathan; Olano, Kelly K.; Osaba, Lourdes; Palomo, Pablo J.; Pappa, Helen; Park, K. T.; Pashankar, Dinesh S.; Pitch, Lisa; Robinson, Michelle; Samson, Charles M.; Sandberg, Kelly C.; Schuchard, Julia R.; Seid, Michael; Shelly, Kimberly A.; Steiner, Steven J.; Strople, Jennifer A.; Sullivan, Jillian S.; Tung, Jeanne; Wali, Prateek; Zikry, Michael; Weinberger, Morris; Saeed, Shehzad A.; Bousvaros, Athos; Medicine, School of Medicine
    Background & Aims Tumor necrosis factor inhibitors, including infliximab and adalimumab, are a mainstay of pediatric Crohn’s disease therapy; however, nonresponse and loss of response are common. As combination therapy with methotrexate may improve response, we performed a multicenter, randomized, double-blind, placebo-controlled pragmatic trial to compare tumor necrosis factor inhibitors with oral methotrexate to tumor necrosis factor inhibitor monotherapy. Methods Patients with pediatric Crohn’s disease initiating infliximab or adalimumab were randomized in 1:1 allocation to methotrexate or placebo and followed for 12–36 months. The primary outcome was a composite indicator of treatment failure. Secondary outcomes included anti-drug antibodies and patient-reported outcomes of pain interference and fatigue. Adverse events (AEs) and serious AEs (SAEs) were collected. Results Of 297 participants (mean age, 13.9 years, 35% were female), 156 were assigned to methotrexate (110 infliximab initiators and 46 adalimumab initiators) and 141 to placebo (102 infliximab initiators and 39 adalimumab initiators). In the overall population, time to treatment failure did not differ by study arm (hazard ratio, 0.69; 95% CI, 0.45–1.05). Among infliximab initiators, there were no differences between combination and monotherapy (hazard ratio, 0.93; 95% CI, 0.55–1.56). Among adalimumab initiators, combination therapy was associated with longer time to treatment failure (hazard ratio, 0.40; 95% CI, 0.19–0.81). A trend toward lower anti-drug antibody development in the combination therapy arm was not significant (infliximab: odds ratio, 0.72; 95% CI, 0.49–1.07; adalimumab: odds ratio, 0.71; 95% CI, 0.24–2.07). No differences in patient-reported outcomes were observed. Combination therapy resulted in more AEs but fewer SAEs. Conclusions Among adalimumab but not infliximab initiators, patients with pediatric Crohn’s disease treated with methotrexate combination therapy experienced a 2-fold reduction in treatment failure with a tolerable safety profile. ClinicalTrials.gov, Number: NCT02772965.
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    Issues in Conducting Randomized Controlled Trials of Health Services Research Interventions in Nonacademic Practice Settings: The Case of Retail Pharmacies
    (2002-08) Weinberger, Morris; Murray, Michael D.; Marrero, David G.; Brewer, Nancy; Lykens, Michael; Harris, Lisa E.; Newell, A Jeffrey; Collins, Joyce; Tierney, William M.
    Objective. To describe unexpected challenges and strategies to overcome them when conducting randomized controlled trials (RCT) of health services research interventions in retail pharmacies. Study Setting. Thirty-six retail drug stores in Indianapolis. Study Design. We conducted an RCT to evaluate the effectiveness of an intervention to increase pharmacists’ involvement in caring for customers. We describe: (1) our RCT as originally designed, (2) unexpected challenges we faced; and (3) how we resolved those challenges. Data Collection/Extraction Methods. Randomized controlled trial. Principal Findings. Major modifications in research design were necessitated by factors such as corporate restructuring, heightened sensitivity to patient confidentiality, and difficulties altering employees’ behavior. We overcame these barriers by conducting research that is consistent with corporate goals, involving appropriate corporate administrators and technical personnel early in the process, and being flexible. Conclusions. Health services researchers should conduct RCTs in a variety of nonacademic practice settings to increase generalizability and better reflect the true impact of interventions. Pragmatic problems, although significant, can be successfully overcome.