Browsing by Subject "Randomized controlled trial"

Now showing 1 - 10 of 25
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    A Cost-Effectiveness Analysis: Personal Systems Approach in Improving Medication Adherence in Adult Kidney Transplant Patients
    (Wolters Kluwer, 2022) Whittington, Melanie; Goggin, Kathy; Glasscock, Ernest L.; Noel-MacDonnell, Janelle; Hathaway, Donna; Remy, Laura; Aholt, Dana; Clark, Debra; Miller, Courtney; Ashbaugh, Catherine; Wakefield, Mark; Bartlett Ellis, Rebecca; Russell, Cynthia; School of Nursing
    Interventions to improve medication non-adherence in transplantation have recently moved from a focus on motivation and intention, to a focus on person-level quality improvement strategies. These strategies link adherence to established daily routines, environmental cues and supportive people. The objective of this evaluation was to estimate the cost of implementation and the cost-effectiveness of a person-level intervention shown to increase medication adherence. To estimate the intervention costs, a direct measure micro-costing approach was used following key informant interviews with project champions and a review of implementation expenditures. Cost-effectiveness was calculated by comparing the incremental implementation costs and healthcare costs associated with non-adherence to the incremental percent adherent, defined as the percent of patients who took greater or equal to 85% of their medication doses, for each pairwise comparison. The intervention was low-resource to implement, costing approximately $520 to implement per patient, and was associated with significant improvements in medication adherence. These implementation costs were more than outweighed by the expected healthcare savings associated with improvements in adherence. This person-level intervention is a low cost, efficacious intervention associated with significant statistical and clinical improvements in medication adherence in adult kidney transplant recipients.
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    A pragmatic, stepped-wedge, hybrid type II trial of interoperable clinical decision support to improve venous thromboembolism prophylaxis for patients with traumatic brain injury
    (Springer Nature, 2024-08-05) Tignanelli, Christopher J.; Shah, Surbhi; Vock, David; Siegel, Lianne; Serrano, Carlos; Haut, Elliott; Switzer, Sean; Martin, Christie L.; Rizvi, Rubina; Peta, Vincent; Jenkins, Peter C.; Lemke, Nicholas; Thyvalikakath, Thankam; Osheroff, Jerome A.; Torres, Denise; Vawdrey, David; Callcut, Rachael A.; Butler, Mary; Melton, Genevieve B.; Surgery, School of Medicine
    Background: Venous thromboembolism (VTE) is a preventable medical condition which has substantial impact on patient morbidity, mortality, and disability. Unfortunately, adherence to the published best practices for VTE prevention, based on patient centered outcomes research (PCOR), is highly variable across U.S. hospitals, which represents a gap between current evidence and clinical practice leading to adverse patient outcomes. This gap is especially large in the case of traumatic brain injury (TBI), where reluctance to initiate VTE prevention due to concerns for potentially increasing the rates of intracranial bleeding drives poor rates of VTE prophylaxis. This is despite research which has shown early initiation of VTE prophylaxis to be safe in TBI without increased risk of delayed neurosurgical intervention or death. Clinical decision support (CDS) is an indispensable solution to close this practice gap; however, design and implementation barriers hinder CDS adoption and successful scaling across health systems. Clinical practice guidelines (CPGs) informed by PCOR evidence can be deployed using CDS systems to improve the evidence to practice gap. In the Scaling AcceptabLE cDs (SCALED) study, we will implement a VTE prevention CPG within an interoperable CDS system and evaluate both CPG effectiveness (improved clinical outcomes) and CDS implementation. Methods: The SCALED trial is a hybrid type 2 randomized stepped wedge effectiveness-implementation trial to scale the CDS across 4 heterogeneous healthcare systems. Trial outcomes will be assessed using the RE2-AIM planning and evaluation framework. Efforts will be made to ensure implementation consistency. Nonetheless, it is expected that CDS adoption will vary across each site. To assess these differences, we will evaluate implementation processes across trial sites using the Exploration, Preparation, Implementation, and Sustainment (EPIS) implementation framework (a determinant framework) using mixed-methods. Finally, it is critical that PCOR CPGs are maintained as evidence evolves. To date, an accepted process for evidence maintenance does not exist. We will pilot a "Living Guideline" process model for the VTE prevention CDS system. Discussion: The stepped wedge hybrid type 2 trial will provide evidence regarding the effectiveness of CDS based on the Berne-Norwood criteria for VTE prevention in patients with TBI. Additionally, it will provide evidence regarding a successful strategy to scale interoperable CDS systems across U.S. healthcare systems, advancing both the fields of implementation science and health informatics.
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    Cognitive-Behavioral Therapy for Schizophrenia: Applications to Social Work Practice
    (Taylor & Francis, 2010) Gregory, Jr., Virgil Lee
    Schizophrenia is a psychotic disorder that has been considered to be the epitome of a severe mental illness. The negative psychosocial consequences of schizophrenia are well documented. Despite the advent of antipsychotic medication, residual symptoms persist for many persons diagnosed with schizophrenia. Cognitive-behavioral therapy (CBT) has emerged as an adjunctive treatment to pharmacotherapy. Cognitive-behavioral theories of positive and negative symptoms are described, as are interventions. Meta-analyses have supported the use of CBT for schizophrenia. This article describes and synthesizes the literature to articulate precise applications to social work practice and the congruence between CBT for schizophrenia and the social work profession. Limitations of CBT are also discussed.
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    Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE): Rationale, study design, methods, and sample characteristics
    (Elsevier, 2022-07) Matthias, Marianne S.; Adams, Jasma; Burgess, Diana J.; Daggy, Joanne; Eliacin, Johanne; Flores, Perla; Hirsh, Adam T.; Myers, Laura J.; Perkins, Anthony J.; Menen, Tetla; Procento, Philip; Rand, Kevin L.; Salyers, Michelle P.; Shanahan, Mackenzie L.; Bair, Matthew J.; Medicine, School of Medicine
    Background Chronic pain is associated with profound negative effects, and racial disparities are well-documented in chronic pain treatment. In addition, Black patients report poorer communication with providers and exhibit lower levels of patient activation (self-management self-efficacy) than White patients. Although the causes of healthcare disparities are complex and require intervention at multiple levels, empowering patients is one critical path to achieving health equity. The current study is a coaching intervention focused on increasing patient activation and building communication skills for Black patients with chronic pain. Methods In this randomized controlled trial, 250 Black patients with chronic pain were randomized to either the coaching intervention or an attention control arm. Intervention patients attended 6 telephone-delivered individual coaching sessions over 12 weeks. Coaching focused on clarifying and prioritizing goals and on communication skills, such as agenda setting. The primary outcome is patient activation. Secondary outcomes include communication self-efficacy, pain intensity and interference, and psychological functioning. Discussion Having the knowledge and confidence to participate in one's pain care, coupled with the skills needed to effectively communicate with providers, is essential to optimize chronic pain care. This is particularly important for Black patients who often experience lower quality pain care. Interventions such as COOPERATE hold promise for helping patients to acquire the requisite tools to take greater control of their chronic pain care.
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    Diet and exercise intervention adherence and health-related outcomes among older long-term breast, prostate, and colorectal cancer survivors
    (Springer, 2014-10) Winger, Joseph G.; Mosher, Catherine E.; Rand, Kevin L.; Morey, Miriam C.; Snyder, Denise C.; Demark-Wahnefried, Wendy; Department of Psychology, School of Science
    BACKGROUND: Diet and exercise interventions for cancer survivors result in health benefits; however, few studies have examined health outcomes in relation to adherence. PURPOSE: We examined associations between adherence to components of a diet-exercise intervention and survivors' physical and mental health. METHODS: A randomized controlled trial tested a telephone and mailed print intervention among 641 older, overweight, long-term survivors of breast, prostate, and colorectal cancer. Dietary and exercise behaviors were assessed at 14 time points throughout the year-long intervention; health outcomes were examined postintervention. RESULTS: Telephone session attendance had significant indirect relationships with health outcomes through intervention-period exercise and dietary behavior. Attendance showed positive indirect relationships with physical function (β = 0.11, p < 0.05), basic and advanced lower extremity function (β = 0.10, p < 0.05/β = 0.09, p < 0.05), and mental health (β = 0.05, p < 0.05), and a negative indirect relationship with body mass index (β = -0.06, p < 0.05). CONCLUSIONS: Session attendance is vital in facilitating improvement in health behaviors and attendant outcomes (Clinicaltrials.gov number NCT00303875).
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    Effect of Modernized Collaborative Care for Depression on Brain-Derived Neurotrophic Factor (BDNF) and Depressive Symptom Clusters: Data from the eIMPACT Trial
    (Elsevier, 2023) Crawford, Christopher A.; Williams, Michelle K.; Shell, Aubrey L.; MacDonald, Krysha L.; Considine, Robert V.; Wu, Wei; Rand, Kevin L.; Stewart, Jesse C.; Psychology, School of Science
    Brain-derived neurotrophic factor (BDNF) levels are lower in people with depression and are normalized following pharmacological treatment. However, it is unknown if psychological treatments for depression improve BDNF and if change in BDNF is a mediator of intervention effects on depressive symptoms. Therefore, using data from the eIMPACT trial, we sought to determine the effect of modernized collaborative care for depression on 12-month changes in BDNF and cognitive/affective and somatic depressive symptom clusters and to examine whether BDNF changes mediate intervention effects on depressive symptoms. 216 primary care patients with depression from a safety net healthcare system were randomized to 12 months of the eIMPACT intervention (internet cognitive-behavioral therapy [CBT], telephonic CBT, and select antidepressant medications) or usual primary care. Plasma BDNF was measured with commercially available kits, and depressive symptom clusters were assessed by the Patient Health Questionnaire-9. The intervention did not influence BDNF but did improve both the cognitive/affective and somatic clusters over 12 months. Changes in BDNF did not mediate the intervention effect on either cluster. Our findings suggest that modernized collaborative care is an effective treatment for both the cognitive/affective and somatic symptoms of depression and that the mechanism of action is not improvements in BDNF.
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    From the Cochrane Library: Interventions for Pityriasis Rosea
    (JMIR, 2023-06-05) Méndez, Alejandra; Stevens, Carly; Murina, Andrea; Dermatology, School of Medicine
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    Impact of acceptance and commitment therapy on physical and psychological symptoms in advanced gastrointestinal cancer patients and caregivers: Secondary results of a pilot randomized trial
    (Elsevier, 2023) Burns, Marcia F.; Secinti, Ekin; Johns, Shelley A.; Wu, Wei; Helft, Paul R.; Turk, Anita A.; Loehrer, Patrick J.; Sehdev, Amikar; Al-Hader, Ahmad A.; Mosher, Catherine E.; Psychology, School of Science
    Patients with advanced gastrointestinal cancer often experience high symptom burden, which is associated with heightened distress in both patients and their family caregivers. Few interventions have been tested to jointly address patient and caregiver symptoms in advanced gastrointestinal cancer. In a randomized pilot trial, telephone-based, dyadic acceptance and commitment therapy (ACT) was found to be feasible in this population. The present secondary analyses examined the impact of this intervention on patient and caregiver physical and psychological symptoms. Patients and caregivers (N = 40 dyads) were recruited from clinics in Indianapolis, Indiana and randomized to either six weeks of telephone-based ACT or education/support, an attention control condition. Outcomes were assessed at baseline and at 2 weeks and 3 months post-intervention. Study group differences in outcomes were not statistically significant. However, when examining within-group change, only ACT patients experienced moderate reductions in pain severity and interference at 2 weeks post-intervention (effect size [ES]=−0.47; −0.51) as well as moderate reductions in depressive symptoms at 2 weeks (ES=−0.42) and 3 months (ES=−0.41) post-intervention. ACT caregivers experienced moderate reductions in sleep disturbance (ES=−0.56; −0.49) and cognitive concerns (ES=−0.61; −0.85) across follow-ups. Additionally, caregivers in both conditions experienced moderate reductions in fatigue (ES=−0.38 to −0.70) and anxiety (ES=−0.40 to −0.49) across follow-ups. Findings suggest that ACT may improve certain symptoms in dyads coping with advanced gastrointestinal cancer and warrant replication in a larger trial.
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    Improving Early Dementia Detection Among Diverse Older Adults With Cognitive Concerns With the 5-Cog Paradigm: Protocol for a Hybrid Effectiveness-Implementation Clinical Trial
    (JMIR, 2025-04-03) Rosansky Chalmer, Rachel Beth; Ayers, Emmeline; Weiss, Erica F.; Fowler, Nicole R.; Telzak, Andrew; Summanwar, Diana; Zwerling, Jessica; Wang, Cuiling; Xu, Huiping; Holden, Richard J.; Fiori, Kevin; French, Dustin D.; Nsubayi, Celeste; Ansari, Asif; Dexter, Paul; Higbie, Anna; Yadav, Pratibha; Walker, James M.; Congivaram, Harrshavasan; Adhikari, Dristi; Melecio-Vazquez, Mairim; Boustani, Malaz; Verghese, Joe; Medicine, School of Medicine
    Background: The 5-Cog paradigm is a 5-minute brief cognitive assessment coupled with a clinical decision support tool designed to improve clinicians' early detection of cognitive impairment, including dementia, in their diverse older primary care patients. The 5-Cog battery uses picture- and symbol-based assessments and a questionnaire. It is low cost, simple, minimizes literacy bias, and is culturally fair. The decision support component of the paradigm helps nudge appropriate care provider response to an abnormal 5-Cog battery. Objective: The objective of our study is to evaluate the effectiveness, implementation, and cost of the 5-Cog paradigm. Methods: We will enroll 6600 older patients with cognitive concerns from 22 primary care clinics in the Bronx, New York, and in multiple locations in Indiana for this hybrid type 1 effectiveness-implementation trial. We will analyze the effectiveness of the 5-Cog paradigm to increase the rate of new diagnoses of mild cognitive impairment syndrome or dementia using a pragmatic, cluster randomized clinical trial design. The secondary outcome is the ordering of new tests, treatments, and referrals for cognitive indications within 90 days after the study visit. The 5-Cog's decision support component will be deployed as an electronic medical record feature. We will analyze the 5-Cog's implementation process, context, and outcomes through the Consolidated Framework for Implementation Research using a mixed methods design (surveys and interviews). The study will also examine cost-effectiveness from societal and payer (Medicare) perspectives by estimating the cost per additional dementia diagnosis. Results: The study is funded by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (2U01NS105565). The protocol was approved by the Albert Einstein College of Medicine Institutional Review Board in September 2022. A validation study was completed to select cut scores for the 5-Cog battery. Among the 76 patients enrolled, the resulting clinical diagnoses were as follows: dementia in 32 (42%); mild cognitive impairment in 28 (37%); subjective cognitive concerns without objective cognitive impairment in 12 (16%); no cognitive diagnosis assigned in 2 (3%). The mean scores were Picture-Based Memory Impairment Screen 5.8 (SD 2.7), Symbol Match 27.2 (SD 18.2), and Subjective Motoric Cognitive Risk 2.4 (SD 1.7). The cut scores for an abnormal or positive result on the 5-Cog components were as follows: Picture-Based Memory Impairment Screen ≤6 (range 0-8), Symbol Match ≤25 (range 0-65), and Subjective Motoric Cognitive Risk >5 (range 0-7). As of December 2024, a total of 12 clinics had completed the onboarding processes, and 2369 patients had been enrolled. Conclusions: The findings of this study will facilitate the rapid adaptation and dissemination of this effective and practical clinical tool across diverse primary care clinical settings.
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    Inhaled nitric oxide as adjunctive therapy for severe malaria: a randomized controlled trial
    (BioMed Central, 2015-10-29) Hawkes, Michael T.; Conroy, Andrea L.; Opoka, Robert O.; Hermann, Laura; Thorpe, Kevin E.; McDonald, Chloe; Kim, Hani; Higgins, Sarah; Namasopo, Sophie; John, Chandy; Miller, Chris; Liles, W. Conrad; Kain, Kevin C.; Department of Pediatrics, School of Medicine
    Background Severe malaria remains a major cause of childhood mortality globally. Decreased endothelial nitric oxide is associated with severe and fatal malaria. The hypothesis was that adjunctive inhaled nitric oxide (iNO) would improve outcomes in African children with severe malaria. Methods A randomized, blinded, placebo-controlled trial of iNO at 80 ppm by non-rebreather mask versus room air placebo as adjunctive treatment to artesunate in children with severe malaria was conducted. The primary outcome was the longitudinal course of angiopoietin-2 (Ang-2), an endothelial biomarker of malaria severity and clinical outcome. Results One hundred and eighty children were enrolled; 88 were assigned to iNO and 92 to placebo (all received IV artesunate). Ang-2 levels measured over the first 72 h of hospitalization were not significantly different between groups. The mortality at 48 h was similar between groups [6/87 (6.9 %) in the iNO group vs 8/92 (8.7 %) in the placebo group; OR 0.78, 95 % CI 0.26–2.3; p = 0.65]. Clinical recovery times and parasite clearance kinetics were similar (p > 0.05). Methaemoglobinaemia >7 % occurred in 25 % of patients receiving iNO and resolved without sequelae. The incidence of neurologic deficits (<14 days), acute kidney injury, hypoglycaemia, anaemia, and haemoglobinuria was similar between groups (p > 0.05). Conclusions iNO at 80 ppm administered by non-rebreather mask was safe but did not affect circulating levels of Ang-2. Alternative methods of enhancing endothelial NO bioavailability may be necessary to achieve a biological effect and improve clinical outcome.