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Accessibility of Somatic Genetic Testing for Cancer Treatment Decisions.
No full textAdvances in cancer genomics have significantly influenced and improved oncologic treatments in recent years. Somatic genetic testing, which assesses for gene amplification and acquired mutations in tumor tissue, enables the identification of actionable mutations (i.e., biomarkers) to determine patients who may benefit from targeted therapies. Despite the progress made in somatic genetic testing, broad accessibility and adoption have been limited due to multifactorial barriers. Systematically addressing obstacles to somatic genetic testing is required to enhance availability, facilitate cancer treatments, and ultimately improve patient care
Connected Care for Older Adults: A Pilot Intervention Engaging Community Health Workers to Advance Age-Friendly Care in Rural Oregon.
No full textBACKGROUND: Aging in a rural setting presents unique challenges including limited access to in-home care, lack of social support, language and cultural barriers, and the lack of transportation. We conducted a pilot study embedding community health workers (CHWs) into rural primary care teams to assist with implementation of the 4Ms of the Age-Friendly Health System: What Matters, Mentation, Medication, and Mobility.
METHODS: The Connected Care for Older Adults model embeds CHWs in primary care and they conduct home visits to implement 4Ms protocols for patients 55 and older, living independently, and considered to be medically frail by a PCP, or meet criteria by the Edmonton Frail Scale. Patients complete the program in approximately 90 days. Feedback was collected from patients, caregivers, providers, and CHWs; health care impact was collected from electronic health records.
RESULTS: We enrolled 388 patients from 79 PCPs at 7 clinics. Patients were 63% female with an average age of 77 years. Over 95% were public payer, 49% had been to the ED in the past 12 months, and 34% had been hospitalized. The program made a positive difference for 95% of responding patients (n = 120) and 100% of responding providers (n = 19) were very satisfied with the program. Clinicians cited the CHWs\u27 ability to support resource connections, address social isolation and social needs, provide regular check-ins, and help to get patients and families engaged in care as positive components of the model. Early data suggests this program may reduce health care utilization.
CONCLUSIONS: Connected Care for Older Adults incorporates CHWs in primary care settings to deliver age-friendly care to rural, underserved adults 55 and older. Early findings and feedback from participating patients, caregivers, providers, and CHWs suggest that this is a promising approach to delivering age-friendly care
Lipoic Acid for Treatment of Progressive Multiple Sclerosis: A Phase 2 Randomized Clinical Trial.
No full textBACKGROUND AND OBJECTIVES: A pilot trial of the antioxidant lipoic acid (LA) in secondary progressive multiple sclerosis (MS) demonstrated a reduction in the whole-brain atrophy, suggesting neuroprotection. This study determined whether LA preserved walking speed, reduced brain atrophy, and was safe in progressive MS (PMS).
METHODS: This phase 2, 24-month, randomized, double-blind, placebo-controlled clinical trial (2018-2023) recruited a convenience sample from 10 US sites, including 5 Veterans Affairs medical centers and 1 Canadian site. Inclusion criteria were as follows: age ≥18 years, primary or secondary PMS, Expanded Disability Status Scale (EDSS) score 3.0-6.5, and relapse-independent disability worsening in the previous 2 years. Exclusion criteria were as follows: confounders of mobility outcomes, LA use in the previous 2 years, and MRI contraindications. Concurrent disease-modifying therapy (DMT) was permitted. Participants were block-randomized by site (1:1) to receive 1,200 mg daily oral LA or placebo. The sample size (n = 118) was powered to detect Timed 25-Foot Walk (primary outcome) speed differences, allowing 25% attrition. Secondary outcomes were brain atrophy, other clinical and patient-reported disabilities, and adverse events. Study visits occurred every 6 months. Laboratory monitoring was increased to every 3 months because of treatment-related proteinuria. Intention-to-treat analysis used linear mixed-effects models.
RESULTS: Participants in the LA (54) and placebo (61) groups were 54.8% female (age 59.1 (SD 8.5) years), with a disease duration of 16.3 (SD 9.7) years and a median EDSS score of 6.0 (interquartile range 4.0-6.0), and 55.7% were on DMT. Groups were matched at baseline. LA participants discontinued from the study more often (37%) than placebo (17%). LA did not slow declines in walking speed (-0.39 ft/sec vs -0.30 ft/sec; -0.08 [-0.33 to 0.17]), nor showed differences in mobility, other clinical, or patient-reported outcomes from placebo. Whole-brain volume seemed stable in LA participants, whereas it trended toward a decrease in placebo, even after accounting for an increased total T2-weighted lesion volume that was greater in the LA group. Deep gray matter volume remained stable in LA participants and decreased in placebo participants. The LA group experienced more proteinuria and fewer suicidal ideation events than the placebo group.
DISCUSSION: LA did not slow decline in walking speed or have other clinical effects different from placebo and was associated with newly described adverse events. Investigating LA mechanisms may help interpretation of volumetric imaging biomarkers in PMS.
TRIAL REGISTRATION INFORMATION: NCT03161028. clinicaltrials.gov/study//NCT03161028, first submission May 18, 2017; first patient enrolled August 17, 2018.
CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that in people with primary or secondary PMS, oral LA did not improve timed walking speed at 24 months compared with placebo
Pharmacodynamics of vicadrostat for aldosterone synthase inhibition in patients with CKD.
No full textOBJECTIVE: Aldosterone synthase inhibition may affect cortisol synthesis due to homology between CYP11B2 (aldosterone synthase) and CYP11B1. The selectivity of vicadrostat, a highly selective aldosterone synthase inhibitor, for aldosterone suppression was evaluated by corticosteroid assessment in participants with albuminuric CKD (with or without T2D) in a randomized, double-blind, placebo-controlled phase 2 trial (NCT05182840).
METHODS: After randomization to receive empagliflozin 10 mg once-daily or matched placebo for an 8-week run-in (plus renin-angiotensin system inhibitors), 586 participants were re-randomized to receive vicadrostat (3, 10, or 20 mg once-daily) or matched placebo for 14 weeks, with a 4-week follow-up. Our analysis included 410 participants who completed treatment. Plasma corticosteroids (aldosterone, cortisol, corticosterone, 11-deoxycorticosterone, and 11-deoxycortisol) were measured using liquid chromatography tandem mass spectrometry. Effects were evaluated via mixed effects models for repeated measures.
RESULTS: Dose-dependent suppression of plasma aldosterone was observed, with maximum suppression at week 14 resulting in geometric mean changes of -49.5% (95% CI: -68.7, -18.5) and -52.1% (-70.7, -21.6) for vicadrostat 20 mg given with and without empagliflozin, respectively. From baseline to week 14, increases were observed in mean plasma corticosterone, 11-deoxycorticosterone, and 11-deoxycortisol. Plasma 11-deoxycorticosterone increased by 222.8% (95% CI: 103.2, 412.7) and 231.5% (95% CI: 106.4, 432.2) for vicadrostat 20 mg given with or without empagliflozin, respectively, and plasma 11-deoxycortisol increased by 112.5% (95% CI: 36.0, 231.9) and 121.0% (95% CI: 40.0, 249.0) for the same dose groups. No increase or decrease in plasma cortisol was observed across vicadrostat dose groups with or without empagliflozin. Aldosterone suppression was sustained to 4 weeks post-treatment, while precursor levels normalized within 1 week of treatment cessation.
CONCLUSIONS: Vicadrostat, with or without background empagliflozin, selectively suppressed aldosterone over cortisol. These findings will be explored in a phase 3 trial program
Mind Over Matter: A group intervention integrating CBT, ACT, and psychoeducation to empower emotional coping in cancer patients and caregivers.
No full textOBJECTIVE: One in three individuals will be diagnosed with cancer, often accompanied by psychological distress that worsens medical outcomes and raises healthcare costs. Mind Over Matter (MOM) is a five-week psychoeducational group program designed to support the emotional well-being of cancer patients and caregivers.
METHODS: MOM integrates Acceptance and Commitment Therapy (ACT), Cognitive Behavioral Therapy (CBT), and psychoeducation. Offered in-person or via telehealth, it helps participants manage the content of, and relationship to, thoughts and feelings.
RESULTS: Since 2014, MOM has expanded to nine annual internal offerings. Externally, 60 facilitators have been trained, with the first cohort delivering 16 MOM programs within one year. Preliminary data indicate reductions in anxiety, depression, and physical symptom severity. MOM has been culturally adapted for Spanish-speaking participants, and feasibility among Black and African American women is under evaluation.
CONCLUSION: MOM is an innovative, evidence-based coping program for cancer care, scalable and adaptable across diverse healthcare settings
5. Driving Participation: Increasing Nurse Participation in Committees Using an Evidence-Based Practice Approach.
No full text
Decreasing Risk Factors for Post-Intensive Care Syndrome Using Nurse-Led Rounds and a Novel ICU Liberation Bundle
No full textBackground: Critically ill patients are more likely to survive today than at any other time in history. As more patients recover from critical illnesses, however, many experience health impairments known as post-intensive care syndrome. The Society of Critical Care Medicine developed the ICU Liberation Bundle to decrease the risk of post-intensive care syndrome. Problem: An audit of 100 patient charts identified complete ICU Liberation Bundle documentation in only 20% of eligible patient days, highlighting the need for increased consistency in bundle implementation. Since the ICU Liberation Bundle addresses modifiable post-intensive care syndrome risk factors, lack of consistency implementing bundle interventions increases the risk of post-intensive care syndrome development. Methods: The unit-based council collaborated with interdisciplinary stakeholders to initiate nurse-led rounds centered around a bundle-based tool to decrease the prevalence of risk factors associated with post-intensive care syndrome . To support the practice change, stakeholders participated in skills days and simulations to train on rounding tool use. Pre-implementation and post-implementation compliance and outcome data were collected and evaluated for change . Results: Post-implementation data demonstrates a 57% increase in ICU Liberation Bundle compliance, as well as a 31% reduction in average mechanical ventilation duration (p=0.014), a 32% reduction in average intensive care unit length of stay (p=0.005), 26.6% reduction in average foley catheter duration (p=0.001), a 23% reduction in average central line duration (p=0.043), and a 135% increase in patient mobility. Conclusion: Implementation of nurse-led rounds using an ICU Liberation Bundle-based framework improved consistency of bundle interventions and reduced risk factors for post-intensive care syndrome development in one intensive care unit