Improving Access to Yoga for Chronic Pain in a Spanish-Speaking Community: A Quality Improvement Initiative.

BACKGROUND: The recent increase in opioid misuse and overdose among the Hispanic population signifies the need for an initiative to increase efforts in pain management in the Hispanic population. Yoga is an evidence-based therapeutic intervention that is effective for several pain-associated disorders. However, in the United States, it is primarily taught in English and not always accessible. This quality improvement (QI) project aimed to assess the outcome of implementing a yoga program on pain and quality of life in the Hispanic population. METHODS: Twenty Spanish-speaking community center members participated in a linguistically-tailored yoga program over the course of 10 weeks that included educational, demonstration, and practice videos. Outcome measures of the QI program included changes in pain interference, physical function, opioid medication use, the overall impression of change in pain, satisfaction with the program, and the likelihood of continuation of yoga practice. RESULTS: Data collected from participants (n = 16) after the 10-week period indicated that nearly 60% experienced an improvement in their overall impression of change in pain; their reported likelihood of continuation of yoga practice at home or another location were 6.8 and 7.4, respectively, on a 10-point scale. While pain interference was unaffected, there was an improvement in markers of physical function, including a two-fold improvement in general activity without limitations. The mean average intensity of pain decreased by 33%. CONCLUSION: The use of a linguistically-tailored yoga program improved self-reported overall pain, physical function, average intensity of pain, and initiated an interest in participants in utilizing yoga practice for self-management of pain. This QI project provides results that can be used for further implementation initiatives at other sites and consideration of use in diverse populations.

Emotional, mental health and physical symptom experience of patients hospitalized with COVID-19 up to 3 months post-hospitalization: A longitudinal study.

AIMS AND OBJECTIVES: To explore emotional, mental health and physical symptoms up to 3 months after discharge for adults hospitalized with COVID-19. BACKGROUND: 10%-30% of adults with COVID-19 experience physical and psychological symptoms 3 months or more following infection. Knowing symptoms can help direct early intervention. DESIGN: A longitudinal descriptive design to study COVID-related symptoms 2 weeks, 6 weeks and 3 months after hospitalization. METHODS: Sixty-six patients were recruited from a hospital system in Midwestern US (October 2020-May 2021). Participants self-reported demographics, hospital and post discharge symptoms, PROMIS measures (depression, anxiety, fatigue, cognitive function, satisfaction social roles, sleep disturbance) and Impact of Event Scale-Revised (IES-R). Hospital length of stay, comorbidities, lowest oxygen saturation, respiratory support and resources used were collected. Descriptive and nonparametric statistics described the sample and identified correlations between variables. The STROBE checklist was used. RESULTS: Data from 1 (T1) and 3 months (T2) post discharge were analysed (N = 52). A majority were female, white and married; 96% experienced ≥1 COVID-related symptoms at T1; 85% at T2. Fatigue was most prevalent, followed by shortness of breath, muscle weakness and foggy thinking. More physical symptoms during hospitalization correlated positively with number of symptoms at T1 and T2; a majority stated these impacted their normal routine 'somewhat' or 'a lot'. T1 depression highly correlated with all T2 PROMIS and IES-R scores and number of physical symptoms. More symptoms at T1 were associated with worse fatigue, lower cognitive function and lower satisfaction with social roles at T2. CONCLUSION: This study adds to the growing knowledge of mental, physical and emotional symptoms and relationships between these early after hospitalization with COVID-19. RELEVANCE TO CLINICAL PRACTICE: Findings can help identify holistic nursing interventions to improve health and mitigate symptoms for people with long COVID. PATIENT OR PUBLIC CONTRIBUTION: Patients contributed via study participation.

Symptoms in Patients Receiving Noninvasive Ventilation in the Intensive Care Unit.

BACKGROUND: Although a multitude of studies have demonstrated the effectiveness of noninvasive ventilation (NIV) for treatment of respiratory insufficiency, there have been few investigations of patients' experiences while receiving this common treatment. Identification of the presence, intensity, and distress of symptoms during NIV will inform the development and testing of interventions to best manage them and improve patients' intensive care unit (ICU) experiences. OBJECTIVE: The objectives of this study were (a) to identify the presence, intensity, and distress of symptoms in patients receiving NIV in the ICU using a modified version of the Edmonton Symptom Assessment Scale (MESAS) and (b) to describe the most common and distressing symptoms experienced by patients. METHODS: A cross-sectional descriptive design was used with a convenience sample of 114 participants enrolled from three ICUs at one Midwestern medical center. Participants were approached if they were English-speaking, were 18 years old or older, and had an active order for NIV; exclusions included use of personal NIV equipment, severe cognitive impairment, or problems communicating. Demographic and clinical data were obtained from the electronic health record. Presence, intensity, and distress of patient-reported symptoms were obtained once using a modified, 11-item version of the MESAS. RESULTS: The mean age of participants was 68 years old, and 54.4% were male. The primary type of NIV was bi-level positive airway pressure; a nasal/oral mask was most frequently used. The symptoms experienced by most of the participants were thirst, anxiety, tiredness, and restlessness; these symptoms were rated as moderate or severe in both intensity and distress by most participants experiencing the symptoms. DISCUSSION: Patients in the ICU experience both intense and distressful symptoms that can be severe while undergoing treatment with NIV. Future research is warranted to determine these symptoms' interrelatedness and develop interventions to effectively manage patient-reported symptoms.

Acceptability, Feasibility, and Efficacy of Telehealth Interventions for HIV Testing and Treatment in Adult Populations.

Introduction: The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to the rapid adoption of telehealth to provide HIV care and treatment. However, limited information exists about the feasibility, acceptability, and efficacy of telehealth interventions at different points of the HIV care continuum. Methods: A systematic search was conducted of Ovid MEDLINE, PsycINFO, and CINAHL databases to synthesize evidence regarding the feasibility, acceptability, and efficacy of videoconferencing and video-based interventions for HIV testing and treatment in adult populations. Seventeen articles published through July 2021 were included in the review. We used descriptive methods to analyze data, and findings were reported using frequencies and percentages. Results: Findings show that videoconferencing and video-based interventions are generally feasible and acceptable. Videoconferencing is effective in improving adherence to HIV treatment and in promoting HIV testing. In addition, video-based interventions were effective in promoting HIV testing, treatment initiation, and adherence to medication. Both modalities enhanced linkage and retention in treatment for HIV-positive patients. Conclusions: Video-based and videoconferencing interventions are beneficial in HIV testing and treatment. However, the scarcity of primary studies employing these telehealth modalities means that there is a need for more research in these areas. Also, reviewed studies suffered from several limitations, including reliance on subjective measures, lack of standardized ways of evaluating acceptability and feasibility, use of small sample sizes, and short follow-up durations. In addition, there was less representation of studies from resource-limited settings disproportionately affected by HIV and AIDS. Thus, future research should focus on addressing these challenges.

Survey of Nurses' Use of the Clinically Aligned Pain Assessment (CAPA) Tool.

BACKGROUND: Limited research is available on tools for assessing pain and its effect on function in the acute care setting. AIM: This research's purpose is to describe nurses' use of the Clinically Aligned Pain Assessment (CAPA) tool and their beliefs about its utility for assessing pain compared to the numeric rating scale (NRS) in a hospital where CAPA had been used for 6 years. DESIGN: A cross-sectional self-report survey. METHODS: Nurses (N = 110) from 13 adult inpatient units in an academic center participated in this survey describing frequency of CAPA and NRS use, CAPA domains documented, and how nurses asked about pain and distinguished between categories when coding for documentation. Beliefs about the tools' effectiveness were also reported. RESULTS: Most nurses used CAPA routinely for assessments; almost half used the NRS at times. They believed both tools were effective for assessment, but CAPA was more effective to determine what intervention was needed. They also believed patient report using CAPA was more likely to match the nurse's assessment; a majority reported incorporating their observations into CAPA documentation. Most asked the patient about pain without using CAPA words, although many used the specific words. Practice varied in how nurses determined which category to select in the comfort domain and which domains were assessed routinely. CONCLUSIONS: Although many nurses believed CAPA was effective, variation existed in how it was used to assess and document pain, increasing potential for inconsistent assessments and interpretations of pain and pain management.

Nurses' use of the clinically aligned pain assessment tool: A mixed methods study.

BACKGROUND: Assessment of pain in the hospital has often relied on intensity rating alone. To address the gap in meeting patients' pain management expectations, a Midwestern medical center implemented the CAPA (Clinical Aligned Pain Assessment) tool for more comprehensive nursing pain assessments. AIMS: This research described nurses' experience using CAPA on an adult general medicine unit and their documentation of the tool in the electronic health record (EHR) more than 5 years after CAPA implementation. DESIGN: Mixed methods exploratory sequential design. METHODS: A convenience sample of nurses (N = 8) participated in 2 focus groups to describe how they used CAPA, how well it assessed pain, how it determined pain interventions, and the challenges and advantages of using CAPA. Patient EHR data (N = 373) for a 6-month period from the same unit were analyzed to evaluate CAPA documentation. RESULTS: Qualitative themes included: benefits of using CAPA, CAPA leads to a more comprehensive picture, variation in how CAPA is used, and challenges. Quantitative findings demonstrated most frequent documentation in the comfort domain and earlier, though still delayed, reassessment when a higher level of pain was noted. Mixed methods analysis revealed variation in knowledge and practice regarding which domains to document each shift and during reassessment. CONCLUSIONS: As patient advocates, nurses are integral to thorough assessment and treatment of pain. Findings identified the need for methodological research of CAPA. As with any assessment tool, when using CAPA, ongoing monitoring is needed to address how it is administered, coded, and used for decision-making about pain management.

A scoping review of outcomes of operational success for nurse scientists in clinical practice settings.

BACKGROUND: The nurse scientist in the clinical setting is a role that has evolved over recent decades to encompass the concomitant development of personal research programs and the facilitation of staff and advanced practice nurse research in health care settings. However, the definition, operationalization, and measures of success are extremely variable. PURPOSE: To identify the defining features and characteristics of the nurse scientist role in clinical practice settings as represented in the existing literature. METHODS: We conducted a scoping review using PubMed and CINAHL databases. We initially identified a total of 3345 references from 1976 to June 2020, 217 of which were published from 2005-2020. We used the Joanna Briggs Institute (JBI) framework to explore the state of the science of the role of nurse scientists in practice settings. DISCUSSION: Approximately 100 articles met the criteria for full-text analysis, and the final review consisted of 20 descriptive analytic studies addressing the nurse scientist role definition, operationalization, and outcome measures. CONCLUSION: Findings suggest that nurse scientist roles serve to promote health system success through a host of research-focused activities that conceivably contribute to improved patient care outcomes. Work is needed to support the cost of requisite resources and infrastructure and to increase acceptance of the role as part of a tenure-earning track in academic settings that also stand to benefit.

Adherence to a Hypoglycemia Protocol in Hospitalized Patients: A Retrospective Analysis.

BACKGROUND: Hypoglycemia can be a common occurrence in hospitalized patients, both those with and without diabetes. Hypoglycemia poses significant risks to hospitalized patients, including increased mortality. OBJECTIVES: This was a retrospective pre-post study of hypoglycemic patients in an academic medical center of an intervention to improve timely staff nurse adherence to a hypoglycemia protocol. The number of mild and severe hypoglycemia events pre- and postintervention, timeliness of adherence to the hypoglycemia protocol, the number of treatment interventions, and time to return patients to euglycemia were analyzed. METHODS: Data from hospitalizations of patients who experienced hypoglycemia (<70 mg/dl) and met inclusion criteria 1 year prior to intervention and 3 years postintervention were extracted, including demographics, glycemic control medications, diagnostic-related group, length of stay, and Charlson comorbidity index. For clarity and to determine if any significant change was sustained, the analysis compared data from 1 year prior to intervention to the second-year postintervention. RESULTS: A total of 7,895 unique hypoglycemic events in 3,819 patients experiencing 20,094 hypoglycemic measures were included in the analysis. Patients were primarily adult, female, and White. Only 58.7% of the sample had diabetes; the median Charlson comorbidity index was 6. Results demonstrated improvement postintervention to registered nurse hypoglycemia protocol adherence regardless of age category or hypoglycemia severity. There was a significant reduction in median time from the first hypoglycemia measure to the second measure. In addition, there was a significant difference in the number of treatment interventions and reduction in time from the first hypoglycemia measure to return of patient to a blood glucose of ≥70 mg/dl. DISCUSSION: These study results support that the use of a standardized hypoglycemia protocol and appropriate nurse workflows enables nurses to manage hypoglycemia promptly and effectively in most acute and critically ill hospitalized patients. Results also supported a differentiation in nurse workflow for patients with mild versus severe hypoglycemia. Implementing these interventions may result in avoidance or mitigation of the potential consequences of severe and/or sustained hypoglycemia.

Who Advances Nursing Science in Practice Settings and How?

Nurse scientist (NS) roles in clinical practice settings are key components of The Future of Nursing and ANCC Magnet® recognition. Despite increased opportunities for NS roles, leveraging these roles to advance nursing science remains at an early stage. We describe opportunities and challenges for NSs in clinical practice settings, highlighting the value of a strong partnership with chief nurse officers as critical for the success of NSs and outcomes associated with these roles.

Recovery Model Implementation for a Medical/Geriatric Psychiatric Unit to Decrease Restraint and Seclusion Episodes: A Quality Improvement Project.

INTRODUCTION: In inpatient behavioral health units, a long-standing behavioral management controversy has been whether to physically restrain or seclude patients. The rate of restraint use at the institution underperformed compared with the national average, which led to the project implementation. AIMS: This quality improvement project's objective was to decrease restraint and seclusion use, improve quality of care, and decrease cost through implementation of recovery model principles. METHOD: Implementation started in October 2019 on a 14-bed inpatient medical/geriatric psychiatric unit with 38 psychiatric RNs at a large academic medical center. The project was a pre-post implementation design with interventions consisting of staff education, RN language observation, and orientation toolkit development. Changes in staff knowledge were measured by Recovery Knowledge Inventory surveys at baseline, 1 week posteducation, and 4 months posteducation. Restraint and seclusion use data were analyzed 3 months preimplementation and 3 months postimplementation. RESULTS: Staff knowledge of the recovery model increased from baseline to 1 week postimplementation in all four survey domains (range = 6% to 9% improvement). While improvements were maintained in two survey domains, two domains of staff knowledge showed slight declines (1% to 2% decline in scores) 4 months postintervention. Restraint use decreased 73.1% and seclusion use decreased 16.3% from pre to postintervention. CONCLUSION: Implementation of recovery model principles can decrease restraint and seclusion episodes, which increases quality and decreases cost to the organization.

Improving the care and health of populations through optimal use of clinical nurse specialists.

Patients with complex and chronic illnesses and those who have significant needs related to care coordination and transitions of care are dependent on access to healthcare providers who are skilled at meeting the distinct needs of these populations and are current in the latest evidence-based practices and guidelines. Clinical nurse specialists (CNSs) are uniquely qualified to care for patients with complex illnesses as well as having the skills to optimize care for entire populations with complex needs. The absence of consistent legislative advanced practice registered nurse recognition of CNSs prevents health care systems from optimal use of this advanced practice registered nurse role to improve and provide safe and quality care for these patients. Additional barriers in optimal utilization of CNSs include lack of consistency: in title protection and licensing from state to state; ensuring patient access through identification and tracking of CNS numbers across the United States in order to determine workforce and educational program requirements; and ensuring appropriate reimbursement for care provided by CNSs. Therefore, it is the position of the American Academy of Nursing that addressing public and private sector regulatory, legislative, and policy concerns related to CNSs is essential to achieving optimal population health outcomes across the nation.

A Novel Research Method for Determining Sedative Exposure in Critically Ill Patients.

BACKGROUND: Although potent sedative and opioid drugs are some of the most commonly used medications to manage pain, anxiety, and discomfort in critically ill patients, conducting clinical trials where sedative and opioid medications are outcome variables within a longitudinal research design can be a methodological challenge. OBJECTIVES: The purpose of this article is to provide in detail a conceptual discussion of the concept and analysis of sedative exposure: A novel research analysis method for aggregating sedative and opioid medication doses from disparate drug classes commonly administered to critically ill patients and used by our team in several clinical research studies. METHODS: Comparing the dose of each sedative and opioid administered to an individual patient (within a defined time interval) to all other patients in a research study receiving the same medications allows for ranking of dosages for each medication by quartiles. Rank values for all sedatives and opioids received can be summed to a single value resulting in a Sedation Intensity Score. In addition, a simple count of how many hours at least one dose of a sedative or opioid medication has been administered can determine sedation frequency. RESULTS: This method can allow for comparison of sedative exposure with medications from disparate drug classes and for analysis of estimates of change in medication use over time. DISCUSSION: This novel research analysis method can overcome the challenges and limitations of determining changes in sedative and opioid medication regimens in cohort and clinical trial study designs.

"Sedation is tricky": A qualitative content analysis of nurses' perceptions of sedation administration in mechanically ventilated intensive care unit patients.

INTRODUCTION: Critical care nurses are responsible for administering sedative medications to mechanically ventilated patients. With significant advancements in the understanding of the impact of sedative exposure on physiological and psychological outcomes of ventilated patients, updated practice guidelines for assessment and management of pain, agitation, and delirium in the intensive care unit were released in 2013. The primary aim of this qualitative study was to identify and describe themes derived from critical care nurses' comments regarding sedation administration practices with mechanically ventilated patients. METHODS: This is a qualitative content analysis of secondary text data captured through a national electronic survey of members of the American Association of Critical-Care Nurses. A subsample (n = 67) of nurses responded to a single, open-ended item at the end of a survey that evaluated nurses' perceptions of current sedation administration practices. FINDINGS: Multiple factors guided sedation administration practices, including individual patient needs, nurses' synthesis of clinical evidence, application of best practices, and various personal and professional practice perspectives. Our results also indicated nurses desire additional resources to improve their sedation administration practices including more training, better communication tools, and adequate staffing. CONCLUSIONS: Critical care nurses endorse recommendations to minimise sedation administration when possible, but a variety of factors, including personal perspectives, impact sedation administration in the intensive care unit and need to be considered. Critical care nurses continue to encounter numerous challenges when assessing and managing sedation of mechanically ventilated patients.

An official American Thoracic Society/International Society for Heart and Lung Transplantation/Society of Critical Care Medicine/Association of Organ and Procurement Organizations/United Network of Organ Sharing Statement: ethical and policy considerations in organ donation after circulatory determination of death.

RATIONALE: Donation after circulatory determination of death (DCDD) has the potential to increase the number of organs available for transplantation. Because consent and management of potential donors must occur before death, DCDD raises unique ethical and policy issues. OBJECTIVES: To develop an ethics and health policy statement on adult and pediatric DCDD relevant to critical care and transplantation stakeholders. METHODS: A multidisciplinary panel of stakeholders was convened to develop an ethics and health policy statement. The panel consisted of representatives from the American Thoracic Society, Society of Critical Care Medicine, International Society for Heart and Lung Transplantation, Association of Organ Procurement Organizations, and the United Network of Organ Sharing. The panel reviewed the literature, discussed important ethics and health policy considerations, and developed a guiding framework for decision making by stakeholders. RESULTS: A framework to guide ethics and health policy statement was established, which addressed the consent process, pre- and post mortem interventions, the determination of death, provisions of end-of-life care, and pediatric DCDD. CONCLUSIONS: The information presented in this Statement is based on the current evidence, experience, and clinical rationale. New clinical research and the development and dissemination of new technologies will eventually necessitate an update of this Statement.

Evaluation of Nurse-Driven Management of Hypoglycemia In Critically Ill Patients.

BACKGROUND: Intensive care unit (ICU) patients experience hypoglycemia at nearly 4 times the rate seen in non-ICU counterparts. Although inpatient hypoglycemia management relies on nurse-driven protocols, protocol adherence varies between institutions and units. OBJECTIVE: To compare hypoglycemia management between ICU and non-ICU patients in an institution with high adherence to a hypoglycemia protocol. METHODS: This secondary analysis used retrospective medical record data. Cases were ICU patients aged 18 years or older with at least 1 hypoglycemic event (blood glucose level < 70 mg/dL); non-ICU controls were matched by age within 10 years, sex, and comorbidities. Time from initial hypoglycemic blood glucose level to subsequent blood glucose recheck, number of interventions, time to normoglycemia, and number of spontaneous hypoglycemic events were compared between groups. RESULTS: The sample included 140 ICU patients and 280 non-ICU controls. Median time to blood glucose recheck did not differ significantly between groups (19 minutes for both groups). Difference in mean number of interventions before normoglycemia was statistically but not clinically significant (ICU, 1.12; non-ICU, 1.35; P < .001). Eighty-four percent of ICU patients and 86% of non-ICU patients returned to normoglycemia within 1 hour. Median time to normoglycemia was lower in ICU patients than non-ICU patients (21.5 vs 26 minutes; P = .01). About 25% of patients in both groups experienced a spontaneous hypoglycemic event. CONCLUSION: Adherence to nurse-driven hypoglycemia protocols can be equally effective in ICU and non-ICU patients. Further research is needed to determine protocol adherence barriers and patient characteristics that influence response to hypoglycemia interventions.

Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial.

IMPORTANCE: Alternatives to sedative medications, such as music, may alleviate the anxiety associated with ventilatory support. OBJECTIVE: To test whether listening to self-initiated patient-directed music (PDM) can reduce anxiety and sedative exposure during ventilatory support in critically ill patients. DESIGN, SETTING, AND PATIENTS: Randomized clinical trial that enrolled 373 patients from 12 intensive care units (ICUs) at 5 hospitals in the Minneapolis-St Paul, Minnesota, area receiving acute mechanical ventilatory support for respiratory failure between September 2006 and March 2011. Of the patients included in the study, 86% were white, 52% were female, and the mean (SD) age was 59 (14) years. The patients had a mean (SD) Acute Physiology, Age and Chronic Health Evaluation III score of 63 (21.6) and a mean (SD) of 5.7 (6.4) study days. INTERVENTIONS: Self-initiated PDM (n = 126) with preferred selections tailored by a music therapist whenever desired while receiving ventilatory support, self-initiated use of noise-canceling headphones (NCH; n = 122), or usual care (n = 125). MAIN OUTCOMES AND MEASURES: Daily assessments of anxiety (on 100-mm visual analog scale) and 2 aggregate measures of sedative exposure (intensity and frequency). RESULTS: Patients in the PDM group listened to music for a mean (SD) of 79.8 (126) (median [range], 12 [0-796]) minutes/day. Patients in the NCH group wore the noise-abating headphones for a mean (SD) of 34.0 (89.6) (median [range], 0 [0-916]) minutes/day. The mixed-models analysis showed that at any time point, patients in the PDM group had an anxiety score that was 19.5 points lower (95% CI, -32.2 to -6.8) than patients in the usual care group (P = .003). By the fifth study day, anxiety was reduced by 36.5% in PDM patients. The treatment × time interaction showed that PDM significantly reduced both measures of sedative exposure. Compared with usual care, the PDM group had reduced sedation intensity by -0.18 (95% CI, -0.36 to -0.004) points/day (P = .05) and had reduced frequency by -0.21 (95% CI, -0.37 to -0.05) points/day (P = .01). The PDM group had reduced sedation frequency by -0.18 (95% CI, -0.36 to -0.004) points/day vs the NCH group (P = .04). By the fifth study day, the PDM patients received 2 fewer sedative doses (reduction of 38%) and had a reduction of 36% in sedation intensity. CONCLUSIONS AND RELEVANCE: Among ICU patients receiving acute ventilatory support for respiratory failure, PDM resulted in greater reduction in anxiety compared with usual care, but not compared with NCH. Concurrently, PDM resulted in greater reduction in sedation frequency compared with usual care or NCH, and greater reduction in sedation intensity compared with usual care, but not compared with NCH. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00440700.

The impact of the COVID-19 pandemic on ICU clinical trials: a description of one research team's experience.

BACKGROUND: Disruptions to clinical trials conducted in the intensive care unit (ICU) due to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2; coronavirus disease 2019 [COVID-19]) pandemic included fewer new trials activated and more trials stopped. While a number of ongoing, non-COVID-19 clinical trials remained open to enrollment, the direct impact of the pandemic on ICUs instilled chaos in this already challenging environment. The numerous challenges need to be reported so investigators can proactively plan and manage these myriad challenges. Thus, the purpose of this study was to describe the impact of the COVID-19 pandemic on screening and accrual for a non-COVID-19 parent clinical trial enrolling critically ill ICU patients receiving mechanical ventilatory support. METHODS: A descriptive, retrospective design using quantitative data from detailed screening logs and qualitative observations with field notes from a parent clinical trial were used to address the objectives. The primary aims of the two-site parent clinical trial (n = 190) are to test the efficacy of self-administration of sedative therapy by mechanically ventilated ICU patients on anxiety and delirium occurrence. ICUs from two academic medical centers [names removed for blinding] plus a community hospital in Minnesota were screened daily for alert patients (Richmond Agitation Sedation Scale [RASS] - 2 to + 1), following commands, hemodynamically stable with sufficient hand grip strength to depress a push-button device. Screening data were summarized based on the primary reason patients were not enrolled (screen failures, declinations of consent). Descriptive statistics (frequencies, percentages), chi-square, and Fisher's Exact test were used to describe the data and to determine any differences among distributions of screening failures and recruitment declinations during the defined pre-pandemic (August 27, 2018-March 15, 2020, 2976 screened patients) and pandemic timeframes (March 16, 2020-February 28, 2022, 3912 screened patients). Qualitative data from varied sources such as screening logs, institutional email communications, staff field notes, and research team meeting minutes were summarized into themes. RESULTS: Despite significantly fewer screen failures due to hypotension, cognitive impairment/dementia, coma, or chemical paralysis with 938 additional patients on the screening log, more were accrued pre-pandemic (n = 55) than during the pandemic period (n = 45); declination reasons were non-significant. Pandemic burdens experienced by study personnel, ICU care providers, and patients/families were revealed that attributed to decreased accrual. CONCLUSIONS: While the parent clinical trial remained opened, cumulative factors adversely impacted the trial during the pandemic period with fewer patients accrued. The human toll of the pandemic on research staff, clinicians, and patients/family members demands that investigators be proactive in managing these challenges to conduct ICU clinical trials successfully, including careful oversight of human and financial resources. TRIAL REGISTRATION: ClinicalTrials.gov NCT#02,819,141 Registered 29 June 2016.

Perceptions, Benefits, and Use of Complementary and Integrative Therapies to Treat Menopausal Symptoms: A Pilot Study.

Background: Menopause symptoms can be debilitating, and the use of menopausal hormone therapy (MHT) has declined significantly since the Women's Health Initiative. Materials and Methods: We surveyed 508 peri- and postmenopausal females to determine (1) the use of complementary and integrative therapies (CIT), MHT; and pharmacotherapies; (2) the perceptions, perceived benefits/risks of CIT, MHT; and pharmacotherapy use; and (3) factors associated with CIT and MHT use for menopause symptom treatment. Results: The majority of respondents used CIT to treat menopause symptoms based on physician recommendation and research studies. Treatments that were perceived as most beneficial included exercise, mind-body therapies, diet, and spiritual practices, with exercise and mind-body therapies chosen to treat the most common symptoms of sleep disturbances, depressive mood, and anxiety. Higher education level was the main predictive variable for choosing exercise (odds ratio [OR] = 1.27, p = 0.02) and mind-body therapies (OR = 1.57, p = 0.02) to treat menopausal symptoms. Perceptions, beliefs, and use of different CIT by primarily white, affluent, and educated peri- and postmenopausal females to treat menopause symptoms, including sleep disturbances, depression, and anxiety, are driven by conversations with physicians and evidence-based research. Conclusion: These findings reinforce the necessity for both additional research in more diverse populations, as well as comprehensive, individualized personalized care from an interdisciplinary team that considers the best options available for all female patients.

Study protocol to test the efficacy of self-administration of dexmedetomidine sedative therapy on anxiety, delirium, and ventilator days in critically ill mechanically ventilated patients: an open-label randomized clinical trial.

BACKGROUND: Administration of sedative and opioid medications to patients receiving mechanical ventilatory support in the intensive care unit is a common clinical practice. METHODS: A two-site randomized open-label clinical trial will test the efficacy of self-management of sedative therapy with dexmedetomidine compared to usual care on anxiety, delirium, and duration of ventilatory support after randomization. Secondary objectives are to compare self-management of sedative therapy to usual care on level of alertness, total aggregate sedative and opioid medication exposure, and ventilator-free days up to day 28 after study enrolment. Exploratory objectives of the study are to compare self-management of sedative therapy to usual care on 3- and 6-month post-discharge physical and functional status, psychological well-being (depression, symptoms of post-traumatic stress disorder), health-related quality of life, and recollections of ICU care. ICU patients (n = 190) who are alert enough to follow commands to self-manage sedative therapy are randomly assigned to self-management of sedative therapy or usual care. Patients remain in the ICU sedative medication study phase for up to 7 days as long as mechanically ventilated. DISCUSSION: The care of critically ill mechanically ventilated patients can change significantly over the course of a 5-year clinical trial. Changes in sedation and pain interventions, oxygenation approaches, and standards related to extubation have substantially impacted consistency in the number of eligible patients over time. In addition, the COVID-19 pandemic resulted in mandated extended pauses in trial enrolment as well as alterations in recruitment methods out of concern for study personnel safety and availability of protective equipment. Patient triaging among healthcare institutions due to COVID-19 cases also has resulted in inconsistent access to the eligible study population. This has made it even more imperative for the study team to be flexible and innovative to identify and enrol all eligible participants. Patient-controlled sedation is a novel approach to the management of patient symptoms that may be able to alleviate mechanical ventilation-induced distress without serious side effects. Findings from this study will provide insight into the efficacy of this approach on short- and long-term outcomes in a subset of mechanically ventilated patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT02819141. Registered on June 29, 2016.