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1.
Nurs Outlook ; 72(4): 102187, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38851165

RESUMEN

The role of the Nurse Scientist in clinical settings represents a relatively new career path that has garnered attention in recent literature. Although there is considerable variability in how this role is operationalized across institutions, Mayo Clinic stands out as one of the few health systems in the United States employing nurse scientists who are fully and exclusively engaged in their own programs of research. Given the need for practical information to guide development and implementation of a research-focused nurse scientist role, the purpose of this paper is to describe the infrastructure and resources supporting Mayo Clinic nurse scientists, share role expectations and metrics for success, discuss both the facilitators of success and ongoing challenges, and compare our current practices to those found in the literature.


Asunto(s)
Investigación en Enfermería , Humanos , Minnesota , Rol de la Enfermera , Modelos de Enfermería
2.
Nurs Res ; 72(6): 456-461, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37733648

RESUMEN

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.


Asunto(s)
Ventilación no Invasiva , Insuficiencia Respiratoria , Humanos , Masculino , Adolescente , Adulto , Anciano , Femenino , Estudios Transversales , Respiración Artificial/efectos adversos , Unidades de Cuidados Intensivos , Insuficiencia Respiratoria/terapia
3.
Nurs Outlook ; 71(3): 101986, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37173158

RESUMEN

Disability results from an interplay between health conditions and environmental and personal factors. People with disabilities face substantial and ongoing health inequities; however, research to mitigate these inequalities is lacking. There is an urgent need for a better understanding of the multilevel factors that influence health outcomes in people with visible and invisible disabilities across all the lenses of the National Institute of Nursing Research strategic plan. Disability research must be a priority of nurses and the National Institute of Nursing Research to advance health equity for all.


Asunto(s)
Personas con Discapacidad , Equidad en Salud , Enfermeras y Enfermeros , Estados Unidos , Humanos , National Institute of Nursing Research (U.S.)
4.
J Clin Nurs ; 31(3-4): 445-453, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33991142

RESUMEN

AIMS AND OBJECTIVES: The purpose of this paper is to describe a model to guide nursing science in a clinical practice-based setting. Exemplars are provided to highlight the application of this nursing research model, which can be applied to other clinical settings that aim to fill evidence gaps in the literature. BACKGROUND: Nurse scientists are well positioned to develop new knowledge aimed at identifying global health solutions to multiple disparities. The generation and application of this knowledge are essential to inform and guide professional nursing practice. While a number of evidence-based practice models exist to guide the integration of literature findings and other sources of evidence into practice, there is a need for additional models that serve as a guide and focus for the conduct of research in distinct scientific areas in practice-based settings. DESIGN: Model development and description. METHODS: Mayo Clinic is a large, comprehensive healthcare system with a mission to address unmet patient needs through practice, research and education. PhD-prepared nurse scientists engage in practice-based research as an integral component of Mayo Clinic's mission. A practice-based nursing research model was developed with the intent to advance nursing research in a clinical setting. RESULTS: The components of the Mayo Clinic Nursing Research model include symptom science, self-management science and caregiving science. The generation of nursing science is focused on addressing needs of patients with complex health conditions, inclusive of caregivers. CONCLUSIONS: While clinical settings provide rich opportunities for the conduct of research, priorities need to be established in which to focus scientific endeavours. The Mayo Clinic Nursing Research model may be applicable to nurses around the globe who are engaged in the generation of knowledge to guide practice. RELEVANCE TO CLINICAL PRACTICE: The Mayo Clinic Nursing Research model can be used by nurse scientists embedded in healthcare settings to address clinically relevant questions, advance the generation of new nursing knowledge and ultimately improve the health and well-being of patients and caregivers.


Asunto(s)
Cuidadores , Investigación en Enfermería , Atención a la Salud , Escolaridad , Práctica Clínica Basada en la Evidencia , Humanos
5.
J Intensive Care Med ; 36(11): 1281-1285, 2021 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-32734840

RESUMEN

BACKGROUND: Pharmacogenomic (PGx) testing has the potential to provide information on specific drug-metabolizing enzymes that may lead to an absence, reduction, or increase in medication effect in patients. There is a paucity of prospective studies examining PGx testing in the intensive care unit (ICU) setting. RESEARCH AIMS: To (1) obtain a PGx panel in a sample of cardiovascular (CV) surgical patients with a planned ICU stay and identify phenotypes, and (2) identify PGx variants that may inform treatment regimens and may warrant prescribing adjustments. DESIGN AND METHODS: Descriptive, single cohort cross-sectional design. Adult (≥18 years) CV patients with an anticipated postoperative ICU stay were enrolled from a large Midwestern tertiary academic medical center. Eligible patients provided informed consent at the time of their CV clinic appointment; PGx testing was then ordered. Pharmacogenomic testing consisted of the Focused Pharmacogenomics panel which included 10 genes and 55 medications. RESULTS: Of the 272 patients screened, 100 (68% male) patients completed PGx testing (mean age 66.2 ± 9.6 years, mean Acute Physiology, Age and Chronic Health Evaluation III score 76.1 ± standard deviation). Pharmacogenomic results were available in the medical record within a median of 52.4 hours (interquartile range: 33.4-80.3). Pharmacogenomic testing results identified 5 CYP2C19 poor metabolizers, 26 CYP2C19 rapid metabolizers, 5 CYP2C19 ultrarapid metabolizers, 6 CYP2D6 poor metabolizers, 5 CYP2D6 poor to intermediate metabolizers, and 2 CYP2D6 rapid metabolizers identified. Overall, 98% of patients had actionable or potentially actionable PGx results, including 82% for warfarin, 65% for propafenone, 65% for tramadol, 46% for oxycodone, 45% for metoprolol, 33% for clopidogrel, 32% for proton pump inhibitors, 25% for statins, and 12% for haloperidol. CONCLUSIONS: A significant portion of patients had identified genetic variants that may warrant changes in medication management during and after CV-ICU stay. It remains to be seen if PGx testing leads to improvements in ICU patient outcomes.


Asunto(s)
Farmacogenética , Pruebas de Farmacogenómica , Anciano , Estudios Transversales , Femenino , Humanos , Unidades de Cuidados Intensivos , Masculino , Persona de Mediana Edad , Estudios Prospectivos
6.
Am J Respir Crit Care Med ; 200(8): 972-981, 2019 10 15.
Artículo en Inglés | MEDLINE | ID: mdl-31161771

RESUMEN

An estimated 14.1 million patients survive sepsis each year. Many survivors experience poor long-term outcomes, including new or worsened neuropsychological impairment; physical disability; and vulnerability to further health deterioration, including recurrent infection, cardiovascular events, and acute renal failure. However, clinical trials and guidelines have focused on shorter-term survival, so there are few data on promoting longer-term recovery. To address this unmet need, the International Sepsis Forum convened a colloquium in February 2018 titled "Understanding and Enhancing Sepsis Survivorship." The goals were to identify gaps and limitations of current research and shorter- and longer-term priorities for understanding and enhancing sepsis survivorship. Twenty-six experts from eight countries participated. The top short-term priorities identified by nominal group technique culminating in formal voting were to better leverage existing databases for research, develop and disseminate educational resources on postsepsis morbidity, and partner with sepsis survivors to define and achieve research priorities. The top longer-term priorities were to study mechanisms of long-term morbidity through large cohort studies with deep phenotyping, build a harmonized global sepsis registry to facilitate enrollment in cohorts and trials, and complete detailed longitudinal follow-up to characterize the diversity of recovery experiences. This perspective reviews colloquium discussions, the identified priorities, and current initiatives to address them.


Asunto(s)
Investigación Biomédica/organización & administración , Cuidados Críticos/normas , Guías de Práctica Clínica como Asunto , Sepsis/diagnóstico , Sepsis/mortalidad , Sepsis/terapia , Supervivencia , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Personas con Discapacidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Proyectos de Investigación
7.
Nurs Res ; 69(5): 347-357, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32404586

RESUMEN

BACKGROUND: Vigilant self-management is associated with positive health outcomes in people living with chronic obstructive pulmonary disease (COPD), yet the predictors of activated self-managers are not well understood. OBJECTIVES: The aims of the study were to identify and describe the predictors of patient activation among a sample of community-dwelling adults with COPD in the United States. METHODS: A postal survey of demographic, mood, symptom, function, health perception, life quality measures, and the patient activation measure was completed by 64 participants. Descriptive and inferential statistics were used to examine and describe associations between personal characteristics, health outcomes, and patient activation measure scores (0-100). Multivariate, linear regression analysis was conducted to identify predictors of patient activation score. RESULTS: Patient activation was high among the sample. Multivariate analysis revealed positive affect, smoking pack-years, overall quality of life, and female gender collectively explained 45.4% of the variance in patient activation. DISCUSSION: Positive life view, gender, and lifestyle factors present novel predictors of high activation in self-managers of COPD that warrant explication through future research.


Asunto(s)
Personas con Discapacidad/rehabilitación , Participación del Paciente/métodos , Enfermedad Pulmonar Obstructiva Crónica/complicaciones , Anciano , Anciano de 80 o más Años , Correlación de Datos , Personas con Discapacidad/estadística & datos numéricos , Femenino , Humanos , Vida Independiente/psicología , Masculino , Persona de Mediana Edad , Participación del Paciente/psicología , Participación del Paciente/estadística & datos numéricos , Enfermedad Pulmonar Obstructiva Crónica/psicología , Autocuidado , Encuestas y Cuestionarios , Estados Unidos
8.
Nurs Res ; 68(1): 73-79, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-30540694

RESUMEN

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.


Asunto(s)
Enfermedad Crítica/enfermería , Hipnóticos y Sedantes/clasificación , Proyectos de Investigación/normas , Adulto , Benzodiazepinas/clasificación , Estudios de Cohortes , Cálculo de Dosificación de Drogas , Femenino , Humanos , Hipnóticos y Sedantes/uso terapéutico , Unidades de Cuidados Intensivos/organización & administración , Masculino , Persona de Mediana Edad , Morfina/clasificación
9.
J Nurs Scholarsh ; 51(6): 651-660, 2019 11.
Artículo en Inglés | MEDLINE | ID: mdl-31566894

RESUMEN

BACKGROUND: Regenerative technologies aim to restore organ form and function. Technological advances in regenerative treatments have led to patients increasingly seeking these therapies. The readiness of nursing to fully contribute to this emerging healthcare field is uncertain. PURPOSE: The goal of this discipline-oriented overview is to enhance awareness in the nursing community regarding regenerative science, and to provide suggestions for nursing research contributions and practice implications. METHODS: Evolving and applied cutting-edge therapies, such as regenerative immunotherapies with chimeric antigen receptor expressing T lymphocytes, are highlighted in the context of emerging opportunities for nurses in practice and research. DISCUSSION: Next generation nurses will increasingly be at the forefront of new therapies poised to make chronic illnesses curable, thus restoring health and function to diverse groups of individuals. CLINICAL RELEVANCE: The regenerative care model imposes on the nursing community the imperative to (a) increase research awareness; (a) educate, develop, and deploy a skilled nursing workforce; (c) integrate regenerative technologies into nursing practice; and (d) embrace the regenerative technologies horizon as a future in health care.


Asunto(s)
Atención a la Salud/organización & administración , Investigación en Enfermería , Medicina Regenerativa , Humanos
10.
Crit Care Med ; 46(9): 1430-1435, 2018 09.
Artículo en Inglés | MEDLINE | ID: mdl-29727366

RESUMEN

OBJECTIVES: Music intervention has been shown to reduce anxiety and sedative exposure among mechanically ventilated patients. Whether music intervention reduces ICU costs is not known. The aim of this study was to examine ICU costs for patients receiving a patient-directed music intervention compared with patients who received usual ICU care. DESIGN: A cost-effectiveness analysis from the hospital perspective was conducted to determine if patient-directed music intervention was cost-effective in improving patient-reported anxiety. Cost savings were also evaluated. One-way and probabilistic sensitivity analyses determined the influence of input variation on the cost-effectiveness. SETTING: Midwestern ICUs. PATIENTS: Adult ICU patients from a parent clinical trial receiving mechanical ventilatory support. INTERVENTIONS: Patients receiving the experimental patient-directed music intervention received a MP3 player, noise-canceling headphones, and music tailored to individual preferences by a music therapist. MEASUREMENTS AND MAIN RESULTS: The base case cost-effectiveness analysis estimated patient-directed music intervention reduced anxiety by 19 points on the Visual Analogue Scale-Anxiety with a reduction in cost of $2,322/patient compared with usual ICU care, resulting in patient-directed music dominance. The probabilistic cost-effectiveness analysis found that average patient-directed music intervention costs were $2,155 less than usual ICU care and projected that cost saving is achieved in 70% of 1,000 iterations. Based on break-even analyses, cost saving is achieved if the per-patient cost of patient-directed music intervention remains below $2,651, a value eight times the base case of $329. CONCLUSIONS: Patient-directed music intervention is cost-effective for reducing anxiety in mechanically ventilated ICU patients.


Asunto(s)
Ansiedad/terapia , Análisis Costo-Beneficio , Musicoterapia/economía , Respiración Artificial , Ansiedad/etiología , Humanos , Unidades de Cuidados Intensivos , Persona de Mediana Edad , Respiración Artificial/efectos adversos , Respiración Artificial/psicología , Autocuidado
11.
Aust Crit Care ; 31(3): 153-158, 2018 05.
Artículo en Inglés | MEDLINE | ID: mdl-29571595

RESUMEN

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.


Asunto(s)
Actitud del Personal de Salud , Sedación Consciente/enfermería , Enfermería de Cuidados Críticos , Hipnóticos y Sedantes/administración & dosificación , Dimensión del Dolor/enfermería , Respiración Artificial/enfermería , Humanos , Unidades de Cuidados Intensivos , Investigación Cualitativa , Encuestas y Cuestionarios
12.
Crit Care Med ; 45(5): 851-857, 2017 May.
Artículo en Inglés | MEDLINE | ID: mdl-28263192

RESUMEN

OBJECTIVES: Delirium severity is independently associated with longer hospital stays, nursing home placement, and death in patients outside the ICU. Delirium severity in the ICU is not routinely measured because the available instruments are difficult to complete in critically ill patients. We designed our study to assess the reliability and validity of a new ICU delirium severity tool, the Confusion Assessment Method for the ICU-7 delirium severity scale. DESIGN: Observational cohort study. SETTING: Medical, surgical, and progressive ICUs of three academic hospitals. PATIENTS: Five hundred eighteen adult (≥ 18 yr) patients. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Patients received the Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, and Delirium Rating Scale-Revised-98 assessments. A 7-point scale (0-7) was derived from responses to the Confusion Assessment Method for the ICU and Richmond Agitation-Sedation Scale items. Confusion Assessment Method for the ICU-7 showed high internal consistency (Cronbach's α = 0.85) and good correlation with Delirium Rating Scale-Revised-98 scores (correlation coefficient = 0.64). Known-groups validity was supported by the separation of mechanically ventilated and nonventilated assessments. Median Confusion Assessment Method for the ICU-7 scores demonstrated good predictive validity with higher odds (odds ratio = 1.47; 95% CI = 1.30-1.66) of in-hospital mortality and lower odds (odds ratio = 0.8; 95% CI = 0.72-0.9) of being discharged home after adjusting for age, race, gender, severity of illness, and chronic comorbidities. Higher Confusion Assessment Method for the ICU-7 scores were also associated with increased length of ICU stay (p = 0.001). CONCLUSIONS: Our results suggest that Confusion Assessment Method for the ICU-7 is a valid and reliable delirium severity measure among ICU patients. Further research comparing it to other delirium severity measures, its use in delirium efficacy trials, and real-life implementation is needed to determine its role in research and clinical practice.


Asunto(s)
Delirio/diagnóstico , Unidades de Cuidados Intensivos/estadística & datos numéricos , Escalas de Valoración Psiquiátrica/normas , Índice de Severidad de la Enfermedad , Adulto , Anciano , Atención , Estado de Conciencia , Femenino , Hospitales Universitarios , Humanos , Masculino , Escala del Estado Mental , Persona de Mediana Edad , Alta del Paciente , Estudios Prospectivos , Reproducibilidad de los Resultados , Factores Socioeconómicos
13.
Am J Respir Crit Care Med ; 190(12): 1437-46, 2014 Dec 15.
Artículo en Inglés | MEDLINE | ID: mdl-25496103

RESUMEN

RATIONALE: Profound muscle weakness during and after critical illness is termed intensive care unit-acquired weakness (ICUAW). OBJECTIVES: To develop diagnostic recommendations for ICUAW. METHODS: A multidisciplinary expert committee generated diagnostic questions. A systematic review was performed, and recommendations were developed using the Grading, Recommendations, Assessment, Development, and Evaluation (GRADE) approach. MEASUREMENT AND MAIN RESULTS: Severe sepsis, difficult ventilator liberation, and prolonged mechanical ventilation are associated with ICUAW. Physical rehabilitation improves outcomes in heterogeneous populations of ICU patients. Because it may not be feasible to provide universal physical rehabilitation, an alternative approach is to identify patients most likely to benefit. Patients with ICUAW may be such a group. Our review identified only one case series of patients with ICUAW who received physical therapy. When compared with a case series of patients with ICUAW who did not receive structured physical therapy, evidence suggested those who receive physical rehabilitation were more frequently discharged home rather than to a rehabilitative facility, although confidence intervals included no difference. Other interventions show promise, but fewer data proving patient benefit existed, thus precluding specific comment. Additionally, prior comorbidity was insufficiently defined to determine its influence on outcome, treatment response, or patient preferences for diagnostic efforts. We recommend controlled clinical trials in patients with ICUAW that compare physical rehabilitation with usual care and further research in understanding risk and patient preferences. CONCLUSIONS: Research that identifies treatments that benefit patients with ICUAW is necessary to determine whether the benefits of diagnostic testing for ICUAW outweigh its burdens.


Asunto(s)
Unidades de Cuidados Intensivos , Debilidad Muscular/diagnóstico , Adulto , Cuidados Críticos , Electromiografía , Humanos , Debilidad Muscular/etiología , Debilidad Muscular/terapia , Conducción Nerviosa/fisiología , Modalidades de Fisioterapia
15.
Am J Crit Care ; 33(2): 126-132, 2024 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-38424019

RESUMEN

BACKGROUND: While in the intensive care unit, critically ill patients experience a myriad of distressing symptoms and stimuli leading to discomfort, a negative emotional and/ or physical state that arises in response to noxious stimuli. Appropriate management of these symptoms requires a distinct assessment of discomfort-causing experiences. OBJECTIVES: To assess patient-reported discomfort among critically ill patients with the English-language version of the Inconforts des Patients de REAnimation questionnaire, and to explore relationships between demographic and clinical characteristics and overall discomfort score on this instrument. METHODS: This study had a cross-sectional, descriptive, single-cohort design. The convenience sample consisted of alert and oriented patients aged 18 years or older who had been admitted to intensive care units at a Midwestern tertiary referral hospital and were invited to participate. An 18-item questionnaire on physiological and psychological stimuli inducing discomfort was administered once. Each item was scored from 0 to 10, with the total possible discomfort score ranging from 0 to 100. Descriptive statistics were used to analyze participants' demographic and clinical characteristics and questionnaire responses. RESULTS: A total of 180 patients were enrolled. The mean (SD) overall discomfort score was 32.9 (23.6). The greatest sources of discomfort were sleep deprivation (mean [SD] score, 4.0 [3.4]), presence of perfusion catheters and tubing (3.4 [2.9]), thirst (3.0 [3.3]), and pain (3.0 [3.0]). CONCLUSIONS: Intensive care unit patients in this study reported mild to moderate discomfort. Additional research is needed to design and test interventions based on assessment of specific discomfort-promoting stimuli to provide effective symptom management.


Asunto(s)
Cuidados Críticos , Enfermedad Crítica , Adulto , Humanos , Estudios Transversales , Cuidados Críticos/psicología , Unidades de Cuidados Intensivos , Encuestas y Cuestionarios
16.
Contemp Clin Trials Commun ; 38: 101269, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38380342

RESUMEN

Background: Pragmatic trials may need to adapt interventions to enhance local fit, and adaptation tracking is critical to evaluation. This study describes the tracking approach for a multisite, stepped-wedge hybrid pragmatic trial testing implementation and effectiveness of a cancer symptom management intervention. Methods: Study activities were documented in a spreadsheet by date and category. Intervention adaptations were tracked across multiple workgroups in a database structured around the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) domains, e.g., reasons for change. Implementation strategies were tracked longitudinally and by cluster in a database using the Longitudinal Implementation Strategy Tracking System (LISTS) method. A logic model was created at the end of the study to describe core intervention components and implementation strategies with dates of adaptations. Results: Between January 2019 and January 2023, 187 study activities were documented. Most intervention activities took place early, but there were important intervention refinements during the course of the trial, including the expansion of interventionist roles to add two new disciplines. Eleven intervention adaptations were documented. Most were unplanned and aimed at improving fit or increasing engagement. Thirty-three implementation strategies were documented, the largest number of which were related to educating stakeholders. Most (but not all) component and strategy additions were consistent with the mechanisms of change as hypothesized at trial launch. Conclusions: A multifaceted approach to adaptation tracking, combined with a logic model, supported identification of meaningful changes for use in evaluation, but further work is needed to minimize burden and ensure robust and practical systems that inform both evaluation and timely decision-making. Trial: Registration: ClinicalTrials.gov, NCT03892967. Registered on March 25, 2019. https://www.clinicaltrials.gov/.

19.
JAMA ; 309(22): 2335-44, 2013 Jun 12.
Artículo en Inglés | MEDLINE | ID: mdl-23689789

RESUMEN

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.


Asunto(s)
Ansiedad/terapia , Hipnóticos y Sedantes/uso terapéutico , Musicoterapia , Respiración Artificial/efectos adversos , Autocuidado , Adulto , Anciano , Ansiedad/etiología , Enfermedad Crítica , Dispositivos de Protección de los Oídos , Femenino , Humanos , Unidades de Cuidados Intensivos , Masculino , Persona de Mediana Edad , Ruido , Prioridad del Paciente , Terapia por Relajación , Respiración Artificial/psicología , Insuficiencia Respiratoria/terapia
20.
JMIR Res Protoc ; 12: e40760, 2023 May 10.
Artículo en Inglés | MEDLINE | ID: mdl-37163350

RESUMEN

BACKGROUND: Many patients experience pain in the intensive care unit (ICU) despite receiving pain medication. Research has shown that music can help reduce pain. Music interventions studied so far have not used music streaming to generate playlists based on patient preferences while incorporating recommended tempo and duration. Previous research has focused on postoperative ICU patients able to self-report, which is underrepresentative of the ICU population that might benefit from a music intervention for pain management. We developed a new patient-oriented music intervention (POMI) that incorporates features based on theoretical, empirical, and experiential data intended to be used in the ICU. Such a music intervention should consider the expertise of ICU patients, family members, and nursing staff, as well as the practicality of the intervention when used in practice. OBJECTIVE: The primary objectives of this study are to (1) evaluate the acceptability and feasibility of the POMI to reduce pain in ICU patients and (2) evaluate the feasibility of conducting a crossover pilot randomized controlled trial (RCT) for intervention testing in the ICU. A secondary objective is to examine the preliminary efficacy of the POMI to reduce pain in ICU patients. METHODS: A single-blind 2×2 crossover pilot RCT will be conducted. Patients will undergo 1 sequence of 2 interventions: the POMI which delivers music based on patients' preferences via headphones or music pillow for 20-30 minutes and the control intervention (headphones or pillow without music). The sequence of the interventions will be inverted with a 4-hour washout period. Timing of the interventions will be before a planned bed turning procedure. Each patient will undergo 1 session of music. Twenty-four patients will be recruited. Patients able to self-report (n=12), family members of patients unable to self-report (n=12), and nursing staff (n=12) involved in the bed turning procedure will be invited to complete a short questionnaire on the POMI acceptability. Data will be collected on the feasibility of the intervention delivery (ie, time spent creating a playlist, any issue related to headphones/pillow or music delivery, environmental noises, and intervention interruptions) and research methods (ie, number of patients screened, recruited, randomized, and included in the analysis). Pain scores will be obtained before and after intervention delivery. RESULTS: Recruitment and data collection began in March 2022. As of July 5, 2022, in total, 22 patients, 12 family members, and 11 nurses were recruited. CONCLUSIONS: Methodological limitations and strengths are discussed. Study limitations include the lack of blinding for patients able to self-report. Strengths include collecting data from various sources, getting a comprehensive evaluation of the intervention, and using a crossover pilot RCT design, where participants act as their own control, thus reducing confounding factors. TRIAL REGISTRATION: ClinicalTrials.gov NCT05320224; https://clinicaltrials.gov/ct2/show/NCT05320224. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40760.

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