Tailoring a Treatment Fidelity Framework for an Intensive Care Unit Clinical Trial

Background: Treatment fidelity (TF) refers to methodological strategies and practices used to monitor and enhance the reliability and validity of behavioral interventions. Treatment fidelity monitoring enhances internal and external validity and is needed for study replication and generalizability. Objectives: The aim of this study was to describe the implementation, monitoring, and impact of TF in an intensive-care-unit-based clinical trial testing music for anxiety self-management with mechanically ventilated patients. Method: Development of the criteria was based on the Five-Component Treatment Fidelity Framework from the Treatment Fidelity Workgroup. Descriptive statistics were used to evaluate adherence rates to the key TF criteria and the reasons criteria were unmet. Descriptive and nonparametric statistics were used to evaluate the impact of TF on participants\u27 use of the assigned intervention. Results: The Treatment Fidelity Framework was adapted easily to fit the study interventions. After the initial implementation phase of monitoring, adherence to key criteria was maintained at the targeted level of 80%. The majority of barriers to adherence affected the research nurses\u27 opportunity to interact with the participant and encourage use of the intervention. There was a trend toward increased use of equipment associated with the assigned condition after the initiation of TF; however, this difference was not statistically significant. Discussion: Treatment fidelity monitoring is an iterative process that requires ongoing vigilance. Identification of barriers and the implementation of methods to enhance protocol adherence are needed to enhance the reliability, validity, and generalizability of clinical trials in the dynamic and challenging research environment of the intensive care unit

Racial and Ethnic Disparities in Time to Cure of Incontinence Present at Nursing Home Admission

Abstract As many as half of older people that are admitted to nursing homes (NHs) are incontinent of urine and/or feces. Not much is known about the rate of cure of incontinence present at NH admission, but available reports suggest the rate is low. There have been racial and ethnic disparities in incontinence treatment, but the role of disparities in the cure of incontinence is understudied. Using the Peters-Belson method and multilevel predictors, our findings showed that there were disparities in the time to cure of incontinence for Hispanic NH admissions. A significantly smaller proportion of older Hispanic admissions were observed to have their incontinence cured and cured later than expected had they been White non-Hispanic. Reducing disparities in incontinence cure will improve health outcomes of Hispanic NH admissions. Significant predictors in our model suggest strategies to reduce the disparity including attention to managing fecal incontinence and incontinence in those with cognitive impairment, improving residents’ functional status, and increasing resources to NHs admitting older Hispanics with incontinence to develop innovative and cost effective ways to provide equitable quality care

Factors Influencing Nurse Sedation Practices with Mechanically Ventilated Patients: A U.S. National Survey

Objectives Mechanically ventilated patients commonly receive sedative medications. There is increasing evidence that sedative medications impact on patient outcomes. Nursing behaviour is a key determinant of sedation administration. The purpose of this study was to determine factors that influence nurse sedation administration to mechanically ventilated patients. Methods The Nurse Sedation Practices Scale was mailed to a random sample of 1250 members of the American Association of Critical Care Nurses. Results A response rate of 39% was obtained. Respondents were primarily staff nurses (73%) with a bachelor\u27s degree in nursing (59%) from various intensive care unit (ICU) settings. We limited the analysis to adult ICU practitioners (n = 423). The majority of nurses (81%) agreed that sedation is necessary for patient comfort. Nurse attitudes towards the efficacy of sedation for mechanically ventilated patients was positively correlated with nurses’ report of their sedation practice ( = .28, p \u3c .001) and their intent to administer sedation ( = .58, p \u3c .001). Attitudes did not vary with respect to individual or practice setting characteristics. Conclusion Nurses’ attitudes impact sedation administration practices. Modifying nurses’ attitudes on sedation and the experience of mechanical ventilation may be necessary to change sedation practices with mechanically ventilated patients

Goals of Fecal Incontinence Management Identified by Community-Living Incontinent Adults

The purpose of this study was to identify goals of fecal incontinence (FI) management and their importance to community-living adults if complete continence would not be possible. Participants expressed their goals of FI management in a semi structured interview, selected others from 12 investigator-identified goals, and rated their importance. Five thematic categories emerged from the 114 participant-identified goal statements: Fecal Incontinence/Bowel Pattern, Lifestyle, Emotional Responses, Adverse Effects of Fecal Incontinence, and Self-Care Practices. Participants selected a median of seven investigator-identified goals (range = 2 to 12). Goals selected by the most participants were decreased number of leaks of stool and greater confidence in controlling fecal incontinence. These goals also had the highest importance along with decreased leakage of loose or liquid stool. The type and number of management goals identified by participants offer a toolbox of options from which to focus therapy when cure is not possible and promote patient satisfaction

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 Critically ill mechanically ventilated patients receive intravenous sedative and analgesic medications to reduce anxiety and promote comfort and ventilator synchrony. These potent medications are often administered at high doses for prolonged periods and are associated with adverse effects such as bradycardia, hypotension, gut dysmotility, immobility, weakness, and delirium.1-3 Despite protocols and sedation assessment tools that guide clinicians, patients still experience significant levels of anxiety.4,5 Unrelieved anxiety and fear are not only unpleasant symptoms that clinicians want to palliate, but increased sympathetic nervous system activity can cause dyspnea and increased myocardial oxygen demand.6 Sustained anxiety and sympathetic nervous system activation can decrease the ability to concentrate, rest, or relax.6,7 Mechanically ventilated patients have little control over pharmacological interventions to relieve anxiety; dosing and frequency of sedative and analgesic medications are controlled by intensive care unit (ICU) clinicians. Interventions are needed that reduce anxiety, actively involve patients, and minimize the use of sedative medications. Nonpharmacological interventions such as relaxing music are effective in reducing anxiety while reducing medication administration.8,9 Music is a powerful distractor that can alter perceived levels of anxiety10 by occupying attention channels in the brain with meaningful, auditory stimuli11 rather than stressful environmental stimuli. Listening to preferred, relaxing music has reduced anxiety in mechanically ventilated patients in limited trials.12-15 It is not known if music can reduce anxiety throughout the course of ventilatory support, or reduce exposure to sedative medications. We evaluated if a patient-directed music (PDM) intervention could reduce anxiety and sedative exposure in ICU patients receiving mechanical ventilation

Improving resident outcomes with GAPN organization level interventions

This research tested the effectiveness of the second tier of interventions in a two-tiered nursing intervention model designed to improve quality of care for residents in long-term care facilities (LTCFs). The first tier of the model called for gerontological advanced practice nurses (GAPNs) to provide direct care and to teach staff to implement care protocols for residents with inconti-nence, pressure ulcers, depression, and aggression. Results of the first-tier study indicated sig-nificant improvement in resident outcomes in incontinence, pressure ulcers, and aggression. In the second tier, GAPNs added a set of organization-level (OL) interventions including member-ship on the LTCF quality assurance committee and collaborating with staff on problem-solving teams. Analysis following the addition of OL interventions revealed significant improvement in both depression scores and in the trajectory of depression in residents of the LTCF where OL interventions were used

Peripheral Muscle Strength and Correlates of Muscle Weakness in Patients Receiving Mechanical Ventilation

Background Intensive care unit–acquired weakness is a frequent complication of critical illness because of patients’ immobility and prolonged use of mechanical ventilation. Objectives To describe daily measurements of peripheral muscle strength in patients receiving mechanical ventilation and explore relationships among factors that influence intensive care unit–acquired weakness. Methods Peripheral muscle strength of 120 critically ill patients receiving mechanical ventilation was measured daily by using a standardized handgrip dynamometry protocol. Three grip measurements for each hand were recorded in pounds-force; the mean of these 3 assessments was used in the analysis. Correlates of intensive care unit–acquired weakness (age, sex, illness severity, duration of mechanical ventilation, medications) were analyzed by using mixed models to explore the relationship to grip strength. Results Median baseline grip strength was variable yet diminished (7.7 pounds-force), with either a pattern of diminishing grip strength or maintenance of the baseline low grip strength over time. With controls for days of measurement, female sex (β = −10.4; P \u3c .001), age (β = −0.24; P = .004), and days receiving mechanical ventilation (β = −0.34; P = .005) explained a significant amount of variance in grip strength over time. Conclusions Patients receiving prolonged mechanical ventilation had marked decrements in grip strength, measured by hand dynamometry, a marker for peripheral muscle strength. Hand dynamometry is a reliable method for measuring muscle strength in cooperative critically ill patients and can be used to develop interventions to prevent intensive care unit–acquired weakness