A Core Outcome Set for Research Evaluating Interventions to Enable Communication in Patients With an Artificial Airway: An International Delphi Consensus Study (Comm-COS).

OBJECTIVES: Critically ill adults requiring artificial airways experience profound communication deficits. Studies of interventions supporting communication report disparate outcomes, creating subsequent challenges in the interpretation of their effectiveness. Therefore, we aimed to develop international consensus for a communication core outcome set (Comm-COS) for future trials of communication interventions in this population. DESIGN: 1) Systematic review, 2) patient/family interviews, 3) two-round modified Delphi, and 4) virtual consensus meetings with a final voting round. A multidisciplinary expert steering committee oversaw all stages. SETTING: Interviews and consensus meetings were conducted via videoconferencing. Digital methods were used for Delphi and final Comm-COS voting. SUBJECTS: Three stakeholder groups: 1) patient and family members with lived experience within 3 years, 2) clinicians with experience working in critical care, and 3) researchers publishing in the field. INTERVENTION: None. MEASUREMENTS AND MAIN RESULTS: We identified 59 outcomes via our systematic review, 3 unique outcomes from qualitative interviews, and 2 outcomes from our steering committee. Following item reduction, 32 outcomes were presented in Delphi round 1; 134 participants voted; 15 patient/family (11%), 91 clinicians (68%), and 28 researchers (21%). Nine additional outcomes were generated and added to round 2; 106 (81%) participants voted. Following completion of the consensus processes, the Comm-COS includes seven outcomes: 1) changes in emotions and wellbeing associated with ability to communicate, 2) physical impact of communication aid use, 3) time to functional communication, 4) ability to communicate healthcare needs (comfort/care/safety/decisions), 5) conversation agency, 6) ability to establish a communication connection to develop and maintain relationships, and 7) acceptability of the communication intervention. CONCLUSIONS: This is the first COS to specifically focus on communication for critically ill adults. Limitations for operationalization include selection of measures to use with these outcomes. Identification of suitable measures and adoption of the Comm-COS in future trials will help establish effective interventions to ameliorate the highly prevalent and negative experience of communicative incapacity.

Development, feasibility testing, and preliminary evaluation of the Communication with an Artificial airway Tool (CAT): Results of the Crit-CAT pilot study.

BACKGROUND: A purpose-built outcome measure for assessing communication effectiveness in patients with an artificial airway is needed. OBJECTIVES: The objective of this study was to develop the Communication with an Artificial airway Tool (CAT) and to test the feasibility and to preliminary evaluate the clinical metrics of the tool. METHODS: Eligible patients with an artificial airway in the Intensive Care Unit were enrolled in the pilot study (Crit-CAT). The CAT was administered at least twice before and after the communication intervention. Item correlation analysis was performed. Participant and family member acceptability ratings and feedback were solicited. A qualitative thematic analysis was undertaken. RESULTS: Fifteen patients with a mean age of 53 years (standard deviation [SD]: 19.26) were included. The clinician-reported scale was administered on 50 attempts (100%) with a mean completion time of 4.5 (SD: 0.77) minutes. The patient-reported scale was administered on 46 out of 49 attempts (94%) and took a mean of 1.5 (SD: 0.39) minutes to complete. The CAT was feasible for use in the Intensive Care Unit, with patients with either an endotracheal or tracheostomy tube, whilst receiving invasive mechanical ventilation or not, and while using either verbal or nonverbal modes of communication. Preliminary establishment of responsiveness, validity, and reliability was made. The tool was acceptable to participants and their family members. CONCLUSION: The clinician-reported and patient-reported components of the study were feasible for use. The CAT has the potential to enable quantifiable comparison of communication interventions for patients with an artificial airway. Future research is required to determine external validity and reliability.

Communication with mechanically ventilated patients in intensive care units: A concept analysis.

AIMS: The aim of this study was to perform a concept analysis of communication with mechanically ventilated patients in intensive care units and present a preliminary model for communication practice with these patients. DESIGN: The Im & Meleis approach for concept analysis guided the study. SEARCH METHODS: A literature search was performed in January 2022 in MEDLINE, Embase, CINAHL, psycINFO and Scopus, limited to 1998-2022. The main medical subject headings search terms used were artificial respiration, communication and critical care. The search resulted in 10,698 unique references. REVIEW METHODS: After a blinded review by two authors, 108 references were included. Core concepts and terminology related to communication with mechanically ventilated patients were defined by content analytic methods. The concepts were then grouped into main categories after proposing relationships between them. As a final step, a preliminary model for communication with mechanically ventilated patients was developed. RESULTS: We identified 39 different phrases to describe the mechanically ventilated patient. A total of 60 relevant concepts describing the communication with mechanically ventilated patients in intensive care were identified. The concepts were categorized into five main categories in a conceptual map. The preliminary model encompasses the unique communication practice when interacting with mechanically ventilated patients in intensive care units. CONCLUSION: Highlighting different perspectives of the communication between mechanically ventilated patients and providers through concept analysis has contributed to a deeper understanding of the phenomena and the complexity of communication when the patients have limited possibilities to express themselves. IMPACT: A clear definition of concepts is needed in the further development of guidelines and recommendations for patient care in intensive care, as well as in future research. The preliminary model will be tested further. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution, as this is a concept analysis of previous research.

Sleep disruption and delirium in critically ill children: Study protocol feasibility.

Delirium is a serious complication of pediatric critical illness. Sleep disruption is frequently observed in children with delirium, and circadian rhythm dysregulation is one proposed cause of delirium. Children admitted to the pediatric intensive care unit (PICU) experience multiple environmental exposures with the potential to disrupt sleep. Although researchers have measured PICU light and sound exposure, sleep, and delirium, these variables have not yet been fully explored in a single study. Furthermore, caregiving patterns have not often been included as a component of the PICU environment. Measuring the light and sound exposure, caregiving patterns, and sleep of critically ill children requires continuous PICU bedside data collection. This presents multiple methodological challenges. In this paper, we describe the protocol for an observational pilot study of the PICU environment, sleep, and delirium experienced by a sample of 10 critically ill children 1-4 years of age. We also evaluate and discuss the feasibility (i.e., acceptability, implementation, practicality) of the study protocol. Light and sound exposure were measured with bedside sensors. Caregiving was quantified through video recording. Sleep was measured via actigraphy and confirmed by video recording. Delirium screening with the Cornell Assessment of Pediatric Delirium was conducted twice daily, either in person or via video review. This study provides a refined measurement framework to inform future, large-scale studies and the development of nurse-driven sleep promotion interventions.

Expect the unexpected: Adolescent and pre-teens' experience of diabetes technology self-management.

OBJECTIVE: Only 17% of adolescents with type 1 diabetes (T1D) are currently meeting their glycemic targets despite advances in diabetes technologies. Self-management behaviors and challenges specific to use of diabetes technologies are insufficiently studied in adolescents. We aimed to describe the experience of diabetes technology self-management, including facilitators and barriers, among preteens/adolescents with low and high A1C. RESEARCH DESIGN AND METHODS: Youth (10-18 years of age) with T1D who use insulin pump therapy were recruited from the larger quantitative cohort of a mixed methods study for participation in semi-structured qualitative interviews. Maximum variability sampling was used to recruit youth with A1C <7.5% (n = 5) and A1C >9% (n = 5). Participants' personal insulin pump and continuous glucose monitoring data were downloaded and served as a visual reference. Interviews were analyzed using a qualitative descriptive approach. RESULTS: Participants were 50% female with a median age of 14.9 years and 80% used CGM. The sample was predominantly white (90.0%). Analysis produced four major themes, Bad Day, Expect the Unexpected, Nighttime Dependence, and Unpredictability, It's Really a Team and interconnecting subthemes. Youth characterized ''Bad Days'' as those requiring increased diabetes focus and self-management effort. The unpredictability (''Expect the Unexpected'') of glucose outcomes despite attention to self-management behaviors was considerable frustration. CONCLUSIONS: Diabetes devices such as insulin pumps are complex machines that rely heavily on individual proficiency, surveillance, and self-management behaviors to achieve clinical benefit. Our findings highlight the dynamic nature of self-management and the multitude of factors that feed youths' self-management behaviors.

Self-management among pre-teen and adolescent diabetes device users.

OBJECTIVE: Despite increased diabetes device use, few adolescents with type 1 diabetes (T1D) meet glycemic targets. We examine associations between utilization of insulin pumps and continuous glucose monitoring (CGM) and glycemic control. RESEARCH DESIGN AND METHODS: This prospective cohort study included 80 youths (10-18 years of age) with T1D. Multiple linear regression and linear mixed models (LMM) were used to estimate the effects of device self-management on HbA1c and daily time in range (70-180 mg/dL), respectively. RESULTS: Every blood glucose (BG) input/day was associated with a 0.2% decrease in HbA1c (95% CI: -0.297, -0.013), each bolus/day was associated with a 0.2% decrease (-0.327, -0.057), and use of CGM was associated with a 0.5% decrease (-1.00, -0.075). Among CGM users (n = 45) every 10% increase in CGM use was associated with a 0.3% decrease in HbA1c (-0.390, -0.180). In LMM accounting for within subject and between subject variability, there was a negative association between BG input/day frequency (coefficient = -1.880, [-2.640, -1.117]) and time in range. Residual random effects for CGM users were large showing time in range varied between youth with a SD of 15.0% (3 hours and 36 minutes) (SE 2.029, [11.484, 19.530]). Time in range varied significantly from day-to-day with SD of 18.6% (4 hours and 40 minutes) (SE0.455, [17.690, 19.473]). CONCLUSIONS: Device self-management behaviors among youth are significantly associated with both HbA1c and time in range. Our findings showing an association between reduced time in range and increased self-management behaviors is novel and deserves further investigation.

Evaluating Feasibility of Personal Diabetes Device Data Collection for Research.

BACKGROUND: Diabetes devices, like insulin pumps and continuous glucose monitors (CGMs), capture and store patient adherence and utilization data that can be retrieved or downloaded providing objective information on self-management behaviors; yet, diabetes device data remain underutilized in research. OBJECTIVE: The aim of the study was to examine the usability and feasibility of personal diabetes device data collected using a clinical download platform retooled for research purposes. METHODS: Investigators evaluated the feasibility of raw diabetes device data collection. One hundred eight preteens and adolescents with Type 1 diabetes and their parents provided consent/assent. RESULTS: Data were successfully collected from the diabetes devices (insulin pumps and CGM) of 97 youth using a clinical download software adapted for research, including data from all three commercially available CGM systems and insulin pumps brands, which contained all current and previous models of each insulin pump brand. The time required to download, mode of connection, and process varied significantly between brands. Despite the use of an agnostic download software, some outdated device brands and cloud-based CGM data were unsupported during data collection. Within the download software, dummy clinical accounts were created for each study participant, which were then linked back to a master study account for data retrieval. Raw device data were extracted into seven to eight Excel files per participant, which were then used to develop aggregate daily measures. DISCUSSION: Our analysis is the first of its kind to examine the feasibility of raw diabetes device data using a clinical download software. The investigators highlight issues encountered throughout the research process, along with mitigating strategies to inform future inquiry. CONCLUSION: This study demonstrates the feasibility of raw data collection, from a wide variety of insulin pump and CGM brands, through the retooling of a clinical download software. Data from these personal devices provide a unique opportunity to study self-management behavior and the glycemic response of individuals in their everyday environments.

Evaluating the Usability and Acceptability of Communication Tools Among Older Adults.

Acutely ill patients may have trouble communicating their symptoms and needs verbally. The current study evaluated the usability and acceptability of six commercially available communication tools with older adults in a non-clinical, controlled setting. Participants evaluated various communication boards and communication applications (apps) by using the tools to communicate needs and symptoms in various scenarios. Participants completed a modified technology acceptance questionnaire and selected the tool they perceived as most useful and easy to use. Bivariate analysis was used to compare communication boards and apps. Performance on most tasks was significantly better using communication boards compared to communication apps. However, participants reported that given more time and training, the apps could be used effectively. A feasibility study is needed to determine whether acutely ill older adults can use these communication tools to successfully convey their symptoms and needs in a hospital setting [Journal of Gerontological Nursing, 44(9), 30-39.].

Prevalence of Advance Directives Among Older Adults Admitted to Intensive Care Units and Requiring Mechanical Ventilation.

Because older adults are at high risk for hospitalization and potential decisional incapacity, advance directives are important components of pre-hospital advanced care planning, as they document individual preferences for future medical care. The prevalence of pre-hospital advance directive completion in 450 critically ill older adults requiring mechanical ventilation from two Mid-Atlantic hospitals is described, and demographic and clinical predictors of pre-hospital advance directive completion are explored. The overall advance directive completion rate was 42.4%, with those in older age groups (75 to 84 years and 85 and older) having approximately two times the odds of completion. No significant differences in the likelihood of advance directive completion were noted by sex, race, or admitting diagnosis. The relatively low prevalence of advance directive completion among older adults with critical illness and high mortality rate (24%) suggest a need for greater awareness and education.

Weighing worth against uncertain work: the interplay of exhaustion, ambiguity, hope and disappointment in mothers breastfeeding late preterm infants.

Poor breastfeeding outcomes among late preterm infants (LPIs) have been attributed to inadequate breast milk transfer stemming from physiological immaturities. However, breastfeeding is more than a biological phenomenon, and it is unclear how mothers of LPIs manage other factors that may also impact the breastfeeding course. Using grounded theory methods and incorporating serial post-partum interviews with several novel data collection techniques, we examined breastfeeding establishment over a 6-8-week-period among 10 late preterm mother-infant dyads recruited from a maternity hospital in Pittsburgh, Pennsylvania, USA. We found that breastfeeding in the LPI population was a fluctuating, cascade-like progression of trial and error, influenced by a host of contextual factors and events and culminating with breastfeeding continuation (with or without future caveats for duration or exclusivity of breastfeeding) or cessation. The trajectory was explained by the basic psychosocial process Weighing Worth against Uncertain Work, which encompassed the tension among breastfeeding motivation, the intensity of breastfeeding work and the ambiguity surrounding infant behaviour and feeding cues. Several sub-processes were also identified: Playing the Game, Letting Him Be the Judge vs. Accommodating Both of Us and Questioning Worth vs. Holding out Hope. If valid, our theoretical model indicates a need for earlier, more extensive and more qualified breastfeeding support for mothers of LPIs that emphasizes the connection between prematurity and observed feeding behaviours.

Adaptation of a communication interaction behavior instrument for use in mechanically ventilated, nonvocal older adults.

BACKGROUND: Valid and reliable instruments are needed to measure communication interaction behaviors between nurses and mechanically ventilated intensive care unit patients who are without oral speech. OBJECTIVES: The aim of this study was to refine and evaluate preliminary validity and reliability of a Communication Interaction Behavior Instrument (CIBI) adapted for use with mechanically ventilated, nonvocal patients in the intensive care unit. METHODS: Raters observed nurse-patient communication interactions using a checklist of nurse and patient behaviors, categorized as positive and negative behaviors. Three-minute video-recorded observations of five mechanically ventilated adults (<60 years old) in the intensive care unit and their nurses were used to establish preliminary interrater reliability and confirm appropriateness of definitions (four observations per dyad, n = 20). On the basis of expert input and reliability results, the behaviors and item definitions on the CIBI were revised. The revised tool was then tested in a larger sample of 38 mechanically ventilated intensive care patients (> 60 years old) and their nurses (four observations per dyad, n = 152) to determine interrater reliability. RESULTS: For preliminary testing, percent agreement for individual items ranged from 60% to 100% for nurse behaviors and 20% to 100% for patient behaviors across the five pilot cases. On the basis of these results, 11 definitions were modified and four items were dropped. Using the revised 29-item instrument, percent agreement improved for nurse behaviors (73%-100%) and patient behaviors (68%-100%). Kappa coefficients ranged from 0.13 to 1.00, with lower coefficients for patient behaviors. CONCLUSION: Preliminary results suggest that the revised CIBI has good face validity and shows good interrater reliability for many of the behaviors, but further refinement is needed. The use of dual raters with adjudication of discrepancies is the recommended method of administration for the revised CIBI.

Surviving with lung cancer: medication-taking and oral targeted therapy.

Oral epidermal growth factor receptor inhibitors (EGFRIs) improve survival for non-small cell lung cancer (NSCLC) patients; however, medication-taking implications are unknown. We used grounded theory to explore the process of medication-taking for NSCLC patients receiving oral EGFRIs. Thirty-two interviews were conducted for 13 participants purposively selected for gender, race/ethnicity, age, time in therapy, dose reductions, and therapy discontinuation and theoretically sampled for age and health insurance carrier. The study produced a grounded theory, Surviving with Lung Cancer, in which participants framed EGFRI therapy within recognition of NSCLC as a life-limiting illness without cure. Medication-taking was a "window" into participants' process of surviving with metastatic cancer that included deciding and preparing to take EGFRIs and treating lung cancer as a chronic condition. Our results contribute to understanding how NSCLC patients view themselves in the context of a life-limiting illness and support development of a theoretically-based intervention to improve medication-taking with EGFRIs.

Measures of Patient and Surrogate Preparedness for End-of-Life Decision-Making.

CONTEXT: Reliable and valid measures are critical in accurately assessing outcomes of advance care planning interventions (ACP) for end-of-life (EOL) decision-making. OBJECTIVES: To develop measures of preparedness for EOL decision-making for patients with end-stage renal disease and their surrogates (an exemplar population). METHODS: In this 3-phase study, Phases 1 and 2 included a cross-discipline concept analysis of the preparedness construct, item generation for patient and surrogate scales (82 items), evaluation of content validity and readability, cognitive interviewing, and item reduction. In phase 3, the retained 26 patient and 25 surrogate items were administered to 426 patients and 426 surrogates during a multisite trial of an ACP intervention versus care-as-usual and evaluated internal consistency, 2-week test-retest reliability, and construct validity. RESULTS: Scales were reduced to 20 patient and 19 surrogate items during phase 3. Cronbach's alphas were 0.86 (patient) and 0.90 (surrogate). There was a strong correlation between preparedness at baseline and two weeks for both scales (r = 0.66-0.69, P < 0.001). Confirmatory factor analysis and item-response analyses suggested unidimensionality. A significant correlation was shown between patient preparedness and patient decisional conflict (r = -0.53, P < 0.001), and surrogate preparedness and surrogate decision-making confidence (r = 0.44, P < 0.001). Among those who received the ACP intervention, the effect size of change was medium: Cohen's d = 0.54, P < 0.001 for patients and d = 0.57, P < 0.001 for surrogates. CONCLUSIONS: The preparedness scales demonstrated strong psychometric properties. Future studies should examine scale performance in other populations.

Parent and child perceptions of a self-regulated, home-based exercise program for children with cystic fibrosis.

BACKGROUND: Despite recognized benefits, many children with cystic fibrosis (CF) do not consistently participate in physical activities. There is little empirical literature regarding the feelings and attitudes of children with CF toward exercise programs, parental roles in exercise, or factors influencing exercise experiences during research participation. OBJECTIVES: The aim of this study is to describe the exercise experiences of children with CF and their parents during participation in a 6-month program of self-regulated, home-based exercise. METHODS: This qualitative descriptive study was nested within a randomized controlled trial of a self-regulated, home-based exercise program and used serial semistructured interviews conducted individually at 2 and 6 months with 11 purposively selected children with CF and their parent(s). RESULTS: Six boys and five girls, ages 10-16 years, and parents(nine mothers, four fathers) participated in a total of 44 interviews. Five major thematic categories describing child and parent perceptions and experience of the bicycle exercise program were identified in the transcripts: (a) motivators, (b) barriers, (c) effort/work, (d) exercise routine, and (e) sustaining exercise. Research participation, parent-family participation, health benefits, and the child's personality traits were the primary motivators. Competing activities, priorities, and responsibilities were the major barriers in implementing the exercise program as prescribed. Motivation waned, and the novelty wore off for several (approximately half) parent-child dyads, who planned to decrease or stop the exercise program after the study ended. DISCUSSION: We identified motivators and barriers to a self-regulated, home-based exercise program for children with CF that can be addressed in planning future exercise interventions to maximize the health benefits for children with CF and the feasibility and acceptability to the children and their families.