Timing of sedation and patient-reported pain outcomes during cardiac catheterization: Results from the UNTAP-intervention study.

BACKGROUND: Invasive cardiac catheterization (CC) temporarily increases pain, discomfort, and anxiety. Procedural sedation is deployed to mitigate these symptoms, though practice varies. Research evaluating peri-procedural patient-reported outcomes is lacking. METHODS AND RESULTS: We randomized 175 patients undergoing CC to short interval ([SI] group, <6 min) or long interval ([LI] group, ≥6 min) time intervals between initial intravenous sedation and local anesthetic administration. Outcomes included: (1) total pain medication use, (2) patient-reported and behaviorally assessed pain and (3) patient satisfaction during outpatient CC. Generalized linear mixed effect models were used to evaluate the impact of treatment time interval on total medication utilization, pain, and satisfaction. Among enrollees the mean age was 62 (standard deviation [SD] = 13.4), a majority were male (66%), white (74%), and overweight (mean body mass index = 28.5 [SD = 5.6]). Total pain medication use did not vary between treatment groups (p = 0.257), with no difference in total fentanyl (p = 0.288) or midazolam (p = 0.292). Post-treatment pain levels and nurse-observed pain were not statistically significant between groups (p = 0.324 & p = 0.656, respectively. No significant differences with satisfaction with sedation were found between the groups (p = 0.95) Patient-reported pain, satisfaction and nurse-observed measures of pain did not differ, after adjustment for demographic and procedural factors. Analyses of treatment effect modification revealed that postprocedure self-reported pain levels varied systematically between individuals undergoing percutaneous coronary intervention (PCI) (SI = 2.2 [0.8, 3.6] vs. LI = 0.7 [-0.6, 2.0]) compared with participants not undergoing PCI (SI = 0.4 [-0.8, 1.7] vs. LI = 0.7 [-0.3, 1.6]) (p = 0.043 for interaction). CONCLUSION: No consistent treatment differences were found for total medication dose, pain, or satisfaction regardless of timing between sedation and local anesthetic. Treatment moderations were seen for patients undergoing PCI. Further investigation of how procedural and individual factors impact the patient experience during CC is needed.

Understanding the patient experience of pain and discomfort during cardiac catheterization.

OBJECTIVES: Patient centeredness is an essential component of high-quality care, yet little is known regarding the patient experience during procedures performed in the cardiac catheterization lab. BACKGROUND: Available literature focuses on the safe delivery of sedation, but does not address patient-reported satisfaction or comfort. Further delineation of how procedural factors impact the patient experience is needed. METHODS: We conducted a retrospective, exploratory analysis of adult cardiac catheterization outpatients (n = 375) receiving physician ordered, nurse administered procedural sedation (benzodiazepine and/or opioids) between April and June, 2017. Data were abstracted from the procedural database, Electronic Health Record, and Press Ganey© surveys. RESULTS: The mean age was 63 (SD 12.2), a majority were male (n = 226; 60%), white (n = 271; 73%), and overweight (mean body mass index = 29, SD 6.8). Patient-reported satisfaction with pain control and perceived staff concern for comfort were >75th percentile (Press Ganey© survey), with no difference in preprocedure and postprocedure pain scores (p = .596). Intraprocedural medication dose range and mean frequency were highly variable: midazolam (0.25-5.5 mg; 1.48); fentanyl (12.5-200 mcg; 1.63); and hydromorphone (0.5-2.5 mg; 1.33). Median time interval between administration of initial sedation and local anesthetic was 6 min. Patients with longer intervals had less frequent dosing (p < .001) and less total procedural sedation (p < .001). Sensitivity analysis revealed that trainee/fellow involvement (p = .001), younger age (p = .002), and shorter time intervals (p < .001) were associated with increased frequency and larger total dose. CONCLUSIONS: Waiting to gain vascular access following administration of procedural was associated with less frequent subsequent dosing, lower overall administration, and similar patient satisfaction. Optimizing processes for administering periprocedural sedation may allow for less medication without impacting patient experience.

Evaluation of a nurse-led safety program in a critical care unit.

This implementation of a formalized safety program in a critical care unit highlights the importance of the "voice of the caregiver," as it relates to patient safety. This nurse-led program featured executive walkrounds and a multidisciplinary core team whose goal was to prioritize and resolve safety issues identified during the 6-month study period. Unit nurses' scores on the Safety Attitudes Questionnaire remained stable from July 2011 to February 2012. Staff identified 77 safety issues during executive walkrounds; 57% were resolved during the study period. Results indicate the clinical significance of nurse-led patient safety programs.

Predicting post-event processing in social anxiety disorder following two prototypical social situations: state variables and dispositional determinants.

This study investigated self-reported state (anxiety, physical symptoms, cognitions, internally focused attention, safety behaviors, social performance) and trait (social anxiety, depressive symptoms, dysfunctional self-consciousness) predictors of post-event processing (PEP) subsequent to two social situations (interaction, speech) in participants with a primary diagnosis of social anxiety disorder (SAD) and healthy controls (HC). The speech triggered significantly more intense PEP, especially in SAD. Regardless of the type of social situation, PEP was best predicted by situational anxiety and dysfunctional cognitions among the state variables. If only trait variables were considered, PEP following both situations was accounted for by trait social anxiety. In addition, dysfunctional self-consciousness contributed to PEP-speech. If state and trait variables were jointly considered, for both situations, situational anxiety and dysfunctional cognitions were confirmed as the most powerful PEP predictors above and beyond trait social anxiety (interaction) and dysfunctional self-consciousness (speech). Hence, PEP as assessed on the day after a social situation seems to be mainly determined by state variables. Trait social anxiety and dysfunctional self-consciousness also significantly contribute to PEP depending on the type of social situation. The present findings support dysfunctional cognitions as a core cognitive mechanism for the maintenance of SAD. Implications for treatment are discussed.

Evaluation of a DVD-based self-help program in highly socially anxious individuals--pilot study.

High social anxiety is a risk factor for the incidence of social anxiety disorder (SAD). Early diagnosis and intervention may prevent more severe psychiatric courses. Self-help programs may be a convenient, accessible, and effective intervention. This study examined the efficacy of a newly developed self-help program for SAD in individuals with subthreshold social anxiety. A total of 24 highly socially anxious individuals were randomly assigned to a DVD-based self-help program or to a wait-list control group. The self-help program is based on the cognitive model according to Clark and Wells (1995; adapted to German by Stangier, Clark, & Ehlers, 2006) and comprises eight sessions. ANOVAs based on an intention-to-treat model were used for data analyses. The self-help program was well accepted; just one person withdrew during the intervention. There were significant Time× Group interactions on all primary outcome measures. For the intervention group moderate to high within-groups effect sizes up to Cohen's d = 1.05 were obtained. Between-groups effect sizes ranged from 0.24 to 0.65 in favor of the active intervention. The newly developed DVD-based self-help program seems to be a promising intervention for highly socially anxious individuals as it reduces social anxiety symptoms.

What determines observer-rated social performance in individuals with social anxiety disorder?

Clark and Wells (1995) proposed that cognitive variables and safety behaviors are related to social performance in social anxiety disorder (SAD). Here, we tested this relationship by concurrent assessment of cognitive, behavioral, and physiological variables and social performance in a prototypical social interaction situation. 103 participants with SAD and 23 healthy controls interacted with a confederate. Anxiety, self-focused attention, cognitions, and safety behaviors were assessed by self-report and by confederate ratings. Social performance was evaluated by independent observers using a behavioral coding system. Social performance was predicted using two regression models for self-report and confederate ratings. Between-group differences in social performance disappeared when talking time was taken into account. Talking time emerged as the most powerful predictor of social performance (54% and 58% accounted variance). Positive cognitions, self-focused attention and safety behaviors accounted for an additional, but marginal amount of variance. Reduced talking time might represent a safety behavior and may be considered an easy to measure final common behavioral outcome of cognitive processes underlying social anxiety.