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Care of Critically Ill Adults and Children Quality of care and resource use among mechanically ventilated patients before and after an intervention to assist nurse-nonvocal patient communication Mary Beth Happ, PhD, RN, FAAN a, b, c, * , Susan M. Sereika, PhD d , Martin P. Houze, MS d , Jennifer B. Seaman, PhD, RN b, c , Judith A. Tate, PhD, RN a , Marci L. Nilsen, PhD, RN c , Jennifer van Panhuis, BSN, RN e , Andrea Scuilli, MS g , Brooke Paull, MS, SLP-CCC g , Elisabeth George, PhD, RN, CCRN g , Derek C. Angus, MD, MPH b, e , Amber E. Barnato, MD, MPH, MS e, f a The Ohio State University College of Nursing, Columbus, OH, USA b The CRISMA Laboratory (Clinical Research, Investigation, and Systems Modeling of Acute Illness), Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA, USA c Department of Acute and Tertiary Care, University of Pittsburgh School of Nursing, Pittsburgh, PA, USA d Department of Health and Community Systems, University of Pittsburgh School of Nursing, Pittsburgh, PA, USA e Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA f Department of Health Policy and Management, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA g University of Pittsburgh Medical Center, Pittsburgh, PA, USA article info Article history: Received 25 March 2015 Received in revised form 1 July 2015 Accepted 4 July 2015 Keywords: Augmentative and alternative communications systems Intubation Endotracheal Nurses Education Quality of health care abstract Objectives: Implement and test unit-wide patient-nurse assisted communication strategies (SPEACS). Background: SPEACS improved nurse-patient communication outcomes; effects on patient care quality and resource use are unknown. Methods: Prospective, randomized stepped-wedge pragmatic trial of 1440 adults ventilated 2 days and awake for at least one shift in 6 ICUs at 2 teaching hospitals 2009e2011 with blinded retrospective medical record abstraction. Main results: 323/383 (84%) nurses completed training; their communication knowledge (p < .001) and satisfaction and comfort (p < .001) increased. ICU days with physical restraint use (p ¼ .44), heavy sedation (p ¼ .73), pain score documentation (p ¼ .97), presence of ICU-acquired pressure ulcers (p ¼ .78), coma-free days (p ¼ .76), ventilator-free days (p ¼ .83), ICU length of stay (p ¼ .77), hospital length of stay (p ¼ .22), and median costs (p ¼ .07) did not change. Conclusions: SPEACS improved ICU nursesknowledge, satisfaction and comfort in communicating with nonvocal MV patients but did not impact patient care quality or resource use. Ó 2015 Elsevier Inc. All rights reserved. Abbreviations: ICU: intensive care unit; SPEACS: Study of PatienteNurse Effec- tiveness with Assisted Communication Strategies; MV: mechanical ventilation; SLP: speech language pathologist; EMR: electronic medical record; APACHE: Acute Physi- ology and Chronic Health Evaluation; NCS: Nurse Communication Survey; ITT: inten- tion to treat. Author contributions: Study concept and design e M.B.H., A.E.B., J.A.T., S.M.S., D.C. A.; Acquisition of data e J.B.S., A.S., J.V.P., J.A.T.; Statistical analysis e M.P.H., S.M.S.; Analysis and interpretation of the data e M.B.H., A.E.B., J.A.T., J.B.S., S.M.S., D.C.A., E. G.; Drafting of the manuscript e A.E.B., M.B.H., S.M.S., J.A.T., M.F.N., M.P.H.; Critical revisions to the manuscript for important intellectual content e all authors; Obtained funding e M.B.H, A.E.B., J.A.T., S.M.S, E.G., B.B., D.C.A.; Study supervision e M.B.H., A.E.B., J.A.T., S.M.S, E.G., B.B., D.C.A. Source of support: Robert Wood Johnson Foundation Interdisciplinary Nursing Quality Research Initiative grant #66633. Potential conict of interest: The SPEACS-2 program is accessible online at http:// go.osu.edu/speacs2. Dr. Happ holds the Creative Commons copyright. * Corresponding author. The Ohio State University, 378 Newton Hall, 1585 Neil Ave, Columbus, OH 43210, USA. Tel.: þ614 292 8336. E-mail address: [email protected] (M.B. Happ). Contents lists available at ScienceDirect Heart & Lung journal homepage: www.heartandlung.org 0147-9563/$ e see front matter Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.hrtlng.2015.07.001 Heart & Lung 44 (2015) 408e415

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Page 1: 1-s2.0-S0147956315001788-main

lable at ScienceDirect

Heart & Lung 44 (2015) 408e415

Contents lists avai

Heart & Lung

journal homepage: www.heartandlung.org

Care of Critically Ill Adults and Children

Quality of care and resource use among mechanically ventilatedpatients before and after an intervention to assist nurse-nonvocalpatient communication

Mary Beth Happ, PhD, RN, FAAN a,b,c,*, Susan M. Sereika, PhD d, Martin P. Houze, MS d,Jennifer B. Seaman, PhD, RN b,c, Judith A. Tate, PhD, RN a, Marci L. Nilsen, PhD, RN c,Jennifer van Panhuis, BSN, RN e, Andrea Scuilli, MS g, Brooke Paull, MS, SLP-CCC g,Elisabeth George, PhD, RN, CCRN g, Derek C. Angus, MD, MPH b,e,Amber E. Barnato, MD, MPH, MS e,f

a The Ohio State University College of Nursing, Columbus, OH, USAb The CRISMA Laboratory (Clinical Research, Investigation, and Systems Modeling of Acute Illness), Department of Critical Care Medicine, University ofPittsburgh, Pittsburgh, PA, USAcDepartment of Acute and Tertiary Care, University of Pittsburgh School of Nursing, Pittsburgh, PA, USAdDepartment of Health and Community Systems, University of Pittsburgh School of Nursing, Pittsburgh, PA, USAeDepartment of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USAfDepartment of Health Policy and Management, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USAgUniversity of Pittsburgh Medical Center, Pittsburgh, PA, USA

a r t i c l e i n f o

Article history:Received 25 March 2015Received in revised form1 July 2015Accepted 4 July 2015

Keywords:Augmentative and alternativecommunications systemsIntubationEndotrachealNursesEducationQuality of health care

Abbreviations: ICU: intensive care unit; SPEACS: “Stiveness with Assisted Communication Strategies”; MVspeech language pathologist; EMR: electronic medicalology and Chronic Health Evaluation; NCS: Nurse Commtion to treat.Author contributions: Study concept and design e M

A.; Acquisition of data e J.B.S., A.S., J.V.P., J.A.T.; StatistAnalysis and interpretation of the data e M.B.H., A.E.BG.; Drafting of the manuscript e A.E.B., M.B.H., S.M.S.revisions to the manuscript for important intellecObtained funding e M.B.H, A.E.B., J.A.T., S.M.S, E.G., B.BM.B.H., A.E.B., J.A.T., S.M.S, E.G., B.B., D.C.A.

0147-9563/$ e see front matter � 2015 Elsevier Inc.http://dx.doi.org/10.1016/j.hrtlng.2015.07.001

a b s t r a c t

Objectives: Implement and test unit-wide patient-nurse assisted communication strategies (SPEACS).Background: SPEACS improved nurse-patient communication outcomes; effects on patient care qualityand resource use are unknown.Methods: Prospective, randomized stepped-wedge pragmatic trial of 1440 adults ventilated �2 days andawake for at least one shift in 6 ICUs at 2 teaching hospitals 2009e2011 with blinded retrospectivemedical record abstraction.Main results: 323/383 (84%) nurses completed training; their communication knowledge (p < .001) andsatisfaction and comfort (p < .001) increased. ICU days with physical restraint use (p ¼ .44), heavysedation (p ¼ .73), pain score documentation (p ¼ .97), presence of ICU-acquired pressure ulcers(p ¼ .78), coma-free days (p ¼ .76), ventilator-free days (p ¼ .83), ICU length of stay (p ¼ .77), hospitallength of stay (p ¼ .22), and median costs (p ¼ .07) did not change.Conclusions: SPEACS improved ICU nurses’ knowledge, satisfaction and comfort in communicating withnonvocal MV patients but did not impact patient care quality or resource use.

� 2015 Elsevier Inc. All rights reserved.

tudy of PatienteNurse Effec-: mechanical ventilation; SLP:record; APACHE: Acute Physi-unication Survey; ITT: inten-

.B.H., A.E.B., J.A.T., S.M.S., D.C.ical analysis e M.P.H., S.M.S.;., J.A.T., J.B.S., S.M.S., D.C.A., E., J.A.T., M.F.N., M.P.H.; Criticaltual content e all authors;., D.C.A.; Study supervision e

Source of support: Robert Wood Johnson Foundation Interdisciplinary NursingQuality Research Initiative grant #66633.Potential conflict of interest: The SPEACS-2 program is accessible online at http://

go.osu.edu/speacs2. Dr. Happ holds the Creative Commons copyright.* Corresponding author. The Ohio State University, 378 Newton Hall, 1585 Neil

Ave, Columbus, OH 43210, USA. Tel.: þ614 292 8336.E-mail address: [email protected] (M.B. Happ).

All rights reserved.

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Table 1Components of the SPEACS-2 Intervention.

Intervention components

1. Six 10-min on-line educational modules involving narrated text slides andvideo exemplars of communication assessment and techniques (60 min).

2. Reference manual, pocket reference cards, assessment e interventionalgorithm.

3. Communication cart in the ICU containing assistive communication tools andmaterials.

4. Communication resource nurses (champions) e minimum of 2 per ICU.5. Weekly teaching posters “communication strategy of the week.”6. Weekly patient case conference with Speech Language Pathologist.

M.B. Happ et al. / Heart & Lung 44 (2015) 408e415 409

Intubation for mechanical ventilation (MV) precludes the abilityto speak. Thus, intensive care unit (ICU) patients who are placed onMV suddenly acquire a profound communication disability, whichcan be a source of distress, frustration, anxiety, and agitation.1,2

Communication disability among nonvocal ICU patients reducesthe accuracy of pain and symptom assessment,3,4 predisposes pa-tients to preventable adverse events,5 and may lead to increaseduse of immobilizing treatments such as sedatives or physicalrestraint.

These negative patient outcomes may be ameliorated by as-sistive communication strategies, such as tagged yes-no ques-tions, communication boards, hearing amplifiers, writing tools.Yet nurses in the ICU lack training in assistive communicationstrategies, readily available communication materials, and accessto communication experts (e.g., speech language pathologists).6

In a prior clinical trial of ICU nurse training in the use of sim-ple assistive communication techniques, communication toolsprovision, and speech pathologist support, the “Study of PatienteNurse Effectiveness with Assisted Communication Strategies”(SPEACS),7 we demonstrated improved communication betweenindividual nurses and their nonvocal ICU patients.8,9 Secondaryanalyses also suggested a positive relationship betweencommunication process and patient outcomes, such as painmanagement and sedation level.10 The training format used inSPEACS e a 4-h small group workshop e limited the feasibility ofdissemination.

The purpose of the current study was to translate themulti-component SPEACS program into a disseminable format(SPEACS-2: web-based ICU nurse training in assistive communi-cation techniques, provision of “low tech” communication tools,and expert consultation), then evaluate prospectively whetherunit-wide implementation of the SPEACS-2 could improve nurseknowledge, satisfaction, and comfort in communicating withnonvocal mechanically ventilated patients and thereby improvepatient-level quality of care and resource use.

Materials and methods

Design

We received University of Pittsburgh Institutional ReviewBoard approval for the study, including approval for a waiver ofinformed consent for medical record review. We conducted arandomized crossover cluster (stepped-wedge) quality improve-ment trial of unit-wide implementation of SPEACS-2 in 6 inten-sive care units (ICUs) at 2 teaching hospitals between August2009 and July 2011. Data collectors were blind to the interventionassignment.

Intervention

The original SPEACS training involved a 4-h course consisting ofinteractive lecture with PowerPoint slides and video exemplars,demonstration, role-play and instructor feedback on performanceof communication strategies.7,8 To facilitate unit-wide, scalabledissemination, we modified SPEACS into SPEACS-2. The SPEACS-2communication skills training intervention involved 1 h of on-line training, including video exemplars of communication tech-niques, for all bedside nurses (http://go.osu.edu/speacs2; seeTable 1). Experienced and novice clinicians and assistive commu-nication experts pretested the on-line training version of SPEACSfor feasibility, acceptability, and content. The intervention alsoincluded the provision of communication supplies (e.g., commu-nication boards, notebooks, felt-tip pens, clipboards, hearing aidbatteries, etc.), and weekly bedside teaching rounds with a speech

language pathologist (SLP) on the unit for a period of 25 weeks(2 quarters). Unit “poster” displays reviewing a different compo-nent of the training program each week reinforced learning. Werandomized each ICU to a 3-month intervention period across 6consecutive quarters (18 months) beginning on November 1, 2009,February 1, 2010, May 1, 2010, August 1, 2010, November 1, 2010, orFebruary 1, 2011 (Fig. 1). As soon as we deployed the intervention ina unit, we gave nurses access to the online training and encouragedthem to complete this self-directed training.

We measured fidelity to the intervention (delivery, receipt andenactment) by tracking the number of eligible nurses whocompleted the on-line course, attendance at weekly communica-tion rounds conducted by the SLP, change in scores on a 10-itempre- and post-test knowledge quiz, and use of communicationtools and strategies assessed by communication supply inventoryand randomly scheduled weekly observations for communicationtools in the room, patient communication support in accordancewith the assessment-intervention algorithm, and bedside use of awritten communication plan.

Study ICUs

The six specialty ICUs included in this study were naïve to theSPEACS and SPEACS-2 programs at the study onset. The unitsincluded: NeuroTrauma, Transplant, Medical, Cardiovascular,Trauma, Neurological. All study ICUs provided 1:2 to 1:1 nurse e

patient ratios and 12-h shift rotations. The Critical Care Medicineservice provided attending physician coverage for all 6 ICUs acrosstwo different hospitals in the academic health system. The SLP rolewas limited to dysphagia consultations and swallowing evalua-tions; consultations for communication support were rare.

Participants

Nurse sampleThe eligible nurse sample included all permanent full and

part-time staff nurses assigned to the study unit at the time ofintervention deployment. Unit nurse managers and clinical nursespecialists provided endorsement of the study, introduction andaccess to the unit nursing staff. Managers recommended 2e3individuals to serve as “nurse champions.” Nurse championsreceived an additional in-person introduction to the program andreview of the communication cart by study staff. Nurse cham-pions to then liaised with the research team and encouraged andsupported unit nurses to complete the training program and usethe communication tools.

Patient sampleWe retrospectively identified all potentially eligible control

(pre-intervention) and intervention cases from consecutive

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Quarter1 2 3 4 5 6 7 8

Uni

t

Neuro Included n=30Excludedn=61

Included n=30Excludedn=65

Included n=30Excludedn=81

Included n=30Excludedn=49

Included n=30Excludedn=32

Included n=30Excludedn=56

Included n=30Excludedn=38

Included n=30Excludedn=51

Trauma Included n=30Excludedn=30

Included n=30Excludedn=18

Included n=30Excludedn=25

Included n=30Excludedn=19

Included n=30Excludedn=19

Included n=30Excludedn=20

Included n=30Excludedn=21

Included n=30Excludedn=18

Medical Included n=30Excludedn=38

Included n=30Excludedn=36

Included n=30Excludedn=49

Included n=30Excludedn=23

Included n=30Excludedn=24

Included n=30Excludedn=41

Included n=30Excludedn=30

Included n=30Excludedn=44

Cardiovascular Included n=30Excludedn=16

Included n=30Excludedn=26

Included n=30Excludedn=22

Included n=30Excludedn=15

Included n=30Excludedn=15

Included n=30Excludedn=23

Included n=30Excludedn=21

Included n=30Excludedn=19

Transplant Included n=30Excludedn=47

Included n=30Excludedn=47

Included n=30Excludedn=58

Included n=30Excludedn=28

Included n=30Excludedn=39

Included n=30Excludedn=43

Included n=30Excludedn=44

Included n=30Excludedn=45

Neuro Trauma Included n=34Excludedn=44

Included n=32Excludedn=32

Included n=23Excludedn=35

Included n=24Excludedn=28

Included n=26Excludedn=24

Included n=37Excludedn=21

Included n=30Excludedn=36

Included n=34Excludedn=31

Unshaded – pre-intervention quarter; Light shading – intervention deployment quarter; Dark shading – post-intervention quarter. The total number of randomly selected patients screened for abstraction eligibility in each quarter = included + excluded; the proportion of patients meeting abstraction eligibility criteria = included/(included + excluded).

Fig. 1. [Box] Screening and Eligibility by Study Unit and Quarter. The unshaded section of the box represents pre-intervention quarters, the light-shaded section represents theintervention deployment quarter, and dark shaded section represents post-intervention quarters. The total number of randomly selected patients screened for abstraction eligibilityin each quarter ¼ included þ excluded; the proportion of patients meeting abstraction eligibility criteria ¼ included/(included þ excluded).

M.B. Happ et al. / Heart & Lung 44 (2015) 408e415410

admissions to the 6 study ICUs using administrative (e.g., billing)data. Potentially eligible admissions met three criteria: (1) age 18years and older; (2) first ICU admission during the hospital stay;and (3) MV of at least 2 days’ duration. From this list of potentiallyeligible admissions, we randomly screened electronic medical re-cord (EMR) charts to assess eligibility until we reached 30 patientsper unit per quarter (3 month period) across 8 quarters, yieldingthe pre-specified sample of 240 patients per unit (total n ¼ 1440;Fig. 1).

Definitively eligible admissions were those confirmed by EMRreview to involve: (1) the first ICU admission during the hospitalstay; (2) invasive MV via endotracheal tube or tracheostomy for 2or more calendar days (e.g., non-invasive MV or invasive MVfor < 2 days excluded); and (3) being awake, alert, and respon-sive to verbal communication from clinicians. We operationalized“awake, alert and responsive” as being awake for at least one 12-h nursing shift while receiving MV defined as responding to and/or following commands; nursing note description as alert,arousable, anxious, or awake; or a score of 6 (obeys verbalcommands) for the Best Motor Response on the Glasgow ComaScale,12 and/or a score of 1e3 on the Modified Ramsay Scale,11

Riker13 Sedation Agitation Score � 3 or responsive to verbalcommunication from clinicians via head nods, gestures, or othernonvocal method. Only patients meeting these basic communi-cation criteria could be served by the communication skills andtools included in the intervention. We required patients to beintubated, ventilated for 2 or more days to exclude brief in-tubations in which patients were extubated shortly after awak-ening and to allow for the communication intervention to effect

quality of care outcomes. Full details of our subject screeningresults are published elsewhere.14

Evaluation

Nurse outcomesWe assessed several process measures to evaluate the fidelity

of the intervention.15 Specifically, we assessed training comple-tion (intervention ‘delivery’) by dates of unit nurses’ completionof the web-based training and post-test, with an a priori targetof 85% completion during the quarter of intervention deploy-ment. We assessed nurse knowledge acquisition (intervention‘receipt’) by comparing nurses’ performance on a 10-item pre-and post-training test. Expert clinicians and nurse educatorsvetted the tests after viewing all six training modules. Werecorded communication supply use during weekly restocking,attendance at SLP bedside teaching rounds, and adherenceto training principles (intervention ‘enactment’) via bedsideobservation.

We also assessed nurse satisfaction and comfort with commu-nication with nonvocal patients using a 16-item Nurse Communi-cation Survey (NCS) administered immediately before and 3months after nurse training.16 This was adapted from a previouslyvalidated 12-item NCS with 4 novel items drawn from our focusgroup analysis from the original SPEACS study.9 The revised 16-item NCS survey revealed 6 factors or subscales explaining 66% ofthe item variance. We confined the outcome analysis to subscaleswith internal consistency above a ¼ .70.

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M.B. Happ et al. / Heart & Lung 44 (2015) 408e415 411

Patient outcomesWe selected quality of care measures proximately related to the

hypothesized mechanism of action of the communication skillstraining, informed by video-analysis8 and focus group interviewswith participants in the original SPEACS trial.9 Specifically, wehypothesized that improved communication with nonvocal butawake mechanically-ventilated ICU patients would: 1) increaseeffectiveness of patient-nurse communication and thereby in-crease the frequency of pain score assessment and documentation,and 2) decrease the frequency of patient frustration and agitationand thereby decrease physical restraint and/or heavy sedation toprevent device disruption and resultant ICU-acquired pressureulcers. We based these hypotheses on research linking commu-nication difficulty to feelings of anxiety and agitation duringMV,1,2,17 survey research indicating that patients perceived thattheir frustration with communication would have been signifi-cantly lower if communication tools had been offered duringMV,18 and our previous finding that seriously ill mechanicallyventilated patients communicated more often during periods ofnon-restraint.19

We operationalized and measured these outcomes in the EMRas follows: physical restraint (proportion of mechanically venti-lated ICU days with one or more upper extremity restraint at anypoint during the 24 h interval), heavy sedation (proportion ofmechanically ventilated ICU days inwhich the patient did not meet“awake” criteria for 8 out of 12 h AM or PM as defined by ModifiedRamsay score 1e3, Glasgow Coma motor score of 6, nursing notedocumentation of being alert, awake, arousable, responsive, orcommunicative), coma-free days (number of days out of 28 inwhich patients were assessed as “awake” or not in heavy sedationstate for at least 8/12 h of both AM and PM nursing shifts),20 paindocumentation (proportion of mechanically ventilated ICU dayswith pain score documented, given documented presence of anypain), any ICU-acquired pressure ulcer grade II or greater, and un-planned endotracheal or tracheal tube extubation (see OnlineSupplement for greater detail).

Secondary patient outcomes included resource use. Wehypothesized that reductions in restraint and heavy sedationwouldreduce length of MV, ICU and hospital stay, and costs. Specifically,wemeasured ventilator-free days,21 ICU and hospital length of stay,and cost-adjusted charges.

Trained staff, blinded to intervention assignment, abstractedclinical data (physical restraint, heavy sedation, coma-free days,pain documentation, ICU-acquired pressure ulcers, unplannedextubation, ventilator days) from the electronic medical record(PowerChart, Cerner Corporation, Kansas City, MO) during theincident ICU admission, for up to 28 days, using a standardizedabstraction instrument. From among the 1440 abstracted cases, 108were randomly selected for co-abstraction by a single rater (10% forquarters 1e4; 5% for quarters 5e8) with inter-rater reliability of�0.8e1.0 (near-perfect agreement)22 for all measures except thepresence of pressure ulcers (k ¼ 0.69). We report details of thedevelopment and validation of the abstraction instrument else-where.23 We collected administrative data (ICU length of stay,hospital length of stay, hospital charges) from billing records(Medical Archival System, Pittsburgh, PA).

Statistical analyses

The study was appropriately powered and an adequate patientsample was obtained to detect a small to medium effect size.Specifically, 30 patients per unit per quarter provided at least 80%power to detect unit by quarter interactions as small as f ¼ 0.136[small to medium effect size based on Cohen (1980)] using atwo-sided F-test from a two-way general linear model at a

significance level of .05, adjusting for clustering effect by unit. Toexamine nurse outcomes at post-intervention, we calculated that asample size averaging 50 nurses per unit (300 total), allowing fornonparticipation and attrition, achieves provided about 80% powerto detect a medium-sized effect of d ¼ 0.523 between the groupmeans assuming an intra-unit correlation of at most .010 using atwo-sidedWald test (or more conservatively t-test) at a significancelevel of .05. Although an adequate sample of nurses participatedoverall, we did not achieve 50 nurses per unit with data at both preand post-intervention periods.

We calculated the proportion of regular staff unit nurses in eachstudy ICU who completed the pre-test, training, and post-testduring the quarter of intervention deployment. In some units,most of the nurses completed the training expeditiously, and somore of the days during the intervention period were staffed bynurses who had completed the modules already. In other units,nurses delayed completion, and therefore, based upon the date ofeach nurses’ post-test, we calculated the proportion of trainednurse days among nurses who completed SPEACS-2 training byunit to estimate the median exposure during the quarter of inter-vention deployment. This number could theoretically range from0 if all the nurses who completed SPEACS-2 training completed thepost-test on the last day of the quarter (akin to the pre-interventioncontrol period) to 1 if all the trained nurses completed the post-teston the first day of the quarter (akin to the post-intervention period).We used a paired sample Wilcoxon rank sum test of the differencebetween pre- and post-training knowledge and attitude scoresof nurses. We used a Wilcoxon rank-sign test to compare nurses’pre- and post-training knowledge and attitude scores for the totalsample.

We conducted analyses of intervention effect on patient out-comes using intention to treat (ITT). That is, we considered patientsadmitted to a study ICU in the intervention and post-interventionperiod ICU “exposed” to SPEACS-2, even if the patient’s nursefailed to complete the training or completed the training but didnot deploy any of the skills or tools from SPEACS-2 in patient care.

We summarized demographic and clinical characteristics(age, sex, race, ethnicity, ICU admission diagnosis, severity of illnessupon ICU admission using the Acute Physiology and Chronic HealthEvaluation III score to measure illness severity24 calculatedfrom clinical variables, and pre-hospital functional status) of therandomly selected and abstracted patient sample and comparedthe characteristics of those admitted during pre-intervention andintervention quarters using t-test, chi-square, and Fisher’s exacttests as appropriate.

We usedmixed-effects linear regression to estimate and test theeffect of the intervention on normally-distributed outcomes(physical restraint, heavy sedation, pain score documentation, andventilator-free days) and mixed-effects logistic regression to assesseffect on binary outcomes (ICU-acquired pressure ulcer). Mixed-effects linear regression was employed to assess the effect oncontinuous outcomes (ICU length of stay, hospital length of stay,and hospital costs) after Winsorizing (e.g., top-coding) outliersat the 90th percentile. We treated intervention assignment andquarter as fixed effects and unit as a random effect, with andwithout adjustment for covariates selected a priori based upontheir influence on the outcome of interest (age, sex, APACHE score).

We treated the intervention assignment during the quarter ofintervention deployment as a fraction between 0 and 1 based uponthe median trained nurse days during the quarter.25

In sensitivity analyses, we explored alternate specifications usedin the stepped-wedge literature, including treating the “step”involving intervention deployment as control (0) or intervention(1).26 Finally, we conducted post-hoc analyses stratified by changein knowledge score after the training intervention.

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M.B. Happ et al. / Heart & Lung 44 (2015) 408e415412

Results

Nurse characteristics

A total of 323 of 383 eligible nurses completed the on-linecourse. These study nurses were predominantly women (77%),43% were bachelors-prepared, 5.5% were masters-prepared, and17% were critical care certified.

Patient characteristics

From a sample of 5476 patients identified as potentially eligibleusing administrative claims, we screened 3087 patient charts toidentify 1440 eligible patients for full chart abstraction (Fig. 1).There were no statistically significant differences in demographicor clinical characteristics age, sex, race, APACHE III, or pre-hospitalfunctional status among abstracted patients admitted duringcontrol and intervention quarters (Table 2). The distribution ofprimary admission diagnoses classified by organ system differedsignificantly among control and intervention quarters due to theorder of crossover of subspecialty study ICUs. Subspecialty ICUsthat were randomized to cross-over earlier in the study period (e.g.,

Table 2Demographic and clinical characteristics of abstracted eligible patients, by inter-vention period.

Pre-intervention(N ¼ 626)

Interventiongroupa

(N ¼ 814)

p-value

Age, mean (SD), y 59.97 (17.65) 62.06 (16.26) 0.07Male sex, n (%) 326 (52.1) 428 (52.6) 0.85Race (N ¼ 1435), n (%)b 0.33c

White 560 (89.7) 731 (90.1)Black 57 (9.1) 75 (9.2)Asian 2 (0.3) 4 (0.5)Other 5 (0.8) 1 (0.1)

APACHE III score, mean (SD) 67.40 (27.8) 64.87 (27.41) 0.08Primary admission diagnosisclassified by organ system, n (%)

<0.01

Cardiovasculard 93 (14.9) 141 (17.3)Respiratory 153 (24.4) 177 (21.7)Neurological 54 (8.6) 181 (22.2)Gastrointestinal 42 (6.7) 41 (5.0)Trauma 105 (16.8) 82 (10.1)Renal or liver 19 (3.0) 6 (0.7)Transplant 23 (3.7) 5 (0.6)Sepsis 31 (5.0) 31 (3.8)Post-surgical 101 (16.1) 137 (16.8)Othere 5 (0.8) 13 (1.6)

Pre-hospital functional dependence, n (%)b

Eating (N ¼ 1036) 25 (4.0) 20 (2.5) 0.10Grooming (N ¼ 1033) 25 (4.0) 26 (3.2) 0.42Bathing (N ¼ 1037) 30 (4.8) 30 (3.7) 0.30Dressing (N ¼ 1031) 27 (4.3) 29 (3.6) 0.47Transfers (N ¼ 1022) 34 (5.4) 28 (3.4) 0.07Toileting (N ¼ 1221) 33 (5.3) 42 (5.2) 0.93

SD e standard deviation; APACHE III e Acute Physiology Age and Chronic HealthEvaluation (APACHE) III score.

a Includes 180 patients abstracted from a quarter of intervention deployment. Inour base-case analysis, we treated the unit as being “partially exposed” to theintervention during the quarter in which the nurses received training. We assigneda value between 0 and 1 corresponding to the median proportion of trained nursedays in the unit. Units in which the nurses completed earlier in the quarter havenumbers closer to 1 than units in which the nurses completed training later in thequarter (see Table 3).

b The proportion reported is among patients with non-missing data; we reportthe number of subjects with non-missing data in parenthesis.

c p-value obtained from Fisher’s exact test.d Includes Cardio/thoracic/vascular surgery, cardiomyopathy, myocardial infarc-

tion, and arrhythmia.e Includes hematology/oncology.

neurological ICU) accrued more time in the post-interventiondeployment intervention period and therefore contribute more oftheir patients with a neurologic admission diagnosis (Table 2).

Intervention fidelity (delivery, receipt, and enactment)

Overall, 323/383 (84%) nurses completed the training duringtheir unit’s intervention deployment quarter (range: 77e93%) witha median fraction of trained nurse days during the deploymentquarter of 46% (range: 11e65%) (Table 3). Among the 273/323 (85%)nurses who completed both the SPEACS-2 course pre- and post-tests, average test scores increased from 49% to 55% correct(p < .001).

We restocked an average of 10.8 items per unit each week,equivalent to 0.5 items/ICU bed (64.8 items/124 ICU beds) duringcommunication cart inventory. A majority (94%) of scheduledweekly SLP rounds were completed during a 25-week period (twoquarters) for each ICU with a total of 24e40 (mean ¼ 30.3; 156/383(41%)) distinct nurses participating per ICU. We conducted 225intervention fidelity monitoring observations during the inter-vention quarter and 257 observations during the quarter immedi-ately following intervention deployment. We did not see anydecrease (i.e., decay) in the adherence to SPEACS-2 program com-ponents between the intervention quarter and the quarter imme-diately following intervention deployment (see Fig. 2).

Nurse comfort and satisfaction with communication

Among the 264/323 (82%) nurses who completed the percep-tions of communication survey, the overall mean item scoreincreased from 3.21 to 3.43 (p < .001). These changes were prin-cipally driven by improvements in items related to comfort andsatisfaction with communication.

Quality of care

Overall, 49.2% of mechanically ventilated ICU days involvedupper extremity physical restraint and 34.7% involved heavysedation (corresponding to 20.8 coma-free days) and, among thosewith pain documented, 26.2% involved documentation of the painscore. 133/1440 (9.2%) patients developed ICU-acquired pressure

Table 3Nurse training receipt, knowledge, and attitude scores.

Measure Overall

Eligible nurses, n 383ReceiptCompleted training during quarter,a n (%) 323 (84)Trained nurse days in quarter,a median proportion (IQR) 0.46 (0.52)

Nurse knowledge about strategies for communication with nonvocal patientsNurses with both pre- and post-test data, n 273Pre-test knowledge: % correct,b mean (SD) 49.0 (14.2)Post-test knowledge: % correct,b mean (SD) 55.4 (14.4)Change: % correct,b mean (SD) 6.3 (17.4)p-value <0.001

Nurse attitudes toward communication with nonvocal patientsNurses with attitude data, n 264Pre-training attitude score,c mean (SD) 3.21 (0.42)Post-training attitude score,c mean (SD) 3.43 (0.42)Change: mean item response, (SD) �0.22 (0.44)p-value <0.001

IQR e interquartile range (75th percentile value minus 25th percentile value); SD e

standard deviation.a Quarter during which the intervention was deployed.b Knowledge outcomes restricted to the 273/323 (84.5%) trained nurses who

competed both the pre- and post-test knowledge assessment tests.c Mean item response for the 16-item survey; each item had a possible range of

1e5 indicating strength of agreement.

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0%10%20%30%40%50%60%70%80%90%

100%

Communication wall cards/careplans

Algorithm use Communication at all, with or without

algorithm

Communication tools in room

Perc

enta

ge A

dher

ent t

o Pr

otoc

ol

Bedside Intervention Fidelity Items

Intervention Fidelity Monitoring (IFM) during and post-intervention quarters

IFM Intervention Quarter IFM Post-Intervention Quarter

p=.268

p=.122

p=.107

p=.141

Fig. 2. [Bar chart] Intervention Fidelity Monitoring (IFM). Direct observations duringthe intervention implementation quarter (N ¼ 225) and during the first post-intervention implementation quarter (N ¼ 257) demonstrated no decreases in theadherence to SPEACS-2 program components (written communication care plans, al-gorithm use, communication at all e with or without algorithm, and assistive andaugmentative communication tools in the patient’s room) over time.

M.B. Happ et al. / Heart & Lung 44 (2015) 408e415 413

ulcers grade II or greater. There were no statistically significantdifferences between intervention and control quarters in propor-tion of ICU days with physical restraint (�2.44, p ¼ .44), heavysedation (1.08, p¼ .73), or pain score documentation (�.11, p¼ .97),in ICU-acquired pressure ulcers (�.11, p ¼ .78), or coma-free days(.32, p ¼ .76), or (Table 4).

These findings were not qualitatively changed in analysesadjusting for age, sex, race, admission APACHE III score, andneurologic disorder as the admitting diagnosis (Table 3), or insensitivity analyses treating the intervention deployment quarteras a control period (0) or a full intervention period (1), instead of afraction corresponding to the median proportion of trained nursedays, or in post-hoc analyses stratified by greater versus lessernurse knowledge change (see Supplemental Appendix).

Table 4Nursing care quality and utilization outcomes, by intervention period.

Outcome Control(N ¼ 626)

Nursing care quality measures, mean (SD); N {%}% ICU days with upper extremity physical restraint 47.9 (36.0)

% ICU days with heavy sedation 37.9 (31.3)

Coma-free days, d 20.3 (10.2)

% ICU days with pain score documented 29.0 (30.1)

Patients With one or more pressure ulcers 62 {9.9}

Utilization outcomes, mean (SD); median [IQR]Ventilator-free days, d 19.1 (7.5)

ICU length of stay, dd 10.0 [12.0]

Hospital length of stay, dd 15.0 [15.0]

Cost, $d 45,876 [47,195]

SD e standard deviation; IQR e interquartile range; ICU e intensive care unit.a Includes quarter of intervention deployment, during which the intervention is treatb Mixed effect regression (standard errors adjusted for clustering by unit).c Mixed effect regression with additional adjustment for patient age, sex, race, admissd Cost-adjusted charges calculated from hospital administrative claims data for ch

(top-coded) at the 90th percentile.

Resource use

Overall, the sample had an average of 19.2 ventilator free days, amedian ICU length of stay of 9.0 days, a median hospital length ofstay of 15.0 days, and a median cost of $48,774. There were nostatistically significant differences between intervention and con-trol quarters in ventilator-free days (.15, p ¼ .83), ICU length of stay(.20, p ¼ .77), hospital length of stay (1.22, p ¼ .22), and mediancosts ($6,380, p ¼ .07) (Table 4).

These findings were not qualitatively changed in analysesadjusting for age, sex, race, admission APACHE III score, andneurologic disorder as the admitting diagnosis (Table 4), or insensitivity analyses treating the intervention deployment quarteras a control period (0) or a full intervention period (1), instead of afraction corresponding to the median proportion of trained nursedays (data not shown). In post-hoc analyses stratified by units withgreater versus lesser nurse knowledge change, the interventionwas associated with an increase of $14,258 in per patient costs inthe 3 study units with less than 5% absolute increase in post-testknowledge (p ¼ .03).

Discussion

In this study conducted in 2 hospitals in a single academichealth system, the SPEACS-2 program implemented sequentiallyacross six heterogeneous specialty ICUs improved nurse knowl-edge of and attitudes toward assistive communication strategiesvery modestly, but had no impact on selected nursing carequality indicators (i.e., physical restraint use, heavy sedation, painrating adherence, and ICU-acquired pressure) or utilization out-comes (i.e., ventilator-free days, length of ICU stay, length ofhospital stay, cost).

There are several possible explanations for the lack of impact ofSPEACS-2 on nursing quality indicators and utilization outcomes.The first is that the communication skills training was not“received.” Although we met the 85% training target in all but

Interventiona

(N ¼ 814)Unadjustedb interventioneffect b [95% CI]p-value

Adjustedc interventioneffect b [95% CI]p-value

50.1 (36.5) �2.44, [�10.27; 4.50]0.44

�2.44, [�9.80; 4.92]0.52

32.3 (29.7) 1.08, [�5.09; 7.25]0.73

0.56, [�5.36; 6.48]0.85

21.1 (9.9) 0.32, [�1.73; 2.36]0.76

0.96, [�0.88; 2.81]0.31

24.0 (27.2) �0.11, [�6.03; 5.80]0.97

�1.44, [�5.97; 3.10]0.53

71 {8.7} �0.11, [�0.90; 0.67]0.78

�0.17, [�0.98; 0.64]0.68

19.3 (7.3) 0.15, [�1.22; 1.51]0.83

0.37, [�0.88; 1.61]0.55

9.0 [11.0] 0.20, [�1.18; 1.59]0.77

�0.08, [�1.28.; 1.13]0.90

15.0 [13.0] 1.22, [�0.66; 3.09]0.20

0.89, [�0.89; 2.68]0.33

50,458 [53,305] 6,380, [�579; 13,339]0.07

5,797, [�936; 12,529]0.09

ed as a fraction corresponding to the median trained nurse days (see Table 2).

ion APACHE III, and neurological disorder as admitting diagnosis.arges, deflated by the hospital-specific cost-to-charge ratio. Outliers winsorized

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M.B. Happ et al. / Heart & Lung 44 (2015) 408e415414

one unit, there were only modest improvements in knowledgeobserved and a relatively high rate of incorrect answers on thepost-test among nurses who completed SPEACS-2 training. Thepre- and post-test was a 10-item knowledge quiz. The observeddifference of 6-percentage points between the pre- and post-testcorresponds to answering 0.6 (<1) additional item correctly. Thistest was pretested with clinicians but did not undergo psycho-metric assessment and test performance cannot be mapped ontobedside nursing behaviors.

These small, though statistically significant, knowledge gainsraise the concern that the training intervention was ineffective.The on-line SPEACS-2 was a condensed version of the face-to-facecommunication skills training course developed and tested in theoriginal SPEACS study,7,8 revised with input from those nurseparticipants9 and vetted with clinicians and communication dis-orders specialists. We did not, however, pretest the online versionto replicate SPEACS study findings. We chose to deliver this con-tent via an online platform to maximize accessibility (24 h a day, 7days a week) and consistency in content delivery. Nurses, partic-ularly those who accessed the training program from bedsidecomputers, may have been distracted or inattentive to the trainingprogram content and video exemplars. Although we sought toreinforce learning with posters featuring a different assessment orcommunication strategy each week and weekly communicationrounds with the Speech Language specialist, enactment wassuboptimal, and overall, fidelity to nurse implementation of theintervention in terms of real practice change was low. A recent on-line training in AAC techniques developed by speech languagepathologists at the University of Iowa Hospitals demonstratedeven less nurse participation.27 Communication skills transfermay require more intensive role modeling, skills practice,boosters, and feedback.28e30

Second, it is possible that, despite some knowledge gain, thecommunication skills training program did not change communi-cation behaviors and achieve practice change. We had no pre-determined expectations of adherence. Critical care provideradherence to known clinical practice guidelines varies widely asevidenced by reported adherence to care bundles in the SurvivingSepsis Campaign (36%),31 trauma patient transfer guidelines(<50%),32 endotracheal suctioning guidelines (51%),33 and enteralnutrition guidelines (>80%).34 Although we identified nursechampions in each ICU to facilitate nurse engagement in the studyand obtained approval and support of the health system’s chiefnursing officer, we conceptualized the intervention as an inter-vention to change knowledge and attitudes. Even demonstrablyacquired skills may not generalize to actual practice if existingcommunication practices are deeply embedded. Attitudinal bar-riers reported by previous nurse focus groups, such as prioritizationof technological caregiving and life sustaining treatments overcommunication and psychosocial needs and preferences for pa-tients who are “sedated” and “quiet,”9 may require a broaderorganizational initiative to change communication practice,recognition for good performance, and more prolonged imple-mentation of 12e24 months.35 For example, a recent study ofphysician simulation-based communication skills training toimprove end-of-life communication between physicians/nursepractitioners and seriously ill patients did not change practice orpatient and family perceptions of encounters with the health careprovider.36

Third, the study results may be constrained by limitations inthe outcomes measurement, which depended on the accuracyand completeness of EMR documentation and assumed sensi-tivity of these particular measures to the impact of changesin communication processes between nurses and nonvocal pa-tients in ICU. This is the first study to attempt longitudinal

quantification of nursing care quality indicators in ICU to mea-sure the effect of communication. The intervention demonstratedmodest improvements in nurse knowledge, and their comfortand satisfaction with communication with nonvocal, intubatedICU patients. Greater improvements in nurses’ knowledgeabout communication using AAC tools and techniques may havebeen achieved with formal educational follow-up or boosters(e.g., webinar, simulation, role play, communication coaching).Because we have no information on minimal clinically importantdifferences in scales measuring satisfaction and comfort withcommunication, we are careful to not over-interpret the signifi-cance. Although the gains were modest, the fact that the programwas able to change attitudes, particularly comfort with andsatisfaction in communicating with impaired patients is animportant step toward practice change. Program enactmentmeasures showed gradual increases over time from the deploy-ment quarter to the post-implementation quarter, most notably,in the use of AAC tools and techniques beyond simple ‘yes/no’appropriate to the patient’s level of communication function, andplacement of AAC tools in the rooms of eligible mechanicallyventilated patients. Although program adherence and adoptionmay not have reached levels necessary to show meaningfulchange in quality indicators or patient outcomes, these achieve-ments suggest that the program can produce measurable practicechange and that longer andmore robust implementationmay yieldbetter results.

Fourth, we powered the study to find a small to moderate effectsize. If the effect size is considerably smaller, the null finding wouldreflect type II error.

Post-hoc sensitivity analysis indicating that units with lowgains in nurse knowledge experienced a substantive increasein per patient costs in the post-intervention quarters aredifficult to interpret because other utilization outcomes thattypically track with costs, such as length of stay and ventilator-free days, did differ between units with low and high gains innurse knowledge, and may reflect Type I error (See OnlineSupplement).

The stepped wedge design was chosen because individual levelrandomization was not possible and to avoid threats to externalvalidity in a classic cluster randomized trial, particularly withrespect to heterogeneity of ICUs,26 and because the interventionshowed initial evidence of effectiveness in improving communi-cation process measures.8 However, the protracted steppedimplementation extends trial duration while limiting the timeavailable for intervention implementation as well as the opportu-nity for follow-up measurement.37

Finally, more granular data collection on nurse “dose” andimplementation may have provided a more robust test of practicechange and the impact of that change on patient well-being. Oneapproach may be to quantify the proportion of days that the pa-tient’s nurse(s) were SPEACS-2 trained. Nurses could be observedfor actual use of SPEACS-2 techniques and tools during patientcommunication.

In conclusion, unit-wide implementation of a program ofnurse training in assistive communication skills, low-techcommunication tools and clinical resources (SPEACS-2) achievedmodest improvements in ICU nurses’ knowledge, satisfaction andcomfort in communicating with nonvocal mechanically venti-lated patients but did not significantly impact on nursing carequality or clinical outcomes. Future studies should include longerintervention periods, pragmatic clinical trial designs38 thatemploy iterative intervention testing responsive to the ICUsetting, more granular intervention measurement, validation ofoutcome measures, and consideration of patient and familypsychological outcomes.

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M.B. Happ et al. / Heart & Lung 44 (2015) 408e415 415

Acknowledgments

Our thanks to research mentorship students, Rebecca Nock,Anna Evans, Jin Lee, Ian Joel, Tiffany Behringer, Rachel Orler Reid,Joe Ciampoli, Joe Kaye, Lauren Mancuso, Cassandra Delp, HannahPark, Alexandra Dreyzin, whoworked on this project and toMelissaSaul, MS and Elan Cohen, MS for database and programmingassistance.

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Appendix Table A1Quality indicator definitions

Quality indicator Definition

Restraint use All restraint devices used within the 24 h interval being evaluated including: soft extremity restraints (specify number of limbs restrained), vests,waist belts, full side-rails, mitts, and enclosure beds.

Heavy sedation Evidence of heavy sedation at any point during the 24 h interval as measured by:� Modified Ramsay score 4e6 or� Riker score of 1e2 or� Nursing note description of unresponsiveness to verbal or tactile stimulation, or being comatose or anesthetized.

Awake for 8 out of 12 h for 12:00 ame11:59 am or 12:00 pme11:59 pm as defined by:� Modified Ramsay score 1e3.� GCS motor score of 6.� Nursing note documentation of being alert, awake, arousable, responsive, or communicative.

Pain Presence of any pain during the 24 h period being evaluated (Y/N).Highest pain score on a scale of 1e10 (including half scores) for the 24 h interval.Any use of the descriptor “unable to communicate” in the pain assessment documentation during the 24 h interval (Y/N).

ICU acquiredpressure ulcers

Any pressure ulcer, stage II or greater, occurring during the index ICU stay that was not documented on admission [cumulative for ICU stay].

Patients reported on the initial eligibility list:

n = 5476

Pre-Interventionn=2,322

Interventionn=3,154

EMR reviewed for eligibility:n=1747

Excluded:n=933

Abstracted:n=814

EMR reviewed for eligibility:n=1340

Excluded:n=714

Abstracted:n=626

Fig. 1. [CONSORT diagram]. We retrospectively identified a representative sample ofcontrol (pre-intervention) and intervention cases from consecutive admissions to the 6study ICUs using administrative (e.g., billing) data. Potentially eligible admissions metthree criteria: (1) age 18 and older; (2) first ICU admission during the hospital stay; and(3) MV of at least 2 days’ duration. From this list of potentially eligible admissions, werandomly screened charts to assess eligibility until we reached 30 patients per unit perquarter, yielding the pre-specified sample of 1440.

Appendix Figure A1

M.B. Happ et al. / Heart & Lung 44 (2015) 408e415415.e1

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Appendix Table A2Post hoc analysis of outcome variables by unit nurse knowledge gain

Low knowledge gain units High knowledge gain units

Intervention effect Statistic p value Intervention effect Statistic p value

Nursing care quality measures% ICU days with upper extremity physical restraint �2.63 t ¼ �0.38 0.71 �6.64 t ¼ 0.87 0.38% days heavy sedation 8.32 t ¼ 1.43 0.15 �7.12 t ¼ �1.18 0.24Coma-free days, d �1.22 t ¼ �0.63 0.53 2.07 t ¼ 1.21 0.23% ICU days with pain score documented �3.36 t ¼ �0.65 0.52 2.98 t ¼ 0.54 0.60Patients With one or more pressure ulcers �0.66 Wald ChiSq ¼ 1.21 0.27 �0.07 Wald ChiSq ¼ 0.01 0.93

Utilization outcomesVentilator-free days, d 0.23 t ¼ 0.17 0.87 �0.3 t ¼ �0.23 0.82Study ICU LOS (days) �0.51 t ¼ �0.4 0.69 1.09 t ¼ 0.84 0.40Hosp LOS (days) 0.52 t ¼ 0.29 0.77 2.94 t ¼ 1.77 0.08Total ICU LOS (days) �0.45 t ¼ �0.33 0.74 1.17 t ¼ 0.88 0.38Cost ($) 14,259 t ¼ 2.15 0.03 5913 t ¼ 0.86 0.39

M.B. Happ et al. / Heart & Lung 44 (2015) 408e415 415.e2