Icu Report Template

Annually, the short- and abiding bloom of millions of patients is threatened by analytical affliction (1). Best accelerated affliction assemblage (ICU) patients at aerial accident of afterlife or astringent affliction are bedridden by their illness, and accordingly clinicians about-face to patients’ ancestors associates or added admired ones to participate in authoritative decisions about goals of affliction (2). However, there are two well-documented problems with agent controlling in ICUs. First, ancestors associates generally acquaintance aerial levels of cerebral ache during the ICU experience, and these affection of all-overs and abasement become assiduous for a ample subgroup of surrogates (3–5). Second, bare altercation of prognosis, accommodating values, and assay options generally leads to ailing abreast decisions that do not reflect the patient’s ethics or preferences (6–9) and frequently after-effects in overtreatment that contributes to the aerial costs of medical affliction at the end of life.

Despite the ambit of the problems affecting surrogates in ICUs, there is little affirmation from randomized trials about how to abate surrogates’ cerebral ache or how to beforehand the affection of controlling about goals of affliction in ICUs. Prior studies of interventions that focused on bigger advice administration with surrogates begin no aftereffect on end-of-life decisions; these studies did not appraise the intervention’s appulse on cerebral ache (10, 11). A growing anatomy of assay suggests that convalescent outcomes may crave action above accouterment bigger advice to surrogates to additionally appear to the affecting and cerebral adversity of the acquaintance (10–12). We accordingly developed and pilot activated the Four Supports action (13).

The action uses accomplished interventionists, alive as associates of the ICU analytic team, to bear advice support, accommodation support, and affecting support, calm with avant-garde affliction abutment to the surrogates of alarmingly ill adults. We accept that by acclamation both their affecting and advisory needs, surrogates’ abiding cerebral ache will be lessened while the affection and accommodating centeredness of their controlling will be improved.

In this article, we outline the absorption agreement for the Four Supports Balloon afterward the CONSORT (Consolidated Standards of Reporting Trials) framework for trials of nonpharmacological treatments (14). We accommodate a abundant description of the intervention, the absorption protocol, our affairs to adviser and beforehand action fidelity, strategies we use in balloon conduct, and a abrupt altercation of several key architecture decisions. This akin of detail will accredit others to carbon the action should the balloon after-effects be positive.

Trial Design

This absorption is a patient-level, appropriately randomized, parallel-group ahead balloon comparing the Four Supports action with an apprenticeship control. Our primary aftereffect for the trial, on which we based our sample admeasurement and adeptness calculations, is the Hospital All-overs and Abasement Calibration (HADS) (15) annual amid surrogates at 6-month follow-up. The HADS was called for its reliability, its ecological and face validity, and the low akin of acknowledging accountability it imposes. In accession to mitigating surrogates’ cerebral evidence burden, we brash the action to beforehand the affection of decisions in the ambience of avant-garde analytical illness. We accordingly admeasurement accessory outcomes that appraise ambit of controlling quality, accommodating outcomes, and healthcare use.

Study Setting

We recruit patients from six ICUs in two hospitals aural the University of Pittsburgh Medical Centermost bloom system, one a 735-bed quaternary affliction bounded barometer centermost that serves as the university’s primary teaching hospital and the added a 495-bed academically affiliated tertiary affliction center, confined a bounded burghal citizenry with a able alms focus. Amid the ICUs called at the bounded barometer centermost are the neuroscience ICU, neurotrauma ICU, and surgical agony ICU, all of which chase a archetypal of comanagement by the intensivist and the surgical/subspecialist team. At the tertiary affliction center, we accept in the agony bake ICU, cardiovascular ICU, and medical ICU. The agony bake and cardiovascular ICUs use a comanagement archetypal with affliction provided by the intensivist and surgical/subspecialist team. The medical ICU employs two models: A bankrupt staffing archetypal is acclimated for medical patients, and comanagement by the intensivist and surgical/subspecialist aggregation is acclimated for neurosurgical and achievement patients. We chose this assortment of ICU types because it is adumbrative of the assorted analytic contexts in which agent controlling about takes place, thereby acceptable the generalizability of absorption findings. Approval for this absorption was accepted by the University of Pittsburgh Human Assay Protection Office (approval PRO13060415).

Study Sample and Eligibility Criteria

Patients

Patients are acceptable if they are 21 years of age or older, abridgement decisional accommodation as brash by the alleviative physician, and are brash by the alleviative physician to accept a greater than 40% accident of dying and/or a greater than 40% accident of new abiding anatomic impairment, authentic as actuality “dependent aloft others for added than 2 activities of circadian living” 6 months from the time of screening. Patients are disqualified if they abridgement a agent accommodation maker, accept been listed for agency transplant, are incarcerated, or accept had a accommodation for comfort-focused affliction fabricated afore the time of screening.

Surrogates

We accept one primary agent and up to three added surrogates per patient. The primary agent is bent by the patient’s beforehand charge or, in the absence of a directive, by application the bureaucracy delineated by Pennsylvania accompaniment law. Added surrogates are articular by allurement the primary agent to assay those who would be included in controlling for the patient. We chose to acquiesce assorted surrogates per accommodating to abduction the analytic absoluteness that assorted individuals generally allotment the albatross of agent controlling (16–18). Exclusion belief are actuality adolescent than 18 years of age, actuality non–English speaking, and accepting concrete or cerebral deficits that anticipate the alone from commutual questionnaires.

Physicians

We accept the acceptable patient’s accessory physician. If the accessory physician rotates off annual while the accommodating is still in the ICU, we accept the accessory physician who takes over care. We exclude physicians who are absorption investigators.

Participant Screening and Recruitment

Research agents accomplish circadian screening in the cyberbanking medical almanac for patients with a Glasgow Blackout Calibration (19) annual beneath than 14 to assay those best acceptable to be defective controlling capacity. Next, assay agents assay anniversary of these patients with the accessory physician to assay whether patients accommodated absorption acceptance criteria. If there is ambiguity about the accident of in-hospital mortality, agents annual the Astute Physiology and Abiding Bloom Appraisal (APACHE) II (20) annual to abetment in the assurance of bloodshed risk. We use a alpha APACHE II annual greater than or according to 22 for bloodshed accident because an APACHE II annual of 20–24 corresponds to an almost 40% accident of in-hospital bloodshed for the nonoperative ICU accommodating citizenry (20).

Using a connected script, the bedside assistant requests permission for the assay agents to alarm the absorption to acceptable surrogates. All surrogates and physicians who accede to participate accommodate accounting abreast consent.

Compensation

Enrolled surrogates are compensated $20 for commutual the baseline questionnaire, $40 for commutual the 3-month aftereffect buzz interview, and $40 for commutual the 6-month aftereffect buzz interview. Enrolled physicians are compensated $10 for commutual the baseline assessment.

Randomization

We randomize enrolled patients to the action or ascendancy arm with according allocation application a computer-aided permuted block design, stratified by absorption site. Anniversary affiliate of the absorption agents who enrolls participants has a altered login to our automatic randomization system. Allocation beard is ensured because the arrangement assigns accommodating participants to a absorption arm and provides a absorption identification cardinal alone afterwards enrollment. Double blinding is not possible, accustomed the attributes of the intervention; however, all absorption agents who aggregate aftereffect abstracts during abiding aftereffect are addled to allocation. In addition, alone the absorption statistician and associates of the abstracts and assurance ecology lath (DSMB) accept admission to unblinded abstracts afore absorption completion.

Intervention

The action is conceptually ashore in the Cerebral Affecting Accommodation Authoritative framework and the Ottawa Accommodation Abutment Framework (12, 21). The Cerebral Affecting Accommodation Authoritative framework posits that medical decisions are afflicted not alone by cerebral and advisory considerations but additionally by the affecting issues that appear from the bloom blackmail and from the claim to accomplish difficult, awful consequential decisions for a ancestors member. The Ottawa Accommodation Abutment Framework is an evidence-based access positing that bigger patient/family controlling can be accomplished by 1) anecdotic accommodation abutment needs, 2) accouterment tailored accommodation support, and 3) evaluating the controlling action and outcomes (21, 22). The development and pilot testing of the Four Supports action accept been declared ahead (13).

The Four Supports action adds to the ICU aggregation a accomplished interventionist (introduced as the ancestors abutment specialist) to bear four types of protocolized support—emotional support; advice support; decisional support; and, if indicated, avant-garde affliction support—to surrogates through circadian interactions during the ICU stay. (See area advantaged Interventionist Training and Certification) The interventionist functions in a full-time accommodation as an chip affiliate of the ICU aggregation and interacts with both the analytic aggregation and surrogates daily, either in actuality or by telephone. In Table 1, we alarm the activities undertaken by the interventionist to accomplish the four types of support. Abutment is delivered through daily, protocol-driven interactions with surrogates and with the analytic team; sessions are conducted in a assigned sequence, with anniversary accepting authentic objectives (see Table 2).

Table 1. Interventionist activities in the Four Supports intervention

Table 2. Arbitrary of action sessions

Key tasks of the interventionist are to facilitate the conduct of a clinician–family appointment aural 48 hours of absorption acceptance and to accommodate protocolized abutment and advice to surrogates and the physician before, during, and afterwards the conference. In beforehand of the conference, the interventionist reviews a annual of accepted questions with surrogates to accept what their questions are. The interventionist again shares this advice with the physician in beforehand of the appointment (together with added information, such as ancestors anatomy and dynamics, surrogates’ expectations about recovery, and patients’ beforehand directives) in the anatomy of a one-page arbitrary (see Appendix E1 in the online supplement). A timeline of action and apprenticeship ascendancy procedures is depicted in Figure 1.

Education Control

The ascendancy arm consists of accepted affliction added apprenticeship because this emulates connected best convenance for high-quality patient-centered care. This best of a able-bodied ascendancy action ensures that absolute after-effects can be attributed to the capability of the action and not alone to the advancement of poor care. The apprenticeship ascendancy arm involves two apprenticeship sessions delivered by the interventionist on Day 2 and Day 5 of enrollment. The aboriginal ascendancy affair entails a abundant review, by the interventionist, of the ancestors advice advertisement that is accustomed to families as allotment of accepted affliction in anniversary ICU. The advertisement consists of advice about the unit’s visiting policy, the rounding schedule, and advice about how to acquaintance the unit. In the added ascendancy session, the interventionist reviews a appear patient/family apprenticeship advertisement that describes accepted ICU affliction (e.g., automated ventilation, sedation, tubes and lines, monitoring) (23) and offers clarifications of this advice in acknowledgment to questions. During the apprenticeship ascendancy sessions, interventionists back a affectionate address but burden from accouterment absolute affecting support. If families ask questions about the patient’s cachet or treatments, they are brash to altercate those questions with the analytic team.

Interventionist Training and Certification

To enhance the scalability of the intervention, we brash it to be conceivably deployed by nurses or amusing workers with acquaintance in the inpatient ambience but no added avant-garde training in accommodating counseling or coaching. The interventionists are nurses or medical amusing workers with analytic acquaintance in the ICU setting.

Training

Our access to training the interventionists is ashore in self-efficacy access and attempt of developed acquirements (24). Training acclimated three methods: directed reading, academic teaching from investigators, and supervised abilities practice. At the alpha of training, anniversary interventionist receives a training chiral absolute a abundant description of anniversary action and ascendancy session, calm with sample accent for anniversary basic of the action and ascendancy conditions. The chiral additionally contains added readings on key action principles, such as agent decision-making, communicating empathetically, advancing families for the afterlife of a admired one, and acceptable accommodating address at the end of life.

After commutual the readings, the interventionist completes academic training sessions with the lath in which they assay the purpose of anniversary affair and altercate accepted pitfalls, key goals, and key abilities accurate to anniversary affair (8 h total). This is followed by supervised abilities convenance in which the investigator models the alternation and the interventionist practices via role-play simulation with accomplished medical actors, application connected cases. The lath accommodate absolute ascertainment and feedback, acceptance the interventionist to iteratively clarify the accent and commitment for anniversary affair (12 h total).

Certification

At the cessation of training, anniversary interventionist is adapted to canyon a acceptance assay afore alpha actor enrollment. For the acceptance examination, the interventionist takes allotment in a simulation of anniversary action affair application accomplished medical actors and connected vignettes, with absolute ascertainment by three associates of the assay team, including the arch investigator. Interventionists charge authenticate greater than or according to 90% adherence to the amount abilities of the action to be certified.

Monitoring and Advancement Action Fidelity

Intervention allegiance monitoring

Our access to ecology and advancement action allegiance was guided by recommendations of the Civic Institutes of Bloom Behavior Change Consortium (25). It involves structured training of interventionists, multimodal appraisal of the allegiance with which the interventionists bear the action and ascendancy protocols, and advancing abutment and apprenticeship of the interventionists. The appraisal methods accommodate 1) circadian achievement of a annual by the interventionist documenting their action and 2) assay by the absorption aggregation of a accidental sample of audiorecorded sessions to actuate the admeasurement to which anniversary protocol-based cold is achieved.

Written documentation

Each day, the interventionist completes a accounting annual to almanac which action sessions (e.g., aboriginal affair with surrogates, circadian check-in) action for anniversary enrolled accommodating (Appendix E2). The apparatus additionally allows interventionists to almanac agreement deviations that are above the ascendancy of the interventionist—, such as surrogates abandoning a affair or the charge to reschedule a affair attributable to a physician emergency.

Trained assay agents assay all cases (using the circadian annual as a antecedent document) to appraise the all-embracing adherence to the arrangement and timing of protocolized sessions with surrogates and analytic staff. All-embracing adherence is denticulate application a customized scoring area (Appendix E3), and the alpha for acquiescence is set at 90%.

Audiorecorded encounters

All sessions (sessions with physicians, sessions with surrogates, and clinician–family conferences) are audiorecorded. Session-specific action allegiance ecology forms were created and activated for anniversary of the action and ascendancy sessions (an archetype is apparent in Appendix E4). Accomplished assay agents about sample 20% of anniversary interventionist’s recorded sessions for evaluation. We use a sampling frame, stratified by session, and sample afterwards backup to ensure according sampling beyond affair types. Application the adapted action allegiance ecology anatomy for guidance, the rater listens to the called audiorecording, integrates advice begin in the acreage notes, again determines and annal a appraisement for anniversary agreeable and affection aspect adapted for the session. The alpha for adherence to agreeable and affection of action commitment are set at 90% and greater than or according to 2 (on a calibration of 1–3), respectively. Raters additionally adviser for the commitment of ambiguous content, such as alms authentic opinion, agreeable in unilateral decision-making, announcement impatience, or disrespecting patient/surrogate values.

Because the interventionists bear both the action and apprenticeship ascendancy sessions, there is accurate acuity to adviser for any “bleed over” of action elements, such as affinity architecture or affecting abutment during the conduct of apprenticeship ascendancy sessions. We fabricated the accommodation to accept the interventionist bear the apprenticeship ascendancy sessions in acknowledgment to allotment limitations that precluded the adeptness to appoint abstracted absorption cadre for ascendancy affair delivery. However, we took a cardinal of accomplish to ensure that the ascendancy sessions did not accommodate any key apparatus of the intervention. First, we developed actual assigned agreeable for the ascendancy sessions. Second, we provided all-embracing training about the charge to abstain carrying action content. Third, the ecology of audiorecorded ascendancy sessions offers the befalling to ensure there is no “bleed over” of action agreeable into the ascendancy sessions.

Intervention allegiance maintenance

Intervention allegiance aliment is accomplished by the afterward means:

Enactment of the ecology plan;

Completion of acreage addendum by interventionists afterwards anniversary action session;

Weekly administration sessions with the investigators, with befalling to altercate apropos acclaimed in the acreage addendum and assay of annual action allegiance ecology reports;

Quarterly booster sessions for the interventionists to beforehand commitment accomplishment and assay abeyant drift; and

Remediation and retesting in acknowledgment to articular deficiencies or alluvion in affection of action delivery.

A address absolute annual and accumulative all-embracing adherence statistics is generated for the arch investigator and absorption staff, summarizing the agreeable and affection of action or ascendancy action commitment by interventionist or by session. This akin of detail permits the aggregation to assay areas area abounding accomplishing is not actuality achieved, and they can undertake antidotal accomplishments to bigger apparatus the intervention. If any potentially ambiguous agreeable is noted, it is flagged for assay during a administration meeting. The affiliation of action allegiance ecology and administration is apparent in Appendix E5.

Outcomes

Table 3 contains a arbitrary of all aftereffect measures, abstracts sources, and time credibility for collection.

Table 3. Primary and accessory outcomes, associated measures, and abstracts accumulating time points

Primary outcome

The primary aftereffect on which we abject our sample admeasurement and adeptness calculations is agent accommodation makers’ affection of all-overs and abasement at 6 months posthospitalization as abstinent by the HADS (15). The HADS has accustomed believability and authority amid ICU surrogates and has been acclimated in added trials of biobehavioral interventions (26, 27). Specifically, admiration of the HADS annual to change has been accurate with assorted psychosocial and advice interventions (28–30).

Prespecified accessory outcomes

Our prespecified accessory outcomes accord to added key hypotheses we affectation apropos the aftereffect of the action on the accommodating centeredness of care, as able-bodied as on healthcare use. Thus, our accessory outcomes accommodate the adapted Accommodating Perception of Accommodating Centeredness (PPPC) calibration (31) annual at 3 months, the Appulse of Event Calibration (IES) (32) annual at 6 months, and measures of healthcare use amid decedents—ICU and hospital lengths of break (LOSs) and hospital costs during the base hospitalization.

Other Measures

We appraise controlling and affection of advice application the Clinician-Surrogate Concordance Calibration annual (baseline, Day 5, weekly), the Affection of Advice Calibration (33) (Day 5), and the Decisional Battle Calibration (34) (baseline, Day 5). We additionally appraise surrogates’ affection of post-traumatic accent ataxia application the IES (32) (3 mo); the HADS (3 mo); and, amid patients who died, afflication affection application the Prigerson Inventory of Complicated Affliction (35) (3 and 6 mo).

We aggregate accommodating aftereffect data, including in-hospital mortality, decisions to change cipher cachet or withdraw/withhold automated blast or added life-sustaining treatments, and acquittal disposition and ability use (cost and LOS) amid survivors. In addition, during 3- and 6-month postdischarge aftereffect calls with surrogates, we aggregate accommodating basic status; accommodating anatomic status, abstinent application the Katz Base of Independence in Activities of Circadian Living (36); and surrogates’ use of brainy bloom treatment.

Mixed Methods Substudy

In accession to the aftereffect measures declared in Table 3, we will conduct a alloyed methods appraisal of surrogates’ and physicians’ adventures with the action afterwards action commitment is completed. The quantitative allocation of the appraisal will absorb questions assessing the amount to which participants apperceive the action afflicted altered domains of affliction processes. The qualitative allocation will abide of semistructured interviews exploring the appulse of the action on aspects the ICU experience, such as advice and decision-making. To abstain biasing the interpretation, these abstracts will be calm and analyzed afore the after-effects of the balloon are known.

Analysis Plan

We will conduct an intention-to-treat assay with a alternate α = 0.05. There are potentially several levels of nesting (e.g., surrogates aural patient, patients aural physician, and physicians aural ICU). For the primary analysis, we will use beeline alloyed furnishings models for scale-ordered outcomes testing the aftereffect of the action on HADS array at 6 months postdischarge. Physicians and absorption sites will be advised as accidental furnishings in the archetypal to acclimatize for the alternation aural a physician and aural a absorption site. To access a added avaricious model, we will actuate which levels of nesting to accumulate on the base of statistical acceptation (α < 0.05) of the likelihood arrangement assay acclimated to assay models with assorted nesting levels. We will use the aforementioned beeline alloyed furnishings clay techniques for all added agent cerebral bloom outcomes. If there are baseline differences in characteristics of participants in the action and ascendancy arms, we will absorb these abeyant confounders into the model.

In the prespecified accessory analyses, we will aboriginal absolute the accomplice to patients’ primary surrogates. We will additionally assay the appulse of Four Supports on the prespecified accessory outcomes application models adapted to the types of data: 1) beeline alloyed furnishings clay for PPPC at 3 months and the IES at 6 months and 2) ambiguous beeline clay with γ-distribution and changed articulation for costs and ICU and hospital LOS outcomes amid decedents, to annual for the nonnegative and skewed attributes of these outcomes.

Finally, application the adapted procedure, we will archetypal the appulse of the action on the actual aftereffect measures. We will use beeline alloyed furnishings clay for the Clinician-Surrogate Concordance Scale, Decisional Battle Scale, and Affection of Advice Calibration at Day 5; the IES and HADS at 3 months; and the Prigerson Inventory of Complicated Affliction at 3 and 6 months. We will use ambiguous beeline alloyed furnishings clay with binomial administration and logit articulation to assay the aftereffect of the action on decisions to withdraw/withhold automated ventilation, decisions to change cipher status, and basic cachet at hospital acquittal and at 6-month follow-up.

Sample admeasurement is based on alternate α = 0.05 tests and bourgeois estimates of agent intraclass alternation accessory (0.25) and agent dropout or accident to aftereffect (20%). With 300 patients and 450 surrogates, our absorption has 80% adeptness to ascertain baby beggarly differences in HADS as baby as 1.7 (SD, 5), admitting the basal clinically cogent aberration in HADS amid ICU patients is in the 1.5–2.3 ambit (37–39). With this sample size, our absorption will accept 80% adeptness to ascertain baby to abstinent aftereffect admeasurement differences (d = 0.36) in PPPC score. Finally, the absorption will accept 80% adeptness to ascertain a aberration as baby as 5 canicule in ICU LOS amid decedents.

We initially planned to access the sample admeasurement from the bare 300 to 400 patients to access the attention of the estimates of healthcare costs beyond arms. However, in the interim, new abstracts were appear advertence that amount analyses in this ambience would crave an alike beyond sample admeasurement based on aftereffect modification accompanying to whether the accommodating lived or died (40). In ablaze of this, and in appointment with the DSMB, the accommodation was fabricated to ambition a sample admeasurement of 300 patients.

Missing Data

If any of the aftereffect or admiration variables are missing, we will appraise the abundance (percent) of missing variables and after conduct two altered analyses: 1) complete case assay by including alone individuals with nonmissing abstracts and 2) assorted accepted assay by application the multivariate allegation by chained equations adjustment with bristles complete datasets. Rubin’s adjustment will be acclimated to amalgamate the after-effects from the bristles accepted datasets. Differences amid the two methods will be discussed.

Ethics

Approval for this absorption was acquired from the University of Pittsburgh Human Subjects Protection Office. The absorption is registered with the Civic Institutes of Bloom analytic trials anthology (NCT01982877) and is overseen by a DSMB that meets annually. At its antecedent meeting, the DSMB recommended adjoin planned acting analyses, accustomed the low-risk attributes of the intervention. The DSMB accordingly will focus on ecology balloon advance and adverse events, if any occur.

Strategies for Balloon Conduct

Conducting analytic assay in the ICU ambience presents challenges, including enrolling afflicted surrogates, preventing addict amid interventionists, and announcement abiding aftereffect amid enrolled surrogates. In Table 4, we annual strategies we apply to affected these challenges.

Table 4. Called strategies for balloon conduct

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