key: cord-0744901-txfrcrub
authors: Lai, Veronica Ka Wai; Lee, Anna; Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John; Joynt, Gavin Matthew
title: Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention
date: 2016-06-22
journal: BMJ Open
DOI: 10.1136/bmjopen-2016-011341
sha: 8c96d28abcf7aa309ce804e40c11c9caf88a7a62
doc_id: 744901
cord_uid: txfrcrub

INTRODUCTION: Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. METHODS AND ANALYSIS: 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. TRIAL REGISTRATION NUMBER: ChiCTR-IOR-15006971.

Patient satisfaction with healthcare services is an important outcome that is increasingly used as a marker for quality of care. Poor satisfaction levels reflect a large difference between expectations and fulfilment of perceived needs, and may have implications for adherence to treatment that subsequently affects patient outcomes. 1 For example, following cardiac surgery, patients dissatisfied with discharge information were more likely to report a poorer physical recovery and psychological state at home 1 month after undergoing surgery. 2 Family satisfaction with care Severe illness and its potential outcome impacts not only on the patient, but also their close family, defined as those persons with close family, social or emotional relationships with the patient. In addition, many intensive care unit (ICU) patients cannot make decisions for themselves. Their family must, therefore, become surrogate decisionmakers for important parts of the care process. Hence, measuring family satisfaction with ICU care has become an important and essential component of quality of care in this setting. 3 Strengths and limitations of this study ▪ This randomised controlled trial will determine the effect of preoperative patient education on patient anxiety and depression levels, and satisfaction with intensive care unit (ICU) care and decision-making process from the perspectives of patient and family. ▪ Patient education intervention (15 min video and an ICU site tour) may help set more achievable recovery goals and expectations. ▪ The overall contact time in the ICU is limited, in most cases for 24 hours after cardiac surgery.

Several family satisfaction surveys measuring satisfaction with general ICU care have been developed with sound psychometric properties, and have been reviewed elsewhere. 4 The key domains related to family satisfaction include ICU environment 5 6 and process of care, 5 sufficient information, and quality communication with medical professionals to make important decisions about care. 5 7 In order to improve the quality of care in ICU, it is essential to examine the perspectives of the patients and their family members, 6 8 and implement strategies to address areas of concern. As an example of the impact of the environment of ICU on patients, the satisfaction levels of patients and family members increased by 6% with the changes due to a shift from a ward with multiple beds to a newly designed ICU with noise-reduced, single rooms with daylight and improved family facilities. 6 Patient and family psychological distress Surgical patients encounter physical trauma and psychological distress after surgery. 9 10 Psychological distress has been defined as a collective term for anxiety and depression levels. 11 Beyond that, an unfamiliar hospital environment, such as the ICU, is another stressful factor that is associated with high anxiety and depression levels. 12 In coronary artery bypass grafting (CABG) patients, anxiety and depression occurs for several reasons: (1) routine procedures during ICU admission, for instance, oral and nasal tubes are important stressors 13 because they result in an inability to talk, affecting communication with ICU staff and (2) the associated time spent on the waiting list before the surgery. The prevalence of clinically significant anxiety and depression in patients awaiting CABG was 28% and 47%, respectively. 14 Results from a systematic review found that higher levels of preoperative anxiety and depression in CABG patients were predictive of psychological distress in the postoperative period. 15 Generally, family members were significantly more anxious than patients themselves about the cardiac surgery. 16 However, family members of the cardiac surgery patients reported lower level of anxiety and high satisfaction if their informational needs about the surgery and treatment of the patients were fulfilled. 17 

Previous studies have shown that multimedia educational interventions can reduce anxiety and foster an understanding of the processes and risks of cardiac surgery for patients 18 and their family members, 17 regardless of the format to convey the patient education: using tape, 19 written leaflets 18 20 or verbally during the preoperative visit by ICU or specialist cardiac nurses. 18 20 Additionally, results from a multicentre study in a non-cardiac ICU 21 showed that disclosing all the available information in a frank, direct and empathetic way could meet the informational needs of family members about the patients and thus, they were more satisfied; conversely, families who felt that they had received contradictory information had 21.1% lower satisfaction scores than their counterparts. 21 Effect of patient education Having a preoperative patient education programme which provides sufficient information on the risk and process of surgery to patients may help to increase their satisfaction levels and reduce their anxiety levels. A randomised controlled trial 18 of a preoperative educational intervention (usual care plus information leaflet and verbal advice) versus usual care for patients undergoing cardiac surgery showed a moderate reduction in anxiety levels (adjusted mean difference −3.6, 95% CI −4.62 to −2.57) and depression levels (adjusted mean difference −2.1, 95% CI −3.19 to −0.92) using the Hospital Anxiety and Depression Scale (HADS). Another recent study showed that an effective nurse-led preoperative education not only reduced anxiety levels, but also reduced the risk of postoperative complications, such as sternal infection, in cardiac surgical patients. 22 However, the evidence to support benefits from patient education in the ICU setting is mixed. In a recent multicentred randomised controlled trial of a structured information programme during the ICU stay as compared with a non-specific conversation of similar duration, there was no reduction in patient anxiety levels (mean difference −0.2, 95% CI −4.5 to 4.1, on a scale from 0 (no anxiety) to 100 (maximum anxiety)) in medical and surgical critically ill ICU patients. 23 In a cross-sectional study of family members visiting ICU patients, although there was a moderate correlation between family perception of informational support and satisfaction with care (r=0.74, p<0.001), very little correlation between informational support and anxiety levels (r=−0.13, p=0.50) was found. 24 Neither of the two studies provided information about the ICU before the ICU admission. 23 24 A non-randomised study examining the effect of a preoperative ICU tour prior to cardiac surgery failed to detect a significant difference in anxiety levels between the control (no ICU tour) and treatment (ICU tour) after adjusting for previous ICU experience ( p=0.43). 25 Nevertheless, the authors showed that patients in the treatment group perceived the tour to be beneficial for themselves and for future patients. 25 In addition, other studies found that in order to reduce psychological distress, both ICU nurses and patients believed that preoperative patient education led by ICU nurses explaining the reasons for ICU admission, ICU environment and the expected postoperative care would be beneficial. 26 27 Significance of the present study The previous studies discussed above have focused individually on the separate issues of satisfaction with general ICU care, preoperative psychological distress and informational needs related to surgical aspects of care. However, few have adequately examined the effect of educational interventions specifically targeting surgical issues and the postoperative ICU stay, or investigated the inter-relationships between patient education, patient and family satisfaction scores, and measures of anxiety and depression. This two-group, parallel, superiority, double-blinded randomised controlled trial will examine the effectiveness of a multifaceted patient education intervention on patient and family satisfaction, and postoperative anxiety and depression in patients undergoing cardiac surgery. The primary objective is to determine the effect of the preoperative patient education package (video and ICU tour) for patients undergoing elective cardiac surgery on patient and family satisfaction with care and decision-making in the ICU. The second objective of the study is to determine the effect of preoperative patient education package on anxiety and depression levels in patients after elective cardiac surgery. The primary hypothesis is that preoperative patient education will increase both patient and family satisfaction levels after elective cardiac surgery, and the secondary hypothesis is that preoperative patient education will reduce patient anxiety and depression measures after cardiac surgery.

We will conduct a single-centre, double-blinded, two-group, parallel, superiority, randomised controlled trial of 100 adults undergoing general anaesthesia for elective CABG, with or without valve replacement (CABG±valve) surgery. Block randomisation with a 1:1 allocation has been planned. Family members and patients will be followed up to the third day and to 1 month after patient's surgery, respectively (figure 1). The study has been designed with reference to the CONsolidated Standards Of Reporting Trials (CONSORT) statement, 28 and reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement. 29 Setting and population The study will be conducted at the Prince of Wales Hospital in Hong Kong, a 1400-bed university teaching hospital. Currently, there are 12-15 adults who undergo elective CABG±valve surgery per month. All elective CABG±valve surgery patients are routinely admitted to our 22-bed ICU for early postoperative care and monitoring with 1:1 nursing at all times, and are expected to be discharged from ICU to a high dependency cardiac ward within 24 hours after surgery.

Only adult patients undergoing primary elective CABG±valve surgery whose primary language is Cantonese will be recruited from the operating theatre list published on the day before cardiac surgery. A face-to-face meeting will be scheduled with potential participants to confirm their study eligibility. Before obtaining written informed consent, the purpose of the study, procedures, risks and benefits of participation, and the time commitment involved will be explained to them. Patients and family members may withdraw from the study without prejudice at any time during the study.

The patient education intervention includes a video in Cantonese, the predominant language used in Hong Kong. Patients will be excluded if they have a history of dementia, psychosis or neurological disease that would prevent them from completing the outcome questionnaires and are unable to provide written informed consent. We will also exclude patients undergoing emergency cardiac surgery (no opportunity to apply the intervention), patients who have had a previous cardiac surgery ( prior exposure) and those who have received previous care in an ICU ( prior exposure).

Family members of the patient will be also invited to join the patient education intervention before the elective cardiac surgery. 'Family' will be defined as persons with close family, social or emotional relationship to the patient; 1 thus, next of kin and adult children of the patient will be included in the study. One family member per patient will be recruited. Family members will be excluded if they are unable to understand Cantonese, have previous experience with ICU care, previously underwent any cardiac surgery or did not visit the patient in ICU. The reasons for exclusion and number of patients or families lost to follow-up will be documented.

A sample size of 45 in each group will have 80% power to detect a difference in means of 10 points (the difference between mean control group satisfaction of 70 and a mean intervention group satisfaction of 80) assuming that the common SD is 16.6 (effect size of 0.60) using a two-group t-test with a 0.05 two-sided significance level. 6 We considered this moderate effect size as clinically important. Given that our fast-track failure rate in cardiac surgery is ∼10%, we will recruit 100 patients for the study (50 patients in each group). A study of 100 is adequately powered to detect a decrease in anxiety (unadjusted mean difference of 2.7) score at day 7 after cardiac surgery (using the Chinese-Cantonese version of HADS 30 ) that was associated with a preoperative education intervention. 18 The sample size calculations were performed using nQuery Advisor V.7.0 (Statistical Solutions, Cork, Ireland).

Block randomisation with 1:1 allocation will be carried out according to a computer-generated sequence, and will be performed by one of the authors (AL) not involved in screening, patient recruitment, clinical care or data collection, using a software program PASS V.11 software (NCSS, Kaysville, Utah, USA). The treatment allocation will be concealed in consecutively numbered sealed opaque envelopes, and opened after obtaining patient consent before surgery and measuring of baseline anxiety and depression levels. Restricting access to, and availability of, the video material will further minimise the selection bias.

To minimise performance bias and a Hawthorne effect, the ICU staff will not be aware of the study objectives and which patients are recruited into the study. We will plan intermittent, ad hoc checks with bedside nurses and ICU physicians to establish whether they remain blinded to the treatment allocation of the patients. The outcome assessor is blinded to treatment allocation and will collect the primary outcome on day 3, secondary outcome on day 7 and health status at day 30 postoperatively (figure 1).

Control arm: standard education Patients in the control group will receive the standard preoperative consultations by surgeons and anaesthesiologists, and nursing care in the cardiac surgical wards. Unstructured information about the general process and risk associated with surgery and anaesthesia, postoperative care, and the care after discharge from hospital will be given in the usual manner to patients and family members 1 day before cardiac surgery. All patients will receive standardised surgical processes and perioperative care under existing protocols for postoperative ICU sedation, analgesia and weaning from mechanical ventilation. Also, all patients will be given a standardised anaesthesia, described in detail elsewhere, 31 with volume-controlled ventilation set at a tidal volume of 8 mL/kg of ideal body weight with a positive, end-expiratory pressure of 5 cm H 2 O.

Intervention arm: video and ICU tour (+standard care) Patients randomly allocated to the treatment group will receive the same standard care provided in the control group, as well as the patient education package conducted in the ward 1 day before cardiac surgery. The family members will be invited to participate in the patient education session with the patient at the time of consent. First, they will be given a 15 min education video describing the ICU environment, invasive tubes and lines, pain management, medical management, communication modes and family support (box 1). Finally, a 5-10 min tour of the ICU, conducted by a dedicated ICU nurse, will be given to patients and their family members after the video intervention.

To help patients and family members retain the information presented, three multiple choice questions will be asked at the conclusion of the video presentation. The research coordinator and ICU nurse will clarify any misconceptions patients may have if the questions are answered incorrectly. A previous study showed that participants spontaneously recalled less than a quarter of the preoperative anaesthesia information in a video, but correctly recalled 83% of the information using multiple choice testing format. 32 

The primary outcome is satisfaction with ICU care and decision-making process, from the perspective of the patients' family members and the patients themselves. The family satisfaction in the ICU (FS-ICU) survey 33 has been well validated in numerous studies, 4 34-36 and translated into Chinese 5 and other languages. The original, 34-item English FS-ICU 33 has been shortened to a 24-item English FS-ICU version. 36 However, the 34-item Hong Kong Chinese FS-ICU has not undergone formal psychometric validation except for face validity. 5 We used a cross-cultural adaption approach 37 to modify the 24-item English FS-ICU questionnaire, and checked for semantic and idiomatic similarities with the 34-item Hong Kong Chinese FS-ICU to establish face and content validity. Items in the patient version were semantically modified for addressing perspectives from the family to fit in with the patient's own satisfaction perceptions with the ICU experience. For example, one of the items in the family version is 'the courtesy, respect and compassion your family member was given' was modified to 'the courtesy, respect and compassion you were given' in the patient version.

Both satisfaction surveys consist of two parts, namely satisfaction with overall care (14 items) and satisfaction with decision-making (10 items). The surveys each take about 10-15 min to complete for patients and a close family member. All items use a five-point Likert scale, and will be recoded and transformed to a 0-100 scale (0 represents poor satisfaction, 100 represent high satisfaction) for both subscales and the total satisfaction score. The reliability of the overall satisfaction score is high (Cronbach's α=0.94), and there are moderate-to-strong correlations with the Quality and Dying and Death questionnaire and nurse-assessed quality indicators. 36 Both the Chinese 24-item FS-ICU survey for family members and its adapted patient version will be used on day 3 after the surgery. In the event that the patient stays longer than 24 hours in the ICU, the questionnaires will be completed on the third day after the time of extubation. Every effort will be made to collect the family satisfaction data during visiting hours by a blinded outcome assessor. Although the questionnaires are self-reported, a blinded assessor will help participants fill in the questionnaire as some have only primary school education or no formal education at all.

The proposed secondary outcomes will be the change in anxiety and depression scores using the Chinese-Cantonese version of HADS. 30 This is a valid and reliable tool comprising of seven questions relating to anxiety (anxiety subscale) and seven questions relating to depression (depression subscale). 30 Each item is scored according to a four-point scale (0-3) and for each subscale, the score ranges from 0 to 21, with higher scores indicating a greater severity of disorder. The incidence of anxiety and depression will be defined as HADS subscale scores of ≥8. 38 The internal reliability Cronbach's α values for the anxiety and depression were 0.77 and 0.82, respectively, and the full scale is 0.86. 30 The Chinese-Cantonese version of the HADS will be used at the time of consent into the study and on the seventh day after cardiac surgery. In the unlikely event that the patient is discharged before postoperative day 7, the blinded outcome assessor will use the HADS at this point in time by conducting a telephone follow-up.

After obtaining consent, one of the authors will enrol the patients and family members into the trial, and collect the following demographic and clinical data: age, gender, education level, American Society of Anesthesiologists Physical Status Classification, predicted mortality using the logistic European System for Cardiac Operative Risk Evaluation (EuroScore) method, 39 patient's comorbidities, details of surgical procedures, duration of anaesthesia, anaesthetic technique, Richmond Agitation-Sedation Scale score 40 during the ICU stay, delirium assessment Box 1 Information covered in the preoperative video and intensive care unit (ICU) tour ICU environment (video and ICU tour ): ▸ The standard bedside setting (cardiac monitors, ventilators, pumps, alarms); ▸ The ICU routine activities-doctor ward rounds, bathing time, etc. Types of invasive tubes and lines for patients after cardiac surgery (video and ICU tour) ▸ Oral endotracheal tube; ▸ The pacemaker; ▸ Chest drainage tubes; ▸ Urinary catheter; ▸ Various intravenous lines. Postoperative pain management (video) ▸ The types of pain experience during the postoperative period; ▸ The pain relieving method. The medical management (video) ▸ The common weaning strategy from mechanical ventilator; ▸ The duration of the placement of the chest drainage tubes; ▸ What delirium is and how to treat it; ▸ The expected length of stay in the ICU. Communication between patients, relatives and ICU staff (video and ICU tour) ▸ Role of case nurse (dedicated bedside nurse); ▸ Communication methods between the patients, family and nurses; ▸ Arrangement of the interview between the family, the ICU doctors and/or surgeons. Family support (video) ▸ The visiting guidelines-number of visitors per visit, visiting hours; ▸ Demonstration of hand washing when visiting patient; ▸ The importance of touch to reassure the patient. which will be defined by routine bedside Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), 41 severity of illness score on ICU admission (APACHE II), 42 duration of mechanical ventilation, ICU length of stay, duration of the hospital stay, and the 30-day mortality status from the patient's medical record and from the Hospital Authority Clinical Management System electronic database. If the patient has the educational intervention without a family member, this will be noted in the standardised data collection form and will be included in the analyses. Data will be entered into a passwordprotected MS Access database with built-in data integrity checks (valid values, range and primary key checks) and list of valid descriptive code options.

Missing data will be checked and imputed using the median for continuous variables or the most common category value for categorical variables to preserve power, if there is <10% missing data. Otherwise, multiple imputation techniques will be used. The Shapiro-Wilk test will be used to check data for normality. Student's t-test and Mann-Whitney U test will be used for group comparisons of continuous parametric and nonparametric variables at baseline. χ 2 or Fisher's exact tests will be used for group comparison of categorical data at baseline.

Intention-to-treat and per-protocol analyses will be performed using SPSS software (IBM). The mean and SD of the patient and family satisfaction scores, and HADS anxiety and depression subscale scores will be reported. The mean differences between groups for satisfaction scores from patients' and family members' perspective will be analysed using independent t-tests. To address the ceiling effect of the satisfaction questionnaires, we will estimate the change in percentage of overall high satisfaction (score=100) between groups by using an empirical logit transformation as it is more difficult to improve from 80% to 90% than from 50% to 60%. 43 A generalised estimating equation population average regression will be used to examine the mean difference in anxiety and depression subscales between groups over time. As some patients and family members may be too apprehensive to join the preoperative ICU tour after the video intervention, we will perform a sensitivity analysis on the three groups (control, video only, video plus ICU tour) to examine how robust the results are. The level of significance will be set at p<0.05.

As there are no planned interim analyses and stopping rules for this study, a formal committee for data monitoring is not required. At the start of the trial, the outcome assessor will undergo training in interviewing patients using the satisfaction in ICU questionnaires, and HADS. A senior author will periodically audit the integrity of the randomisation, source data verification of the paper data collection forms, and overall quality and completeness of the data. Data will be kept confidential in secure offices of the Department of Anaesthesia and Intensive Care. Only group data will be published. The first, fourth and corresponding authors will have access to the final data set. It is anticipated that there will be no serious adverse events caused by trial patient education intervention.

Any protocol amendment will be submitted to the local clinical research ethics committee for approval. This trial is registered with the Chinese Clinical Trial Registry is ChiCTR-IOR-15006971.

To meet the cardiac service expansion at the Prince of Wales Hospital in 2001, we planned a quality improvement exercise and audit. A designated care team was formed, consisting of a group of ICU nurses who were trained in the postoperative care of cardiac surgical patients, as well as for conducting preoperative ICU site visits. The aim of the preoperative ICU visit was to decrease patients' anxiety levels due to unfamiliarity with the ICU environment and to have a better understanding of the immediate postoperative management in the ICU. As the feedback to the site visit by the healthcare team, patients and family members were positive, a preoperative video was developed in 2002. When severe acute respiratory syndrome (SARS) outbreak occurred in 2003, the video viewings and ICU tours stopped. We did not reinstitute the ICU education intervention after the outbreak.

Using the literature to establish the factors associated with anxiety and those important to patients and family members regarding ICU care (outlined in the introduction), as well as the experience gained in the brief education intervention before SARS, we developed an updated video. To improve the portrayal accuracy of the video, we employed a professional actor to play the role of a patient for this project. The video aimed to standardise the information content of the visit and included information about the ICU environment, routine care and expected postoperative course of the patient (box 1).

This study builds on the work performed in the past. The video provides comprehensive and standardised preoperative information to patients and family members about ICU care to complement preoperative information given by other healthcare professionals working in the cardiac surgical ward. Early informal feedback from patients and family members in the treatment arm is positive, with a common theme that the intervention makes the perioperative pathway processes more transparent to them. This may help set more achievable recovery goals and expectations, and therefore affect satisfaction levels related to the healthcare provided. However, a limitation of the study is that the overall contact time in ICU is limited, in most cases to 24 hours after cardiac surgery. Also, we did not include family members' anxiety and depression levels due to the time constraints during visiting hours.

We are unaware of studies examining both patient and family satisfaction levels with ICU care associated with preoperative patient education for major surgery requiring postoperative ICU care. This paper describes a patient education intervention for use within the Hong Kong health service and the video (in Cantonese dialect) will be made available to others after completing the trial on request to the authors. The results of this study will highlight aspects of ICU care and decision-making process for further quality health services improvement. As part of the knowledge translation approach, study participants will receive a one-page plain language summary of the results. The results will be disseminated at an international critical care medicine conference and in a peer-reviewed journal.

Contributors The protocol was jointly written by VKWL and AL, and was critically reviewed by PL, CHC, KMH, CDG, MJU and GMJ. All authors were involved in the study concept and design of the study, and approved the final version of the manuscript. Provenance and peer review Not commissioned; externally peer reviewed.

Data sharing statement Anonymised data will be made available on written request to the authors 12 months after publication.

Open Access This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work noncommercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http:// creativecommons.org/licenses/by-nc/4.0/

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