- Academic Editor
Background:
Complex surgical plans and consideration of risks and benefits often cause
decisional conflicts for decision-makers in aortic dissection (AD) surgery,
resulting in decision delay. Shared decision-making (SDM) improves decision
readiness and reduces decisional conflicts. The purpose of this study was to
investigate the impact of SDM on decision quality in AD. Methods:
One hundred and sixty AD decision-makers were divided into
two groups: control (n = 80) and intervention (n = 80). The surgical plan for the
intervention group was determined using patient decision aids. The primary
outcome was decisional conflict. Secondary outcomes included decision
preparation, decision satisfaction, surgical method, postoperative complications,
actual participation role, and duration of consultation. The data were analyzed
with SPSS 26.0 (IBM Corp., Chicago, IL, USA). p
Aortic dissection (AD) is a serious life-threatening cardiovascular disease, which has garnered much attention in recent years. AD has an acute onset and a variety of initial symptoms. The incidence is approximately 6/100,000, and the mortality rate is second only to acute myocardial infarction [1]. With the development of medicine and biotechnology, the treatment of AD is a long-term dynamic clinical exploration and practice process that includes thoracotomy, minimally invasive surgery, hybrid surgery, and other treatment schemes. It cannot be ignored that the treatment decisions for either type A or type B AD are risky decisions made in a limited time, because regardless of which treatment is chosen, patients may have risks of bleeding, pain, AD rupture, and reoperation, among others [1]. In addition, most AD patients are in a sedative and analgesic state before surgery, making them lose decision-making ability; thus, their medical decisions are mostly made by family members [2]. Affected by the uncertainty of disease trajectory and individual differences, most AD decision-makers have negative emotions such as anxiety and helplessness [3]. Our previous study showed that approximately 99.09% of AD patients and 98.91% of their family members had decisional conflicts, which were not related to the type of AD [2, 4].
The decision-making of AD is complex, and not only requires doctors to inform disease information within a limited time but also needs consideration of patients’ views and other nonmedical factors. The guidelines for the diagnosis and management of aortic disease jointly issued by the American College of Cardiology/American Heart Association strongly recommend that patients and medical staff jointly decide on treatment plans to determine the endoluminal surgery, thoracotomy, hybrid surgery, etc. [5] Shared decision-making (SDM) is key to improving the quality of decision-making and is a concrete embodiment of “patient-centered” care in clinical practice. SDM is a process by which medical staff and patients work together to integrate care plans that are responsive to patients’ goals and values [6]. It has been advocated as a clinical counseling approach that improves disease knowledge, and reduces anxiety and decisional conflict by encouraging patients to participate in clinical decision-making [7].
At present, SDM has been widely applied to the decision-making process of patients and their surrogate decision-makers in orthopedics [8], cancer [9], and so on, but there are few reports on critical cardiovascular diseases [10, 11]. Under the guidance of the Ottawa Decision Support Framework (ODSF) and the International Patient Decision Aid Standards (IPDAS), we developed a patient decision aid (PtDA) for AD decision-makers. We used PtDA on admission day, preoperative conversation and discharge day, which we termed a “patient-centered SDM”, to be used as part of the medical decision-making of AD. The whole decision-making process was jointly performed by doctors, nurses, patients and their family members with a clear division of labor. The primary objective of this study was to assess the impact of SDM on the decisional conflict of AD decision-makers. Secondarily, this study quantified differences between intervention and control groups on the decision preparation, satisfaction, participation role, final surgical method, postoperative complications, duration of consultation, post-operative intensive care unit (ICU) stay time and hospital stay time.
A single-center, before-and-after comparison study of SDM for AD decision-makers was conducted from March 2021 to June 2022, after approval from the Research Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology (s146; Wuhan, Hubei Province, China). We conducted the study in the Department of Cardiovascular Surgery, Tongji Hospital (Wuhan, Hubei Province, China). The annual operation volume of AD was 1000–1200, and most patients were from different parts of China. Our research team included five cardiac surgeons, four SDM experts, three cardiac surgery nurses, and two information and knowledge translation specialists. The whole process of this study was completed by team members without blinding.
The uncertainty of the development of AD makes it difficult to recruit
participants by phone or email. We allocated AD decision-makers from March to
June 2021 to the control group and from March to June 2022 to the intervention
group through convenience sampling. Our study object was AD decision-makers,
including not only patients but also surrogate decision-makers. Inclusion
criteria for patients were: diagnosed with aortic AD, including type A AD and
type B AD; age
Medical decisions for limited/incapacitated aortic coarctation patients were
often made by surrogate decision-makers, who were the legal guardian of patients.
Inclusion criteria for the surrogate decision-makers were: age
Participants in the intervention group received SDM that involved the use of a PtDA booklet developed by the researchers by referring to the ODSF and IPDAS [13, 14]. This tool is an available booklet that is designed for AD decision-makers to choose a treatment plan (Supplementary Material).
The intervention group emphasized “patient-centered” SDM, including four contents (Fig. 1). First, identifying current decision needs by recording the disease diagnosis, and judging whether the patient has decision-making ability and decision-making type, etc. Second, providing necessary information including the definition, epidemiological characteristics, clinical manifestations, and treatment principles of AD. We used three simple questions to evaluate the decision-makers’ psychological status, social support, and views on the treatment plans. Third, evaluating the decision-makers’ expectations of treatment results and their acceptance of risks. Finally, the decision-makers evaluated the decision-making process and selected the treatment plan. The whole decision-making process was jointly performed by doctors and nurses with a clear division of labor (Fig. 2). There was no follow-up.
Flowchart of shared decision-making in the intervention group.
The tasks of doctors, patients and family members, and nurses at different time points. AD, aortic dissection.
Participants in the comparison group received patient education with standard educational material on AD, which contained textual and pictorial information on the definition, diagnosis, epidemiological characteristics, and postoperative health guidance of AD. The doctor explained the operational risks and benefits to the decision-maker, and finally decided the surgery plans. Nurses had minimal interaction with the participants and did not perform teach-back or monitor comprehension in the process. Therefore, the participants did not raise questions or verbalize their concerns; consequently, their values, feelings, and thoughts on the material were not explored.
The two groups of subjects were investigated from March to June 2021 and from March to June 2022, and did not interfere with each other. Clinical staff screened the patients after admission and explained the purpose, procedures, risks, and benefits of the study, after which written informed consent was obtained from the participants. We had our first conversation on the day of admission. Doctors used PtDA to introduce the patient’s condition to the decision-makers of the intervention group, mainly including the definition, risk, and pre-operative treatment measures, etc. of AD. The decision-makers in the control group received the contents from the standardized health education sheet. Although most AD patients needed to receive surgical treatment, not all patients could receive it immediately due to factors such as physical evaluation and other surgical arrangements in the operating room [15]. Even in direct circumstances, there is usually time to have some discussion with patients and surrogates that adheres to the goals of SDM [10]. The second conversation was usually the day before the operation. All participants were interviewed by doctors. The preoperative conversation was completed in the conference room. The control group received the routine procedure. The intervention group received the SDM on the basis of understanding the content of PtDA. The decision-makers continued to communicate with the medical staff until the questions were resolved. We used a stopwatch to record the time from the start of preoperative conversation to signing of the informed consent form. Decision-makers completed the scales such as decision satisfaction on the day of discharge. Fig. 3 shows the content of the procedures.
The content of the procedures. PtDA, patient decision aid; AD, aortic dissection; ODSF, Ottawa Decision Support Framework; IPDAS, International Patient Decision Aid Standards; GCS, Glasgow Coma Scale.
This section was designed by the researchers and included sex, age, decision-makers, habitation, education, marital status, and income.
Decisional conflict: The Decisional Conflict Scale (DCS) prepared by O’Connor in
1995 (Cronbach’s
Decision preparation: The Preparation for Decision-Making (PreDM) scale was
prepared by Bennett et al. [18] (Cronbach’s
Decision satisfaction: This scale was prepared by Xu
(Cronbach’s
Participation role: The Control Preferences Scale (CPS) was prepared by Degner
et al. [21] (Cronbach’s
In addition to the above scales, we included the final surgical method, postoperative complications, duration of consultation in minutes, hospital stay time, and post-operative ICU stay time in the secondary measures to explore the impact of SDM.
Our study evaluated the impact of SDM on decision quality. The decisional
conflict score was the primary outcome index [23]. There was no relevant
study on the decision-making of AD; thus, we calculated the sample size according
to the results of the pre-experiment. The survey results of two groups reported
that the decisional conflict scores were 30.20
We used SPSS 26.0 (IBM Corp., Chicago, IL, USA) for statistical analysis.
Histograms, P-P diagrams, and Q-Q diagrams were used to comprehensively assess
whether the data were a normal distribution. Continuous normally distributed
variables are expressed as the mean
Ten participants were excluded from the intervention group due to different reasons, including preoperative death (n = 2), tensions between doctors and patients (n = 1), giving up treatment (n = 1), and withdrawal (n = 6). Moreover, 10 cases were ruled out from the control group due to different reasons, including preoperative death (n = 3), giving up treatment (n = 3), and withdrawal (n = 4). Finally, 160 people were included in the study (Fig. 4).
Patient flowchart.
In total, 80 decision-makers of AD were included in the intervention group and the control group. There were no significant differences in sociodemographic characteristics between the two groups (Table 1).
Variable | Control group (n = 80) | Intervention group (n = 80) | p value | |
Sex | 0.465* | |||
Male | 22 (27.50%) | 18 (22.50%) | ||
Female | 58 (72.50%) | 62 (77.50%) | ||
Age | 0.356* | |||
17 (21.30%) | 15 (18.80%) | |||
40–60 | 52 (65.00%) | 47 (58.80%) | ||
11 (13.80%) | 18 (22.50%) | |||
Decision-makers | 0.059* | |||
Patients | 30 (37.50%) | 19 (23.80%) | ||
Proxy decision-makers | 50 (62.50%) | 61 (76.30%) | ||
Residence | 0.103* | |||
Rural | 64 (80.00%) | 55 (68.80%) | ||
Urban | 16 (20.00%) | 25 (31.30%) | ||
Education | 0.591* | |||
Primary school and below | 13 (16.30%) | 9 (11.30%) | ||
Junior middle school | 31 (38.80%) | 38 (47.50%) | ||
High school/junior college | 25 (31.30%) | 25 (31.30%) | ||
Bachelor’s degree or above | 11 (13.80%) | 8 (10.00%) | ||
Marital status | 0.416* | |||
Married | 71 (88.75%) | 74 (92.50%) | ||
Others | 9 (11.25%) | 6 (7.50%) | ||
Income | 0.358* | |||
12 (15.00%) | 9 (11.30%) | |||
3000–6000 | 35 (43.80%) | 44 (55.00%) | ||
33 (41.30%) | 27 (33.80%) | |||
Expected participation role | 0.712** | |||
Active decision-making | 1 (1.25%) | 3 (3.75%) | ||
SDM | 40 (50.00%) | 40 (50.00%) | ||
Passive decision-making | 39 (48.75%) | 37 (46.25%) |
The number or number (percentage) is shown; AD, aortic dissection; SDM, shared decision-making.
*chi-square test, ** Fisher’s exact test.
Table 2 shows the difference in decisional conflict scores between the
intervention group and the control group. Compared with the control group, the
decision-making conflict score in the intervention group was lower and a
significant difference was observed between groups (p
Variable | Control group (n = 80) | Intervention group (n = 80) | p value |
Decisional conflict | 35.33 (5.74) | 32.04 (4.74) | |
Decision uncertainty | 7.41 (1.87) | 6.34 (1.28) | |
Decision uncertainty factors | 20.04 (4.05) | 18.40 (3.23) | 0.005* |
Perceived decision effectiveness | 8.00 (6.00, 9.00) | 7.00 (6.00, 9.00) | 0.058** |
The mean
* independent t-test, ** Mann-Whitney U test.
Table 3 shows the score difference in secondary outcome measures between the intervention group and the control group. Compared with the control
group, the decision-making preparation and satisfaction of the intervention group
were significantly improved (p
Variable | Control group (n = 80) | Intervention group (n = 80) | p value | |
Decision preparation | 25.43 (2.04) | 32.39 (2.95) | ||
Decision satisfaction | 46.81 (5.22) | 50.30 (3.59) | ||
Information | 11.08 (1.89) | 12.56 (2.18) | ||
Communication | 12.37 (2.25) | 12.24 (1.83) | 0.672* | |
Decision-making | 9.20 (1.63) | 10.11 (1.88) | 0.001* | |
Total satisfaction and confidence | 14.16 (2.59) | 15.38 (2.05) | 0.001* | |
Actual participation role | ||||
Active decision-making | 2 (2.50%) | 2 (2.50%) | ||
SDM | 16 (20.00%) | 42 (52.50%) | ||
Passive decision-making | 62 (77.50%) | 36 (45.50%) | ||
Whether the decision maker’s expected participation role is consistent with the actual participation | 1.000*** | |||
Yes | 33 (41.25%) | 33 (41.25%) | ||
No | 47 (58.75%) | 47 (58.75%) | ||
Final treatment plans | 0.267*** | |||
Thoracotomy | 22 (27.50%) | 17 (21.30%) | ||
Minimally invasive surgery | 49 (61.30%) | 47 (58.80%) | ||
Hybrid surgery | 9 (11.30%) | 16 (20.00%) | ||
Postoperative complications | 0.130*** | |||
No | 66 (82.50%) | 58 (72.50%) | ||
Yes | 14 (17.50%) | 22 (27.50%) | ||
Duration of encounter, interquartile, min | 33.00 (30.00, 37.75) | 33.00 (29.25, 35.75) | 0.070**** | |
Hospital stay time | 16.26 (3.05) | 15.79 (3.97) | 0.397* | |
Post-operative ICU stay time | 3 (2, 6) | 5 (2.25, 6) | 0.421**** |
Data are expressed as the mean
* independent t-test, ** Fisher’s exact test, *** chi-square test, **** Mann-Whitney U test.
Significant variables in univariate analysis of residence (p
Variable | SE | t | p value | |||
(Constant) | 43.749 | 0.776 | 56.392 | |||
Income |
||||||
3000–6000 | –5.650 | 0.830 | –0.515 | –6.811 | ||
–7.969 | 0.987 | –0.704 | –8.077 | |||
Education |
||||||
Junior middle school | –3.072 | 0.811 | –0.278 | –3.787 | ||
High school/junior college | –4.996 | 0.968 | –0.422 | –5.159 | ||
Bachelor’s degree or above | –7.364 | 1.253 | –0.435 | –5.877 | ||
Residence |
–2.064 | 0.723 | –0.164 | –2.856 | 0.005 |
R
Heart and macrovascular diseases are important areas of SDM. We developed a PtDA for AD incorporating decision needs, patient education, preference assessment, and personalized estimations of clinical outcomes, which were presented in the form of words, tables and pictures. We used PtDA in the SDM of AD, defined the tasks of doctors, nurses, patients and family members, and emphasized building trust relationships between medical staff and patients in the process of communication. Compared with traditional preoperative conversations, this study evaluated the impact of SDM on the outcome of AD surgery. Our study demonstrated that the implementation of SDM for patients undergoing AD surgery was possible and effective in our institution. SDM was capable of improving the quality of decision-making without changing the choice of surgical methods or impacting medical outcomes.
Decisional conflict is a state of uncertainty in the course of action that
exists and permeates the decision-making process of AD, increasing the pressure
on decision-makers [25]. Previous studies have shown that for each unit increase
in DCS score, decision-makers are 59 times more likely to change their minds and
23 times more likely to delay their decisions [26, 27]. AD surgery is risky and
uncertain, and the delay in treatment leads to increased complications, which
greatly increases the risk of death [28]. Encouragingly, we found that SDM could
reduce decisional conflict, which was consistent with the results of previous
randomized controlled trials [29]. Subscale analysis showed that decision
uncertainty and decision uncertainty factors scores compared between the two
groups were statistically significant (p
Decision control preference reflects the desire of patients and their families to make decisions independently. The results showed that the actual decision-making participation in the control group was mostly passive decision-making (77.50%), and the intervention group was SDM (52.50%). Low decision control preference means high treatment expectations [33]. SDM reduces the gap between the expectation and reality of surgical results, and attaches importance to the doctor-patient relationship based on trust. In the PtDA, we sorted out and objectified the issues most concerned by decision-makers and encouraged them to actively ask questions, enhancing their perception of decision-making participation. The PtDA was an optimized logical path that included four steps: determining the current decision needs, providing decision information support, clarifying the values of the decision-makers, and guiding decision-making, which can help decision-makers choose options consistent with their values according to a fixed process and help them realize the situation they are facing. In this study, the use of SDM improved the decision readiness of participants. We used PtDA on the admission day to assess the decision needs of patients and help them gain an initial understanding of AD. During the preoperative conversation, we present the pros and cons of various treatment options in the form of drawings and tables to enhance their understanding of AD, and encourage them to express values. A systematic review in 2016 showed that using SDM could improve decision-makers’ confidence and promote a positive healthcare experience and decision-making process, regardless of their final surgical decision [34].
It should be noted that the core of high-quality decision-making is that the results are consistent with patients’ values, goals, and preferences. Increasing knowledge alone is not enough to make high-quality decisions, especially emotional decisions about life and death [35]. Similarly, encouraging the decision-maker to determine the surgical plans in fear and denial cannot guarantee satisfactory results. After the intervention, the total score of decision satisfaction was significantly improved, especially the information and decision subscale, consistent with the results of Alden [36]. On the one hand, the PtDA for AD improved the decision makers ability to grasp disease knowledge and reduced the inner fear caused by lack of information. On the other hand, in the process of intervention, medical staff respected patients and encouraged them to express their values, which helps to build trust and improve decision-making satisfaction.
We also found that the use of PtDA did not improve the communication between doctors and patients. With the rapid development of AD, decision-making time is limited, and it is difficult to ensure timely communication between doctors and patients. Nurses have the longest contact with patients and their families. With the transformation of nurses’ functions and their prominent role in the SDM process, nurses can transmit information and improve the efficiency of communication.
In contrast to some research results, our study did not find that SDM changed patients’ choice of surgical plans and postoperative situation [37]. At the same time, it did not shorten the time of hospitalization and stay in ICU. For AD patients, the survival advantage of surgery is certain. The choice of surgical plans and the occurrence of complications is affected by medical conditions, such as surgical techniques and basic conditions of patients. The time of hospitalization and stay in ICU are also affected by the operation effect [38]. Although PtDA have deepened the understanding of disease knowledge of decision-makers, enabling them to view the occurrence of risks objectively and rationally, they cannot change the medical outcomes of patients. In addition, the use of PtDA did not have a significant impact on the duration of the conversation, which was consistent with the results of Kunneman et al. [39]. PtDA optimizes and supplements the content of informed consent, but does not simplify the medical decision-making process. The SDM 3 Circle Model, the three-stage conversation model, and the SDM model mediated by the decision-making coach, were used to improve the decision-making efficiency [40]. In the future, similar theories can be combined to optimize the intervention process, shorten the preoperative talk time, and improve the quality of decision-making.
Income, education, and residence were the main influencing factors of decisional conflict. In China, the median hospitalization cost for patients with acute AD was as high as 115,296 RMB [41]. Restrictions on medical insurance, post-discharge medication, and rehabilitation, etc., place greater financial pressure on AD patients. Although SDM has been widely used in the clinic, high-income decision-makers have a relatively light economic burden, fewer adverse emotions, and more firm decision results. Highly educated decision-makers have high health literacy and the ability to acquire and understand disease knowledge [42]. They can more effectively receive the information transmitted by medical staff and make medical decisions. Compared with urban patients, the lack of knowledge and medical resources may cause decision-making conflict among rural patients.
To the best of our knowledge, this was the first study to assist decision-makers in participating in the SDM of AD patients through the PtDA. The results was gratifying, which proved the feasibility and effectiveness of PtDA in AD patients. However, some limitations need to be considered. First, the study was conducted in a relatively developed city in China, with strict inclusion and exclusion criteria, which may limit the generalizability of the research results. Second, we could not measure the subjects’ mastery of disease knowledge due to the lack of an AD knowledge scale. Third, we only evaluated each decision-maker once and did not design a follow-up study. Fourth, the acceptance of AD complications, rehabilitation expectations, and other clinical outcome indicators were important. However, due to the lack of specific evaluation methods, we did not conduct an investigation. Moreover, convenience sampling was used and most of the data were self-reported. It was unable to avoid potential selection bias. Finally, this was a before-and-after comparison study. We did not randomize the patients, which weaken the conclusions that we can draw. A larger controlled trial is warranted to evaluate the effectiveness of such an approach and to measure the change in behavior over a longer term.
In view of the complexity of decision-making in AD, this study shows that the use of SDM can reduce decision-making conflict, improve decision-making participation, and improve decision-making readiness and decision satisfaction, without affecting the choice of surgical methods and complications. It is suggested that SDM should be rationally incorporated into the process of informed consent of AD. Income, education level, and residence are the influencing factors of decision-making conflict. It is necessary to improve the family’s economic burden by strengthening medical insurance, and ensuring the readability and objectivity of the content of PtDA to improve decision-making conflicts.
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
DZ, JL, LSZ, KLH, QSW—conception of the study, major drafting of the work, analysis and interpretation of data, final approval and agreeing to the accuracy of the work. YRZ, XXW YMP, ZZ, ZBZ—conception of the study, help in the design of the study, drafting of the work, final approval and agreeing to the accuracy of the work. HYZ, ZLC, KPBN—supervision, acquisition of data, analysis of data, final approval and agreeing to the accuracy of the work. All authors contributed to editorial changes in the manuscript. All authors read and approved the final manuscript. All authors have participated sufficiently in the work and agreed to be accountable for all aspects of the work.
Informed written consent was collected from all participants in the study. The study was conducted in accordance with the Declaration of Helsinki and was approved by the Research Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology (approval number: s146).
We are very grateful to Doctor Gabriella Ricciardi from the department of Cardiac Surgery, Leiden Universitair Medisch Centrum, Leiden, Netherlands, for providing us with many beautiful hand drawings.
Yanrong Zhou received fund support from Huazhong University of science and technology (2021-3-10, 202008).
The authors declare no conflict of interest.
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