This study will be a two-group, single-center, parallel-group, mixed-method research project that focuses on the design and application of an ACP communication plan for ICU patients based on the PFCC model. The study will be divided into four phases and will follow the SPIRIT guidelines [20]. The research will be conducted by a multidisciplinary team composed of ICU doctors, nurses, and ACP professional researchers, all of whom will be required to undergo systematic training. Figure 2 illustrates the division of this study into four independent and interrelated phases. Phase 1 will involve reviewing relevant literature to understand the research content and strategy of randomized controlled trials (RCTs) related to ACP. In Phase 2, qualitative interviews will be conducted to gain a deeper understanding of the attitudes and needs of ICU patients and their families regarding ACP. Phase 3 will focus on designing and determining an ACP communication program for ICU patients using the Delphi method, followed by feasibility verification through an RCT in Phase 4. The study will be carried out in the Department of Critical Care Medicine at a Class A tertiary hospital in China. Data collection is scheduled to commence in July 2024, with the study expected to be completed by the end of 2025.
Figure 2. Flow chart of the study
Phase 1: Literature review
This study will follow the scoping review guidelines published by the Joanna Briggs Institute (JBI) [21]. Comprehensive searches will be conducted across 10 databases, including www.cnki.net, WanFang Date, VIP, SinoMed, Web of Science, PubMed, Cochrane Library, Embase, PsycINFO, and CINAHL, using both subject headings and free-text keywords. The inclusion criteria for this study will be based on the “participants, concept, and context” principle, as follows: the participants will be patients aged ≥ 18 years old with chronic conditions, such as cardiovascular, cerebrovascular, and respiratory diseases, as well as cancer; the concept will involve advance medical care planning; and the context will be communication related to advance care planning. Studies will be excluded if they are duplicate publications, are in non-Chinese or non-English languages, or do not involve RCTs. The retrieved literature will then be classified based on the description of the interventions, providing a reference and guidance for the design of the ACP communication plan and the preliminary framework.
Phase 2: Qualitative interviews
In this phase, semi-structured interviews will be conducted with patients and their families in the ICU. The interviews will consist of both focus-group discussions and individual, in-depth interviews. The objectives will be to comprehensively understand the perceptions and needs of patients and their families regarding ACP, identify implementation issues and influencing factors in ICU patients with chronic diseases, and establish a program framework for reference. The interviews will take place at a tertiary hospital located in Guizhou Province, China. The timing, duration, and location of the interviews will be determined according to the participants’ preferences.
Participant recruitment
The participants will be selected through purposive sampling at a tertiary general hospital located in Guizhou Province, China, and the interviews will be conducted based on predetermined sampling criteria. Efforts will be made to select interviewees representing various education levels and economic statuses to enhance the representativeness of the sample until data saturation is achieved. In the case that no new themes arise during data analysis, two additional samples will be included to determine the final sample size.
Inclusion criteria
The inclusion criteria for patients will be as follows: (1) ICU patients aged ≥ 18 years old; (2) ICU stay > 24 hours; (3) patients with chronic diseases (e.g., renal failure, chronic heart failure, chronic obstructive pulmonary disease, etc.); (4) assessment of suitability by the attending doctor for interview participation; and (5) voluntary participation in this study and signed informed consent form. The inclusion criteria for family members will be as follows: (1) family members aged ≥ 18 years; and (2) core family members of the patient who have provided informed consent to participate in the study.
Data collection and analysis
The data collection process will primarily involve introducing the research purpose to the interviewees and utilizing a voice recorder for on-site recording. After obtaining informed consent from the patients and their families, the time and place of the interviews will be determined. During the interviews, interviewees will be encouraged to freely express their genuine emotions and verbally provide any non-conforming information. To ensure data accuracy, two researchers will independently transcribe the recordings into textual format within 24 hours of conducting the interviews. Colaizzi’s phenomenological seven-step analysis method will be employed to organize, analyze, and summarize the qualitative interview data from patients and their families, which will then be entered into Nvivo12 software for data management and analysis [22].
Phase 3: Developing an ACP communication plan for ICU patients utilizing the PFCC model
By integrating the findings from the qualitative interviews and the literature review, the ACP communication plan for ICU patients will be developed based on the PFCC model. The research team will engage in discussions based on the content of the communication plan. Following the team member meeting discussions, an intervention communication plan will be formulated, which will encompass determining the purpose, content, communication timing and format, communicators, and relevant observation indicators.
Inquiry letter to Delphi experts
To ensure the scientific rigor and effectiveness of the communication plan, 15 experts will be invited to participate in two rounds of expert consultation focusing on plan design, content, communication guidance, and other relevant aspects [23]. The experts’ opinions will be collected and used to enhance the plan, resulting in the final version.
Expert selection criteria
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The inclusion criteria for the experts will be as follows: (1) must be from fields such as hospice care and the ICU; (2) a minimum of 10 to 30 years of working experience will be required; and (3) must have professional titles of Deputy, Senior, or higher.
Data collection and analysis
Expert consultation questionnaires will be administered either face-to-face or via email, with a time gap of two to three weeks between each round. The intervention plan will be revised in accordance with the experts’ opinions in the second round, continuing until a basic consensus among the experts is reached.
Experts’ level of expertise
An authority coefficient (Cr) ≥ 0.70 is considered an acceptable value, while a higher authority coefficient indicates more reliable research results. The Cr value in this study will depend on the experts’ judgment basis for the consulted content (Ca) and their familiarity with the assessment content (Cs). The experts’ judgments will be based on practical experience, theoretical analysis, references to domestic and foreign literature, and intuition. The expert authority coefficient will be calculated using the formula Cr = (Ca + Cs) / 2 [23].
Expert opinion consistency level
The level of consistency among the expert opinions will be represented by the coefficient of variation (CV). A smaller value indicates a higher level of coordination among the expert opinions. Generally, a CV value of ≤ 0.25 is considered acceptable [23].
Expert opinion importance level:
The level of importance assigned to each indicator in the plan will be expressed as the mean (M), and the mean should be ≥ 3.5 [23].
Indicator deletion criteria
If the average importance assignment value is < 3.5 and the CV is > 0.25, indicators will be deleted to prevent the removal of important indicators [23]. If only one of the conditions is not met, the research team will evaluate the indicators based on their scientific and comprehensive nature, feasibility, and other principles. The final decision will be made through discussion.
Phase 4: Validate feasibility through an RCT
In this phase, an RCT will be conducted to answer the following three research questions:
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Is ACP feasible for patients with chronic diseases in the ICU?
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What is the best time to provide ACP for patients with chronic diseases in the ICU?
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Will ACP increase the pain of patients and their families?
Participation and recruitment
The study population will be comprised of 52 patients admitted to the adult ICU and their respective families [24]. The recruitment of study participants will be carried out in two comprehensive ICUs located within a tertiary general hospital in Guizhou Province, China. Patients who meet the inclusion criteria will be directly screened by the research team in accordance with the predefined inclusion and exclusion criteria. The researchers will communicate face-to-face with patients and their families to obtain informed consent and administer baseline surveys.
Inclusion criteria
The inclusion criteria for patients will be as follows: (1) aged ≥ 18 years old; (2) ICU stay > 24 hours; (3) patients with chronic diseases (e.g., renal failure, chronic heart failure, chronic obstructive pulmonary disease, etc.); (4) deemed capable by the attending physician of participating in the interviews; and (5) voluntary participation in the study and signed informed consent form. The inclusion criteria for family members will be as follows: (1) aged ≥ 18 years old; and (2) members of the patient’s core family who provided informed consent to participate in the study.
Exclusion criteria
Patients will be excluded from the trial if they: (1) have signed advance directives; and (2) have impaired consciousness or are unable to express their thoughts clearly. Adult family members will be excluded from the trial if they: (1) have mental disorders or diseases; (2) have visual or auditory impairments; and (3) are unable to express their thoughts.
Dropout criteria
The criteria for dropping out of the study will be as follows: (1) participants who dropped out midway; and (2) patients whose condition worsened or who died during the intervention period.
Randomization and blinding
This study will employ a randomized controlled design. Random numbers will be generated using SPSS 29.0, and the participants will be evenly allocated into either the control group or the intervention group to ensure equal sample sizes [25]. Allocation concealment will be achieved by placing random allocation plans in sealed envelopes. Blinding will be implemented for both the participants and the data collectors.
Control treatment
The participants in the control group will receive standard care, which will include appropriate management of clinical symptoms, pain, daily living activities, and exercise, as well as proper adherence to patient placement and physician instructions. The medical staff will provide care to the patients’ family members based on individual patients’ needs, condition, and level of acceptance. The researchers will conduct regular follow-up communication and provide verbal education to the participants. Additionally, questionnaires will be administered to the participants on the day of enrollment, seven days after enrollment, and 30 days after enrollment.
Intervention duration and termination
The participants in the intervention group will begin the intervention on the first day of enrollment. In the event that the intervention is suspended due to illness or personal reasons caused by the patient or family members, whether to terminate the intervention or consider it as a dropout will be determined based on the specific circumstances. If a participant withdraws from the study, s/he will be considered as having dropped out in the pre-intervention phase. A multidisciplinary collaborative intervention and implementation team for chronic disease patients in the ICU will establish an ACP communication plan, including ICU medical staff, rehabilitation therapists, psychotherapists, ICU managers, and graduate students. Before the project begins, all team members will receive training on the purpose and aims of the study, their role in the project, and the work they will undertake. The division of tasks among team members is outlined in Table 1.
Table 1
Formation and division of labor of the ACP communication team members
Personnel | Division of Labor |
ICU Director | Responsible for guiding and coordinating to ensure smooth progress of the study |
Chief Nurse | Responsible for managing and coordinating the work of the ACP communication team members |
Nurses 1 and 2 | Responsible for training and guiding the ACP communication team members and recruiting patients and their families who meet the inclusion criteria |
Nurses 3 and 4 | Responsible for collecting and organizing communication materials and following up on transferred patients |
Nurses 5 and 6 | Responsible for collecting problems in the intervention process, and then coordinating and rectifying them |
Research Assistant | Responsible for data analysis, liaising and coordinating with various departments, data review, tracking of patients’ whereabouts, and ensuring timely and effective implementation of communication plans |
ICU = intensive care unit; ACP = advance care planning.
Intervention phase
In addition to routine care, the intervention group will be introduced to the ACP communication plan based on the PFCC model. The ACP communication process will involve step-by-step discussions on topics such as ICU-related treatment, ACP-related knowledge, and the significance of ACP implementation. These communication sessions will be conducted over the course of one week. Surveys will be administered to both groups at the time of enrollment, seven days after enrollment, and 30 days after enrollment to assess outcomes. Detailed information regarding the intervention plan can be found in Table 2.
Table 2
Grouping methods and intervention timing
Timepoints | Groups | Participants |
Control Group Usual Nurse | Intervention Group Usual Nurse + ACP Communication |
T0 | Demographics, (1), (2), (3), (4) | Demographics, (1), (2), (3), (4) | Patients and main family members |
T1 | Usual nurse | Usual nurse + ACP communication | Patients and main family members |
T2 | (1), (2), (3), (4) | (1), (2), (3), (4) | Patients and main family members |
T3 | (1), (2), (3), (4) | (1), (2), (3), (4) | Patients and main family members |
T0 = first day of enrollment; T1 = five to six days after enrollment; T2 = one day after the end of the intervention; T3 = 30 days after the end of the intervention. (1) End-of-Life Treatment Intention Questionnaire; (2) Willingness Consistency Questionnaire; (3) ACP Readiness Scale for Chronically Ill Patients (patient participants only); (4) Project Satisfaction Survey.
Outcomes and measurements
For the primary outcome, the feasibility analysis will include an assessment of the patient enrollment rate, consent rate, loss to follow-up rate, and phase completion rate.
The secondary outcomes will include the following:
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End-of-Life Treatment Intention Questionnaire [26] (for patient participants): The questionnaire has demonstrated a strong internal consistency, with a Cronbach’s α coefficient of 0.791. The survey primarily consists of the following key questions: (1) Are you willing to participate in discussions regarding end-of-life treatment wishes? (2) If you had to make a choice for the future, what would be your preference? (3) In the event that your disease continues to worsen and your life is at risk, what actions would you like your doctor to take?
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Willingness Consistency Questionnaire [26] (for patient participants): The questionnaire has demonstrated strong internal consistency, with a Cronbach’s α coefficient of 0.791. It primarily consists of the following key question: If your condition becomes severe or you fall into a coma, and life-saving measures are required to maintain your life, would you be willing to accept interventions such as cardiopulmonary resuscitation, mechanical ventilation, gastrointestinal nutrition, blood transfusion, surgery, hemodialysis, vasopressor drugs, transfer to the intensive care unit (ICU), intravenous nutrition, and analgesics?
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ACP Readiness Scale for Chronically Ill Patients [27] (for patient participants): This scale will be used as the primary measurement tool to evaluate patients’ readiness for advance care planning encompassing three key aspects: (1) attitudes toward advance care planning; (2) beliefs about readiness; and (3) motivation for participating in advance care planning. The scale employs a 5-point rating system, with scores ranging from 22 to 110. A higher total score indicates a greater level of preparedness for advance care planning. The score ranges are as follows: 22–43 for a low level, 44–65 for a lower-middle level, 66–87 for an upper-middle level, and 88–110 for a high level of readiness. The scale has exhibited strong internal consistency, with a total Cronbach’s α coefficient of 0.923.
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Project Satisfaction Survey (for patient participants): This survey primarily includes the following questions: (1) Did you find the project meaningful? (2) How do you feel after participating in the project? (3) Would you recommend this project to others? (4) What are your suggestions and opinions on this project?
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End-of-life Treatment Intention Questionnaire [26] (for family member participants): The questionnaire has demonstrated strong internal consistency, with a Cronbach’s α coefficient of 0.757. It primarily includes the following key questions: (1) Do you want the patient to participate in discussions about end-of-life care wishes? (2) If the patient had to make a decision for the future, what do you think their preference would be? (3) If the patient’s condition worsens and his/her life is at risk, who would you prefer to be their doctor?
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Willingness Consistency Questionnaire [26] (for family member participants): The questionnaire has exhibited strong internal consistency, with a Cronbach’s α coefficient of 0.804. This questionnaire primarily focuses on whether the family member would be willing to have the patient undergo various life-sustaining interventions, such as cardiopulmonary resuscitation, mechanical ventilation, gastrointestinal nutrition, blood transfusion, surgery, hemodialysis, vasopressors, transfer to the intensive care unit (ICU), intravenous nutrition, gastrointestinal nutrition, and analgesics, if his/her condition became severe or s/he fell into a coma.
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Project Satisfaction Survey (for family member participants): This survey primarily comprises the following key questions: (1) Did you consider the project to be meaningful? (2) How do you feel about your participation in the project? (3) Would you recommend this project to others? (4) What are your suggestions and opinions regarding this project?
Data management and monitoring
Data management and monitoring responsibilities will be undertaken by the coordinating investigator site’s clinical trial unit. The trial will strictly adhere to national and international standards for good clinical practice, ensuring compliance with regulatory and ethical requirements. Any serious adverse events, whether related or unrelated, that affect the participants (including family members) will be meticulously collected and documented in reliable source documents. Regular monitoring will be conducted to ensure the study’s quality and regulatory compliance. It is important to note that the monitoring personnel will not be involved in the research activities. The ethics committee has granted approval for supervision, including the verification of the investigators’ and research team members’ qualifications and the monitoring of document integrity and appropriateness.
Data analysis
This study will utilize EpiData 3.1 software for data entry, with two individuals performing the task. Following data correction, the imported dataset will be analyzed using SPSS 29.0. Normally distributed measurement data will be expressed as mean ± standard deviation. Group t-tests will be employed to compare the sample means of the two groups, while count data will be presented as percentages. The chi-squared test (χ2) will be used to compare the two groups of binary count data. Median and interquartile ranges (M [P25-P75]) will be utilized to describe rank or non-normally distributed data, and the rank sum test will be employed to compare the two groups. Two-sided tests will be used in all analyses. For the analysis of discrete repeated-measurement longitudinal data, such as decision certainty and end-of-life treatment intentions, generalized estimated equations will be applied. Statistical significance will be determined at a significance level of p < 0.05.