The development and pilot testing of an ACP simulation-based communication-training program: Feasibility and acceptability

Jui-O Chen; Shu-Chen Chang; Chiu-Chu Lin

doi:10.1371/journal.pone.0254982

Peer Review History

Original SubmissionDecember 15, 2020
9 Feb 2021 Decision Letter - Alessandra Solari, Editor PONE-D-20-39392 The development and pilot testing of an ACP simulation-based communication-training program: feasibility and acceptability PLOS ONE Dear Dr. Chiu-Chu Lin, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Mar 13 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Partly Reviewer #3: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: N/A ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: No ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: The article describes a very interesting project. The analysis reports that the program can be used as training material for communication of ACP in the future, to promote ACP and advanced directives in clinical settings. It would be interesting to extend the study to a broader change, and to verify after some time whether there is an increase to ACP in care settings Reviewer #2: The research is carried out with attention at each learning step and effective for the purpose of changing attitudes in the relationship with the patient in communicating the bad news. I think the method is very interesting, even if it is very demanding of resources. I wonder how much it is possible to replicate it in other formative realities. I would expand and argue the conclusion more. Reviewer #3: With the limitations of my English and my scarce knowledge of some part of the theoretical framework and of methods to calculate content validity index, I had some problems in getting the information contained in the text. See attached comments. ****** 6. 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If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. Attachments Attachment Submitted filename: notes for Authors.docx https://doi.org/10.1371/journal.pone.0254982.r001
Revision 1
10 Apr 2021 Author Response Reviewers’ Comments and Response to Reviewers I have incorporated all of your comments and suggestions into my revision. There were very helpful and improve the quality of the article. Thank you very much. •24 ESRD: it is better to explain the abbreviation the first time it appears in your article. Not only death …It could be better to explain that ESRD is a condition difficult to cope with, and distressing for the patients and their significant ones, with end-of –life decisions which can include situation in which patients are not able to speak for themselves, and so on… p.4 (Lines 26-29) Revised as follows: Chronic kidney disease (CKD) is a significant worldwide health issue with heavy economic burden [1].In Taiwan, the incidence of end-stage renal disease (ESRD) is the highest in the world. ESRD is a difficult condition to cope with. For patients and their loved ones, end-of-life decisions may include patients’ distressing inability to speak for themselves. 29. “If advance care planning (ACP) can be discussed with patients and the ADs can be signed, patients may avoid the suffering of medical futility” This statement is incorrect. ACP does not concern with medical futility. p.4 (Lines 35-40) Revised as follows: The roles of advance directives (ADs) are two-fold. First, ADs help patients appoint a medical agent to speak on their behalf if they are unable to do so. Second, ADs work with patients and their families in clarifying and documenting the medical care they want towards the end of their lives [4]. The guiding principle for ADs is the respect for autonomy. ADs are legal documents in which people can explicitly state what medical assistance they choose to receive or refuse. Despite the importance of ADs, it is estimated that advance care planning (ACP) internationally has only been implemented for 6% to 49% in CKD patients [6]. 31 I suggest to delete the term “medical” to consider care in an holistic approach aligned with patients’ preferences and values. It should be stressed tat ACP differs from general medical decision-making in being based on the person’s wishes for the time when their decisional capacity is impaired. As far as the family is concerned, it should be better to say that the family can be involved in the process, if the patient wishes... I understand that different cultural, ethical and legal issues may be important in how the family is involved in ACP. p.4 (Line 42) We agreed with the reviewer's suggestion and deleted the term “medical” 32 disability I suggest to use terms such as “severe impairment” and/or “new condition of life” and/or “treatments they would or would not be willing to endure”. p.4 (Line 42-43) We agreed with the reviewer's opinion. Revised as follows: ACP is a dynamic communication process between patients, families, and healthcare professionals so that patients can receive the expected care when faced with an uncertain treatments that they would or would not be willing to endure in the future. 33 The phrase sounds wrong and should be reformulated to underline the prominent ethical value of ADC?, that is autonomy. p.5 (Lines 46-53) Revised as follows: The ESRD treatment process requires many complex decisions. Cognitive impairment is common in patients receiving long-term dialysis [9], so it is extremely important for patients to have shared decision-making (SDM) relationship. The SDM can achieve the goals of fully informing the patient of the ethical treatment options, the possible risks, and benefits, and ensuring that the patient's values and preferences are taken into account in the medical decision-making process. Studies have demonstrated numerous benefits corresponding to the discussion of ACP, such as increased patient and family satisfaction with care [10] and the likelihood that physicians and families will understand and comply with patients' end-of-life care wishes [10,11], thereby reducing "aggressive" medical care at the end of life [12]. 44 I suggest to remove "including the scaffolding theory, the scenario simulation model, and the PREPARED model, as the basis of the ACP simulation-based communication training (ACP-SCT) program and adopted team-based learning (TBL) as the teaching method for program training”. It is confusing to me to have such terms anticipated and I can read about them easily in the next section “Theoretical framework “ p.5 (Line 62) Removed "including the scaffolding theory, the scenario simulation model, and the PREPARED model, as the basis of the ACP simulation-based communication training (ACP-SCT) program and adopted team-based learning (TBL) as the teaching method for program training”. 70 Robinson et al p.6 (Line 92) Added “et al” 73-76 “ask them to preview the assigned reading materials before classes. In the second phase, learners will be asked to undertake the individual reading assurance test before classes so that lecturers can understand the learning outcomes before classes. After the individual test, the group readiness assurance test will be introduced to ensure the efficacy of group learning and to obtain the effect of real-time feedback. ask them to preview the assigned reading materials before classes “ I don’t understand… Please help me … Revised the section: p.6 (Line 94) to p.7 (Line 111) The process of TBL..... Teams can then challenge each other while defending their own thinking. 81 Eneanya et al p.5 (Line 62 ) Added “et al” 81-86 I suggest to move at the end of the introduction p.5 (Line 62) to p.6 (Line 67) Moved the following to the end of the introduction. “Eneanya et al. noted that health care professionals in nephrology are limited in discussing end-of-life topics with patients due to lack of training on how to communicate prognoses with patients [15]. Therefore, in this study, an attempt was made to develop a theory-based communication training program to address this clinical dilemma, using cases of CKD patients as an example. The purposes of this study were (1) to develop and pilot the ACP simulation-based communication training (ACP-SCT) program and (2) to assess the feasibility and acceptability of the program.” 112 Polit (typo) p.8 (Line 141) Fixed typo, changed ‘polit’ to ‘pilot’ 150 The way in which recruitment was done is not clear. Probably as a consequence of this, I don’t understand the difference between recruitment and consent to participate. Moreover since the 12 nurses were enrolled by convenience sampling it is difficult to think that recruitment may be a way to measure feasibility For this study, a convenience sample was taken and the researcher visited the head of the nephrology unit of a medical center to explain the purpose of the study. Posters were used to promote the study to the nursing staff. QR code was included to facilitate the enrollment of interested nurses. The number of recruits was reached within one week. The feasibility measures of the ACP-SCT program in this study followed Khumsaen & Stephenson's study and included (a) recruitment rate of participants, (b) percentage of interested participants willing to provide consent, and (c) retention rate of participants. 283 It should be correct to consider this paper as a first step within a research program. Is available the protocol of the “future definitive randomized clinical trial”? Is that trial protocol registered in a trail registry? The current study protocol has been registered on: Clinical Trails.gov PRS. Clinical Trails.gov ID: NCT 04312295 I think that educational program in palliative care and in ACP should involve all the health professionals at the same time (in this case both physician and nurse from hemodialysis room). Training programs could be more effective if carried out in multi-professional equipe dealing with with communication problems among heath professionals. In fact, a challenge in the ACP process may be the different approach of the health professionals involved in patients’ care for several reasons (different values, different skill, hierarchy, team flexibility and so on).(1 ) Was this issue considered in the goal “improve communication skills of learners”? Did the ACP-STC program deal with team communication and factors within the health professional team that influence the success of the ACP process? How much concern was given to the item “D” of the PREPARED recommendations? Q: Was this issue considered in the goal “improve communication skills of learners”? Did the ACP-STC program deal with team communication and factors within the health professional team that influence the success of the ACP process? A: Although it is the responsibility of all healthcare professionals to promote ACP, the researcher found through literature review and focus group interviews that nursing staff are the frontline healthcare providers. They spend the most time with patients and families and are the most trusted. However, the nursing staff are nervous to discuss ACP with patients and families due to lack of communication skills. Given manpower and resource constraints, the researcher started with the training of nursing staff. If the ACP- SCT program is effective, it can then be widely applied to other healthcare professionals. Q: How much concern was given to the item “D” of the PREPARED recommendations? A: 1. Write a summary of what was discussed in the medical record. 2. Talk or write to other key healthcare providers involved in the patient’s care. 3. The IC health insurance card will be used to record a patient’s medical wishes so that health care providers do not go against the patient's wishes. •Please amend your current ethics statement to confirm that your named institutional review board or ethics committee specifically approved this study. Once you have amended this/these statement(s) in the Methods section of the manuscript, please add the same text to the “Ethics Statement” field of the submission form (via “Edit Submission”). For additional information about PLOS ONE ethical requirements for human subjects research, please refer to http://journals.plos.org/plosone/s/submission-guidelines#loc-human-subjects-research. •Thank you for stating in the text of your manuscript "The study was preceded after the researchers obtained informed consents from the study participants and agreements were signed." Please also add this information to your ethics statement in the online submission form. The IRB statement and informed consent form have been amended in the Methods section and submitted on the "Ethics Statement". Reviewer #3: With the limitations of my English and my scarce knowledge of some part of the theoretical framework and of methods to calculate content validity index, I had some problems in getting the information contained in the text. In this study, the Content Validity Index (CVI) was used to evaluate the program design and content by considering the appropriateness and accuracy of content, semantic clarity. CVI calculation= The number of experts which item scoring above 3/ total number of experts. Appropriateness of content=3/3 Accuracy of content=2/3 Semantic clarity=3/3 CVI=(1+0.67+1)/3=0.89 Please provide training and educational materials used for the three phases of the study. The handbook of the ACP-SCT program totals 63 pages. Since the target subjects of this study are Taiwanese, the training and teaching materials for this study are in Chinese. If you are interested in any part, we will try our best to provide the English version you need. We suggest you thoroughly copyedit your manuscript for language usage, spelling, and grammar. The manuscript has been carefully reviewed by experienced editors who specialize in editing papers written by researchers whose first language is not English. Attachments Attachment Submitted filename: Response to reviewers.docx https://doi.org/10.1371/journal.pone.0254982.r002
15 Jun 2021 Decision Letter - Gwo-Jen Hwang, Editor PONE-D-20-39392R1 The development and pilot testing of an ACP simulation-based communication-training program: feasibility and acceptability PLOS ONE Dear Dr. Lin, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Jul 30 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed Reviewer #3: (No Response) ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #3: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #3: N/A ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #3: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #3: Yes ******** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: It would be important in the future to carry out a training and simulation path with different professionals with different training and backgrounds, to validate the central role of the team in advanced care planning. Reviewer #3: Sorry, but I insist on the concept that educational program in ACP should involve all the health professionals at the same time who are involved in the patients' care. I would like that the Authors discuss this issue/limit of the their study in the discussion. https://doi.org/10.1371/journal.pone.0254982.r003
Revision 2
7 Jul 2021 Author Response Reviewer’s comments Response to reviewers Reviewer #1: It would be important in the future to carry out a training and simulation path with different professionals with different training and backgrounds, to validate the central role of the team in advanced care planning. Agreed. Added the reviewer’s comments to the limitations paragraph. (Page 15, lines 308-317) Reviewer #3: Sorry, but I insist on the concept that educational program in ACP should involve all the health professionals at the same time who are involved in the patients' care. I would like that the Authors discuss this issue/limit of their study in the discussion. Agreed. Thank you for the very important and specific suggestion. The limitations paragraph has been added to this study: (Page 15, lines 308-317) ACP is a communication process in which various health professionals, such as physicians, nurse practitioners, social workers, and psychologists, discuss with patients and their families their personal preferences for future medical care in the face of loss of decision-making capacity. Accordingly, ACP is a person-centered, interdisciplinary, and collaborative approach to patient care that involves professionals of diverse backgrounds and areas of expertise. However, due to time, personnel, and resource constraints, only the nurses who are often the front-line caregivers were prioritized for training to test the feasibility and acceptability of this ACP-SCT program. It is recommended that future research could develop an ACP training program derived from our protocol but further includes a variety of healthcare professionals to validate the team's central role in ACP. Attachments Attachment Submitted filename: Response to reviewers.docx https://doi.org/10.1371/journal.pone.0254982.r004
8 Jul 2021 Decision Letter - Gwo-Jen Hwang, Editor The development and pilot testing of an ACP simulation-based communication-training program: feasibility and acceptability PONE-D-20-39392R2 Dear Dr. Lin, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Gwo-Jen Hwang Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0254982.r005
Formally Accepted
13 Aug 2021 Acceptance Letter - Gwo-Jen Hwang, Editor PONE-D-20-39392R2 The development and pilot testing of an ACP simulation-based communication-training program: feasibility and acceptability Dear Dr. Lin: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Gwo-Jen Hwang Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0254982.r006

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