Exploring the acceptability of a community-enhanced intervention to improve decision support partnership between patients with chronic kidney disease and their family caregivers

Shena Gazaway; Rachel Wells; John Haley; Orlando M. Gutiérrez; Tamara Nix-Parker; Isaac Martinez; Claretha Lyas; Katina Lang-Lindsey; Richard Knight; Ruth Crenshaw-Love; Allen Pazant; J. Nicholas Odom

doi:10.1371/journal.pone.0305291

Peer Review History

Original SubmissionOctober 31, 2023
9 Apr 2024 Decision Letter - André Luis C Ramalho, Editor PONE-D-23-34188Exploring the acceptability of a community-enhanced intervention to improve decision support partnership between patients with chronic kidney disease and their family caregiversPLOS ONE Dear Dr. Gazaway, 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 May 24 2024 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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Please ensure that your ethics statement is included in your manuscript, as the ethics statement entered into the online submission form will not be published alongside your manuscript. 5. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. 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 If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.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. 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 #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: N/A Reviewer #2: Yes ****** 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 ****** 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 ****** 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: Overall: Thank you for the opportunity to review this manuscript. This was a qualitative evaluation of a community-based intervention pilot that sought to improve decision making support for patients with stage three chronic kidney disease and above. The intervention was a lay-coach, telephone delivered intervention for decision support called ImPART, and this particular manuscript evaluated the acceptability of the patient focused component of the intervention. This feasibility study represented a phase of the larger intervention trial, guided by the multiphase optimizing strategy., a well-validated framework for multi-component interventions. The manuscript is well written and concise, however there were sections in the manuscript body that switched between present and past tense, e.g. pg 8, 190-193. Please standardize the tenses. Introduction: The authors clearly describe why they were focusing on patients solely in this study although the larger trial was designed for dyads. However, the introduction as written seems geared towards a caregiver intervention. Expanding the literature review on the benefits and rationale for psychoeducation for patients in structured decision making support/communication coaching, and the use of lay coaches may be helpful to align the introduction to the intervention components. The use of the theoretical models were appropriate and is as strength and outcomes are clearly defined; it would be helpful to highlight on Figure 2 to map which theories guided the intervention components.. Methods: Study procedures were well described. Analysis: The analytic plan was appropriate, justified, and supported trustworthiness and transparency. Results: The diverse representation of the participants interviewed is a strength. The purpose of the study was acceptability and feasibility but results reported on mostly acceptability; would have expected to see more feasibility discussed regarding recruitment response rate, dropout, attrition, etc. Future Directions: Results focused on three themes: 1) Frequent and deliberate disease-focused communication., 2) Future planning activation, and 3) Coaching relationship. The statement in page 18, line 380 states that the results support the model that highlights the effectiveness of social support and communication training on support and coping. Social support impacts support is a circular statement, while coping suggests a stress process; would rephrase this statement or perhaps start with line 381 instead. There was a high representation of children caregivers, would the intervention be different with partners? Was the intervention applicable across various caregiver relationships? There is a bit of overlap with future directions and the conclusions paragraph. It also will be helpful to understand how this patient focused component fits with the caregiver component. Perhaps also discussing why MOST is useful here, for example if it is effective just focusing on one member of the dyad, future interventions can be more targeted while maintaining effectiveness. Reviewer #2: The pilot study addresses a fundamental area of health that, in most cases, is omitted - the training of the sick individual to include the management of the therapeutic regimen in their self-care, making decisions that have an impact on their health. As an improvement to the method, it is suggested that in future studies, in order to increase the reliability of the qualitative data analysis, clients and their family caregivers could have been consulted regarding the interpretation given to their words. Greater participation by family caregivers is also suggested, as mentioned in the study conclusions. ****** 6. 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Revision 1
24 May 2024 Author Response Journal Requirements Formatting and author affiliations requirements The manuscript and author affiliations have has been reviewed and comply with PLOS ONE formatting requirements. Financial disclosures The role of the funders has been updated to state the approved language from the funder - The research reported in this publication was supported by the Palliative Care Research Cooperative Group funded by the National Institute of Nursing Research under the National Institutes of Health under Award Number U2CNR014637. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health: this is located in the cover letter as requested but must be placed in the final published document per funder's requirement. The additional sentence The funders had no role in study design, data collection, and analysis, the decision to publish, or manuscript preparation has also been added to clarify since it is not explicit in the sentence provided by the funders. Ethics statement The ethics statement is in the methods section. The second statement at the end of the manuscript has been removed. Data availability The data is available through the Palliative Care Research Cooperative QDR Collective here - https://data.qdr.syr.edu/privateurl.xhtml?token=50e6171d-1dd6-4146-9a90-be79630c5152 References References have been reviewed. All are present; there are not retracted references. Reviewer 1 The manuscript is well written and concise, however there were sections in the manuscript body that switched between present and past tense, e.g. pg 8, 190-193. Please standardize the tenses. The entire manuscript has been reviewed for tense. Tense has been updated to the past, where needed throughout (everything before discussion). Thank you. The authors clearly describe why they were focusing on patients solely in this study although the larger trial was designed for dyads. However, the introduction as written seems geared towards a caregiver intervention. Expanding the literature review on the benefits and rationale for psychoeducation for patients in structured decision making support/communication coaching, and the use of lay coaches may be helpful to align the introduction to the intervention components. We agree, and the foundational study that urged our development of this patient component is published; we have been able to add this data to the background section. Lay coach rationale is shared in The Intervention section, and we would like to keep it that way to keep the why for intervention components separate from the why for doing the study. To address the comment, we added additional support articles for why we are using lay coach navigation to the 2 articles cited, including a systematic review on health coaching and its benefits (page. 8). The use of the theoretical models were appropriate and is as strength and outcomes are clearly defined; it would be helpful to highlight on Figure 2 to map which theories guided the intervention components. Thank you. We added two sentences describing the interconnection of the theories and how they fit in regard to the models on page 7. The purpose of the study was acceptability and feasibility but results reported on mostly acceptability; would have expected to see more feasibility discussed regarding recruitment response rate, dropout, attrition, etc. Our shared aims are: … to share the results of a formative evaluation pilot study that explored the acceptability of a patient-focused psychoeducation decision support training component of ImPart (31). By undergoing this work, we ensure that the patient component is feasible to use and meets the needs of participants before implementation in a larger factorial trial (pg. 4). Thus, we did not explore protocol feasibility as described in the reviewer's comment. We focused on the feasibility of use. However, we can address details about attrition and dropout once a participant consented to the study. These details were added in the results and Study Process Feasibility sections. Results focused on three themes: 1) Frequent and deliberate disease-focused communication., 2) Future planning activation, and 3) Coaching relationship. The statement in page 18, line 380 states that the results support the model that highlights the effectiveness of social support and communication training on support and coping. Social support impacts support is a circular statement, while coping suggests a stress process; would rephrase this statement or perhaps start with line 381 instead Thank you for this note. I understand the confusion. We have rewritten the sentence to emphasize that undergoing social support and community training appears to impact the patient's perception that they have support available from friends and family members, impacting one's ability to cope better. This restructured sentence is on page 18. There was a high representation of children caregivers, would the intervention be different with partners? Was the intervention applicable across various caregiver relationships? Thank you for this note. We think this is a great future research area as we do not know how different types of dyads will respond to training. We know there was an impact with spousal partners and other partners. However, this pilot will be limited to finding those associations. The reflection of this question has been added to future research questions/implications on page 18. There is a bit of overlap with future directions and the conclusions paragraph. It also will be helpful to understand how this patient focused component fits with the caregiver component. Perhaps also discussing why MOST is useful here, for example if it is effective just focusing on one member of the dyad, future interventions can be more targeted while maintaining effectiveness. We agree with this statement. On page 19, at the end of the future directions section, we have added a brief description of the dyadic intervention (as we are starting that work now) and how MOST will assist in setting this work up for success. Reviewer 2 As an improvement to the method, it is suggested that in future studies, in order to increase the reliability of the qualitative data analysis, clients and their family caregivers could have been consulted regarding the interpretation given to their words. Thank you. We will ensure to address this in future studies. Since this is not written as a critique and we can not address it now, we will not add a tacked item to the submission to address this review. Greater participation by family caregivers is also suggested, as mentioned in the study conclusions. Thank you, since this is reflected, we will not address this in the resubmission. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0305291.r002
28 May 2024 Decision Letter - André Luis C Ramalho, Editor Exploring the acceptability of a community-enhanced intervention to improve decision support partnership between patients with chronic kidney disease and their family caregivers PONE-D-23-34188R1 Dear Dr. Gazaway, 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 will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, 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, André Luis C Ramalho, PhD Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0305291.r003
Formally Accepted
31 May 2024 Acceptance Letter - André Luis C Ramalho, Editor PONE-D-23-34188R1 PLOS ONE Dear Dr. Gazaway, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, 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 customercare@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 Prof. Dr. André Luis C Ramalho Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0305291.r004

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