Scaling up the primary health integrated care project for chronic conditions in Kenya: study protocol for an implementation research project

Introduction Amid the rising number of people with non-communicable diseases (NCDs), Kenya has invested in strengthening primary care and in efforts to expand existing service delivery platforms to integrate NCD care. One such approach is the AMPATH (Academic Model Providing Access to Healthcare) model in western Kenya, which provides the platform for the Primary Health Integrated Care Project for Chronic Conditions (PIC4C), launched in 2018 to further strengthen primary care services for the prevention and control of hypertension, diabetes, breast and cervical cancer. This study seeks to understand how well PIC4C delivers on its intended aims and to inform and support scale up of the PIC4C model for integrated care for people with NCDs in Kenya. Methods and analysis The study is guided by a conceptual framework on implementing, sustaining and spreading innovation in health service delivery. We use a multimethod design combining qualitative and quantitative approaches, involving: (1) in-depth interviews with health workers and decision-makers to explore experiences of delivering PIC4C; (2) a cross-sectional survey of patients with diabetes or hypertension and in-depth interviews to understand how well PIC4C meets patients’ needs; (3) a cohort study with an interrupted time series analysis to evaluate the degree to which PIC4C leads to health benefits such as improved management of hypertension or diabetes; and (4) a cohort study of households to examine the extent to which the national hospital insurance chronic care package provides financial risk protection to people with hypertension or diabetes within PIC4C. Ethics and dissemination The study has received approvals from Moi University Institutional Research and Ethics Committee (FAN:0003586) and the London School of Hygiene & Tropical Medicine (17940). Workshops with key stakeholders at local, county, national and international levels will ensure early and wide dissemination of our findings to inform scale up of this model of care. We will also publish findings in peer-reviewed journals.

interesting for readers and useful for researchers. English is clear.
The key words seem to be appropriate. The title is suitable. The abstract is well written. Objectives are well-aligned. Methods are very well described. Discussion is scientifically sound and acceptable. However, few changes are suggested to make it more understandable and implementable protocol, especially to the general public. The following few suggestions/comments would be helpful: 1. Add a reference to line 3, page 6, behind NCDs regarding the double burden of diseases 2. It's better (for papers compared to reports or policy documents) to enter references inside before the points or commas at the end of every referenced statement. 3. Page 8, line 2 or somewhere else, A graphically or diagrammatically presented conceptual framework (or the adapted one) would portray well the project and all those factors you described. If you think you can quickly draw based on the description you put together, that it would be helpful otherwise leave it. 4. Page 8, line 5, though multiple method design is well described, I would however consider this to be a mixed methods study. The navigating between qual. And quant. data collection and analysis would just lead the conclusion of mixed methods that are nowadays most used in most of integrated interventions and research projects. 5. Page 15, lines 14-25 I like this knowledge translation section! 6. Discussion mentioned the expected outcomes in terms of integrated management of NCDs within PHC in Kenya and beyond (pages 17-18), I would suggest to add a paragraph or a few lines arguing how this would work in other LMICs with similar contexts or in the same situation.
Looking forward to reading your paper after your research project is completed.

Reviewer 1
1. The protocol lends to itself to implementation science research and the study design should be framed in this context We agree and indeed, the title of the manuscript already reflects this notion. We have also now amended the introductory sentence to the 'Methods/design' section (p. 8, line 6ff) as follows: "This implementation research project uses a multimethod design combining qualitative (sequential in-depth interviews with health workers, decision-makers, and patients), and quantitative approaches (patient surveys, a cohort study with an interrupted time series analysis and a cohort study of households" 2. Objective 1-could be classified as a formative evaluation. I have reservations of how only key informant interviews with decision makers address the outcome of assessing implementation. In my understanding there should be an input process and output assessment that includes onsite evaluation at sampled sites Thank you for this comment. There are different definitions of formative research, but we do believe that our methodological description is appropriate. Objective 1 is seeking to assess the key components of the implementation process of the PIC4C model as we state in our paper and involves interviews with decision-makers and health care workers. As we argue in Table 1, our starting point are the various stakeholders who are affected by the changes related to the introduction of PIC4C. We know from the evidence (which we cite) that organisational innovations such as the PIC4C are unlikely to succeed long-term if they fail to take into account the diverse patterns of interests, values and power relationships between those involved in the development, implementation and delivery of the new service model. This is what work carried out under Objective 1 is seeking to understand and so inform options for sustaining and potential scaling of the care model. We have not changed the text.
3. In order to understand your conceptual framework, a pictorial depiction will be appreciated We thank you for raising this point. The conceptual framework guiding our work derives from a comprehensive review of the key lessons that can be learned from the implementation science literature rather than providing a 'new' framework as such (Nolte 2018). Its key components, thus, reflect the main insights identified by studies of the implementation, sustaining and spreading of innovation in health service delivery and organisation and as such sought to guide data collection and analytical strategy in the current study. As requested we have now produced a visual ( Figure 1) depicting the relationship between the conceptual framework, study objectives and data collectio.

Assessment of sustainability of the intervention needs to be considered
We absolutely agree with the Reviewer and sustainability forms one of the core components of our conceptual framework (p. 7, line 20ff). 2. It's better (for papers compared to reports or policy documents) to enter references inside before the points or commas at the end of every referenced statement.

Reviewer
Thank you very much for this comment. We have followed BMJ Open guidance which states that "Reference numbers in the text should be inserted immediately after punctuation (with no word spacing)." We are seeking advice from the Journal Editors on this point.
3. Page 8, line 2 or somewhere else, A graphically or diagrammatically presented conceptual framework (or the adapted one) would portray well the project and all those factors you described. If you think you can quickly draw based on the description you put together, that it would be helpful otherwise leave it.
Thank you for this suggestion. We have now added a graphical representation of our study conceptual framework (see also response (3) to Reviewer 1).
4. Page 8, line 5, though multiple method design is well described, I would however consider this to be a mixed methods study. The navigating between qual. And quant. data collection and analysis would just lead the conclusion of mixed methods that are nowadays most used in most of integrated interventions and research projects.
Thank you very much for raising this point. We agree that the study design includes elements of a mixed-methods approach (especially Objective 2 and, so some degree, Objective 4) and each method will contribute to informing the potential scale up of the PIC4C model of care as well as its transferability to other contexts/settings. However, we believe that the study design overall does not quite meet what we would consider as mixed methods as described by for example Greene et al. (1989) or Creswell et al. (2011). We would therefore consider that the term 'multimethod design' our study best.

Page 15, lines 14-25 I like this knowledge translation section!
Thank you so much for your kind comment.
6. Discussion mentioned the expected outcomes in terms of integrated management of NCDs within PHC in Kenya and beyond (pages 17-18), I would suggest to add a paragraph or a few lines arguing how this would work in other LMICs with similar contexts or in the same situation.
We agree and we have already included this in the discussion page 17 where we note that the study "will provide important new insights into the requirements for scaling up a novel approach to managing NCDs in primary health care from the perspective of those organising, delivering, and receiving the enhanced services while also expanding our understanding of the unintended consequences of integrating NCD management into the primary care platform on existing care programmes. This knowledge can then be leveraged to inform and improve the design and implementation of similar programmes elsewhere in Kenya and other low-resource countries settings."

GENERAL COMMENTS
Thank you for the revised manuscript. I thank you for the explanation provided. I have the following two points to note: 1. Figure 1 is not enclosed in the revised word document 2. Having now clearly understood the objective 1-my humble opinion is that the articulation of the objective is clearer in the table than the main manuscript. As a qualitative study the word assess depicts a more qualitative measure. It is my opinion that the word explain or explore the quality of leadership and management; levels of stakeholder involvement; adequacy of support mechanisms and resources; ability to adapt the intervention locally; and quality of communication and of monitoring and feedback clearly articulates the objective Although, the authors mention sustainability and refer to it page 7 line 20, the methodology of the protocol does not reflect how the sustainability will be assessed. There are tools such as theNational Health Service (NHS) Institute for Innovation and Improvement Sustainability Model could be easily added to enhance the methods of the study

VERSION 2 -AUTHOR RESPONSE
Author response to reviewer comments 1. Figure 1 is not enclosed in the revised word document Author response: Thank you for highlighting this. We had embedded Figure 1 in our revised document but were advised by the Journal to remove all figures in the main document and upload them separately. We have subsequently resubmitted the (revised) main document and uploaded the figure as a separate pdf file ('bmjopen-2021-056261 Figure 1'). As this is a Journal requirement we are unable to change this.
2a. Having now clearly understood the objective 1-my humble opinion is that the articulation of the objective is clearer in the table than the main manuscript. As a qualitative study the word assess depicts a more qualitative measure. It is my opinion that the word explain or explore the quality of leadership and management; levels of stakeholder involvement; adequacy of support mechanisms and resources; ability to adapt the intervention locally; and quality of communication and of monitoring and feedback clearly articulates the objective Author response: You recommend we replace the word 'assess' with 'explain' or 'explore' in relation to Objective 1 of our paper, on the basis that the former depicts a more qualitative measure. Since Objective 1 indeed uses entirely qualitative methods, we believe that the term captures our aims well and we would like to retain it. We have not changed the text 2b. Although, the authors mention sustainability and refer to it page 7 line 20, the methodology of the protocol does not reflect how the sustainability will be assessed. There are tools such as theNational Health Service (NHS) Institute for Innovation and Improvement Sustainability Model could be easily added to enhance the methods of the study Author response: Thank you very much for your suggestion. We believe your comment refers to the following sentence "It [the conceptual framework] posits that ensuring that service innovation, such as the PIC4C model, is sustained, spread and scaled up, requires supportive and committed leadership and management at different tiers; ..". We should clarify that our study does not seek to assess sustainability as such; instead, as highlighted in the aims and objectives and Table 1 specifically, our study will explore the degree to which the various factors that have been shown in the literature to be important for sustaining and scaling up service innovations are present in PIC4C. The NHS Institute for Innovation and Improvement Sustainability Model is designed to support organisations in understanding the likely sustainability of improvement initiatives by raising awareness of factors considered important for sustainability and encouraging teams to consider actions to increase the likelihood of sustainability. We accept the potential usefulness of this model although note that it has not been widely used, with some authors raising questions about the applicability of the model in practice (see e.g. Doyle et al. 2013;Lennox et al. 2017). The conceptual framework guiding this study is based on a comprehensive review of the extant literature and draws, among others, on seminal work by Greenhalgh et al (2004), which explored understandings and drivers of sustainability of innovations in service delivery and organisation, along with the work by Lennox and colleagues, who have provided extensive reviewes around sustainability of health service innovation (e.g. Lennox et al. 2018). We therefore believe that our study will provide insights into the likely sustainability of PIC4C, or elements of it.

GENERAL COMMENTS
The authors have made. case in their rebuttal letter and the differences are merely semantic and will not have a serial impact on the outcome of the study. I will like to suggest that instead of having assess for two objectives consider revising one of the adjectives but that is entirely up to you