Diabetes is a serious chronic condition affecting more than 415 million people worldwide, and this number is rising [1]. The 2 most common forms are type 1 and type 2 diabetes. Diabetes is characterized by high blood glucose levels, which over many years increase the risk of diabetes-related complications. Therefore, it is important to manage the condition to maintain optimal glucose levels (and minimize other risk factors) [2]. This is highly reliant on daily self-care (eg, taking medications, checking glucose levels, and maintaining a healthy lifestyle). Living with and managing diabetes can place considerable psychological burden on the person and their family [3]. Psychological problems can be both diabetes-specific (eg, diabetes distress and fear of hypoglycemia) and generic (eg, depression and anxiety) [4]. They are relatively common among adults with both types of diabetes, with many similarities in terms of the nature and prevalence of presenting problems as well as the strategies to address them. Preservation of psychological well-being is important in its own right [5] but impaired well-being is also associated with suboptimal diabetes self-care, biomedical outcomes (eg, HbA_1c), and quality of life.

Clinical guidelines recommend person-centered, holistic diabetes care, including routine monitoring for psychological problems [6-9]. However, such guidelines are rarely implemented in clinical practice and the emotional health needs of people with diabetes often go unmet [10-13]. Few evidence-based, comprehensive, practical resources exist for health professionals about how to implement psychological care, beyond book chapters [14,15], books highly specific to 1 psychological problem [16,17], and student texts [18]. Although these have value, they are not freely available to health professionals and are limited in their practical application. For example, they are often heavily text-based or do not provide a step-by-step guide, including the practical elements that health professionals need, such as practice points, suggestions for open-ended questions and responses, and copies of validated screening tools for psychological problems. Health professionals have expressed unmet needs, including lacking skills, confidence, training, and resources, to properly attend to the psychological needs of people with diabetes [19-21]. Recommendations have been made recently for improved communications between health professionals and people with diabetes and for additional training and improved skills among health professionals to assist with overcoming these barriers [22].

Therefore, our aim was to address health professionals’ unmet needs, using a formative evaluation approach, by developing a practical, evidence-based resource: Diabetes and Emotional Health: A handbook and toolkit for health professionals supporting adults with type 1 or type 2 diabetes [23]. The objectives of the handbook and toolkit were to raise awareness, provide practice points and tools, and foster skill development, for identifying, communicating about, and addressing psychological problems experienced by adults with diabetes. This paper describes the formative evaluation of the handbook and toolkit.

To develop the handbook and toolkit, we used a formative evaluation approach, that is, “a set of activities designed to develop, identify and test program materials and methods … [which] occurs as a part of program planning and occurs before any elements of the program are implemented” [24]. We selected this approach to enable us to shape the resources in accordance with the literature, best practice clinical recommendations, and stakeholder consultations, to meet the needs of diabetes health professionals. The formative evaluation steps we applied (ie, review the problem, understand the target population, and pretest the intervention material) [24] are shown in Figure 1 and described in the following sections. The methods of each phase were informed by the results of the previous phase (ie, an iterative process). The decisions made after each phase are described in each corresponding results section.

To begin, we established a project team that included health and clinical psychologists and researchers with expertise in the psychological aspects of diabetes. We also established a multidisciplinary Expert Reference Group (ERG), representing various stakeholders (eg, general practitioner, endocrinologist, diabetes nurse educator, psychologist, key organizations, and people with diabetes). The project team worked collaboratively throughout the project, meeting regularly, holding workshops to discuss and progress ideas, and constructively reviewing each other’s work. We engaged the ERG at least quarterly to discuss plans and progress.

In 2013, we conducted a narrative literature review to investigate 7 research questions (see Multimedia Appendix 1). We developed these research questions using a stepwise approach, to help formulate an evidence base for developing a resource to support diabetes health professionals with providing psychological support. We engaged our ERG in the process of formulating the research questions. We searched MEDLINE, Scopus, Google (for gray literature), and the reference lists of relevant literature. Peer-reviewed narrative and systematic reviews and meta-analyses, empirical research (quantitative and qualitative), expert commentaries, reports, and clinical guidelines were consulted. The search was limited to literature relevant to adults with type 1 or type 2 diabetes, published in English from the year 2000 onward. Search terms varied according to the research question (eg, Diabetes and Psychological). Truncations and synonyms were used as appropriate.

The literature review confirmed the need for practical, user-friendly, and evidence-based resources; thus, we decided to develop a handbook to meet this need (See “Review the Problem and Previous Efforts to Address It: Literature Review” in the Results for further information).

From late 2013 to early 2014, JH and LB consulted with each ERG member individually to (1) gain a deeper understanding of their current practice related to diabetes-related psychological care and (2) ascertain their needs (individual and professional, content and design) for the handbook. The consultations were unstructured to ensure the relevance to all ERG members and used funneling (moving from broad to specific topics). Before the consultations, the project team agreed on a general list of topics to discuss, but they also agreed to allow the stakeholders to expand on any relevant topic (consistent with an unstructured consultation approach). For example, after the person had spoken, unprompted, about their experiences and needs, they were shown pre prepared examples of draft handbook content, in long (chapter) and short (3 summary versions—5 A’s model, flowchart, and factsheet) formats. We explored their preferred version, positive and negative aspects of each version, how each version would meet their needs (or not), and how we could adapt each version to better suit their needs. We also built on topics raised by other ERG members (eg, “Someone else suggested X, what do you think?”) and presented a draft list of topics (chapters) to check relevance and completeness. We made comprehensive notes during the consultations. JH examined all notes for commonalities and differences in views, then summarized the results (see “Understand the Target Population: Stakeholder Consultation” in the Results) and discussed them with the team. We reported back to the ERG to validate the findings and seek agreement for proposed plans and decisions, which included a decision to develop both a handbook and a toolkit, to meet the varying needs of different health professional disciplines (see “Understand the Target Population: Stakeholder Consultation” in Results).

The literature review demonstrated that psychological problems are common among Australian adults with type 1 and type 2 diabetes [25-27]. Furthermore, Australian adults with diabetes attending tertiary diabetes clinics respond well to the use of psychological screening questionnaires [27,28]. International guidelines recommend attention to and routine screening for psychological problems as a part of routine care [29] yet health professionals report lacking resources, training, and confidence to do so [19,30]. We presented these results in a report that the ERG reviewed and approved. These findings and “Lessons Learned and Actions” are summarized in Multimedia Appendix 1.

On the basis of the literature review findings (see Multimedia Appendix 1), we decided to develop a practical, user-friendly, and evidence-based resource (ie, the Diabetes and Emotional Health handbook). The handbook would cover a range of diabetes-specific and general psychological problems common to adults with type 1 or type 2 diabetes, which affect their diabetes self-care and outcomes and quality of life. It would provide health professionals with practical tools and strategies for identifying, communicating about, and addressing psychological problems. The ERG supported our proposed plans. They also pointed out that health professionals often have limited time and would appreciate short (eg, 1 page) summaries, with an option to access more detail and background information in the handbook.

The literature review informed the handbook planning and content. We began by brainstorming a list of proposed topics (ie, chapters; see Figure 2) and chapter content (proposed headings and sections). Drawing on content-specific literature, we prepared a draft chapter, proposing a standardized format with the following headings (structure): key messages, prevalence, risk factors, impacts, what to look for, treatment or management, case studies, resources, and a copy of a validated screening questionnaire. We also investigated formats for the summaries and prepared drafts in three formats (5 A’s model, flowchart, and factsheet). We selected these potential formats because they are common layouts in other resources (eg, the 5 A’s model appeared in existing Australian health professional guidelines) [31]. The 5 A’s model is a well-cited adaptation of the 4 A’s model (see Figure 3) [32-34].

The ERG consultations facilitated greater understanding of the roles of different health professional disciplines and their needs. A summary of the key results is included in Table 1. The consultations highlighted the diverse needs (eg, learning styles and scope of practice) and preferences of the ERG members. While some preferred the detail of the chapter, others preferred the brevity of the summaries. The 5 A’s model was the preferred summary format. The ERG suggested to develop complementary factsheets for people with diabetes about the emotional problems in the handbook.

On the basis of the consultation results, we decided to develop both a handbook and toolkit to meet the diverse needs of the various health professionals involved in routine diabetes care. The handbook would provide detailed information, with each chapter using a consistent format to enable quick reference (eg, consistent headings and structure, guided by the 5 A’s model, which was the preferred summary format) [31]. The toolkit would provide practical resources for use in clinical consultations, that is, 1-page summary cards of each chapter (focused on the 5 A’s model), copies of validated questionnaires, and factsheets for people with diabetes.

Drafting the handbook and toolkit was a collaborative process. We divided the topics among the individual authors (CH, JH, LB, and JS) to lead preparation. For some chapters, the writing was shared (eg, by multiple authors or with a contributor from outside the core authorship team). Overall, a minimum of 3 authors contributed to each draft chapter. We drew upon clinical practice guidelines, published peer-reviewed literature, the findings of the ERG consultation, our own clinical and research experience, and iterative ongoing discussions (with the ERG and team). We held writing workshops regularly to discuss writing progress and content and to make adjustments for consistency between chapters.

While guidelines recommending psychological care in diabetes have existed for 25 years [5], to our knowledge, the Diabetes and Emotional Health handbook and toolkit [23] represents the first attempt to develop evidence-based, clinically informed, freely available, practical resources for multidisciplinary diabetes health professionals supporting the emotional health of adults with type 1 and type 2 diabetes. These resources are a tailored response to the expressed unmet needs of health professionals, who cite lack of resources and confidence to address diabetes-related emotional problems as significant barriers to providing holistic diabetes care. The handbook offers strategies and tools for recognizing psychological problems and providing support for them. The toolkit contains practical resources to facilitate implementation: chapter summary cards, questionnaires, and factsheets for people with diabetes. The handbook and summary cards implement the 7 A’s model. A model such as this provides a memorable acronym for application in busy health settings and is consistent with the expectations of people with diabetes about support from health professionals [34]. The 7 A’s model is a useful framework to provide a consistent and logical structure with a clear path to implementation in clinical practice. The reviewers and qualitative study participants favorably viewed its application in the handbook.

Formative evaluation is an essential first step for developing high quality and effective interventions that are acceptable to the target population [24]. In this case, formative evaluation helped us to comprehensively explore the problem, while ensuring accountability and quality control. The formative evaluation approach is a key strength of the resources. The inclusion of several stages of end-user (health professionals) and stakeholder (eg, academic experts and people with diabetes) consultation means that we are confident that the resources align with expressed needs and published evidence. Given our combined expertise, we could have developed these resources with less consultation, which would have been less resource and time intensive. However, we would have been less confident with the final product and the rigorous review process was well received by and inspired confidence among stakeholders and potential users [24]. The methods described in this study demonstrate how formative evaluation can inform the development of high quality, evidence-based resources, and the processes described herein may be valuable for informing the development of similar resources in other areas.

These resources are important stepping stones toward more consistent implementation of clinical practice guidelines and better integration of psychological health into routine diabetes consultations. As described by 1 qualitative study participant, the handbook has “really normalized that our role is working with a whole person, their emotional health and their physical health.” When we commenced this project, there was no specific Australian guideline for the psychological care of people with diabetes. In addition to developing Diabetes and Emotional Health, we concurrently advocated for recognition of psychological care within existing Australian guidelines to align them more closely with international recommendations. Since then, recommendations for routine screening for depression and diabetes distress have been included in the Australian General Practice Management of Type 2 Diabetes guidelines [7,9]; the Australian guidelines for type 1 diabetes [36] are yet to be revised. Importantly, mental health has been recognized in the Australian Government’s National Diabetes Strategy: 2016-2020 [37]. Moving forward, we continue promoting these resources via seminars, workshops, conferences, and social media. These resources are part of the training curriculum for the next generation of credentialed diabetes educators (eg, at Flinders University and Deakin University). We have developed, and are currently evaluating, a Diabetes Distress e-Training for health professionals, on the basis of the handbook and toolkit content. Additionally, we have collaborated internationally on a Diabetes UK adaptation of the handbook and toolkit to suit the UK health care context, which is now available on the Web [38]. We have also been able to address the resource gap raised by the MESAC (see “Phase 2: Review by Funding Body” in the Results) by subsequently developing a factsheet for family and friends of people with diabetes [39].

We acknowledge that there is more work to do. For example, a limitation of this study was the exclusive focus on adults with type 1 and type 2 diabetes. We selected these 2 groups as they represent the largest populations in need of psychological support, and our previous research had focused largely on adults [25-28]. However, there is a need for similar resources to enhance support for children and adolescents with diabetes (and their families) and women with gestational diabetes. Furthermore, the diabetes-related psychological needs of specific subgroups (such as Aboriginal and Torres Strait Islanders, culturally and linguistically diverse communities, people with psychiatric conditions, and people with disabilities) are under-researched and important areas for future work. Evaluation of the process and impact of the real-world implementation of the resources would also be valuable in the future [24] but was not within our project scope.

Diabetes and Emotional Health is a practical, evidence-based, clinically informed handbook and toolkit developed in consultation with end-users and other stakeholders. The findings of our formative evaluation suggest that the resources are comprehensive yet user friendly, addressing the previously unmet needs of multidisciplinary health professionals, enabling professional development and supporting real-world implementation of clinical practice guidelines related to the psychological care of people with diabetes.

Diabetes and Emotional Health provides health professionals with practical information and tools required to implement clinical practice guidelines related to the psychological aspects of diabetes. More than 1000 hardcopies have been distributed to Australian health professionals and more than 1400 electronic copies have been downloaded. The resources remain freely available on the Web. [23] Health professionals find the handbook and toolkit useful for their clinical practice, are implementing them, and are taking ownership of them (eg, discussing with others and making plans to train others). These resources are likely to have clinical utility internationally (until international adaptations are developed), owing to the evidence-based content, robust stakeholder review, and shared goals with international clinical practice guidelines (holistic and person-centered care and attention to psychological problems). Similarly, our adapted 7 A’s model may have clinical utility for routine screening and monitoring for other problems (psychological or other) as part of a person-centered approach to routine care.