Study setting
The study is being conducted in the primary and secondary healthcare sectors in the Region of Southern Denmark, which includes 349 general practices with a total of 795 capacities (full-time GPs). Each capacity makes approximately 6–8 T2DM diagnoses per year, resulting in about 4,770 newly diagnosed patients annually. Additionally, the Region of Southern Denmark comprises 22 municipalities and four hospital units, providing a comprehensive healthcare network in the region.
Eligibility criteria
General Practitioner Eligibility Criteria:
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General practitioners must practice within the Region of Southern Denmark.
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To prevent potential contamination between current studies, participating GPs must not also be part of the randomized controlled trial study, DICTA (11), which is currently being implemented in the Region of Southern Denmark.
Patient Eligibility Criteria:
Patients must be at least 18 years of age.
Patients must have been diagnosed with Type 2 diabetes by a general practitioner and according to Danish clinical guidelines.
Patients must have the ability to speak, read, and understand Danish.
Intervention
The intervention has been designed to support people with T2DM in the first three months following their diagnosis. This comprehensive approach includes four fundamental elements.
1. Improving cross-sectoral communication and information sharing
To improve cross-sectoral collaboration, SDCO has organized a series of face-to-face meetings involving general practitioners, municipal representatives, and representatives from regional hospitals. These gatherings aim to foster interpersonal relationships, promote knowledge sharing, and facilitate discussions regarding the unique healthcare services that each sector offers to people with newly diagnosed T2DM.
2. Systematic care
In Denmark, comprehensive clinical guidelines for the treatment of T2DM are currently available. While these guidelines provide valuable information, their extensive nature and complexity represents a barrier to implementation. To address this issue, and to ensure systematic and uniform care for people recently diagnosed with T2DM, SDCO has developed Quick Guides, which offers concise and easily understandable resources specifically designed for general practitioners. This efficient tool aims to streamline the application of best practices in T2DM management (see appendix 1). The guidelines establish a framework outlining the essential information that patients should receive within the initial three months following their diagnosis. Moreover, to optimize the implementation process, SDCO plans to conduct individual meetings with each general practitioner, allowing for a tailored approach that caters to their specific needs.
3. A "one-stop-shop" and a start-up conversation at the municipality
Each patient will be referred for an introductory consultation at their respective municipality to evaluate the relevance and necessity of health-related programs tailored to their individual needs. Furthermore, all patients will be directed to a "one-stop-shop" health-screening appointment, where they can undergo multiple essential examinations, such as blood sample collection, blood pressure measurement, and eye and foot screenings. These referrals aim to promote consistency in T2DM treatment and establish a foundation for enhanced and optimal care.
4. Improving patient overview
In partnership with individuals affected by Type 2 Diabetes Mellitus, SDCO has created patient information materials, which have been designed to provide patients with a structured, coherent, and comprehensive overview during the initial stages post-diagnosis. The materials include a checklist and essential information about the disease (see appendix 2 and 3) and were developed to assuage the uncertainty that patients may encounter after being diagnosed. These materials are thus designed to enhance patients' understanding of the nature, symptomatology, and treatment of T2DM. As a result, this initiative is expected to alleviate diabetes-related distress by bolstering patients' sense of confidence and knowledge about their chronic disease.
Outcomes
Primary outcome
This study primarily investigates longitudinal changes in DD at baseline, 4 months, and 12 months. The DDS is a validated and reliable 17-item self-report tool that measures emotional burden, regimen-related distress, physician-related distress, and interpersonal distress. (5, 12, 13) Participants rate items on a six-point Likert scale, with overall and subscale scores calculated by averaging responses. Physician-related distress might be a key focus in the analysis, as it may be directly influenced by the intervention.
Secondary outcomes (measured at baseline, 4, and 12 months) Several secondary outcomes will be assessed, including the perceived quality of care using study-specific items, patients' ability to self-manage using the Patient Activation Measure (PAM) (14), quality of life using the 12-item Short Form (SF-12) (15), patients' self-care ability using the Summary of Diabetes Self-Care Activities Measurement (SDSCA) (16), and clinical components such as HbA1c, blood pressure, and blood lipids will be measured.
Tertiary outcomes (measured at baseline, 4, and 12 months)
Depression, stress, and resilience will be assessed using the Major Depression Inventory (MDI) (17), the two single-item measures of psychosocial stress (18), and the Connor-Davidson Resilience Scale (CD-RISC-10) (19). Furthermore, the extent and quality of social networks will be assessed using the Lubben Social Network Scale (Lubben-6) (20) and sleep quality and quantity will be measured using the Pittsburgh Sleep Quality Index (PSQI).
For a complete overview of the primary, secondary, and tertiary outcomes, see table 1.
Items created for the study (measured at baseline, 4, and 12 months)
These items were developed to address experiences of care that the aforementioned questionnaires do not cover. Specifically, items were developed based on other Danish patient surveys and validated (4, 21) in terms of respondent interpretation and understanding of each item. See the full list of questions in appendix 4 and 5.
Sample size
The required minimum number of clusters was calculated, based on the means and standard deviations reported in the REDEEM trial conducted by Fisher et al. (26).. Assuming a low intraclass correlation of 0.05 and a mean group cluster size of 6 T2DM patients observed per year in the control and intervention groups, it was determined that 32 clusters (16 in each arm) are needed to achieve power at 80% and a statistical significance level of 5%. Although a dropout rate of 40% is considered high, it is likely for the present study due to the comprehensive patient-reported outcomes, which require three follow-ups. As such, a total of 270 patients are required for analysis.
Recruitment
General Practitioners
Strategies to recruit GPs to the project were: telephone calls, followed up with emails and postal mail. To maintain engagement, control group GPs were scheduled for a later intervention. GP recruitment took place from May to December 2022.
Patients
Participating GPs began recruiting patients in May 2022. Recruitment will continue through August 2023. Participants can access the patient-reported outcome questionnaire via e-Boks, a widely used Danish digital platform for secure communication with public authorities and private companies.
Patients lacking access to e-Boks or who were unable to complete the electronic questionnaire, will be provided a hard copy by their GP or schedule a phone interview with a member of the research team.
Participant timeline
The time schedule for the enrolment of both GPs and patients is presented in Fig. 1.
METHODS: ASSIGNMENT OF INTERVENTIONS (FOR CONTROLLED TRIALS)
Allocation
GPs were randomized into intervention or control clusters at a 1:1 allocation ratio using a computer-generated block size of six. The randomization process was divided into two groups: One with general practitioners with 1 or 2 capacities, and another with 3 or more capacities. This approach aimed to ensure a homogeneous distribution of small and large general practices in each intervention arm. A statistician blinded to the practice identities performed the allocation, and the process was concealed within sealed envelopes to minimize the risk of unintentional allocation bias or interference.
Blinding
The study design does not allow blinding of GP. However, patients and data analysts are blinded to the treatment allocation.
Methods: Data collection, management, and analysis
Data Collection Methods
The present study utilizes an electronic patient-reported questionnaire as the primary method for data collection, with the option of completing a hard copy or telephone version of the questionnaire. The questionnaire was designed to gather information on outcomes that are deemed essential to the study's objectives. These outcomes were selected based on their validation as reliable tools for measuring key outcomes.
Data Management
The present study utilizes e-Boks and the Open Patient data Explorative Network (OPEN) for the collection of data. The survey instrument has been developed using OPEN REDCap, and the resulting data is stored on the server provided by OPEN. For security purposes, the data will be extracted from the OPEN server and transferred to a secure S4 server provided by SDU. All data management and handling will be carried out exclusively on the S4 server, adhering to the most stringent standards of data security and confidentiality.
Statistical Methods
To evaluate the effectiveness of the intervention, intention-to-treat analysis will be performed. The Generalized Estimating Equations model (GEE), which accounts for cluster randomization, will be utilized for data analysis. The model will be adjusted for the main potential confounding variables. Data analysis for this research will be conducted using RStudio (RStudio Team, 2022), a widely used open-source integrated development environment for the R programming language. Statistical significance set at P < 0.05. Ad-hoc analyses will also be conducted as necessary to support future hypotheses.
Ethics and dissemination
Research ethics approval
This study has been granted approval by the Research Ethics Committee (REC) at SDU.
Protocol amendments
The following is the plan for communicating important protocol amendments:
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Identify the need for a protocol amendment: When a need for a protocol amendment is identified by the research team.
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Develop a plan for the amendment: The research team will develop a detailed plan for the protocol amendment, including the rationale for the change, the impact on study procedures and outcomes, and any necessary revisions to the informed consent process.
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Submit the amendment to the appropriate review board: The amendment will be submitted to the REC at SDU.
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Communicate the amendment to all stakeholders: Once the amendment has been approved, the changes will be communicated to all stakeholders, including study participants, investigators, and research staff. This may involve, but not limited to, meetings and email updates.
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Update study documents: All research documents, including the protocol, informed consent form, and study reports, will be updated to reflect the changes made in the amendment.
By following this plan, the research teams can effectively communicate important protocol amendments to all stakeholders, ensuring that the study is conducted in an ethical and safe manner.
Consent
General practitioners are responsible for obtaining informed consent from patients prior to their participation. Once patients receive the questionnaire, they must provide digital consent by accepting and signing a consent form before proceeding to answer the questions (Appendix 6). This process ensures that patients fully understand the nature of the study and have given explicit consent to participate in the research.
Confidentiality
The confidentiality of personal information will be maintained through the storage of data on secure servers, with access restricted solely to the research team. Upon completion of the trial, the data will be retained for a designated period, after which it will be permanently deleted.