GIANT: General Practitioner Implementation in Asia of Normoglycaemic Targets
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      To test whether the International Diabetes Federation - Western Pacific Region (IDF-WPR)
      Guidelines are more effective than standard practices in primary care (general practitioner)
      clinics for the management of type 2 diabetes mellitus (T2DM) in Asia. A 12-month
      multinational multicentre prospective cluster randomisation clinical trial within a primary
      care setting, with 2 parallel treatment arms: diabetes management using IDF-WPR guidelines
      versus standard clinic practices. 400 subjects will be recruited from 100 sites (4 subjects
      per site) in ten Asian countries (China, Hong Kong, Indonesia, Korea, Malaysia, Philippines,
      Singapore, Taiwan, Thailand and Vietnam).
    

Detailed description: 
      Description of intervention(s) / exposure and control treatment: This is a prospective
      multinational, multicentre, cluster-randomised study conducted within the primary care
      setting, with two parallel treatment arms: standard clinical practice versus education on
      diabetes management using International Diabetes Federation - Western Pacific Region
      (IDF-WPR) "Type 2 diabetes practical targets and treatments". The study duration will be 12
      months.

      100 General Practitioners (GPs) (10 per country) will be randomised to receive education on
      the IDF-WPR guidelines or to receive no trial-related education.

        -  GPs in both groups will be required to recruit 4 of their own patients meeting the
           eligibility criteria. The complete entry criteria are detailed in a following section.

        -  GPs in both groups will manage the recruited patients according to their own clinical
           judgement. Frequency of patient visits to the GP's clinic will be determined by the GP.
           All medication prescribed by the GPs should already be registered in the participating
           countries.

        -  Blood sampling of patients will be required at Study Visit 1 (Screening/Baseline), Study
           Visit 2 (month 6) and Study Visit 3 (month 12).

      The intervention will comprise an educational program on the guidelines for GPs, and will be
      carried out by the national coordinating centre in each country, based on a template provided
      by the international coordinating centre (International Diabetes Institute, Australia). The
      educational program for the GPs randomised to the intervention arm will:

        1. Combine didactic and interactive sessions.

        2. Involve opinion leaders, i.e. the national lead investigator

        3. Aim to resolve barriers to practical implementation of guidelines already identified
           from previous studies (e.g. discuss starting insulin)

        4. Present the evidence for the guidelines.

        5. Highlight any conflicts between the guidelines and local prescribing regulations, and
           confirm the need to follow the local prescribing regulations in these instances

        6. Involve an initial educational symposium and a follow-up continuing medical education
           symposium at 3 months

      Organisational changes to improve guideline adherence for the study will include:

        1. Paper or electronic reminders of the guidelines will be sent to GPs every 3 months.

        2. Desktop reminders cards with key guideline algorithms.

        3. Insertion of a flowsheet (diabetes action plan) into the patient's medical notes by the
           study nurse (at the time of review of the practitioner's baseline HbA1c utilisation).

      Patient-centred approaches to improve guideline adherence for the study will include:

        1. Encouragement and empowerment of patients to ask questions of the treating practitioners

        2. Provision of each patient with a "diabetes passport" to be held by the patient, to
           encourage discussion between the patient and practitioner and also recording of results
           of medical examinations. This will be provided at the baseline visit to the national
           coordinating centre.
    

Intervention name(s): Education of general practitioners on the IDF-WPR guidelines
Intervention type(s): Behavioral
Intervention description(s): The intervention will comprise an educational program on the guidelines for GPs, and will be carried out by the national coordinating centre in each country, based on a template provided by the international coordinating centre (International Diabetes Institute, Australia). This will involve:
an initial educational symposium and a follow-up continuing medical education symposium at 3 months; paper or electronic reminders of the guidelines sent to GPs every 3 months; desktop reminder cards with guideline algorithms; insertion of a flowsheet (diabetes action plan) into the patient's medical notes by the study nurse; provision of each patient with a "diabetes passport" to be held by the patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes; Management guidelines; Efficacy