Educative Intervention to Improve Type 2 Diabetes Mellitus Control in Corrientes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Objective: To evaluate the effect of system interventions (data recording procedures and
      complete coverage of medications and supplies) with or without physician and/or patient
      education, upon the psychological, clinical, metabolic and therapeutic indicators and the
      costs of care of people with type 2 diabetes.

      Design: Randomized 2x2 design; sample size was determined considering the change in
      haemoglobin A1c (primary outcome variable) using a two-sided test at the 5% level of
      significance, and 80% power using a paired t-test. Sample size was increased by 25% to
      account for non-independence and patient drop-out.

      Setting: Primary care level in the city of Corrientes, Argentina with involvement of all
      three Argentinean health subsectors (public health, social security and the private, prepaid
      system).

      Participants: 36 general practitioners and 468 adults (62-71% women, mean age 62 years) with
      type 2 diabetes. Patients of the participating physicians (nine in each group), were randomly
      selected and assigned to one of four groups (117 patients each): control, provider education,
      patient education, and provider/patient education.

      Intervention: Structured group education programmes were delivered to provider and/or people
      with type 2 diabetes by trained professionals; identical system interventions were applied to
      all four groups.

      Main outcome measures: Body mass index, blood pressure, fasting glucose, haemoglobin A1c
      levels, lipid profile, drug consumption, resource use, and patient well being (WHO-5
      questionnaire and Lowe score), at baseline and up to 42 months at every 6 months intervals.
    

Detailed description: 
      The study protocol was evaluated and approved by an external ethical committee; patients gave
      informed consent to participate in the study according with the guidelines from the
      International Conference on Harmonisation and WHO good clinical practice standards. The study
      design has been previously described in detail.30 Briefly, the investigators implemented a
      randomized 2x2 design to address the effectiveness of different education strategies
      involving the health provider and people with diabetes).

      Sample size: for its determination in each of the four groups, the investigators considered
      the change in haemoglobin A1c (from baseline to the end of the study) as the primary outcome
      variable. This was done using a two-sided test at the 5% level of significance and 80% power
      using a paired t-test. The sample size was increased by 25% to account for non-independence
      and dropout, resulting in the number of providers and patients listed in table 1.

      Educational strategies The investigators used the Diabetes Training Course for Physicians and
      Diabetes Structured Education Courses for People with T2DM, whose characteristics and
      usefulness have been previously reported.

      Data collection Patients' clinical, psychological, biochemical, therapeutic and economic data
      before and after PRODIACOR were recorded using the Physician Data Form, the Annual and
      Bi-annual Clinical Record Form and the Feedback Report Form. The investigators developed
      software that compares the first two mentioned forms and generates a Biannual Feedback Report
      for physicians and patients; it compares the values recorded for haemoglobin A1c, serum
      lipids and blood pressure, and the goal proposed for each parameter according to
      international standards. It also includes recommendations about appropriate treatment to
      achieve therapeutic goals.31 Additionally, the investigators used the Patient Questionnaire,
      based on the one previously used in the Diabetes Advantage Program (DAP) which includes
      questions about the disease, and the WHO-5 well-being questionnaire. Data collection was
      completed with the Personalized Checkbook, a tool initially developed for the PROPAT study,
      whose aim and content have been previously described. It serves to order procedures,
      consultations, laboratory tests, prescription of drugs and strips for glucose
      self-monitoring, to record and communicate results, and as a payment voucher for all those
      items.

      Study and Data management The Local Coordinator (city of Corrientes) together with the
      Central Cordinating Center (CENEXA), oversaw the education courses and the overall trial and
      maintained periodic contact with the participating physicians. Performance of the physicians
      and their patients was monitored at regular intervals (6 months) during the whole study
      period. Every physician was visited twice a year by a physician monitor who assessed the
      quality of the data he has recorded.30 Participating physicians collect their own patients´
      data, sent it to the Local Coordinator who controlled its completeness and forwarded to the
      Central Coordinating Centre.

      Resource utilization and costs The data recorded include all direct medical items used by
      each of the patients ascribed to the programme, and were obtained from the checkbook and the
      utilization and cost records from each of the participating health coverage entities.

      Utilization was classified into five groups: i) hospitalizations, ii) drugs and supplies,
      iii) diagnostic tests, iv) special studies, and v) physician office visits. Drugs were
      identified by their generic and commercial name and their corresponding presentation. Their
      costs were assessed from retail prices published by Alfabeta.net and adjusted to July 2004
      using the health chapter of local Consumer Price Index.

      Estimated drug costs and haemoglobin A1c reduction experienced by each treatment group were
      used to construct marginal figures of cost-consequence ratio. For this purpose, the
      investigators calculated such ratio figures for each experimental group, i.e., the
      investigators expressed the total drug cost associated to 1% haemoglobin A1c decrease to 10
      mm Hg of systolic blood pressure or 10 mg/dL of triglyceride levels. The investigators did
      not currently estimate the costs of the educational interventions themselves, namely, all the
      physical and human resources involved in the management and administrative activities of the
      programme.

      Statistical analysis To estimate the effects of the different educational interventions
      tested, intention to treat analysis was used. Initial univariate differences among groups for
      quantitative data were analyzed by one-way ANOVA (Bonferroni post hoc test). Factorial ANOVA
      and two-way ANOVA models (Bonferroni post hoc test) were used to assess the differences among
      groups along the study. ANOVA was also used to explore initial vs. end-of-study differences
      among quantitative data. Differences among qualitative measures were explored by Chi-squared
      (Yates corrected). P values of less than 0.05 were considered as significant (two tailed).
      Missing data strategies applied to the primary endpoint were last observation carried forward
      and complete case analysis. Both strategies were compared to evaluate the impact of missing
      data on the efficacy analysis of the primary endpoint.
    

Intervention name(s): Education
Intervention type(s): Other
Intervention description(s): Structured group education programmes were delivered to provider and/or people with type 2 diabetes by trained professionals; identical system interventions were applied to all four groups.
Other intervention name(s): Diabetes Education
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Keywords: T2DM; Cardiovascular risk factors; Metabolic control; Well-being; Cost; Cost-consequence