Impact of Community Pharmacist-Involved Collaborative Care Model for the Management of Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Background: In Singapore, the prevalence of diabetes mellitus was approximately 12.8% in 2014
      and the prevalence was projected to rise to 22.7% in 2035. In view of the complexity of
      diabetes management, collaborative efforts by nurses and other allied health professionals
      such as dietitians and pharmacists have shown to play a significant role in improving
      clinical care of individuals with diabetes. Currently in Singapore, the effectiveness of the
      collaborative care model has only been evaluated prospectively in the primary and tertiary
      care settings involving clinical pharmacists. The impact of the unique, synergistic roles of
      community pharmacists with family physician on the clinical, humanistic and economic outcomes
      have yet to be elucidated.

      Aims: This study aims to evaluate the clinical, humanistic, and economic outcomes of a
      community pharmacist-involved collaborative care model in the management of individuals with
      type 2 diabetes mellitus.

      Hypothesis: Incorporating community pharmacist into the care model with family physician and
      nurse can improve the clinical, humanistic, and economic outcomes of individuals with type 2
      diabetes mellitus.

      Methods: This study is a prospective, open label, parallel arm, randomized controlled trial.
      The study will be conducted over 6 months at a family medicine clinic in Singapore.
      Individuals aged 21 years and above, diagnosed with type 2 diabetes (HbA1c > 7.0%) and taking
      5 or more chronic medications will be eligible. Individuals with Type 1 diabetes or who are
      unable to communicate independently in English, Mandarin or Malay will be excluded from this
      study. The participants will be randomly assigned to 2 groups using a random number generator
      or an equivalent: (1) Usual diabetes care with physician (control), (2) diabetes care with
      physician and community pharmacist (intervention). The community pharmacist will adopt the
      core elements of the medication therapy management model in reviewing the medications of
      participants as well as provide relevant lifestyle counselling and health education via a
      face-to-face consultation at the clinic and subsequently through telephonic correspondences.
      The primary outcome will be change in HbA1c over 6 months. Secondary outcomes include blood
      pressure, lipid markers, distress level, self-care capabilities, quality of life,
      productivity, and direct medical costs.

      Significance: The outcomes of the community pharmacist-involved collaborative care model will
      support future implementation and integration of this care model into the standard of care in
      Singapore so as to optimize the management of type 2 diabetes.
    


Intervention name(s): Community pharmacist-involved collaborative care; Usual care
Intervention type(s): Other; Other
Intervention description(s): Community pharmacist-involved collaborative care in the management of individuals with type 2 diabetes mellitus; Usual care with physician and as needed visit to the nurse
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research