Clinical trial NCT03531944: Impact of Community Pharmacist-Involved Collaborative Care Model for the Management of Type 2 Diabetes Mellitus
Official title: The Impact of Community Pharmacist-Involved Collaborative Care in the Management of Primary Care Patients With Type 2 Diabetes Mellitus in Singapore (IMPACT-C)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 265
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: Inclusion Criteria:

* All individuals aged 21 years and above, diagnosed with type 2 diabetes mellitus with a baseline HbA1c of more than 7.0% and taking 5 or more chronic medications

Exclusion Criteria:

* Individuals with type 1 diabetes mellitus
* Mentally incapacitated individuals
* Individuals who are illiterate and unable to communicate in English, Malay, or Chinese (Mandarin)
* Individuals who are not able to complete the questionnaires

Primary outcomes:
measure: Change in HbA1c level
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in blood pressure
timeFrame: Baseline and 6 months
measure: Change in lipid markers
timeFrame: Baseline and 6 months
measure: Change in diabetes-related distress
timeFrame: Baseline and 6 months
measure: Change in general health status
timeFrame: Baseline and 6 months
measure: Change in diabetes-specific quality of life
timeFrame: Baseline and 6 months
measure: Change in general work productivity
timeFrame: Baseline and 6 months
measure: Change in self efficacy and self-care capabilities
timeFrame: Baseline and 6 months
measure: Incidence of hypoglycemia
timeFrame: Baseline and 6 months
measure: Cost effectiveness analysis
timeFrame: 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Keat Hong Family Medicine Clinic
Study officials:
References: