Several clinical trials have demonstrated that both lifestyle change and metformin significantly reduce the risk of progression to diabetes. Prior efforts to disseminate treatment with lifestyle have resulted in very limited population reach, and there has been minimal uptake of metformin for the treatment of prediabetes. Within the UCLA Health System, we have developed a successful program called Managing your Medications for Education and Daily Support (MyMEDS) that fully integrates pharmacists in primary care settings to co-manage patients with poorly controlled diabetes. We propose a pragmatic diabetes prevention program that extends the existing MyMEDS infrastructure to also treat patients with prediabetes. Within 14 of 28 randomly selected clinics, MyMEDS pharmacists will use a decision aid developed by HealthWise(c) to educate patients about the DPP and engage them in shared decision-making about diabetes prevention. The pharmacist and patient will jointly develop a care plan that includes intensive lifestyle change (preferred strategy) and/or metformin, or take no immediate action and the pharmacist will communicate the plan to the primary care physician. For those who select lifestyle change, we will partner with the YMCA of Los Angeles, which offers the DPP at multiple locations. Our primary endpoint will measure improvements in use of any treatment for prediabetes, a critical first step for stemming the impending diabetes epidemic.
Our Specific Aims are: 1) In a clinic level, cluster-randomized, intention-to-treat trial, to test the effectiveness of using pharmacists to implement diabetes prevention among patients with prediabetes, as compared to those receiving usual care, on uptake of intensive lifestyle change and/or metformin at 4 months (primary outcome). Secondary hypothesis generating outcomes include impact of the intervention on weight, A1c, and blood pressure control. 2) To evaluate characteristics that will influence sustainability of ths intervention, we will measure: a) Acceptability to patients, physicians, pharmacists, and community partners; b) Psychosocial impact of pre-diabetes, stratified by the treatment selected; c) Uptake of intensive lifestyle change and/or metformin at 4 months, by age (< 60 vs. 60+); d) The cost of program implementation per participant who successfully initiates any treatment. Our analyses will use GLM adjusted models to compare the rate of uptake of treatment for prediabetes in the randomly selected 14 MyMEDS clinics to the rates observed in the 14 control clinics. We will measure the health system costs of implementing this program and if it improves the proportion of prediabetics engaged in care, will partner with the University of California Office of the President to disseminate this program to the other 4 UC medical centers. In summary, there is a critical need to educate and engage patients with prediabetes in treatment to prevent diabetes, and this trial will test the effectiveness of clinical pharmacists i primary care practices, using a shared decision making tool to help patients with prediabetes select a treatment that is best suited for them.
It is estimated that 1 in 3 adults in the United States has prediabetes. Prior efforts to disseminate treatment with life style change have resulted in very limited population reach, and there has been minimal to virtually no uptake of metformin for the treatment of prediabetes. Therefore, we propose to evaluate a novel program that uses the electronic health record to identify patients with prediabetes and offers consultation with a primary care based pharmacist who uses a shared decision making tool to increase the proportion of patients with prediabetes who know about the condition and who participate in lifestyle change and/or use of metformin to prevent diabetes.
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