Comparison of Two Pharmacist-led Population Management Approaches to Increase Monitoring of Vitamin B12 and Serum Creatinine Levels for Patients on Metformin

Study Overview
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Brief Summary
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The purpose of this project is to compare two pharmacist-led population management strategies designed to increase the rate of appropriate monitoring of vitamin B12 and serum creatinine for patients taking metformin.

Official Title
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Comparison of Two Pharmacist-led Population Management Approaches to Increase Monitoring of Vitamin B12 and Serum Creatinine Levels for Patients on Metformin

Conditions
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Type 2 Diabetes, Vitamin B12 Deficiency, Neuropathy, Anemia

Intervention / Treatment
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* Behavioral: Office visit intervention
* Behavioral: Electronic Message Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: On Metformin for at least one year Activated patient portal for electronic messaging Patient of an attending physician at Ohio State General Internal Medicine No serum vitamin B12 and/or no serum creatinine measurement in the past year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Office visit-based intervention<br> | Behavioral: Office visit intervention<br>* Pharmacist communicates monitoring recommendations to physician through the electronic medical record prior to a scheduled patient office visit<br>|
| Experimental: Electronic message-based intervention<br> | Behavioral: Electronic Message Intervention<br>* Pharmacist communicates need for monitoring directly to patients and instructs them to obtain monitoring on their own time without need for an office visit with physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients in each arm who obtain monitoring of vitamin B12 as recommended |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with newly identified vitamin B12 deficiency |  | 6 months | 
| Percentage of patients with newly identified vitamin B12 deficiency who have prior evidence of anemia upon chart review | When a patient's serum vitamin B12 level comes back and is low the chart will be reviewed immediately to determine this. This could happen anytime during the 6 month study period. | within 6 months | 
| Percentage of patients with newly identified vitamin B12 deficiency who have prior evidence of neuropathy upon chart review | When a patient's serum vitamin B12 level comes back and is low the chart will be reviewed immediately to determine if neuropathy is also listed as a medical problem. This could happen anytime during the 6 month study period. | within 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metformin, Vitamin B12 Deficiency, Population Management, Pharmacist