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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02076347

Enrollment

489

Registered

2014-03-03

Start date

2014-02-28

Completion date

2015-10-31

Last updated

2015-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Neuropathy, Type 2 Diabetes, Vitamin B12 Deficiency

Keywords

Metformin, Vitamin B12 Deficiency, Population Management, Pharmacist

Brief summary

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.

Interventions

BEHAVIORALOffice visit intervention

Pharmacist communicates monitoring recommendations to physician through the electronic medical record prior to a scheduled patient office visit

BEHAVIORALElectronic Message Intervention

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage of patients in each arm who obtain monitoring of vitamin B12 as recommended	6 months

Secondary

Measure	Time frame	Description
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	within 6 months	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.
Percentage of patients with newly identified vitamin B12 deficiency who have prior evidence of neuropathy upon chart review	within 6 months	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026