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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076347
• Other study ID #: 2013H0307
• Status: Completed
• Phase: N/A
• First received: February 26, 2014
• Last updated: October 15, 2015
• Start date: February 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: October 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Anemia
• Neuropathy
• Type 2 Diabetes
• Vitamin B 12 Deficiency
• Vitamin B12 Deficiency

Intervention

Behavioral:
• Office visit intervention
Pharmacist communicates monitoring recommendations to physician through the electronic medical record prior to a scheduled patient office visit
• Electronic 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

Locations

Country	Name	City	State
United States	The Ohio State University General Internal Medicine	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients in each arm who obtain monitoring of vitamin B12 as recommended		6 months	Yes
Secondary	Number of patients with newly identified vitamin B12 deficiency		6 months	Yes
Secondary	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	Yes
Secondary	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	Yes