Comparison of Two Pharmacist-led Population Management Approaches to Increase Monitoring of Vitamin B12 and Serum Creatinine Levels for Patients on Metformin
1 other identifier
interventional
489
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 26, 2014
CompletedFirst Posted
Study publicly available on registry
March 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 19, 2015
October 1, 2015
6 months
February 26, 2014
October 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients in each arm who obtain monitoring of vitamin B12 as recommended
6 months
Secondary Outcomes (3)
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
Percentage of patients with newly identified vitamin B12 deficiency who have prior evidence of neuropathy upon chart review
within 6 months
Study Arms (2)
Office visit-based intervention
EXPERIMENTALElectronic message-based intervention
EXPERIMENTALInterventions
Pharmacist communicates monitoring recommendations to physician through the electronic medical record prior to a scheduled patient office visit
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
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University General Internal Medicine
Columbus, Ohio, 43221, United States
Related Publications (1)
Matthews DE, Beatty SJ, Grever GM, Lehman A, Barnes KD. Comparison of 2 Population Health Management Approaches to Increase Vitamin B12 Monitoring in Patients Taking Metformin. Ann Pharmacother. 2016 Oct;50(10):840-6. doi: 10.1177/1060028016655180. Epub 2016 Jun 20.
PMID: 27323792DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Clinical Pharmacy
Study Record Dates
First Submitted
February 26, 2014
First Posted
March 3, 2014
Study Start
February 1, 2014
Primary Completion
August 1, 2014
Study Completion
October 1, 2015
Last Updated
October 19, 2015
Record last verified: 2015-10