Back to resultsComparison of Two Pharmacist-led Population Management Approaches to Increase Monitoring of Vitamin B12 and Serum Creatinine Levels for Patients on Metformin
Primary Purpose
Type 2 Diabetes, Vitamin B12 Deficiency, Neuropathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Office visit intervention
Electronic Message Intervention
Sponsored by
About this trial
This is an interventional screening trial for Type 2 Diabetes focused on measuring Metformin, Vitamin B12 Deficiency, Population Management, Pharmacist
Eligibility Criteria
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
Sites / Locations
- The Ohio State University General Internal Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Office visit-based intervention
Electronic message-based intervention
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients in each arm who obtain monitoring of vitamin B12 as recommended
Secondary Outcome Measures
Number of patients with newly identified vitamin B12 deficiency
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.
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.
Full Information
NCT ID
NCT02076347
First Posted
February 26, 2014
Last Updated
October 15, 2015
Sponsor
Ohio State University
1. Study Identification
Unique Protocol Identification Number
NCT02076347
Brief Title
Comparison of Two Pharmacist-led Population Management Approaches to Increase Monitoring of Vitamin B12 and Serum Creatinine Levels for Patients on Metformin
Official Title
Comparison of Two Pharmacist-led Population Management Approaches to Increase Monitoring of Vitamin B12 and Serum Creatinine Levels for Patients on Metformin
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Vitamin B12 Deficiency, Neuropathy, Anemia
Keywords
Metformin, Vitamin B12 Deficiency, Population Management, Pharmacist
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
489 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Office visit-based intervention
Arm Type
Experimental
Arm Title
Electronic message-based intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Office visit intervention
Intervention Description
Pharmacist communicates monitoring recommendations to physician through the electronic medical record prior to a scheduled patient office visit
Intervention Type
Behavioral
Intervention Name(s)
Electronic Message Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of patients in each arm who obtain monitoring of vitamin B12 as recommended
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of patients with newly identified vitamin B12 deficiency
Time Frame
6 months
Title
Percentage of patients with newly identified vitamin B12 deficiency who have prior evidence of anemia upon chart review
Description
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.
Time Frame
within 6 months
Title
Percentage of patients with newly identified vitamin B12 deficiency who have prior evidence of neuropathy upon chart review
Description
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.
Time Frame
within 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Ohio State University General Internal Medicine
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27323792
Citation
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.
Results Reference
derived
Learn more about this trial
Comparison of Two Pharmacist-led Population Management Approaches to Increase Monitoring of Vitamin B12 and Serum Creatinine Levels for Patients on Metformin
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