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

October 15, 2015 updated by: Kelli Barnes, Ohio State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

489

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43221
        • The Ohio State University General Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Office visit-based intervention
Behavioral: Office visit intervention
Pharmacist communicates monitoring recommendations to physician through the electronic medical record prior to a scheduled patient office visit
Experimental: Electronic message-based intervention
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Estimate)

October 19, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013H0307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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