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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02076347
First Posted: March 3, 2014
Last Update Posted: October 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kelli Barnes, Ohio State University
  Purpose
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.

Condition Intervention
Type 2 Diabetes Vitamin B12 Deficiency Neuropathy Anemia Behavioral: Office visit intervention Behavioral: Electronic Message Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Comparison of Two Pharmacist-led Population Management Approaches to Increase Monitoring of Vitamin B12 and Serum Creatinine Levels for Patients on Metformin

Resource links provided by NLM:


Further study details as provided by Kelli Barnes, Ohio State University:

Primary Outcome Measures:
  • Percentage of patients in each arm who obtain monitoring of vitamin B12 as recommended [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Number of patients with newly identified vitamin B12 deficiency [ Time Frame: 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.

  • 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.


Enrollment: 489
Study Start Date: February 2014
Study Completion Date: October 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076347


Locations
United States, Ohio
The Ohio State University General Internal Medicine
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
Ohio State University
  More Information

Responsible Party: Kelli Barnes, Assistant Professor of Clinical Pharmacy, Ohio State University
ClinicalTrials.gov Identifier: NCT02076347     History of Changes
Other Study ID Numbers: 2013H0307
First Submitted: February 26, 2014
First Posted: March 3, 2014
Last Update Posted: October 19, 2015
Last Verified: October 2015

Keywords provided by Kelli Barnes, Ohio State University:
Metformin
Vitamin B12 Deficiency
Population Management
Pharmacist

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Avitaminosis
Malnutrition
Nutrition Disorders
Metformin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypoglycemic Agents
Hematinics