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OpenTrials
Completed

NCT Number: NCT02076347

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

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.

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Key information

Conditions

Type 2 Diabetes Anemia Avitaminosis Deficiency Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hematologic Diseases Hemic and Lymphatic Diseases Malnutrition Metabolic Diseases Neuropathy Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B 12 Deficiency Vitamin B Deficiency Vitamin B12 Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University General Internal Medicine

Columbus, Ohio, 43221, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Office visit intervention

Behavioral

Pharmacist communicates monitoring recommendations to physician through the electronic medical record prior to a scheduled patient office visit

Electronic Message Intervention

Behavioral

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 outcomes

  1. Percentage of patients in each arm who obtain monitoring of vitamin B12 as recommended

    Time frame: 6 months

Secondary outcomes

  1. Number of patients with newly identified vitamin B12 deficiency

    Time frame: 6 months

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 3, 2014
Registry last updated
Oct 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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