Trial record 11 of 82 for:    vitamin B12 deficiency

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Kelli Barnes, Ohio State University
ClinicalTrials.gov Identifier:
NCT02076347
First received: February 26, 2014
Last updated: February 27, 2014
Last verified: February 2014
  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: 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 Ohio State University:

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

Secondary Outcome Measures:
  • Number of patients with newly identified vitamin B12 deficiency [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Percentage of patients with newly identified vitamin B12 deficiency who have prior evidence of anemia upon chart review [ Time Frame: within 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 500
Study Start Date: February 2014
Estimated Study Completion Date: August 2014
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kelli Barnes, Assistant Professor of Clinical Pharmacy, Ohio State University
ClinicalTrials.gov Identifier: NCT02076347     History of Changes
Other Study ID Numbers: 2013H0307
Study First Received: February 26, 2014
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Vitamins
Anemia
Diabetes Mellitus, Type 2
Hematologic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Avitaminosis
Malnutrition
Nutrition Disorders
Metformin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses
Hypoglycemic Agents

ClinicalTrials.gov processed this record on July 28, 2014