Type 2 DiabetesNCT02076347
Comparison of Two Pharmacist-led Population Management Approaches to Increase Monitoring of Vitamin B12 and Serum Creatinine Levels for Patients on Metformin
A study testing Office visit intervention and Electronic Message Intervention in people with Type 2 Diabetes and Vitamin B12 Deficiency, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Vitamin B12 Deficiency, Neuropathy
- What is being tested?
- Office visit intervention and Electronic Message Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 489 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University General Internal Medicine
Columbus, Ohio, 43221
About this study
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.
- Conditions
- Type 2 Diabetes, Vitamin B12 Deficiency, Neuropathy, Anemia
- Being tested
- Office visit intervention, Electronic Message Intervention
- Keywords
- Metformin, Vitamin B12 Deficiency, Population Management, Pharmacist
- Medical subject headings
- Diabetes Mellitus, Type 2, Vitamin B 12 Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office visit interventionBehavioural
Pharmacist communicates monitoring recommendations to physician through the electronic medical record prior to a scheduled patient office visit
Electronic Message InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Office visit-based intervention | Experimental | Not described Receives: Behavioral: Office visit intervention |
| Electronic message-based intervention | Experimental | Not described Receives: Behavioral: Electronic Message Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients in each arm who obtain monitoring of vitamin B12 as recommended
Measured: 6 months
Secondary outcomes (3)
Number of patients with newly identified vitamin B12 deficiency
Measured: 6 months
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.
Measured: within 6 months
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.
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelli Barnes, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076347
- Sponsor's protocol ID
- 2013H0307
- Status last verified
- Oct 2015
- First submitted
- 26 Feb 2014
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27323792
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Pharmacist-led Population Management Approaches to Increase Monitoring of Vitamin B12 and Serum Creatinine Levels for Patients on Metformin
- ClinicalTrials.gov ID
- NCT02076347
- Acronym / sponsor ID
- 2013H0307
- Conditions
- Type 2 Diabetes, Vitamin B12 Deficiency, Neuropathy, Anemia
- Keywords
- Metformin, Vitamin B12 Deficiency, Population Management, Pharmacist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Office visit-based intervention | Experimental | Behavioral: Office visit intervention |
| Electronic message-based intervention | Experimental | Behavioral: Electronic Message Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Office visit interventionPharmacist communicates monitoring recommendations to physician through the electronic medical record prior to a scheduled patient office visit | Behavioural | Office visit-based intervention |
| Electronic Message InterventionPharmacist 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 | Behavioural | Electronic message-based intervention |
Primary outcome
Percentage of patients in each arm who obtain monitoring of vitamin B12 as recommended
Time frame: 6 months
3 secondary outcomes
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
Percentage of patients with newly identified vitamin B12 deficiency who have prior evidence of neuropathy upon chart review
Time frame: within 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Derived from this study: PubMed 27323792Matthews 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Office visit intervention and Electronic Message Intervention in people with Type 2 Diabetes and Vitamin B12 Deficiency, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients in each arm who obtain monitoring of vitamin B12 as recommended (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02076347, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.