Pharmacists Provide Telemedicine in Addition to Clinic Visits to Improve Diabetes Management

Study Overview
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Brief Summary
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This prospective study will include both an intervention and control arm. The control arm will receive face-to-face pharmacy clinic visits per standard of care. The intervention arm will receive pharmacy clinic visits plus additional telephone follow-up. Patients with a hemoglobin A1c in the last 3 months greater than 9% will be eligible. Eligible patients must have a primary care physician at Johns Hopkins Outpatient Center (JHOC) or East Baltimore Medical Center (EBMC). Purpose: To compare the change in hemoglobin A1c over the 3 month study period in the intervention group in which patients participate in telemedicine, to a control group in which they do not

Conditions
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Telemedicine

Intervention / Treatment
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* Other: Telemedicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with a primary care provider at JHOC or EMBC Patients have seen primary care provider within last 6 months Patients with hemoglobin A1c greater than 9% Exclusion Criteria: Patients <18 years of age Patients with previously established care with JHH ambulatory care pharmacist Patients with communication barriers who do not have a caregiver Patients with new diagnosis of diabetes Patients who are pregnant or planning to become pregnant during the time of the study Patients followed by Endocrinology or Diabetes Center

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>The control arm will receive face-to-face pharmacy clinic visits per usual care. | |
| Active Comparator: Intervention Arm<br>The intervention arm will receive pharmacy clinic visits plus additional telephone follow-up. | Other: Telemedicine<br>* The intervention arm will receive pharmacy clinic visits plus additional telephone follow-up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin A1c | A1c at 3 months - A1c at Baseline | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient adherence to office visits (# visits attended/# of visits scheduled) | # visits attended/# of visits scheduled | 3 months | 
| Pharmacist interventions (Number of pharmacist interventions (lifestyle or medication changes) made) | Number of pharmacist interventions (lifestyle or medication changes) made | 3 months | 
| Patient satisfaction (Based on survey results) | Based on survey results at final pharmacy clinic visit | 3 months | 
| Telemedicine in Usual Care (Percent of patients who receive telephone call under usual care) | Percent of patients who receive telephone call under usual care | 3 months | 
| Telemedicine Adherence (Percent of telephone encounters completed in intervention arm) | Percent of telephone encounters completed in intervention arm | 3 months |