- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02373059
Shared Decision Making With Pharmaceutical Care (SDMPC)
May 6, 2016 updated by: Joseph R. Herges, Pharm.D., R.Ph., Mayo Clinic
Examining the Use of a Shared Decision Making Tool With Pharmaceutical Care in Type 2 Diabetes
A research study to enhance clinical discussion between patients and pharmacists using a shared decision making tool for type 2 diabetes or usual care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Kasson, Minnesota, United States, 55944
- Mayo Clinic Kasson
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults ≥ 18 years of age
- Diagnosed with type II diabetes by ICD-9 code for more than one year
- HbA1c of 7%-9.5% within past 6 months
- Prescribed three or less anti-hyperglycemic medications as indicated by the medication list within the medical record
Exclusion Criteria:
- Prescribed insulin
- Pregnancy
- Appointment with provider within a month
- Appointment with provider within the last month
- Followed by endocrinology
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pharmaceutical care with shared decision making
Use of Diabetes Issue Cards Decision Aids
|
|
Active Comparator: Usual Pharmaceutical care
Usual Care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient Involvement Questionnaire
Time Frame: Post-Visit up to 2 weeks
|
Post-Visit up to 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient Knowledge regarding Diabetes treatments Questionnaire
Time Frame: post visit up to 2 weeks
|
post visit up to 2 weeks
|
Patient Medication Adherence Questionnaire
Time Frame: 1 month post visit
|
1 month post visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
February 16, 2015
First Submitted That Met QC Criteria
February 20, 2015
First Posted (Estimate)
February 26, 2015
Study Record Updates
Last Update Posted (Estimate)
May 9, 2016
Last Update Submitted That Met QC Criteria
May 6, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 14-009665
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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