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

  • United States
    • 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
Other: Diabetes Issue Cards Decision Aids
Active Comparator: Usual Pharmaceutical care
Usual Care
Other: Usual Pharmaceutical 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

Mayo Clinic

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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