Shared Decision Making With Pharmaceutical Care | NCT02373059

Studies
Shared Decision Making With Pharmaceutical Care

NCT02373059

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

May 9, 2016Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Diabetes

Interventions

Diabetes Issue Cards Decision Aids
Usual Pharmaceutical Care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Feb 16, 2015

First Submission Date that Met QC Criteria

Feb 20, 2015

First Posted Date

Feb 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2016

Last Update Posted Date

May 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A research study to enhance clinical discussion between patients and pharmacists using a shared decision making tool for type 2 diabetes or usual care.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pharmaceutical care with shared decision making	Experimental	Use of Diabetes Issue Cards Decision Aids	Other: Diabetes Issue Cards Decision Aids
Usual Pharmaceutical care	Active Comparator	Usual Care	Other: Usual Pharmaceutical Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diabetes Issue Cards Decision Aids	Other		Pharmaceutical care with shared decision making
Usual Pharmaceutical Care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient Involvement Questionnaire		Post-Visit up to 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Patient Knowledge regarding Diabetes treatments Questionnaire		post visit up to 2 weeks
Patient Medication Adherence Questionnaire		1 month post visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Kasson		Kasson	Minnesota	55944	United States

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided