Validation of a Patient Decision Aid for Type 2 Diabetes

The objectives of this study are to compare measurements in knowledge of decision options, support for decision making, uncertainly in decision making, and clarity of values important to decision making among two groups of type 2 diabetes patients, those who receive a Patient Decision Aid and those who receive usual care.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Use of a PDA to assist shared decision making

Detailed Description

This study uses a randomized, controlled trial design to compare knowledge of decision options, support for decision making, uncertainly in decision making, and clarity of values important to decision making among patients with uncontrolled type 2 diabetes who are only taking metformin medication. The intervention is a Patient Decision Aid (PDA) video delivered via the internet.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Oak Brook, Illinois, United States, 60523
      • EPI-Q Inc
    • Oak Brook, Illinois, United States, 60523
      • EPI-Q

Participation Criteria

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:

1. Type 2 diabetes
2. Age 18 or older
3. English speaking
4. Currently taking metformin
5. Inadequate glycemic control in the opinion of the investigator
6. Is considering additional medication options on the advice of their physician
7. Can provide a valid email address
8. Access to the internet and able to read and respond to internet questionnaires

Exclusion Criteria:

1. Participation in a clinical trial of a diabetes medication within 1 year
2. Currently taking more than two (2) medications for diabetes
3. Has been exposed to diabetes medications from more than three (3) drug classes
4. Adults unable to consent
5. Individuals who are not yet adults (infants, children, teenagers)
6. Pregnant women
7. Prisoners

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PDA; Subjects receive an internet-based patient decision aid video. The PDA is viewed outside of the doctor's office via a personal computer in preparation for regularly scheduled face to face interaction between patients and clinicians.	Behavioral: Use of a PDA to assist shared decision making; Other Names: Patient Decision Aid
No Intervention: Usual care; Patients receive usual care as determined by their clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge score	The primary endpoint for this investigation is the knowledge total score at final followup 4- 6 weeks after randomization between the PDA versus usual care groups. Questions are about available treatments and specific to the information on medication options available to people with type 2 diabetes when metformin alone does not achieve adequate glycemic control.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional conflict	Measured by using the Decisional Conflict Scale (DCS). Scale will measure domains including: (1) uncertainty in choosing among alternatives; (2) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about values and unsupported in decision making; and (3) perceived quality of decision making. Global decision conflict score and perceived effective decision sub-score will be summarized descriptively following decision and will be compared between arms. Sub-scores are: Uncertainty, Informed, Values clarity, and Support.	6 weeks

Collaborators and Investigators

• Sponsor: EPI-Q
• Investigators: Principal Investigator: Alicia Shillington, PhD, EPI-Q

Publications and helpful links

General Publications

• Bailey RA, Pfeifer M, Shillington AC, Harshaw Q, Funnell MM, VanWingen J, Col N. Effect of a patient decision aid (PDA) for type 2 diabetes on knowledge, decisional self-efficacy, and decisional conflict. BMC Health Serv Res. 2016 Jan 14;16:10. doi: 10.1186/s12913-016-1262-4.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 7, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Estimate): August 7, 2015
• Last Update Submitted That Met QC Criteria: August 5, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Shared Decision Making; Patient Decision Aid
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 70-1036-015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No