Measuring the Preferences of Patients With Type II Diabetes Using Best-worst Scaling and Discrete Choice Experiment

Type II Diabetes Clinical Trial

Official title:

Advancing Stated-preference Methods for Measuring the Preferences of Patients With Type II Diabetes

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02637622
• Other study ID #: PCORI 90056532 PF
• Status: Unknown status
• Phase: N/A
• First received: November 18, 2015
• Last updated: December 18, 2015
• Start date: July 2013
• Est. completion date: June 2016

Study information

• Verified date: October 2015
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In 2012, the FDA Center for Devices and Radiological Health (CDRH) issued guidance to clarify the principal benefit-risk factors FDA considers during the reviews for premarket approval applications and de novo classification requests. In addition to a detailed description of benefits and risks, CDRH listed "patient tolerance for risk and perspective on benefit" as a factor that CDRH may consider in regulatory reviews. It underlined the need for developing methods to measure patient preference and incorporate it into regulatory decision-making. The purpose of this study is to advance methods for patient and community engagement in patient-centered outcome research (PCOR) and has three objectives.

First, demonstrate good practices for patient and community involvement in PCOR projects by applying principles of community-based participatory research (CBPR).

Second, address methodological gaps pertaining to the use of stated-preference methods in studying preferences in PCOR. These include identifying the best methods for designing a preference study and strategies for analyzing variation in preferences. The investigators also seek to assess the relevance of stated-preference methods to patients and stakeholders using both qualitative and quantitative methods.

Third, demonstrate good practices for applying stated-preference methods by studying the preferences of patients with type II diabetes. While type II diabetes provides an important case study, this research will advance approaches and methods that will be broadly generalizable to other diseases, and to diverse patient and stakeholder groups.

Clinical Significance:

This project will illustrate and advance methods for assessing the values of patients and stakeholders. It will demonstrate how CBPR methods apply to PCOR studies and the value of stated-preference methods in measuring the preferences of patients and stakeholders and directing health care.

Description:

This study will apply the principles of CBPR to involve patients and stakeholders associated with a local community board and a national diabetes advisory board in key decisions in the project. During year 1, the investigators will utilize mixed methods to develop, pretest, and pilot the survey instruments to assess the preferences of patients with type II diabetes. In year 2, the investigators plan further engagement to finalize the survey instruments, and will implement a nationally representative, racially/ethnically diverse sample of patients with type II diabetes. Based on further consultation, the investigators will conduct statistical analysis, including stratified analyses and segmentation of patients with similar preferences. In year 3, mixed methods will be applied to assess beliefs of patients and other consumers about the relevance of this work and its generalizability to other PCOR topics. Finally, lay language reports will be developed to highlight patient and stakeholder engagement and the application of stated-preference methods to the study of the preferences of patients with type II diabetes.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 1000
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participate in the GfK's KnowledgePanel

• Self-reported Type II diabetes diagnosis

Exclusion Criteria:

• Does not have Type II diabetes diagnosis

• Unable to communicate in English or Spanish

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type II Diabetes

Intervention

Other:
• Best-Worst Scaling (Case 2)
Respondents receive questions asking them to choose the best and worst features of a hypothetical medication.
• Discrete Choice Experiment
Respondents receive questions asking them to choose the medication they prefer between a pair of hypothetical medications.

Locations

Country	Name	City	State
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported difficulty in understanding and answering the survey questions	The survey will ask the respondents to evaluate if the questions are easy to understand and answer using Likert scale.	This outcome will be evaluated in a survey that will be conducted one year after the start of the study.
Primary	The importance of lowering hemoglobin A1C level from patient perspective	The investigators will measure patients' view on the importance of lowering hemoglobin A1C level using surveys with two different stated-preference methods. One study arm will use the best-worst scaling (case 2) technique and the other arm will use discrete choice experiment method. Results from the two arms will be compared.	This outcome will be evaluated during a one-time survey that will be conducted one year after the start of the study.
Primary	The importance of having stable blood glucose levels from patient perspective	The investigators will measure patients' view on the importance of having stable blood glucose levels using surveys with two different stated-preference methods. One study arm will use the best-worst scaling (case 2) technique and the other arm will use discrete choice experiment method. Results from the two arms will be compared.	This outcome will be evaluated during a one-time survey that will be conducted one year after the start of the study.
Primary	The importance of avoiding hypoglycemia from patient perspective	The investigators will measure patients' view on the importance of avoiding hypoglycemia using surveys with two different stated-preference methods. One study arm will use the best-worst scaling (case 2) technique and the other arm will use discrete choice experiment method. Results from the two arms will be compared.	This outcome will be evaluated during a one-time survey that will be conducted one year after the start of the study.
Primary	The importance of avoiding nausea from patient perspective	The investigators will measure patients' view on the importance of avoiding nausea using surveys with two different stated-preference methods. One study arm will use the best-worst scaling (case 2) technique and the other arm will use discrete choice experiment method. Results from the two arms will be compared.	This outcome will be evaluated during a one-time survey that will be conducted one year after the start of the study.
Primary	The importance of minimizing treatment burden from patient perspective	The investigators will measure patients' view on the importance of minimizing treatment burden using surveys with two different stated-preference methods. One study arm will use the best-worst scaling (case 2) technique and the other arm will use discrete choice experiment method. Results from the two arms will be compared.	This outcome will be evaluated during a one-time survey that will be conducted one year after the start of the study.
Primary	The importance of medication cost from patient perspective	The investigators will measure patients' view on the importance of medication cost using surveys with two different stated-preference methods. One study arm will use the best-worst scaling (case 2) technique and the other arm will use discrete choice experiment method. Results from the two arms will be compared.	This outcome will be evaluated during a one-time survey that will be conducted one year after the start of the study.