Using Patient Feedback to Improve Communication Regarding Glycemic Control to Patients With Diabetes

Diabetes Clinical Trial

Official title:

Using Patient Feedback to Improve the Ways we Communicate Information Regarding Glycemic Control to Patients With Poorly Controlled Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886170
• Other study ID #: 817693
• Secondary ID: 00000notapplicab
• Status: Completed
• Phase: N/A
• First received: June 20, 2013
• Last updated: September 21, 2015
• Start date: October 2013
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In this two-phase mixed methods study, the investigators will first use patient feedback from semi-structured interviews to explore the ways in which patients with diabetes understand their diabetes and assess their disease control. The investigators will also use these interviews to elicit patient feedback on promising alternative communication formats to the hemoglobin A1C (A1C). In the second phase of the study, the investigators will test new formats to communicate information regarding diabetes control to patients with poorly controlled diabetes. This phase will be a three arm RCT comparing the effect of A1C (standard medical information) versus two alternative formats on several participant outcomes, primarily glycemic control at 6 months post-intervention.

Description:

The noted importance of understanding glycemic control is concerning given studies estimating that only 25% of patients understand the hemoglobin A1C value (A1C). The A1C is a blood test value reflecting average blood sugars over the previous 3 months and is used as both a clinical indicator of diabetes control with guideline-set targets and as a communication format to express level of disease control to patients.Past work has demonstrated the potential effectiveness of translating poorly understood medical values, like the A1C, into more universally understood forms. We believe applications can be used to address the problem of the poorly understood A1C. This study is two-phase mixed methods approach. We will design alternative communication formats to convey the information provided by the A1C to patients and evaluate the effectiveness of these formats in improving glycemic control, increasing patient understanding of their diabetes control, and altering patient behaviors. In Phase I of the study,we will use patient feedback from semi-structured interviews with 17-25 patients with diabetes to explore the ways in which patients assess and gauge their diabetes control, as well as to elicit patient feedback on promising communication formats. Potential alternative communication formats include categories represented by color-based scales (red/yellow/green), comparisons to averages or norms, trajectories of control over time and modified medical terminology (i.e., changing the name of the test). In phase II, patients with poorly controlled diabetes will be randomized to receive information on their glycemic control through one of three study arms, A1C (control) or one of two experimental format arms (chosen based on phase I results) and the effects of these different communication formats will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

For Phase I:

Inclusion Criteria:

• Adults who report a diagnosis of diabetes

Exclusion Criteria:

• People without diabetes

For Phase II:

Inclusion Criteria

-Adults seen at University of Pennsylvania primary care practice with a diagnosis of diabetes documented in the electronic health record and a recent hemoglobin A1C >8 %

Exclusion

• No diabetes

• No A1C or recent A1C <8%

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes

Intervention

Other:
• Phase II of the Study: Information regarding Current Diabetes Control
Participants will receive information regarding their current diabetes control in different ways depending on their assigned study arm.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	For Phase I of the Study: Metrics Used to Understand Diabetes Control	Identification of common factors patients use to understand their diabetes and diabetes control via a qualitative analysis of the patient interview responses	4 months	No
Primary	For Phase II of the Study: Change in Hemoglobin A1C	Change in A1C between enrollment and 6-months compared between study arms.	6 months following enrollment	No
Secondary	For Phase I of the study: Feedback on alternative formats	qualitative and quantitative analysis of the feedback received on the alternative communication formats reviewed with participants during the interviews.	4 months	No
Secondary	For Phase II of the Study: Understanding of diabetes control	Accuracy of participant knowledge of level of current diabetes control	At the time of enrollment	No