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

NCT ID: NCT01886170

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-07-31

Brief 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.

Detailed 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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Hemoglobin A1C

The arms apply to the second phase of the study. This is the control arm. Participants will receive information regarding their diabetes control using the hemoglobin A1C value (standard medical information)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental Format #1

In phase II of the study, participants in this arm will receive information about their current diabetes control conveyed using experimental format #1. The experimental formats will be determined based on the results from Phase I of the study.

Group Type: EXPERIMENTAL

Phase II of the Study: Information regarding Current Diabetes Control

Intervention Type: OTHER

Participants will receive information regarding their current diabetes control in different ways depending on their assigned study arm.

Experimental Format #2

In phase II of the study, participants in this arm will receive information about their current diabetes control conveyed using experimental format #2. The experimental formats will be determined based on the results from Phase I of the study.

Group Type: EXPERIMENTAL

Phase II of the Study: Information regarding Current Diabetes Control

Intervention Type: OTHER

Participants will receive information regarding their current diabetes control in different ways depending on their assigned study arm.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults who report a diagnosis of diabetes

-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%

Exclusion Criteria

• People without diabetes

For Phase II:

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Anjali Gopalan

Robert Wood Johnson Clinical Scholar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Gopalan A, Suttner L, Troxel AB, McDonough K, Schapira MM. Testing patient-informed approaches for visually depicting the hemoglobin A1c value to patients with poorly controlled diabetes: a randomized, controlled trial. BMC Health Serv Res. 2020 Mar 6;20(1):178. doi: 10.1186/s12913-020-5035-8.

Reference Type: DERIVED

PMID: 32143649 (View on PubMed)

Other Identifiers

00000notapplicable

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

817693

Identifier Type: -

Identifier Source: org_study_id