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NCT Number: NCT01886170

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Phase II of the Study: Information regarding Current Diabetes Control

Other

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

Primary outcomes

  1. For Phase I of the Study: Metrics Used to Understand Diabetes Control

    Time frame: 4 months

    Identification of common factors patients use to understand their diabetes and diabetes control via a qualitative analysis of the patient interview responses

  2. For Phase II of the Study: Change in Hemoglobin A1C

    Time frame: 6 months following enrollment

    Change in A1C between enrollment and 6-months compared between study arms.

Secondary outcomes

  1. For Phase I of the study: Feedback on alternative formats

    Time frame: 4 months

    qualitative and quantitative analysis of the feedback received on the alternative communication formats reviewed with participants during the interviews.

  2. For Phase II of the Study: Understanding of diabetes control

    Time frame: At the time of enrollment

    Accuracy of participant knowledge of level of current diabetes control

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 25, 2013
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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