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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Anjali Gopalan, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01886170
First received: June 20, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Diabetes
Other: Phase II of the Study: Information regarding Current Diabetes Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Using Patient Feedback to Improve the Ways we Communicate Information Regarding Glycemic Control to Patients With Poorly Controlled Diabetes

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • For Phase I of the Study: Metrics Used to Understand Diabetes Control [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Identification of common factors patients use to understand their diabetes and diabetes control via a qualitative analysis of the patient interview responses

  • For Phase II of the Study: Change in Hemoglobin A1C [ Time Frame: 6 months following enrollment ] [ Designated as safety issue: No ]
    Change in A1C between enrollment and 6-months compared between study arms.


Secondary Outcome Measures:
  • For Phase I of the study: Feedback on alternative formats [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    qualitative and quantitative analysis of the feedback received on the alternative communication formats reviewed with participants during the interviews.

  • For Phase II of the Study: Understanding of diabetes control [ Time Frame: At the time of enrollment ] [ Designated as safety issue: No ]
    Accuracy of participant knowledge of level of current diabetes control


Estimated Enrollment: 200
Study Start Date: June 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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)
Experimental: 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.
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.
Experimental: 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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886170

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: Anjali Gopalan, Robert Wood Johnson Clinical Scholar, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01886170     History of Changes
Other Study ID Numbers: 817693, 00000notapplicable
Study First Received: June 20, 2013
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Adults with self-reported diagnosis of diabetes recruited from waiting rooms at outpatient primary care sites at the University of Pennsylvania

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 23, 2014