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The Partnership to Improve Diabetes Education Trial: a Cluster Randomized Trial Addressing Health Communication in Diabetes Care

  • Richard O. WhiteEmail author
  • Rosette James Chakkalakal
  • Kenneth A. Wallston
  • Kathleen Wolff
  • Becky Gregory
  • Dianne Davis
  • David Schlundt
  • Karen M. Trochez
  • Shari Barto
  • Laura A. Harris
  • Aihua Bian
  • Jonathan S. Schildcrout
  • Sunil Kripalani
  • Russell L. Rothman
Original Research

Abstract

Background

Effective type 2 diabetes care remains a challenge for patients including those receiving primary care in safety net settings.

Objective

The Partnership to Improve Diabetes Education (PRIDE) trial team and leaders from a regional department of health evaluated approaches to improve care for vulnerable patients.

Design

Cluster randomized controlled trial.

Patients

Adults with uncontrolled type 2 diabetes seeking care across 10 unblinded, randomly assigned safety net clinics in Middle TN.

Interventions

A literacy-sensitive, provider-focused, health communication intervention (PRIDE; 5 clinics) vs. standard diabetes education (5 clinics).

Main Measures

Participant-level primary outcome was glycemic control [A1c] at 12 months. Secondary outcomes included select health behaviors and psychosocial aspects of care at 12 and 24 months. Adjusted mixed effects regression models were used to examine the comparative effectiveness of each approach to care.

Key Results

Of 410 patients enrolled, 364 (89%) were included in analyses. Median age was 51 years; Black and Hispanic patients represented 18% and 25%; 96% were uninsured, and 82% had low annual income level (< $20,000); adequate health literacy was seen in 83%, but numeracy deficits were common. At 12 months, significant within-group treatment effects occurred from baseline for both PRIDE and control sites: adjusted A1c (− 0.76 [95% CI, − 1.08 to − 0.44]; P < .001 vs − 0.54 [95% CI, − 0.86 to − 0.21]; P = .001), odds of poor eating (0.53 [95% CI, 0.33–0.83]; P = .01 vs 0.42 [95% CI, 0.26–0.68]; P < .001), treatment satisfaction (3.93 [95% CI, 2.48–6.21]; P < .001 vs 3.04 [95% CI, 1.93–4.77]; P < .001), and self-efficacy (2.97 [95% CI, 1.89–4.67]; P < .001 vs 1.81 [95% CI, 1.1–2.84]; P = .01). No significant difference was observed between study arms in adjusted analyses.

Conclusions

Both interventions improved the participant’s A1c and behavioral outcomes. PRIDE was not more effective than standard education. Further research may elucidate the added value of a focused health communication program in this setting.

KEY WORDS

diabetes care disparities health communication vulnerable populations public health 

Abbreviations

ARMS

Adherence to Refills and Medication Scale

A1c

Hemoglobin A1c

BMI

Body mass index

DNT

Diabetes Numeracy Test

DTSQ

Diabetes Treatment Satisfaction Questionnaire

NDEP

National Diabetes Education Program

PCMH

Patient-centered medical home

PDQ

Personal Diabetes Questionnaire

PDSMS

Perceived Diabetes Self-Management Scale

PRIDE

Partnership to Improve Diabetes Education

SDSCA

Summary of Diabetes Self-Care Activities

s-TOFHLA

Short Test of Functional Health Literacy in Adults

TDOH

Tennessee Department of Health

T2D

Type 2 diabetes mellitus

Notes

Acknowledgments

The PRIDE team thanks the leadership at the TDOH, especially Cathy Taylor DrPH, RN, and all of the patients who gave their time and efforts. We acknowledge the recruitment efforts of Laura Chambers, Alexis and Nicolas Ludi, and Ricardo Trochez.

Author Contributions

All authors attest to meeting the International Committee of Medical Journal Editors uniform requirements for authorship. DS, KAW, LAH, JSS, SK, and RLR led the development of the PRIDE partnership, study design, and implementation. ROW, KW, BPG, DD, SB, SK, and RLR conducted provider trainings and evaluated the low-literacy materials, including the cultural adaptation of Spanish materials led by ROW. ROW, KMT, and SB were responsible for data and program management and recruitment. AB and JSS led data analyses. ROW, RJC, and JSS led data interpretation and manuscript writing. All authors gave final manuscript approval. ROW guarantees the work.

Funding Information

This study was funded by 5R18 DK083264 and ROW supported by K23 5DK092470 from the NIDDK. Additional support was obtained from Vanderbilt University CTSA 5UL1TR000445, Vanderbilt CDTR DK092986, and study data were collected and managed using Research Electronic Data Capture.

Compliance with Ethical Standards

Conflict of Interest

Dr. Rothman is a consultant for edLogics and Abbott, unrelated to the current project.

Supplementary material

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Copyright information

© Society of General Internal Medicine 2020

Authors and Affiliations

  • Richard O. White
    • 1
    Email author
  • Rosette James Chakkalakal
    • 2
  • Kenneth A. Wallston
    • 3
  • Kathleen Wolff
    • 4
  • Becky Gregory
    • 5
  • Dianne Davis
    • 5
  • David Schlundt
    • 6
  • Karen M. Trochez
    • 3
  • Shari Barto
    • 3
  • Laura A. Harris
    • 7
  • Aihua Bian
    • 8
  • Jonathan S. Schildcrout
    • 8
  • Sunil Kripalani
    • 2
    • 3
  • Russell L. Rothman
    • 2
    • 3
  1. 1.Division of Community Internal Medicine Mayo ClinicJacksonvilleUSA
  2. 2.Department of General Internal Medicine and Public HealthVanderbilt University Medical CenterNashvilleUSA
  3. 3.Center for Health Services ResearchVanderbilt University Medical CenterNashvilleUSA
  4. 4.School of NursingVanderbilt University Medical CenterNashvilleUSA
  5. 5.Vanderbilt Diabetes Research and Training CenterVanderbilt University Medical CenterNashvilleUSA
  6. 6.Department of PsychologyVanderbilt UniversityNashvilleUSA
  7. 7.Mid-Cumberland Regional OfficeTennessee Department of Health NashvilleUSA
  8. 8.Department of BiostatisticsVanderbilt UniversityNashvilleUSA

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