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Randomized Controlled Trial
. 2020 Apr;35(4):1052-1059.
doi: 10.1007/s11606-019-05617-z. Epub 2020 Jan 9.

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

Richard O White  1 , 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
Affiliations
Randomized Controlled Trial

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

Richard O White et al. J Gen Intern Med. 2020 Apr.

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.

Keywords: diabetes care; disparities; health communication; public health; vulnerable populations.

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Conflict of interest statement

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

Figures

Fig. 1
Fig. 1
PRIDE study consolidated standards of reporting trials flow diagram. NDEP, National Diabetes Education Program; PRIDE, Partnership to Improve Diabetes Education.
Fig. 2
Fig. 2
Differential impact of PRIDE vs NDEP conditions on change in A1c from baseline to 24 months. Error bars indicate 95% CI. A1c, hemoglobin A1c; NDEP, National Diabetes Education Program; PRIDE, Partnership to Improve Diabetes Education.
See this image and copyright information in PMC

Comment in

References

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