Effectiveness of Shared Decision-making for Diabetes Prevention: 12-Month Results from the Prediabetes Informed Decision and Education (PRIDE) Trial
Intensive lifestyle change (e.g., the Diabetes Prevention Program) and metformin reduce type 2 diabetes risk among patients with prediabetes. However, real-world uptake remains low. Shared decision-making (SDM) may increase awareness and help patients select and follow through with informed options for diabetes prevention that are aligned with their preferences.
To test the effectiveness of a prediabetes SDM intervention.
Cluster randomized controlled trial.
Twenty primary care clinics within a large regional health system.
Overweight/obese adults with prediabetes (BMI ≥ 24 kg/m2 and HbA1c 5.7–6.4%) were enrolled from 10 SDM intervention clinics. Propensity score matching was used to identify control patients from 10 usual care clinics.
Intervention clinic patients were invited to participate in a face-to-face SDM visit with a pharmacist who used a decision aid (DA) to describe prediabetes and four possible options for diabetes prevention: DPP, DPP ± metformin, metformin only, or usual care.
Main Outcomes and Measures
Primary endpoint was uptake of DPP (≥ 9 sessions), metformin, or both strategies at 4 months. Secondary endpoint was weight change (lbs.) at 12 months.
Uptake of DPP and/or metformin was higher among SDM participants (n = 351) than controls receiving usual care (n = 1028; 38% vs. 2%, p < .001). At 12-month follow-up, adjusted weight loss (lbs.) was greater among SDM participants than controls (− 5.3 vs. − 0.2, p < .001).
Absence of DPP supplier participation data for matched patients in usual care clinics.
Conclusions and Relevance
A prediabetes SDM intervention led by pharmacists increased patient engagement in evidence-based options for diabetes prevention and was associated with significantly greater uptake of DPP and/or metformin at 4 months and weight loss at 12 months. Prediabetes SDM may be a promising approach to enhance prevention efforts among patients at increased risk.
This study was registered at clinicaltrails.gov (NCT02384109)).
KEY WORDSshared decision-making diabetes mellitus
The authors would like to thank Mr. RM for his help with project coordination, Mr. SL for help with data acquisition, and Ms. KS, Ms. SS, Dr. WS, and Ms. MK for their help with DPP implementation/delivery. The authors would also like to thank Drs. SLE and GM for their input throughout the trial. The authors would also like to thank Healthwise for providing the DA at no cost to the study and Dr. MB for facilitating the collaboration. The authors would also like to thank all the clinics, providers, and patients who made this study possible.
This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (R18DK105464). Dr. Moin also receives support from the Department of Veterans Affairs (QUE15-272, QUE15-286, and CSP2002). Dr. Mangione receives support from the University of California at Los Angeles (UCLA), Resource Centers for Minority Aging Research Center for Health Improvement of Minority Elderly under National Institutes of Health (NIH)/NIA Grant P30-AG021684, and from NIH/National Center for Advancing Translational Sciences UCLA Clinical and Translational Science Institute Grant UL1TR000124. Dr. Mangione holds the Barbara A. Levey and Gerald S. Levey Endowed Chair in Medicine, which partially supported her work. Drs. Duru’s effort is also supported in part by the University of California, Los Angeles, Resource Center for Minority Aging Research, Center for Health Improvement of Minority Elderly (RCMAR/CHIME) under NIH/NIA Grant P30-AG021684 and NIH Career Development Award K08-AG033360. Dr. Mangione is a member of the U.S. Preventive Services Task Force.
Compliance with Ethical Standards
The study was approved by the Institutional Review Board at the University of California, Los Angeles. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional review board and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Conflict of Interest
Dr. Duru is on the Healthwise scientific board. None of the other authors disclosed any potential conflicts of interest.
The findings and conclusions in this manuscript are those of the authors and do not necessarily represent the views of the National Institutes of Health (NIH) and the US Preventive Services Task Force.
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