The Diabetes Telephone Study: Design and Challenges of a Pragmatic Cluster Randomized Trial to Improve Diabetic Peripheral Neuropathy Treatment
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The Diabetes Telephone Study: Design and Challenges of a Pragmatic Cluster Randomized Trial to Improve Diabetic Peripheral Neuropathy Treatment
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  • Alternative Title:
    Value Health
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    Background Challenges to effective pharmacologic management of symptomatic diabetic peripheral neuropathy include the limited effectiveness of available medicines, frequent side effects, and the need for ongoing symptom assessment and treatment titration for maximal effectiveness. We present here the rationale and implementation challenges of the Diabetes Telephone Study, a randomized trial designed to improve medication treatment, titration and quality of life among patients with symptomatic diabetic peripheral neuropathy. Methods We implemented a pragmatic cluster randomized controlled trial to test the effectiveness of an automated interactive voice response tool designed to provide physicians with real-time patient-reported data about responses to newly prescribed diabetic peripheral neuropathy medicines. 1,830 primary care physicians treating patients in the diabetes registry at Kaiser Permanente Northern California were randomized into the intervention or control arm in September 2014. Patients assigned to physicians in the intervention group receive three brief interactive calls every 2 months after a medication is prescribed to alleviate diabetic peripheral neuropathy symptoms. These calls provide patients with the opportunity to report on symptoms, side effects, self-titration of medication dose and overall satisfaction with treatment. We plan to compare changes in self-reported quality of life between the intervention group and patients in the control group who receive three non-interactive automated educational phone calls. Results Successful implementation of this clinical trial required robust stakeholder engagement to help tailor the intervention and to address pragmatic concerns such as provider time constraints. As of October 27, 2015, we had screened 2,078 patients, 1,447 of whom were eligible for participation. We consented and enrolled 1,206 or 83% of those eligible. Among those enrolled, 53% are women and the mean age is 67 (sd 12). The racial ethnic make-up is 56% white, 8% Asian, 13% black or African American, and 19% Hispanic or Latino. Conclusions Innovative strategies are needed to guide improvements in healthcare delivery for patients with symptomatic diabetic peripheral neuropathy. This trial aims to assess whether real-time collection and clinical feedback of patient treatment experiences can reduce patient symptom burden. Implementation of a clinical trial closely involving clinical care required researchers to partner with clinicians. If successful, this intervention provides a critical information feedback loop that would optimize diabetic peripheral neuropathy medication titration through widely available interactive voice response technology.
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