title: The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment.
abstract: 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.
  
  
  
  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. A total of 1834 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, we began identification and recruitment of patients assigned to physicians in the intervention group who 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.
  
  
  
  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 27 October 2015, we had screened 2078 patients, 1447 of whom were eligible for participation. We consented and enrolled 1206 or 83% of those eligible. Among those enrolled, 53% are women and the mean age is 67 (standard deviation = 12) years. The racial ethnic make-up is 56% White, 8% Asian, 13% Black or African American, and 19% Hispanic or Latino.
  
  
  
  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.
authors.affiliation: Division of Research, Kaiser Permanente, Oakland, CA, USA Alyce.S.Adams@kp.org.
authors.forename: Alyce S
authors.initials: AS
authors.lastname: Adams
authors.affiliation: Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, USA.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Bayliss
authors.affiliation: Division of Research, Kaiser Permanente, Oakland, CA, USA.
authors.forename: Julie A
authors.initials: JA
authors.lastname: Schmittdiel
authors.affiliation: Division of Research, Kaiser Permanente, Oakland, CA, USA.
authors.forename: Andrea
authors.initials: A
authors.lastname: Altschuler
authors.affiliation: Division of Research, Kaiser Permanente, Oakland, CA, USA.
authors.forename: Wendy
authors.initials: W
authors.lastname: Dyer
authors.affiliation: Division of Research, Kaiser Permanente, Oakland, CA, USA.
authors.forename: Romain
authors.initials: R
authors.lastname: Neugebauer
authors.affiliation: South San Francisco Medical Center, Kaiser Permanente, South San Francisco, CA, USA.
authors.forename: Marc
authors.initials: M
authors.lastname: Jaffe
authors.affiliation: Oakland Medical Center, Kaiser Permanente, Oakland, CA, USA.
authors.forename: Joseph D
authors.initials: JD
authors.lastname: Young
authors.affiliation: Oakland Medical Center, Kaiser Permanente, Oakland, CA, USA.
authors.forename: Eileen
authors.initials: E
authors.lastname: Kim
authors.affiliation: Division of Research, Kaiser Permanente, Oakland, CA, USA.
authors.forename: Richard W
authors.initials: RW
authors.lastname: Grant
mesh_terms: D000368:Aged; D001331:Automation; D003929:Diabetic Neuropathies / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010358:Patient Participation; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D013689:Telephone; D016896:Treatment Outcome
keywords: Diabetic peripheral neuropathy; quality of life; stakeholder engagement research; treatment titration