The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment

Abstract

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.

Automated symptom and treatment side effect monitoring for improved quality of life among adults with diabetic peripheral neuropathy in primary care: a pragmatic, cluster, randomized, controlled trial

“…We conducted a pragmatic, cluster RCT in primary care clinics within the Kaiser Permanente Northern California health system between July 2014 and July 2016 [11]. The clusters were primary care physicians treating people with diabetes.…”

“…The intervention was designed and evaluated in close collaboration with three individuals with neuropathy being cared for in our settings and three clinician stakeholders who were active members of the research team [11]. In addition, we received ongoing feedback from two community-based neuropathy support groups.…”

“…To address these individual, provider and temporal barriers to the effective treatment of neuropathy symptoms, the Diabetes Telephone Study [11] was designed as a cluster randomized controlled trial (RCT) to test whether automated monitoring of participants' treatment experiences and feedback to physicians using interactive voice response technology and an electronic health record (EHR) could support communication with primary care providers, facilitate guidelineconsistent care, and result in improvements in quality of life and symptoms for individuals with neuropathy compared with usual care.…”

Overcoming barriers to diabetic polyneuropathy management in primary care

“…25 Additional advantages of these technologies include the ability to tailor educational messaging about foot care for patient language preference and health literacy levels and to systematically engage patients in discussions about symptoms, treatment goals and effectiveness to facilitate timely diagnosis, treatment initiation and treatment changes. 17,25,26 Several short questionnaires have now been validated among patients with DPN for use in practice for both diagnostic and symptoms monitoring purposes. [27][28][29][30][31] In addition, patient-reported information about symptoms and treatment side effects has the potential to facilitate clinically appropriate and timely treatment adjustments.…”

“…[27][28][29][30][31] In addition, patient-reported information about symptoms and treatment side effects has the potential to facilitate clinically appropriate and timely treatment adjustments. 26 Heath systems with integrated electronic medical records may hold a strategic advantage in leveraging technology to facilitate the collection and feeding back of patient reported data. For example, EMR data can be used to develop risk models to identify patients at high risk for adverse drug events related to DPN medications or to identify those patients at high risk for catastrophic health events such as falls, foot ulceration and lower extremity amputation.…”