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Balancing treatment outcomes and medication burden among patients with symptomatic diabetic peripheral neuropathy
Investigator (PI): Adams, Alyce Sophia
Performing Organization (PO): (Current): Kaiser Permanente, Division of Research / (510) 891-3400
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2013
Final Year: 2018
Record Source/Award ID: PCORI/CE-1304-7250
Funding: Total Award Amount: $1,936,710
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Painful diabetic peripheral neuropathy (DPN) affects more than 5.5 million people with diabetes. People with painful DPN have trouble sleeping, participating in social events, and conducting daily activities such as going to the store. The following vignette describes the challenges of balancing treatment outcomes and burden in DPN: A 67-year-old woman with DPN is prescribed a tricyclic antidepressant after nearly eight months of persistent pain that interferes with her ability to sleep. Soon after starting treatment, she begins to experience dizziness that she believes is caused by her new drug and is considering stopping treatment. Several prescription medications are available for the treatment of DPN symptoms, but none work perfectly and all have side effects that may be difficult for some patients. When patients report their symptoms and side effects to their doctor, they provide the doctor with important information to help them make adjustments to treatment that will help with symptoms and that the patient can tolerate in terms of side effects. In some cases, doctors may encourage patients to make these changes on their own at home based on their experience with therapy. However, patients may have a long time between visits to their doctor and may have trouble describing their symptoms to their doctor during a brief 10 to 15 minute visit. This proposal will explore the possibility of computerized telephone calls to patients to gather information about treatment experiences that can then be reported to the doctor or used to guide patients to make changes in how they take the medication. It will address the following question: Can routinely asking patients about their experiences with medications and using that information to encourage clinically appropriate titration improve patient quality of life? We believe that asking patients about their experiences can encourage better communication between patients and doctors about treatment, as well as encourage treatment changes that improve patient outcomes. More on this project: (1) Adams AS, Bayliss E, Schmittdiel JA, Altschuler A, Dyer W, Neugebauer R, Jaffe M, Young JD, Kim E, Grant RW. The Diabetes Telephone Study: Design and Challenges of a Pragmatic Cluster Randomized Trial to Improve Diabetic Peripheral Neuropathy Treatment. Value Health. 2015 Nov;18(7):A723-4. doi: 10.1016/j.jval.2015.09.2748. Epub 2015 Oct 20. PubMed PMID: 26534052. (2) Bredfeldt C, Altschuler A, Adams AS, Portz JD, Bayliss EA. Patient reported outcomes for diabetic peripheral neuropathy. J Diabetes Complicat. 2015 August;29(8):1112-8. doi: 10.1016/j.jdiacomp.2015.08.015.
MeSH Terms:
  • Aged
  • Antidepressive Agents, Tricyclic /administration & dosage
  • /adverse effects
  • Communication
  • Diabetic Neuropathies /*drug therapy
  • Humans
  • * Outcome Assessment, Health Care
  • Pain Management
  • Patient Participation
  • Peripheral Nervous System Diseases /*drug therapy
  • Physician-Patient Relations
  • Symptom Assessment
  • Telemedicine
Country: United States
State: California
Zip Code: 94612
UI: 20143535
CTgovId: NCT02056431
Project Status: Completed
Record History: ('2017: Project extended to 2017.',) ('2018: Project extended to 2018.',)