Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy

NCT ID: NCT02056431

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-09-30

Brief Summary

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. 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 clinical trial explores the possibility of computerized telephone calls to patients (Interactive Voice Response, IVR, technology) 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 addresses 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?

The investigators hypothesize that systematic collection and feedback of information about DPN treatment preferences and experience from newly treated patients to their primary care physician will facilitate treatment changes that improve patient outcomes

Detailed Description

Among newly-treated Diabetic Peripheral Neuropathy (DPN) patients, the investigators will compare the systematic collection and feedback of information about patients' treatment experiences on changes in quality of life (intervention group) to newly treated DPN patients in usual care who will receive generic educational messages by phone but no active data collection and feedback (comparator group). The investigators have chosen usual care as the control to evaluate the potential for the intervention to enhance current practice.

Aim 1: Refine and pilot test instruments for collecting the patient-reported data most important for guiding changes in treatment.

Aim 2: Implement a seven-month cluster randomized trial to improve quality of life among patients newly treated for DPN symptoms by collecting data on patient treatment experiences and facilitating evidence-based patient and provider-initiated treatment titration.

Aim 3: Examine patient and physician initiated treatment changes as secondary outcomes in order to inform the development of this type of rapid feedback process for guiding decision making about initial treatment selection among patients with DPN.

Conditions

Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

IVR Intervention Group

Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.

Group Type: EXPERIMENTAL

IVR Intervention Group

Intervention Type: BEHAVIORAL

Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.

IVR Control Group

Participants will receive 3 non-interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) containing general messages regarding diabetic education.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

IVR Intervention Group

Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• All patients newly prescribed medication to treat diabetic peripheral neuropathy symptoms.

Exclusion Criteria

• Patients with any evidence of use of diabetic peripheral neuropathy study medications.
• Patients with evidence of gestational diabetes (ICD-9: 648.8) due to variation in treatment and monitoring for women who are pregnant.
• Patients who simultaneously received a new diagnosis for depression or seizure conditions

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alyce S. Adams, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Division of Research Kaiser Permanente

Oakland, California, United States

Countries

United States

References

Adams AS, Bayliss EA, Schmittdiel JA, Altschuler A, Dyer W, Neugebauer R, Jaffe M, Young JD, Kim E, Grant RW; Diabetes Telephone Study Team. The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment. Clin Trials. 2016 Jun;13(3):286-93. doi: 10.1177/1740774516631530. Epub 2016 Mar 31.

Reference Type: RESULT

PMID: 27034455 (View on PubMed)

Adams AS, Schmittdiel JA, Altschuler A, Bayliss EA, Neugebauer R, Ma L, Dyer W, Clark J, Cook B, Willyoung D, Jaffe M, Young JD, Kim E, Boggs JM, Prosser LA, Wittenberg E, Callaghan B, Shainline M, Hippler RM, Grant RW. 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. Diabet Med. 2019 Jan;36(1):52-61. doi: 10.1111/dme.13840. Epub 2018 Nov 7.

Reference Type: DERIVED

PMID: 30343489 (View on PubMed)

Other Identifiers

CE-1304-7250

Identifier Type: -

Identifier Source: org_study_id