Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy
| Status: | Completed |
|---|---|
| Conditions: | Diabetic Neuropathy, Neurology |
| Therapuetic Areas: | Endocrinology, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/30/2018 |
| Start Date: | October 2014 |
| End Date: | September 2016 |
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
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
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.
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.
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
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