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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVR Intervention Group | Experimental | 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. |
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| IVR Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVR Intervention Group | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Quality of Life at Baseline and 8 Months | The primary outcome measure is change in quality of life from baseline at eight months following study entry. We calculated the EuroQOL (EQ-5D) from the Global Health Scale, a 10-item Patient-Reported Outcomes Measurement Information System measure developed and validated in patients with neuropathy as part of the Quality of Life in Neurological Disorders Measures. The range for EQ-5D is 0-1, with "0" being the worst and "1" being the best. | Baseline and 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Minimally Effective Dose in 12 Months | Count of patients who ever received a minimally effective dose of the medications they started on during the 12 months following treatment start (measured post only). | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alyce S. Adams, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Research Kaiser Permanente | Oakland | California | 94612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27034455 | Result | 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. | |
| 30343489 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. IVR Intervention Group: 595 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Patient Quality of Life at Baseline and 8 Months | The primary outcome measure is change in quality of life from baseline at eight months following study entry. We calculated the EuroQOL (EQ-5D) from the Global Health Scale, a 10-item Patient-Reported Outcomes Measurement Information System measure developed and validated in patients with neuropathy as part of the Quality of Life in Neurological Disorders Measures. The range for EQ-5D is 0-1, with "0" being the worst and "1" being the best. | 1179 patients completed the close out survey | Posted | Mean | Standard Deviation | units on a scale | Baseline and 8 months |
|
Adverse event data were collected for each participant from the time of enrollment through 8 months.
Given that this is a low risk study, we do not anticipate that any of the adverse events are associated with the intervention itself. We created an algorithm to extract information on deaths among participants from the electronic medical record every 6 months and reported these to the independent safety monitor.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment | We created an algorithm to extract information on all hospitalizations and deaths in our population regardless of organ system. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alyce S. Adams | Kaiser Permanente Division of Research | 510-891-5921 | Alyce.S.Adams@kp.org |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | 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. |
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| Secondary | Number of Participants With Minimally Effective Dose in 12 Months | Count of patients who ever received a minimally effective dose of the medications they started on during the 12 months following treatment start (measured post only). | 1179 Patient completed the close out survey | Posted | Count of Participants | Participants | 12 months |
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| 138 |
| 604 |
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| 604 |
| EG001 | 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. | 149 | 666 | 0 | 666 |
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| Any Hospitalizations Occurring During the Study Period | General disorders | Systematic Assessment | We did not collect cause of death due to a 2-year lag between the time of death and assignment of the cause of death by the state. |
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