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Automated Tracking of Symptoms and Treatment Side Effects to Help Patients Starting New Medicines for Diabetes-Related Nerve Pain

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Results Summary and Professional Abstract

Results Summary
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Results Summary

What was the research about?

Diabetes can damage nerves, causing numbness, tingling, or a “pins and needles” feeling. These symptoms start in the toes or fingers. This health problem is known as diabetic peripheral neuropathy, or DPN. There is no cure for DPN, but taking medicines may help manage symptoms. It can be hard for doctors to find the right medicines and doses that will work for patients. DPN medicines have side effects that may be hard for some patients to live with. The research team wanted to find an easy way for patients to tell doctors about symptoms and side effects when starting new medicines.

The research team compared two groups of patients who had new prescriptions for DPN medicines. The first group received automated phone calls from a tracking system. The system asked patients how their medicines were working. Patients’ doctors received an alert message if the patients reported that

  • The medicine wasn’t working.
  • They experienced side effects.
  • They had stopped using the medicine.

The second group received usual care. This group also listened to recorded diabetes-related phone messages about exercise, diet, and foot checks.

The research team wanted to learn if the tracking system improved patients’ quality of life, symptoms, and communication with their doctors. The team also looked at whether frequent patient feedback helped doctors prescribe the right medicines and doses for patients.

What were the results?

About three-quarters of the patients who used the tracking system said they had problems with their medicines. The team didn’t find any differences in quality of life or symptoms between patients who used the tracking system and those who received usual care and heard the educational messages. There were also no differences in how well patients felt their doctors communicated with them or how often doctors found the right medicines and doses for patients.

Who was in the study?

The study included 820 primary care doctors and 1,270 of their patients with DPN. The average patient age was 67. Slightly more than half of the patients were female. The study included patients who were white (57 percent), Hispanic (20 percent), black (13 percent), Asian (8 percent), and other races (2 percent).

What did the research team do?

The research team assigned doctors to one of the two groups by chance. The team assigned patients to the same group as their doctors. The automated phone system called both groups of patients every two months for six months. For patients who answered the tracking system questions, the research team entered their answers into their medical records. When patients reported problems, doctors whose patients used the automated tracking system received alert messages. If doctors felt the need, they could talk to patients, run tests, or change care in response to the alert messages.

The research team interviewed all patients about quality of life, symptoms, and communication with their doctors before and at the end of the study. The team also looked at the patients’ health records to see if their doctors changed the prescribed dose of DPN medicine.

What were the limits of the study?

All the patients were in one health system. Results may be different for patients in other health systems. After receiving email alert messages, doctors didn’t have to respond to their patients in a specific way. The tracking system may not have affected how doctors treated their patients.

Future research could see whether the results change if doctors must respond to their patients after getting alert messages. Also, future research could see if the tracking system works for other health problems that are easier to treat than DPN.

How can people use the results?

The tracking system didn’t improve care, quality of life, or health compared with usual care for patients with DPN. Doctors may want to look for other ways to help patients who are having problems with their DPN medicines.

Professional Abstract

Professional Abstract

Objective

To compare the effectiveness of (1) an automated tracking system that allows patients with diabetic peripheral neuropathy (DPN) to report concerns about newly prescribed DPN medicines to their physicians by phone versus (2) usual care supplemented with automated calls delivering diabetes-related educational messages on improving patient quality of life and DPN symptoms

Study Design

Design Elements Description
Design Randomized controlled trial
Population 1,270 patients with DPN and 820 primary care physicians
Interventions/
Comparators
  • Automated phone survey of medicine use, effectiveness, and side effects
  • Usual care supplemented with automated phone calls delivering diabetes-related educational messages
Outcomes

Primary: patient quality of life (overall health, mood, physical and social functioning, pain severity) and DPN symptoms (pain, functional interference because of pain, sleep disturbance, lower extremity function)

Secondary: patient-perceived changes in physician communication and the likelihood of reaching the minimum effective medicine dose
Timeframe 8-month follow-up for primary outcomes

This study was a physician-level cluster randomized controlled trial. Researchers randomized physicians to the intervention or control group and placed patients into the same groups as their physicians. Patients in the intervention group received three automated, interactive five-minute phone surveys administered two, four, and six months after beginning treatment. The surveys asked about symptom relief and medicine use, titration, discontinuation, and side effects. Researchers entered all survey results into patients’ medical records. If patients reported side effects from medicines, expressed dissatisfaction with symptom relief, or discontinued medicines, the tracking system forwarded the results to physicians as secure messages. The control group received three two-minute non-interactive phone calls with a diabetes-related educational message at the same time intervals as the intervention group. Each call played one of three messages regarding exercise, diet, or foot checks.

At the start and end of the study, researchers phoned all patients to collect data on patient quality of life and DPN symptoms. Researchers also asked patients how well their doctors communicated with them. To assess whether physicians reached minimum effective medicine dose, researchers retrospectively reviewed electronic health records.

The intervention group included 400 primary care physicians and 604 patients. The control group included 420 primary care physicians and 666 patients. All enrolled patients had recently started a new DPN medicine. Patients’ average age was 67, and 54% were female. The study included patients who were white (57%), Hispanic (20%), black (13%), Asian (8%), and other races (2%). There were no differences in demographic or clinical characteristics between intervention and control groups.

Results

  • Automated phone surveys. Researchers reported an 83% response rate and a 93% retention rate for the entire study population at the end of the study. There were no significant differences between the intervention and control groups in patient quality of life, DPN symptoms, patient-perceived changes in physician communication, and likelihood of reaching the minimum effective dose.
  • Patient concerns about medicines. Among patients responding to the automated survey, 74% reported problems with their medicines at two months after starting treatment. More than 50% of patients reported side effects from medicines. There were no statistically significant differences in the demographics or clinical characteristics between the patients who did and those who did not have concerns about medicines.

Limitations

The study took place in one integrated healthcare system; the results may be different in other settings. At the request of health system stakeholders, physicians in the study were not required to follow a specific protocol for responding to patients’ complaints; it is unclear how or whether the secure message alerts affected care. DPN treatments have variable efficacy and high side effect rates, so the follow-up time may have been too short to find an effective medicine and dose.

Conclusions and Relevance

The tracking system was not better than usual care with educational messages at improving care, quality of life, or health for patients with DPN. The lack of clinically significant changes in quality of life or other outcomes may reflect the challenges of treating DPN symptoms.

Future Research Needs

Future research could include specific protocols for physician responses to email alerts and observation of patients for a longer period. Studies could also test the intervention with patients with other clinical conditions that have more effective treatments.

Final Research Report

View this project's final research report.

Journal Articles

Related Articles

The Permanente Journal

Clinical Response to Real-Time Patient-Reported Diabetic Peripheral Neuropathy Symptoms

Healthcare

Overcoming barriers to diabetic polyneuropathy management in primary care

Journal of Health Communication

Communication Barriers and the Clinical Recognition of Diabetic Peripheral Neuropathy in a Diverse Cohort of Adults: The DISTANCE Study

Clinical Trials

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

Journal of Diabetes and Its Complications

Patient reported outcomes for diabetic peripheral neuropathy

Clinical Therapeutics

Effects of eliminating drug caps on racial differences in antidepressant use among dual enrollees with diabetes and depression

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Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.

In response to peer review, the PI made changes including

  • Indicating that the patient preference instrument was developed based on data collected from a diverse group of patients in a prior substudy. That substudy identified unmet healthcare needs, factors that were most important to patients, and patients’ willingness to use alternative communication methods (e.g., automated calls or email).
  • Providing details about the intervention that was being tested, the outcome measures, the analytic plans, and how they involved the patient stakeholder panel in study development and execution.
  • Describing the purpose and execution of the added physician survey. The PI responded to reviewers’ concerns about the very low survey completion rate (31 of 186 physicians) by noting that this was a convenience sample recruited for this late addition to the study.

Conflict of Interest Disclosures

View the COI disclosure form.

Project Details

Principal Investigator
Alyce Sophia Adams, PhD
Project Status
Completed; PCORI Public and Professional Abstracts, and Final Research Report Posted
Project Title
Balancing Treatment Outcomes and Medication Burden among Patients with Symptomatic Diabetic Peripheral Neuropathy
Board Approval Date
September 2013
Project End Date
May 2018
Organization
Kaiser Foundation Research Institute
Year Awarded
2013
State
California
Year Completed
2018
Project Type
Research Project
Health Conditions  
Neurological Disorders
Nutritional and Metabolic Disorders
Diabetes
Intervention Strategies
Other Health Services Interventions
Technology Interventions
Funding Announcement
Assessment of Prevention, Diagnosis, and Treatment Options
Project Budget
$1,936,710
DOI - Digital Object Identifier
10.25302/5.2019/CE.13047250
Study Registration Information
HSRP20143535
NCT02056431
Page Last Updated: 
August 30, 2021