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.