Background and Objectives: Diabetic peripheral neuropathy (DPN) is a highly prevalent and costly complication of diabetes that is frequently underdiagnosed and undertreated in primary care settings. Our primary research goal was to facilitate automated monitoring of patient-reported symptoms and medication side effects using interactive voice response telephone calls that systematically fed information to providers via patients' electronic health records. We hypothesized that this technology-enabled communication feedback tool would improve patient quality of life by promoting clinically appropriate treatment changes.
Methods: Using a cluster (physician level) randomized controlled trial design, we randomized 1834 primary care physicians to the treatment or control condition (usual care plus brief, noninteractive educational telephone message), screened 2203 patients newly treated for DPN symptoms by these providers and recruited 1270 patients (83% of eligible patients) to participate in the intervention. Our primary outcomes were quality of life (EuroQol 5-dimension questionnaire [EQ-5D]) and select DPN symptoms (ie, pain interference—level of functional interference due to pain, sleep disturbance, and lower extremity functioning), which we assessed via telephone interviews with patients approximately 2 to 4 weeks after they initiated DPN medication and 8 months following baseline assessment. Process outcomes included receipt of a therapeutically effective dose of therapy at 8 and 12 months posttreatment start and patients' assessment of the quality of communication with their provider during the prior 12 months. We used generalized estimating equations to evaluate patient-level changes in the primary outcomes, controlling for clustering of patients within physicians. We conducted sensitivity analyses to assess the robustness of our findings to missing data.
Results: Among the 1270 enrolled patients, 1255 (99%) completed the baseline assessment and 1179 (93%) completed follow-up. We found no effect of the intervention on change in quality of life (EQ-5D = −0.002 [95% CI, −0.01 to 0.01], P = .623); symptoms (pain interference = 0.29 [95% CI, −0.75 to 1.34]; P = .579); sleep disruption (0.34 [95% CI, −0.18 to 0.86]; P = .196); lower extremity functioning (−0.08 [95% CI, −1.27 to 1.11]; P = .896); or depressive symptoms (−0.46 [95% CI, −1.24 to 0.32]). We also found no statistically significant changes in either of our process measures: receipt of a therapeutically effective dose (0.13 [95% CI, −0.11 to 0.38]; P = .289) or patient-provider communication (−0.45 [95% CI, −0.97 to 0.07]; P = .091). Intervention effectiveness did not vary by the degree of perceived shared decision-making. More than 70% of patients in the intervention group reported problems with treatment on the first call, most due to side effects.
Limitations: Absence of a protocol for physician response to patient reports, possible inclusion of patients who may have been prescribed study medications for another condition, use of a communication measure that extended into the baseline period, and the short time frame of the study (ie, 8 months) limited our ability to observe gradual changes in medication dosing.
Conclusions: Monitoring of patient-reported symptoms and side effects through automated telephone calls did not significantly improve quality of life, symptoms, dosing, or patient-provider communication among patients newly treated for DPN symptoms. Given the high rates of side effects related to DPN medications reported, automated monitoring may have reinforced more conservative dosing strategies among providers in an attempt to limit treatment-related harms. To be effective in the management of DPN symptoms, automated monitoring may first require accurate identification of those patients most likely to benefit from, or be harmed by, available medications.
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