Home Health Management of Parkinson Disease Deep Brain Stimulation: A Randomized Clinical Trial

Abstract

Importance: The travel required to receive deep brain stimulation (DBS) programming causes substantial burden on patients and limits who can access DBS therapy.

Objective: To evaluate the efficacy of home health DBS postoperative management in an effort to reduce travel burden and improve access.

Design, settings, and participants: This open-label randomized clinical trial was conducted at University of Florida Health from November 2017 to April 2020. Eligible participants had a diagnosis of Parkinson disease (PD) and were scheduled to receive DBS independently of the study. Consenting participants were randomized 1:1 to receive either standard of care or home health postoperative DBS management for 6 months after surgery. Primary caregivers, usually spouses, were also enrolled to assess caregiver strain.

Interventions: The home health postoperative management was conducted by a home health nurse who chose DBS settings with the aid of the iPad-based Mobile Application for PD DBS system. Prior to the study, the home health nurse had no experience providing DBS care.

Main outcomes and measures: The primary outcome was the number of times each patient traveled to the movement disorders clinic during the study period. Secondary outcomes included changes from baseline on the Unified Parkinson's Disease Rating Scale part III.

Results: Approximately 75 patients per year were scheduled for DBS. Of the patients who met inclusion criteria over the entire study duration, 45 either declined or were excluded for various reasons. Of the 44 patients enrolled, 19 of 21 randomized patients receiving the standard of care (mean [SD] age, 64.1 [10.0] years; 11 men) and 23 of 23 randomized patients receiving home health who underwent a minimum of 1 postoperative management visit (mean [SD] age, 65.0 [10.9] years; 13 men) were included in analysis. The primary outcome revealed that patients randomized to home health had significantly fewer clinic visits than the patients in the standard of care arm (mean [SD], 0.4 [0.8] visits vs 4.8 [0.4] visits; P < .001). We found no significant differences between the groups in the secondary outcomes measuring the efficacy of DBS. No adverse events occurred in association with the study procedure or devices.

Conclusions and relevance: This study provides evidence supporting the safety and feasibility of postoperative home health DBS management.

Trial registration: ClinicalTrials.gov Identifier: NCT02474459.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Okun serves as a consultant for the Parkinson’s Foundation and has received research grants from the National Institutes of Health, Parkinson’s Foundation, the Michael J. Fox Foundation, the Parkinson Alliance, the Smallwood Foundation, the Bachmann-Strauss Foundation, the Tourette Syndrome Association, and the UF Foundation, as well as deep brain stimulation research support from the National Institutes of Health (grants R01 NR014852 and R01NS096008); he is also a principal investigator of the National Institutes of Health Training Grant (R25NS108939). Dr Okun has received royalties for publications with Demos, Manson, Amazon, Smashwords, Books4Patients, Perseus, Robert Rose, Oxford, and Cambridge (for movement disorders books); is an associate editor for New England Journal of Medicine Journal Watch Neurology; has participated in continued medical education and educational activities on movement disorders sponsored by the Academy for Healthcare Learning, PeerView, Prime, QuantiaMD, WebMD/Medscape, Medicus, MedNet, Einstein, MedNet, Henry Stewart, American Academy of Neurology, Movement Disorders Society, and Vanderbilt University; and has participated as a site principal investigator and/or coinvestigator for several National Institutes of Health–sponsored, foundation-sponsored, and industry-sponsored trials over the years but has not received honoraria. His institution receives grants from Medtronic, AbbVie, Boston Scientific, Abbott, and Allergan, and research projects at the University of Florida receive device and drug donations. Dr Ramirez-Zamora serves as a consultant for the Parkinson’s Foundation; has received consulting honoraria from Medtronic, Signant Health, CNS ratings, and Rho Inc; has received consulting honorarium for educational activities from Medtronic Inc outside the submitted work; and has participated as a site principal investigator and/or coinvestigator for several National Institutes of Health–sponsored, foundation-sponsored, and industry-sponsored trials over the years but has not received honoraria. Dr Duffley reported a grant from National Institute of Nursing Research (grant NR014852) during the conduct of the study. Dr Zeilman reported personal fees from Medtronic during the conduct of the study and nonfinancial support from Boston Scientific and Abbott outside the submitted work. Dr Szabo reported personal fees from University of Utah during the conduct of the study. Dr Lutz reported grants from the National Institutes of Health during the conduct of the study. Dr Foote reported grants from Medtronic for research support and fellowship support to the University of Florida and research grants from Boston Scientific and Functional Neuromodulation to the University of Florida outside the submitted work. Dr Butson reported grants from the National Institutes of Health during the conduct of the study and personal fees from Abbott outside the submitted work; in addition, Dr Butson has a patent for deep brain stimulation licensed. No other disclosures were reported.

Figures

Figure 1.. CONSORT Patient Flow Diagram

DBS indicates deep brain stimulation.

Figure 2.. Deep Brain Stimulation (DBS) Postoperative Management Visit Types Grouped by Study Arm