Home Health Management of Parkinson Disease Deep Brain Stimulation: A Randomized Clinical Trial | Movement Disorders | JAMA Neurology | JAMA Network
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Visual Abstract. Home Health vs Standard Management of Parkinson Disease Deep Brain Stimulation
Home Health vs Standard Management of Parkinson Disease Deep Brain Stimulation
Figure 1.  CONSORT Patient Flow Diagram
CONSORT Patient Flow Diagram

DBS indicates deep brain stimulation.

Figure 2.  Deep Brain Stimulation (DBS) Postoperative Management Visit Types Grouped by Study Arm
Deep Brain Stimulation (DBS) Postoperative Management Visit Types Grouped by Study Arm
Table 1.  Demographics and Baseline Characteristics
Demographics and Baseline Characteristics
Table 2.  Mean Change From Baseline to 6-Month Outcomes for Rating Scales and Levodopa Equivalent Daily Dose Valuesa
Mean Change From Baseline to 6-Month Outcomes for Rating Scales and Levodopa Equivalent Daily Dose Valuesa
Table 3.  All Recorded Adverse Eventsa
All Recorded Adverse Eventsa
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    1 Comment for this article
    EXPAND ALL
    Post-op DBS management at home might be improved more if remote supervision by a DBS expert is added to home visits.
    DAVID KELLER, MD, MSEE | retired internist with advanced PD
    This trial demonstrated that post-op management after DBS surgery by home-care nurses with no expertise in DBS programming required fewer office visits than standard of care post-op management, which was based on office visits with an expert trained in DBS programming, with no decrease in quality of outcomes.

    It seems logical that adding the remote participation of a DBS expert to home management by a nurse without DBS expertise should improve the outcomes measured, which might require the power of a larger trial to reveal.

    However, follow-up care by a home nurse plus remote participation by
    a DBS expert would be more expensive than care provided by a lone home nurse without DBS expertise, at least by first-order analysis, which does not include cost savings provided by improved clinical outcomes. Neither improved outcomes nor their associated second-order savings were statistically significant in this trial, but might become evident in larger trials, and in clinical practice, where personnel such as home-care nurses might not have the aptitude or the inclination to learn DBS programming as well as clinical personnel who work in research settings like this trial.
    CONFLICT OF INTEREST: None Reported
    READ MORE
    Original Investigation
    June 28, 2021

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

    Author Affiliations
    • 1Scientific Computing and Imaging Institute, University of Utah, Salt Lake City
    • 2Department of Biomedical Engineering, University of Utah, Salt Lake City
    • 3School of Nursing, University of North Carolina–Wilmington, Wilmington
    • 4Division of Biostatistics, Institute for Health & Equity, Medical College of Wisconsin, Milwaukee
    • 5Norman Fixel Institute for Neurological Diseases, Program for Movement Disorders and Neurorestoration, Departments of Neurology and Neurosurgery, University of Florida, Gainesville
    • 6Departments of Neurology, Neurosurgery, and Psychiatry, University of Utah, Salt Lake City
    JAMA Neurol. 2021;78(8):972-981. doi:10.1001/jamaneurol.2021.1910
    Key Points

    Question  Can patients receiving deep brain stimulation for the treatment of Parkinson disease be postoperatively managed from the home by a home health nurse with no prior deep brain stimulation experience?

    Findings  In a 1:1 randomized clinical trial at the University of Florida, we found that patients could be managed with significantly fewer trips to the clinic while receiving similar clinical benefit as those receiving the existing standard of care.

    Meaning  In this study, a home health–based care deep brain stimulation model was effective, safe, feasible and able to reduce patients' travel burden.

    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

    Introduction

    Although deep brain stimulation (DBS) has been shown to be an effective treatment for refractory tremor and motor fluctuations in select patients with Parkinson disease (PD),1-3 the barriers to access to the therapy are substantial. Postoperative management, specifically the selection of the stimulation parameters, plays a large role in the efficacy of DBS.4,5 Changes in DBS settings and medications are the only modifiable variables after lead implantation. Because of the importance and perceived complexity, the parameter selection process, which is commonly referred to as DBS programming, is most commonly performed by highly experienced experts employed by urban-located academic medical centers.6 The programming of DBS typically requires 4 to 5 clinic visits during the first 6 months after surgery and often regular adjustments for the remainder of a patient’s life.7 As a result, patients, especially those who do not live close to a major medical center offering DBS, experience substantial out-of-pocket costs and travel-associated burdens to access DBS programming. Travel demands also create a substantial burden for patients’ caregivers, because PD-associated mobility deficits and other comorbidities often prevent independent travel. This is particularly evident as mobility and balance worsen with disease progression and severity.

    Previously, when conducting the randomized National Institutes of Health COMPARE study (NCT00360009) of subthalamic nucleus vs globus pallidus internus as DBS targets, we addressed improvements in motor functioning and the potential worsening of cognitive symptoms.3 As a result of that study, we concluded that by tailoring DBS to the individual patient,8 the therapy can provide a substantial benefit to a wide range of patients with PD. Despite the potential benefit, many patients who are good candidates for DBS still are unable to access the therapy.

    To address this gap in DBS access, we designed an intervention to occur in the home, directed by a home health nurse without prior DBS experience. The current study was designed to test a care model that could improve DBS access in 2 ways: first, by reducing the need for the patients to travel to the clinic for DBS postoperative management, and second, by expanding the pool of clinicians who can provide postoperative care to patients. Using home health care to deliver DBS postoperative management is a pragmatic solution, since more than 40% of patients with PD who receive Medicare already use some form of home health care.9 Combined with recent research that demonstrates the efficacy of telemedicine-based preoperative screening,10 effective in-home DBS postoperative management could create a future where the only travel required to receive DBS is for the surgery itself.

    To create a home health management model that could be feasibly implemented in a community setting, we designed the experimental arm of the study for home health nurses who lacked the years of experience thought to be needed to manage patients with DBS to treat PD. To address this issue, we developed the Mobile Application for PD DBS (MAP DBS), a mobile decision support system to aid in DBS programming. MAP DBS contains patient-specific computational models that provide interactive visual feedback on the association between DBS settings and activation of anatomical structures near the active electrode(s). The design of this system was based on a retrospective pilot study,11 which found that the platform provided substantial benefit to expert DBS programmers. We followed this with a prospective study (Gordon Duffley, PhD, written communication, October 9, 2020), which demonstrated that MAP DBS improved the efficacy and efficiency of some aspects of DBS programming performed at expert DBS centers. This first prospective study also allowed us to develop workflows in a controlled clinical environment and provided the experience required to deploy the platform in a home health setting. In this study, we hypothesized that the burden of accessing DBS postoperative care could be substantially reduced by enabling home health nurses to perform DBS postoperative management, including programming, within the home setting.

    Methods

    We conducted a 2-arm clinical trial comparing outcomes between participants who received standard of care (SOC) with those who received home health postoperative DBS management. The study design was a parallel, 1:1 randomized, open-label trial.

    Participants

    Participants provided written consent to trained study personnel from University of Florida (UF) for a ClinicalTrials.gov–registered (NCT02474459) and UF Institutional Review Board–approved protocol (Supplement 1) at the UF Health Norman Fixel Institute for Neurological Diseases in Gainesville. The inclusion criteria were patients between 30 and 80 years old with idiopathic PD who were planning to receive DBS at UF as a part of standard of care for PD or who already had a DBS device implanted by UF but had not yet received DBS programming. Participants resided within 250 miles of the UF clinic in Gainesville, Florida. Participants had to be speakers of fluent English who had not previously undergone DBS programming conducted by a different institution. Those who had unilateral and bilateral procedures (DBS leads implanted 1 month apart) were eligible to participate, but participants were screened to ensure that they did not expect to receive an additional DBS surgery during the 6-month study period. All were implanted with a Medtronic DBS system (ACTIVA PC or SC). The primary caregiver of each participant, usually a spouse, was offered the opportunity to enroll into the study for the collection of caregiver strain data.

    Randomization and Interventions

    Participants were randomized to either SOC or home health. Randomization was performed using stratified blocks of size 4 to control for concurrent changes in DBS management and factors potentially contributing to the likelihood of patients traveling to the UF movement disorders clinic for care. These factors were the number of DBS leads implanted (unilateral or bilateral) and whether participants lived greater or less than 100 miles from the UF clinic. The blocked randomization scheme was generated by study staff (G.D.) at the University of Utah, Salt Lake City. No attempt was made to conceal the randomization from the participant or study personnel.

    Participants randomized to SOC were given a schedule of 5 clinical DBS postoperative management visits during the first 6 months following surgery. In this arm, DBS programming and medication management for patients were performed by experts at the UF clinic (P.Z. and M.S.O.). Participants could undergo extra, unscheduled programming visits if necessary. The SOC programming consisted of a traditional approach. Participants typically saw the same programmer for all visits, although scheduling conflicts caused occasional exceptions. Programmers did not use patient imaging or any decision support system, including MAP DBS, while programming the devices of participants in the SOC arm.

    Participants assigned to the home health arm were given a schedule of 5 DBS postoperative management visits, with the 1-month and 3-month visits occurring in the patients’ homes and the 2-month, 4-month, and 5-month visits occurring via telephone. Telephone visits consisted of the home health nurse (A.W.) calling the participants and recommending DBS setting changes that the participants could make using their patient programming device. The participants assigned to home care were informed that if they were not satisfied with their care, they could receive additional home health visits or appointments with experts at the UF movement disorders clinic. Just as with the SOC arm, expert clinicians performing the in-clinic programming for these participants did not have access to the MAP DBS system. All home health and phone visits were performed by a registered nurse who had no prior experience with PD DBS management. The nurse shadowed expert DBS clinicians at the UF clinic for 4 weeks prior to the start of the study to learn the operation of the programmer tablet and the participant’s remote programmer. Home health postoperative management visits consisted of collecting vital signs, DBS programming with the aid of MAP DBS, medication management, and collection of clinical rating scales. MAP DBS is a mobile decision support system that contains patient-specific lead locations and target nuclei segmentations visualized in both 3 dimensions and overlaid on slices of patient imaging. MAP DBS provides an interface that allows the programming clinician to select a range of DBS stimulation settings and visualize the overlap of the computationally simulated volume of tissue activation with the patient’s target nuclei. The platform enabled the home health nurse to identify stimulation settings that activated tissue within and near the target nuclei, which was used to guide the selection of stimulation parameters. The patient-specific models were downloaded by the home health nurse prior to the patient’s first DBS programming session and used prior to and during each DBS programming session. Additional details of the MAP DBS system are available in other articles,11 as well as the eMethods and eFigure 1 in Supplement 2.

    All participants, regardless of study arm assignment, underwent a postoperative, pre–initial DBS programming baseline and a 6-month visit at the UF clinic for outcome collection. No DBS programming or medication management was performed at either of these study visits.

    Outcomes

    The purpose of the study was to determine whether patients with PD could be safely and effectively managed using home health DBS postoperative care. The primary outcome was the number of times each participant traveled to the UF movement disorders clinic for care between their baseline and 6-month study visits. This metric is subsequently referred to as clinic visits. Secondary outcomes were the change from baseline to 6-month outcomes in PD motor symptoms, as measured by the Unified Parkinson’s Disease Rating Scale part III (UPDRS III) in both the on-medication and off-medication state; overall PD symptom severity, as measured by the total UPDRS (sum of parts I, II, III, and IV) in the off-medication state; PD-associated quality of life, as measured by the 39-question Parkinson’s Disease Questionnaire (PDQ-39); PD medication doses, as measured by levodopa equivalent daily doses (LEDDs; in milligrams); and caregiver strain, as measured by the Multidimensional Caregiver Strain Index (MCSI). The baseline for UPDRS III was the last assessment performed prior to DBS surgery. The baselines for all other rating scales and LEDDs were recorded at the initial postoperative baseline study visit. Baseline rating scales were captured in the off-stimulation state, and all subsequent assessments were done in the on-stimulation state. The MCSI was completed by the primary caregivers who consented to the study. All LEDDs were calculated using the Parkinson Measurement Toolbox (https://www.parkinsonsmeasurement.org). For all rating scales, a negative change from baseline indicates improvement in symptom severity. At the baseline and the 6-month outcomes visits, off-medication UPDRS III assessments were additionally performed via video review by an assessor (S.C.) who was blinded to the study arm of the participant.

    We performed 3 unplanned analyses: a comparison of the number of in-person (clinic or home health) and total DBS postoperative management visits (clinic, home health, and telephone) between study arms; a correlation of participant’s initial DBS postoperative management visit order with the secondary outcomes, to see if the home health nurse improved at DBS programming as the study progressed; and a subanalysis of change in rating scales and LEDDs comparing participants who underwent at least 1 clinic DBS postoperative management visit with participants who were exclusively managed in a home health capacity. We performed this subanalysis to test whether participants who were exclusively managed by home health received effective DBS therapy. Adverse events were captured for all participants while they were active study participants. The severity of adverse events, as well as if they were associated with study procedures, was determined by the study’s clinical principal investigator (M.S.O.). The study was overseen by a data and safety monitoring board.

    Statistical Methods and Sample Size Calculations

    A Mann-Whitney U test was used to evaluate differences in the number of clinic, in-person (home or in clinic), and total DBS postoperative management visits between participants randomized to SOC vs home health. Prior to statistical analysis, participants who discontinued the intervention had the locations of their missed visits linearly extrapolated from their attended visits. Changes in clinical rating scales and LEDD values between the baseline and the 6-month outcomes visits were compared using analysis of covariance, correcting for baseline values as a covariate. Missing rating scale and LEDD data were handled using listwise deletion. To evaluate if the home health nurse’s DBS programming improved over the duration of the study, we computed the Spearman partial rank coefficient, correcting for baseline, between the order of initial DBS postoperative management visits and change in clinical rating scales from baseline for the participants in the home health arm. The Pearson correlation coefficient was used to quantify the agreement between the UPDRS III scores as recorded by the treating clinician and those assessed in a blinded review. Rigidity questions and questions in which the blinded rater (S.C.) felt they could not make an accurate assessment because of video quality were not included in this calculation. Outcomes are reported as mean (SD) values.

    We selected a sample size of 21 participants per group (42 total) to have 80% power to detect a difference in number of clinic DBS postoperative management visits at a 2-sided, 5% significance level, if a participant randomly selected from the home health arm had fewer clinic visits than a patient randomly selected from the SOC arm with 75% probability.

    Participants were recruited for the study between November 1, 2017, and March 20, 2020, and we finished outcome collection on April 24, 2020. Data analysis was completed with Python version 3.7.2 (Python Software Foundation) and Pingouin version 0.3.1 (Raphael Vallat).

    Results
    Study Participants

    Forty-six patients consented to participate in the study, of whom 44 were randomized. Twenty-one patients were assigned to SOC and 23 patients to home health. All 23 patients in the home health arm underwent at least 1 DBS postoperative management visit (mean [SD] age, 65.0 [10.9] years; 13 men), and 18 completed the 6-month outcomes visit. Nineteen participants in the SOC arm underwent at least 1 DBS postoperative management visit (mean [SD] age, 64.1 [10.0] years; 11 men), and 15 of these participants completed the 6-month outcomes visit (Figure 1). Participants assigned to the home health arm had slightly higher PD symptom severity, reflected by a difference in mean (SD) baseline UPDRS III off-medication scores (SOC: 33.5 [9.4]; home health: 40.5 [12.9]). However, mean (SD) levodopa responsiveness levels at baseline were similar between the 2 study arms (SOC: 31.0% [24.0%]; home health: 37.0% [21.0%]) (Table 1). Because the study site (UF) as a standard frequently uses a staged DBS approach, which is safer, especially in older participants, most study participants in both arms had unilateral lead implants during the study period (SOC: n = 11; home health: n = 12).

    DBS Postoperative Management Visits

    We found that participants in the home health arm traveled to the UF movement disorders clinic for care significantly less frequently than participants in the SOC arm (mean [SD]: SOC, 4.8 [0.4] visits; home health, 0.4 [0.8] visits; P < .001). Of the 23 participants randomized to home health, 3 traveled to the UF clinic for a single visit and 2 patients traveled to the UF clinic 2 times each (Figure 2). Because the patients in the home health arm were partially managed using telephone visits, participants randomized to home health also had fewer in-person DBS postoperative management visits (mean [SD]: SOC, 4.8 [0.4] visits; home health, 3.5 [1.0] visits; P < .001). Overall, we found no significant difference in the total number of DBS postoperative management visits (the sum of in-person and telephone visits) for participants in the SOC arm (4.8 [0.4]) compared with those randomized to home health (5.2 [0.7]; P = .06) (eTable 1 in Supplement 2).

    Secondary Outcomes and Safety

    We found no significant differences between the study arms in the change between baseline and 6-month mean (SD) outcomes in UPDRS III off-medication scores (SOC: −5.3 [14.3]; home health: −13.4 [12.6]; P = .27), UPDRS III on-medication scores (SOC: −2.7 [12.7]; home health, −0.4 [9.6]; P = .90), total UPDRS off-medication scores (SOC: −0.8 [20.2]; home health: −16.9 [15.7]; P = .08), or PDQ-39 scores (SOC: −3.9 [23.4]; home health: −9.0 [15.5]; P = .97). The agreement between the original and blinded off-medication UPDRS III ratings were good (Pearson r values: baseline, 0.73; 6-month outcomes, 0.56). Additionally, we found no significant difference in the changes in caregiver strain as measured by mean (SD) MCSI scores (SOC: −4.2 [11.2]; home health: −1.3 [6.7]; P = .53) or in medications as measured by mean (SD) LEDDs (SOC: −86.8 [397.0] mg; home health: −70.5 [438.2] mg; P = .91) between the 2 study arms (Table 2; eFigure 2 in Supplement 2).

    We repeated the analysis to determine if the 24 participants who traveled to the UF clinic for at least 1 DBS postoperative management visit experienced different outcomes than the 18 who were exclusively managed by home health. Participants who were managed exclusively via home health care experienced a significant greater change in total mean (SD) UPDRS off-medication scores compared with those who received some expert care (some expert care: −1.6 [18.7]; home health only: −19.5 [15.5]; P = .04). Similar to the intent-to-treat analysis, there were no significant differences between the 2 subanalysis groups in mean (SD) UPDRS III off-medication values (some expert care: −5.1 [13.1]; home health only: −15.6 [12.8]; P = .20), UPDRS III on-medication values (some expert care: −1.3 [12.2]; home health only: −1.8 [9.7]; P = .85), or PDQ-39 scores (some expert care: −5.0 [21.1]; home health only: −8.9 [17.2]; P = .90). We found no difference in the changes in mean (SD) MCSI scores (some expert care: −3.4 [9.3]; home health only: −1.3 [7.4]; P = .42) or mean (SD) LEDDs (some expert care: −26.9 [428.6] mg; home health only: −152.5 [389.8] mg; P = .40) between the subanalysis groups (Table 2; eFigure 3 in Supplement 2).

    Participants randomized to home health experienced 11 adverse events, 4 of which were classified as serious. Participants randomized to the SOC arm experienced 2 adverse events; neither was classified as serious. No adverse events in either arm were found to be associated with study procedures. None resulted in withdrawal of study participants or modifications to study protocols (Table 3).

    Analysis of Home Health Experience Level

    To evaluate the progression in DBS programming ability of the home health nurse over the course of the study, we calculated the correlation between the initial DBS postoperative management visit order of participants in the home health arm and clinical efficacy of their DBS therapy. The analysis did not reveal any significant correlation between the order of initial DBS postoperative management visits, which indicated the progressively increasing level of DBS programming experience for the home health nurse, with changes in UPDRS III off-medication, UPDRS III on-medication, total UPDRS, PDQ-39, or MCSI scores (eTable 2 in Supplement 2).

    Discussion
    Home Health Management of DBS

    The results of this study provide evidence that home health visits and telephone calls can potentially provide an effective and safe alternative to the traditional in-clinic, expert-based, DBS postoperative care model. The overall effectiveness of DBS therapy in the home health arm of the study was no different from the therapy received by the patients in the SOC arm in this study, with UPDRS off-medication values and PDQ-39 scores with patients in the home health arm receiving similar improvement in symptom severity as those in the SOC arm. The lack of difference between the arms occurred despite the patients in the home health arm having undergone fewer in-person DBS postoperative management visits than the participants in the SOC arm. Our data also show that patients who received some expert care received significantly less benefit than participants who received home health–only management. This result was likely associated with the finding that participants in the home health arm who were not responding well to DBS were more likely to ask for expert care than those who were responding well to home health management. We do not interpret this result to mean that home health management is superior to SOC, but rather, we present data to demonstrate that for at least some patients, exclusive home health management is effective. These results suggest that PD DBS postoperative management, including DBS programming using MAP DBS, warrants further investigation in a larger, multicenter trial.

    Home health postoperative management is likely suitable for most but not all patients with PD and DBS. As demonstrated by the robust clinical outcome of the patients who were exclusively managed at home, at least a subset of patients can receive effective DBS therapy without ever entering the clinic for postoperative management. However, 5 of the 23 participants (22%) in the home health arm underwent at least 1 clinic visit. The reasons participants in the home health arm underwent clinic visits were a combination of hardware complications, non-PD comorbidities, and lack of response to initial DBS programming. One clinic visit occurred because COVID-19 travel restrictions prevented the home health nurse from traveling to the participant’s home. Although clinic postoperative management may be necessary for some patients, it likely does not need to be as extensive as the current SOC; all participants in the home health arm had most of their DBS postoperative management visits in their homes.

    The current DBS postoperative care model needs to be altered, because the time and travel demands associated with multiple clinic visits is burdensome for both patients and caregivers, especially those who live long distances from a DBS center. The primary reason for the repeated visits is DBS programming, which this study demonstrates can be effectively performed by a home health nurse without previous DBS programming experience when provided with our MAP DBS platform. Because of the demands of accessing DBS programming, the therapy is not functionally available to many patients, especially given that the PD population often has difficulty traveling because of severe mobility issues and other comorbidities. Access to DBS is an increasingly important public health problem because of the alarming rate of increase in PD prevalence; it is estimated that approximately 14 million people worldwide will be diagnosed with PD by the year 2040.12 Using home health is a promising direction to address this issue because many patients with PD already receive some form of home health care.9 The current COVID-19 pandemic has also highlighted the need for in-home management options for medical devices such as DBS,13-15 which often require in-person contact for management. In recent years, there has been a growing push to create a more home-centric care model for the treatment of chronic neurological conditions such as PD,16,17 and the pandemic has only further highlighted this need.18-21 Although not directly addressed by this study, the time, burden, and expense of travel contribute to barriers in DBS access, especially in underserved populations.6,22 Patients not only require access to DBS but access specifically during phases of limited disease progression in which DBS has the potential to provide maximal benefit.8,23

    This study demonstrates the capacity for patients to be managed in the home. Additionally, the potential for expansion in home health management of DBS remains substantial. The emergence of reliable, kinetic-tracking wearables for monitoring motor symptom profiles could provide remote clinicians with detailed insights into real-time patient status.24 The information from these wearables could be used to inform clinicians when a patient needs care and guide DBS programming.25,26 Wearables are particularly attractive for their ability to monitor fluctuating symptom profiles.27 Emerging technologies will likely facilitate modification of patients’ DBS devices via the internet by the use of remote DBS programming. This approach has been shown to be effective13,15,28; however, safety and security concerns will require further testing.29,30 Remote programming could be paired with a nurse to provide an effective, travel-free solution, which will expand access to even more patients in the future. Combining remote programming with devices designed to measure patient status (ie, wearables) could result in a future where patients with DBS will be managed completely in the home without in-person follow-up visits.

    Association With Prior DBS Trials

    Higher baseline UPDRS III off-medication scores have been shown to be correlated with larger improvements from DBS.31 To account for this outcome, we tested for differences in changes in rating scales between the study arms, using an analysis of covariance with the baseline as a covariate. Because the home health arm had higher mean baseline scores, it is unsurprising that they trended toward a larger mean improvement than the SOC arm. However, this outcome would not have been possible if the patients did not receive effective DBS programming. After correcting for baseline values, there were no statistically significant differences between the arms in mean improvements in any of the rating scales.

    The relatively small sample size likely increased the variability in the SOC group UPDRS III off-medication changes. However, the level of improvement in UPDRS III scores for the patients in the home health arm was consistent with the benefit reported in large randomized clinical trials of DBS conducted at expert centers.2,3,32 The adverse events in our study were similar to those reported in other major DBS trials.2,32 There was a slight trend toward more adverse events for the participants in the home health arm, but none of the reported events were deemed to be associated with the study protocol.

    MAP DBS

    This study was the second of 2 studies we have done investigating if MAP DBS could disrupt the traditionally expert-based DBS programming care model. Our first study deployed MAP DBS into multiple expert DBS clinics around the US and demonstrated that the platform enabled expert DBS programming clinicians to perform some aspects of programming more efficiently and effectively. Additionally, this first study allowed us to ensure that MAP DBS could be reliably deployed to clinicians performing DBS programming while maintaining the safety net provided by testing the system among experienced DBS programmers. Conducting this study provided us with the experience to safely design and execute the current home health study.

    The collective results of the 2 studies demonstrated that the visual feedback on the effects of stimulation provided by MAP DBS positively altered the DBS programming process. Traditionally, DBS programming is performed entirely on visual and verbal feedback from the patient concerning the benefits and adverse effects of each setting tested. By introducing visual models of activation into the DBS programming process, the typically opaque electrophysiological effects of different stimulation settings are made clear and a more complete picture of the therapy emerges.

    Adapting to Changes in DBS Technology

    At present, DBS systems are evolving in complexity. The additional features available in the current generation of devices recently introduced to the market to improve DBS patient outcomes33 have increased the complexity of DBS programming.34-37 We argue that further improvements in DBS technology could in some scenarios create greater challenges, because as the complexity of DBS devices increases, more specialized training will be required for programming and management. We see potential for improvement in MAP DBS, in that the current version of the platform makes predictions based only on imaging and does not update based on any information gathered during the programming process. Given the recent advances in wearable technology for tracking PD motor symptoms24 and the possibility to stream recordings of a patient’s physiology (eg, local field potentials),38 updated real-time models should be possible. Finally, image-based connectivity markers39 and stimulation sweet spots40,41 could be integrated into the system to allow for automatic predictions of settings.5,42,43

    Limitations

    One limitation was that the primary outcome, the number of times each participant traveled to the movement disorders clinic during the study period, was influenced by differences in the schedules of visits provided to the 2 arms of the study. However, we believe that when evaluated within the context of the strong clinical benefit received by the participants in the home health arm, this intervention can be considered a success. A more powerful study would be designed to show noninferiority in clinical outcomes between home health postoperative management and the SOC, but given the high variability of DBS clinical outcomes, a large multicenter trial would be required to adequately power for noninferiority. An additional limitation is the open-label study design, since we could not identify a practical way of blinding the participants or clinicians.

    Within the broader goal of comparing a home health care model to the current SOC postoperative care model, the 2 study arms differed in 3 ways: (1) expert vs nonexpert programmers, (2) the use of MAP DBS vs traditional programming, and (3) programming in the home vs the clinic. We have previously compared the effect of MAP DBS on expert programmers in a multicenter randomized clinical trial, which showed that some aspects of programming effectiveness and efficiency are improved when experts use MAP DBS. It has also been shown that patients present symptoms differently in the home than the clinic,44 which likely influences the programming process. Future studies should evaluate these variables independently to establish a care model that maximizes benefit and minimizes cost.

    Our study used a single home health nurse caring for patients from a single DBS center. Because we used a single nurse, the experience level of the nurse increased as the study progressed. However, we have no evidence that the home health nurse was a more effective DBS programmer at the end of the study than the beginning. Additionally, our use of a single, centralized home health nurse, who often had to travel long distances, is likely not a cost-effective way to deliver care. This study should be repeated with multiple home health nurses at multiple centers to establish how the care model used in this study generalizes. A challenge for larger-scale implementation of a home health care model will be the training of nurses on the basics of DBS postoperative management. The home health nurse who performed the home health visits for this study shadowed expert DBS clinicians for a 4-week period prior to the initiation of the study. This aspect of the care model is likely not scalable, because multiple logistical hurdles will prevent home health nurses from receiving this level of in-person training. Online simulation-based training may be the most feasible approach for training home health nurses on the basics of DBS postoperative management.45 Training modules could be integrated directly into MAP DBS.

    Conducting a larger, multicenter study could also provide insights into whether DBS telemedicine can improve access for populations who are underserved or lack access to necessary technology (eg, broadband internet, computers, videoconferencing). According to a US Census report, households with internet access, including smartphones and tablets, grew from 74% in 2013 to 81.4% in 2016.46 This growth is expected to continue as internet access becomes more ubiquitous, even in nonmetropolitan areas. Furthermore, 84.7% of those aged 45 to 64 years have internet access. As this group continues to age, the percentage of those 65 years and older who have internet access will likely increase. The pandemic “catalyzed rapid adoption of telehealth and transformed healthcare delivery at a breathtaking pace”47(p957) and has led to more older adults becoming familiar with virtual visits, asynchronous communication, and remote monitoring. However, disparities in access will likely continue, especially for those living in the rural South, those with lower education levels and financial resources, those of Hispanic origin, and those who are not English speaking.47 As we move forward with testing innovative mobile health applications, we need to ensure that our research includes groups with less access to these newer technologies. An associated potential change in a future study is to replace telephone visits with video visits. Despite the possible benefit from video interaction between clinician and patient, technology barriers involved with requiring patients have access to video have the potential to further disparities in terms of access to care.48 Further research could be done comparing the efficacy of phone with video programming visits.

    The use of 3-dimensional visual models on the MAP DBS platform allows for quick localization of the DBS leads relative to the anatomical target, as well as identification of potentially poor lead placement. Although the MAP DBS system supports and has been evaluated for all DBS leads approved in the US, this study was only evaluated using the Medtronic DBS leads, and the MAP DBS system is currently only available on the Apple iOS operating system.

    Conclusions

    This study demonstrated that a home health postoperative DBS care model was safe and feasible and significantly reduced the need for traditional clinic management. Further evidence was collected to demonstrate the capability of the MAP DBS technology to simplify the DBS programming process. Disruption of the traditional expert-based care model should lead to the thoughtful development of new care models designed to substantially reduce the burden on patients and caregivers and improve access to DBS therapy.

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    Article Information

    Accepted for Publication: May 1, 2021.

    Published Online: June 28, 2021. doi:10.1001/jamaneurol.2021.1910

    Corresponding Author: Christopher R. Butson, PhD, Norman Fixel Institute for Neurological Diseases, Program for Movement Disorders and Neurorestoration, Departments of Neurology and Neurosurgery, University of Florida, 3011 SW Williston Road, Gainesville, FL 32608 (butsonc@ufl.edu).

    Author Contributions: Drs Butson and Okun had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Okun and Butson are co–senior authors who contributed equally to this work.

    Concept and design: Duffley, Szabo, Foote, Okun, Butson.

    Acquisition, analysis, or interpretation of data: Duffley, Wright, Hess, Ramirez-Zamora, Zeilman, Chiu, Szabo, Lutz, Okun, Butson.

    Drafting of the manuscript: Duffley, Hess, Lutz, Okun, Butson.

    Critical revision of the manuscript for important intellectual content: All authors.

    Statistical analysis: Duffley, Szabo, Butson.

    Obtained funding: Butson.

    Administrative, technical, or material support: Wright, Hess, Ramirez-Zamora, Lutz, Foote, Okun, Butson.

    Supervision: Ramirez-Zamora, Foote, Butson.

    Other—blinded rater video ratings: Chiu.

    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.

    Funding/Support: The study funder was the National Institute of Nursing Research.

    Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

    Data Sharing Statement: See Supplement 3.

    Additional Contributions: We thank Jens Krüger, PhD, University of Duisburg-Essen, for his collaboration in the development of the ImageVis3D Mobile iOS application. We thank Matt Barabas, MS, Derek Ridgeway, BS, Erin Monari, PhD, and Julie Segura, BA, University of Florida, and Elizabeth Sanguinetti, MS, Melissa Butson, PhD, Elizabeth Nuttall, BA, and Theresa Lins, MS, University of Utah, for their help collecting data and managing the study. They were compensated for their contributions.

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