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Abstract

Background:

Parkinson’s disease (PD) is a progressive neurodegenerative disorder with a myriad of motor and non-motor symptoms. Although deep brain stimulation (DBS) has a dramatic impact in the lives of people with PD, care delivery remains complex. There is a lack of evidence on the implementation and role of integrated care and self-management support in people with PD and chronic DBS.

Objective:

To evaluate care needs, implementation and impact of a pragmatic network for PD care, the Integrated Parkinson Care Network (IPCN) in people with PD and chronic DBS.

Methods:

This is a subgroup analyses of a 6-month, pre–post design, single-centre, phase 2 study to assess a patient-centred care model based on integrated care, self-management support in PD (IPCN), focusing on those participants with chronic DBS.

Results:

We included 22 people with PD and chronic DBS (median time since DBS - 30 months). The mean age was 63.9 (7.6) years and mean disease duration was 15.2 (6.9) years. The top three care priorities were speech (54.5%), mobility (40.9%) and mood (31.8%). After the IPCN program, there was a positive change in the perception of support for chronic care (Patient Assessment of Chronic Illness Care +: –0.84; 95% CI: –1.2 to –0.5) and self-management (5As: –0.77; 95% CI: –1.1 to –0.4), along with quality of life (PDQ8 : 7.1, 95% CI:1.8 –12.4).

Conclusion:

The IPCN is a care delivery model that addresses specific care needs of people with PD and chronic DBS. The current study showed its feasibility and warrants further evaluation.

Keywords

Parkinson’s disease deep brain stimulation care quality of life

INTRODUCTION

Parkinson’s disease (PD) is a neurodegenerative disorder with a wide spectrum of both motor and nonmotor symptoms which contribute to the overall disease burden. The treatment of PD is limited to symptom management. Deep brain stimulation (DBS) is known to improve quality of life (QoL) in patients with PD and motor complications [1]. There is robust evidence that, in well-selected candidates, DBS can lead to significant impact on the motor aspects of PD, with a clinically meaningful reduction of off-time and improvement in the on-time without disabling dyskinesia [2]. Nevertheless, DBS does not prevent disease progression and people with PD (PwP) eventually experience symptoms such as gait difficulties, balance, speech and cognitive impairment, which become key determinants of worsening QoL [3]. In addition, the motor improvement and QoL measures observed after DBS in PD do not necessarily translate into a positive subjective outcome as reported by PwP [4]. A negative subjective perceived outcome after DBS may be experienced by as much as 25% of PwP with bilateral subthalamic nucleus (STN)-DBS [4], which has been associated with unrealistic expectations of benefit, pre-existing apathy, depression, and the experience of symptoms non-responsive to DBS [5]. Other factors like poor selection of candidates for DBS, suboptimal lead implantation and programming can also lead to poor outcomes after DBS [6]. In addition, in a scenario of successful DBS, PwP can encounter challenges to re-adjust to personal, familial, and socio-professional roles [7].

In PD, various integrated care models have been tested. These care models vary in terms of care setting, care team composition, level and mode of clinical integration. A meta-analysis of randomized controlled trials evaluating integrated care reported a significant but modest effect of outpatient-based care delivery models on QoL compared to standard of care [8]. The meta-analysis also evaluated levels of care integration using the Rainbow Model of Integrated Care [9], and found that clinical and professional integration was more commonly present compared with organizational and population-based integration elements.

Considering the various determinants of QoL in PwP after DBS and the current evidence on integrated care in PD, we hypothesize that integrated care with emphasis on self-management support and patient education could help PwP navigating these care issues better in their lives. We also evaluated how care needs are contingent on the stage of the disease considering those recently diagnosed and a more advanced disease stage with more complex care needs. There are many unanswered questions about the adequacy and impact of integrated care models based on the stage of PD.

In this study, we aimed at evaluating the feasibility and the potential impact of a pragmatic care delivery model in PwP and chronic DBS on a range of patient-centred and physician-reported health outcomes.

METHODS

We conducted a 6-month pre-post study to evaluate an integrated care delivery intervention (Integrated Parkinson’s care network, IPCN) in PwP regularly followed at a tertiary movement disorders clinic [10]. In this study, we evaluated the group of PwP with chronic DBS, initially enrolled in the strata of “patients with more complex care needs” which was pragmatically defined by a PD clinical diagnosis more than 8 years or off-state Hoehn and Yahr stage equal or greater than 3, with preserved autonomy, without significant dementia (based on the clinician judgement), and not living in a chronic care facility.

The IPCN is a care delivery model based on integrated care, self-management support and technology-enabled care. The clinical care integrator (CCI), a specialized PD nurse, plays a central role in the IPCN with promotion of its care values, namely, developing a tailored care plan for each study participant based on their care priorities in a spirit of shared decision making. The program started with a 90-minute visit with the CCI to define care plan and facilitation of access to appropriate health care resource in the community that form a virtual care network. Thematic tip sheets based on current evidence and guidelines were created as a vehicle of education for study participants on a range of care needs. The participants were followed at one month by phone to review the implementation of the care plan and provision of additional support they needed. At three months, an optional in-person visit with the CCI was offered. Outside the study scheduled visits, the CCI was reachable by telephone or e-mail. At 6 months, there was a close-out visit to evaluate the degree of completion of the personal care path. The study was conducted after approval from the institutional ethics review board. The study was conducted in accordance with the Helsinki Declaration of 1975.

Study outcomes

Processes outcomes

We identified the type and prevalence of care priorities of study participants in the initial visit. We also collected data on the use of the various health resources available in the IPCN and the degree of completeness of individual care paths. We also evaluated the accessibility to a family physician before enrolling in the care program, and the rate of successful referral for those participants without access to a family physician at baseline.

Health outcomes

We used a combination of patient-centred and physician-reported health outcomes. Patient-centred outcomes included the Parkinson’s Disease Questionnaire–8 items (PDQ-8) [11], the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS Parts Ib and II) [12], the Geriatric Depression Scale [13], the Clinical Global Impression – Change and Clinical Global Impression–Satisfaction Scales, and the Zarit Caregiver Burden Questionnaire [14]. We also assessed the patient perception of care for a chronic condition using the Patient Assessment of Chronic Illness Care + [15] (PACIC+) and a Likert-type scale for patient and caregiver satisfaction of the program. The physician-reported outcomes included the MDS-UPDRS Part Ia and III [12] and a clinician-reported Clinical Global Impression–Change (CGIC). The assessments were completed at baseline, 3-and 6-month visits.

Data analyses

We used descriptive statistics (means and standard deviations) for continuous variables with normal distribution and frequencies or proportions for categorical variables. Median and interquartile range (IQR) was used for data with skewed distribution. Group differences at baseline were assessed using a t test for continuous variables.We conducted a repeated-measures linear regression analysis of the outcomes at baseline and 3 and 6 months using restricted maximum likelihood estimation with suitable covariance structure to account for correlation over time. The unadjusted least square means change from baseline to 3 and 6 months (with 95% confidence interval [CI]) was obtained from the model. All the statistical analyses was conducted on SAS Studio (version 5.2, SAS Institute Inc. 2019)

RESULTS

We included 22 PwP with bilateral STN-DBS and a median time since lead implantation of 30 months (IQR:38.8 months). The mean (SD) age was 63.9 (7.6) years and disease duration was 15.2 (6.9) years. At baseline, the mean score of the MDS-UPDRS part III in ON state was 24.1 (10.8) and the PDQ-8 was 37.6 (5.6). History of falls was present in 36.4% of the participants and subjective cognitive impairment was reported in 36.4%. The median Levodopa equivalent daily dose (LEDD) pre-DBS was 1408.6 mg (IQR: 993.5) with a significant reduction in LEDD to 674.3 mg (CI: 392.2 to 956.4 mg, paired t test, p < 0.001) at study baseline. (See Table 1 for additional demographic and clinical characterization).

Table 1

Baseline demographic and clinical characteristics of the study participants

	Mean (SD)
Age (y)	63.9 (7.58)
Gender	16 (M) 6(F)
Education
College degree, n (%)	4 (18.2%)
Secondary education (grade 7–12), n (%)	4 (18.2%)
University(Post Graduate), n (%)	4 (18.2%)
University level undergraduate, n (%)	10 (45.5%)
Married/Common law, n (%)	18 (81.8%)
Duration of disease, y	15.2 (6.99)
Cognition, n (%)	7 (31.8%)
Falls, n (%)	8 (36.4%)
MDS-UPDRS Part I score	11.0 (3.05)
MDS-UPDRS Part II score,	18.2 (8.42)
MDS-UPDRS Part III score	24.1 (10.82)
PDQ-8	37.6 (5.65)
PACIC+	2.47 (0.33)
5As	2.59 (0.37)

Values are expressed as mean and standard deviation unless otherwise stated. MDS-UPDRS, Movement Disorder Society–Unified Parkinson’s Disease Rating Scale; PDQ-8, Parkinson’s Disease Questionnaire–8; PACIC+, Patient Assessment of Chronic Illness Care +.

Care path in the IPCN

The care priorities more frequently elicited in the IPCN in this group of PwP with chronic DBS were speech and communication (54.5%), mobility, balance and falls (40.9%), and anxiety and depression (31.8%). Other care priorities chosen by participants have been tabulated Supplementary Table 1. After the initial encounter with the CCI, the most used healthcare resources were speech-language pathology (78.3%), physiotherapy (43.4%), and community seniors services (34.8%), accordingly (Supplementary Table 2). At the final visit, 77.7% (n = 54) of the referrals were completed. Supplementary Table 3 tabulates the referral and completion of various health care resources. The healthcare resource with the lowest rate of completed referral was speech-language pathology (50%). At the end of the IPCN program, 45.4% participants were “very satisfied”, 40.9% were “satisfied”, and only 13.6% were “not satisfied” with the IPCN program. Caregivers rated their satisfaction as “very satisfied” (45.4%) or “satisfied” (45.4%).

Change in health outcomes after completion of the IPCN program

At 6 months, there was an improvement in perception of chronic care (PACIC+: –0.84; CI: –1.2 to –0.5) and self-management (5As: –0.77; CI: –1.1 to –0.4) (Table 2). In addition, we found a positive change in quality of life (PDQ-8 : 7.1, CI: 1.8 to 12.4), MDS -UPDRS part III (3.5, CI: 0.4 to 6.6) and an overall clinical improvement (CGI-change) reported by 86.4% of the participants.

Table 2

Changes in health outcomes and care perception by study participants

	Estimate 3 mo	95% CI 3 mo	Estimate at 6 mo	95% CI 6 mo	P Baseline vs. 3 mo	P Baseline vs. 6 mo
5As	–0.88	–1.34 to –0.43	–0.77	–1.15 to –0.39	0.0006	0.0003
PACIC+	–0.87	–1.32 to –0.42	–0.84	–1.22 to –0.47	< 0.0001	< 0.0001
MDS-UPDRS Part I Score	1.04	–0.30 to 2.39	0.90	–0.58 to 2.40	0.12	0.22
MDS-UPDRS Part II Score	1.63	–0.04 to 3.32	1.09	–0.71 to 2.90	0.05	0.22
MDS-UPDRS Part III score	2.13	–0.82 to 5.09	3.50	0.41 to 6.58	0.14	0.0281
PDQ 8	6.39	0.52 to 12.26	7.10	1.75 to 12.44	0.03	0.01
Zarit	1.36	–1.38 to 4.12	0.84	–2.44 to 4.13	0.31	0.60

Results presented correspond to the difference between baseline and study visits at 3 and 6 months using linear mixed effects regression analysis (unstructured covariance matrix). CI, confidence interval; PDQ-8, Parkinson’s Disease Questionnaire–8; MDS-UPDRS, Movement Disorder Society–Unified Parkinson’s Disease Rating Scale; PACIC: Patient Assessment of Chronic Illness Care; mo, months.

DISCUSSION

In this study, we found that the IPCN was feasible as a care model documented by the ability to meet satisfactorily the care needs of PwP and chronic DBS and the role of care partners.

In contrast to patients who are newly diagnosed [10], speech and communication were the most common care priority in this subgroup of PwP with DBS and speech-language pathology was the most utilized health resource. There are no studies which have evaluated care needs and subsequent use of health resources in PwP with DBS. This finding is likely related to the negative impact DBS can have on speech. A recent systematic review reported that bilateral STN-DBS (the DBS procedure observed in our cohort) was often associated with deterioration of speech [16]. Speech and communication dimension in QoL have the least improvement after STN-DBS [17]. Additionally, PwP who have received bilateral STN-DBS have highly variable speech change scores over time and a more heterogeneous speech symptom profile, with worse outcomes compared to PwP whose symptoms are managed with medical management only [16].

We explored the change in health outcomes after completion of the IPCN program in PwP and chronic DBS. There was a positive experience of care in the IPCN concomitant with a clinically meaningful change in QoL as measured by the PDQ-8 in this specific subgroup of patients [18]. In this study, the study population had a median time since lead implantation surgery of 30 months, when DBS is expected to continue to have a strong impact, with lesser detrimental effect of disease progression.

The positive change in QoL of PwP with DBS suggests that although DBS leads to improvement in motor symptoms, care optimization has a place in the life of this selected group of PwP and can enhance experience of life further.

At our centre, standard of care for PwP with chronic DBS includes regular follow-up with a movement disorder specialist and a DBS nurse based on care needs, either telephonically or in person. There is an open line of communication with the care team and referrals are optimized to psychiatry, social worker and community support. In this scenario, the current data suggest that IPCN focusing on proactive management of care needs of PwP with chronic DBS and their care partners can further improve QoL.

The current study has limitations. We conducted a subgroup analyses of a pilot study [10] and thus the current results and the hypothesis formulated require further evaluation in future research. The study was not powered to answer questions about the cost effectiveness or evaluate which individual care components had the highest impact in this group of patients compared with those with advanced PD without DBS. Larger studies focusing on this subgroup are warranted to address these unanswered questions. Additionally, women were underrepresented in this study, which may limit generalizability. This finding is in agreement with most of the clinical trials in PD and the gender imbalance in recruitment is particularly more marked in trials of neurosurgical interventions [20].

In the future, it will be relevant to consider if care delivery paradigms such as the IPCN focused on self-management and patient education could have a place during the process of preparation for DBS and soon after the DBS implantation and initial programming. It is now known that patients with unrealistic expectations, or with suboptimal education on the benefits of DBS prior to surgery, report lower postoperative satisfaction or QoL [21, 22]. The early post-operative period is demanding for PwP, with numerous personal, familial and socio-professional adjustments reactive to a new “normal” [23]. The improvement in self-management and the support to patient navigation provided by the IPCN may serve as a pre-habilitation before DBS and mitigate the impact of burden of normality syndrome after DBS [24]. There is emerging evidence about the beneficial effects of designing specific rehabilitation programs in perioperative period on measures of social adjustment and mental health well-being [25].

In summary, the current study explores a line of enquiry not explicitly evaluated in the development of other integrated care models, in PD, i.e., individualization of integrated care delivery according to different stages defined pragmatically in terms of expected care needs. The analyses herein reported further explore this concept by looking at a group with chronic DBS and provides preliminary evidence that specific needs of PwP with chronic DBS may be addressed with a tailored integrated care program that supports self- management and patient navigation in the health care system with better care satisfaction and possible gain in QoL.

Footnotes

ACKNOWLEDGMENTS

We acknowledge the collaborators Dr. Ahmed Basndwah and Dr. Heba Shinawi for their roles in data collection during the study.

The funding agencies are The Physicians Service Foundation, Ontario, Canada, and Parkinson Research Consortium and University of Ottawa Brain and Mind Research Institute, Ottawa, Ontario, Canada.

CONFLICT OF INTEREST

Tiago A. Mestre received speaker honorarium from AbbVie and the International Parkinson and Movement Disorder Society; consultancies from CHDI Foundation/Management, Sunovion, Valeo Pharma, Roche, nQ Medical, and Merz; advisory board from AbbVie, Biogen, Sunovion, and Medtronic; and research funding from the EU Joint Programme— Neurodegenerative Disease Research, uOBMRI, Roche, Ontario Research Fund, CIHR, MJFF, Parkinson Canada, PDF/PSG, LesLois Foundation, PSI Foundation, Parkinson Research Consortium, and Brain Canada. David Grimes received honorarium for speaking from Sunovion, Paladin Labs Inc and honorarium for consulting from Sunovion, Paladin Labs Inc, research funding from CIHR, Genzyme Corporation/Sanofi Canada, Eli Lilly and Company, CIHR, Parkinson Canada, Brain Canada, Ontario Brain Institute, PSI Foundation, Parkinson Research Consortium, EU Joint Programme – Neurodegenerative Disease Research, uOBMRI. Deepa Dash has received research funding from Parkinson Canada.

Diane Cote and Jennifer Conway have no financial disclosures.

The supplementary material is available in the electronic version of this article: .

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Evaluation of the Impact of Integrated Care and Self-Management After Deep Brain Stimulation in Parkinson’s Disease

Abstract

Background:

Objective:

Methods:

Results:

Conclusion:

Keywords

INTRODUCTION

METHODS

Study outcomes

Processes outcomes

Health outcomes

Data analyses

RESULTS

Care path in the IPCN

Change in health outcomes after completion of the IPCN program

DISCUSSION

Footnotes

ACKNOWLEDGMENTS

CONFLICT OF INTEREST

References