A Model of Hospital-Territory Management Coordinated by a Case Manager to Improve the Care of Patients With Parkinsonism.

Study Overview
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Brief Summary
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The present multicenter randomized study investigates whether the management of patients with parkinsonism by a nurse specialist (case-manager) can significantly improve patients' quality of life over 12 months, compared to control patients managed with the standard-of-care process. Participants will be evaluated with clinical scales testing quality of life, motor and non-motor symptoms, and the number of unscheduled hospital access throughout the course of the study.

Detailed Description
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Several studies provide evidence that a multidisciplinary management of individuals with Parkinson's disease (PD) including a specialized nurse may offer significant benefits to patients, in the management of disability due to motor and non-motor symptoms as well as in monitoring compliance to therapy and incident adverse events. A number of retrospective studies demonstrated that frequent neurologic consultations and a strict adherence to pharmacological therapy can reduce the risk of hospitalization up to 50%. Falls, fractures, infections and cognitive and motor deterioration represent risk factors for hospitalization in patients with PD. These complications are even more frequent in patients affected by atypical parkinsonisms (e.g. multiple system atrophy and progressive supranuclear palsy). The optimization of management of motor and non-motor symptoms and pharmacological side effects, through telemedicine services carried out by nurses specialized in movement disorders, can prevent falls and hospitalization, increase quality of life and reduce comorbidities and caregiver's burnout. In the present study, a case-manager will follow-up patients and caregivers, cooperating at the same time with other members of a multidisciplinary team (neurologists, psychologists, physiatrists, general practitioners, social assistants), either within or outside the institute where the neurologist visits, aiming to achieve a better global management of frail patients. The present multicenter, randomized, double-blind study will recruit 164 patients affected by Parkinson's disease, atypical parkinsonism or secondary parkinsonism with motor and/or non motor complications, living in the Lombardy region (Northern Italy). Patients will be enrolled in a tertiary referral clinic with expert knowledge ('hub': Fondazione IRCCS Istituto Neurologico Carlo besta) and in a community hospital ('spoke': Azienda Socio Sanitaria Territoriale Nord Milano). The participants will be randomized into two treatment arms: (i) the interventional arm (patients followed by a case manager); (ii) the control arm (the standard-of-care). At the baseline and at the visits at 6 and 12 months, clinical scales and questionnaires will be administered to determine if there are differences between the quality of life and the disability of patients between the two arms of treatment.

Official Title
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A Model of Hospital-territory Management Coordinated by a Case Manager to Improve the Care of Patients With Parkinsonism. A Multicenter, Randomized, Double-blind Study. The PROUD Study

Conditions
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Parkinson Disease, Atypical Parkinsonism, Secondary Parkinsonism, Nurse-Patient Relations, Nurse Physician Relations

Intervention / Treatment
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* Other: Case Manager
* Other: Standard-of-care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Living in the Lombardy region (Northern Italy) Duration of Parkinson's disease, atypical or secondary parkinsonism ≥ 3 years Presence of at least (i) n=1 motor complication and/or (ii), n=2 non-motor symptoms, defined as follows: (i) Motor complication: Motor fluctuations ≥ 2 Falls in the last 6 months Dysphagia (ii) Non Motor symptoms Non-motor fluctuations ≥ 2 items of the non-motor symptoms scale with a score ≥ 2 Exclusion Criteria: Hoehn and Yahr Stage = 5 in the ON-medication condition Psychiatric comorbidity or other neurological chronic diseases that, in the opinion of the recruiting neurologist, could compromise the study participation. Patients on infusional therapies (continuous infusion of levodopa-carbidopa intestinal gel or Continuous Subcutaneous Apomorphine Infusion). Severe medical disease (liver or kidney failure, decompensated heart disease, neoplasms, coagulopathy)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case Manager<br>Patients are followed up by a case manager | Other: Case Manager<br>* Patients are followed up by a nurse specialist in parkinsonism (case manager) who interacts with the treating neurologist and a multidisciplinary team<br>|
| Active Comparator: Standard-of-care<br>Patients are followed up only by the neurologist | Other: Standard-of-care<br>* Patients are managed only by the neurologist according the institution's clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in total score of the Parkinson's Disease Questionnaire 39-items scale | Thi is a 39-items questionnaire assessing the quality of life of patient with Parkinson's disease. The higher the score the lower the quality of life | baseline, week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of unscheduled hospital access over the 12-month study period | The investigators will collect the sum of the number of (i) extra unscheduled outpatient visits, (ii) emergency room visits, (iii) hospital admissions directly or indirectly associated with parkinsonism | baseline, week 26, week 52 | 
| Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part II | This is a scale (MDS-UPDRS) used to assess activities of daily living. The higher the score the worse the Disability | baseline, week 52 | 
| Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part IV | This is a scale (MDS-UPDRS) used to assess complications of dopaminergic therapy. The higher the score the worse the disability | baseline, week 52 | 
| Changes in the Non-Motor Symptoms Scale score | This is a scale used to assess the burden of non-motor symptoms in Parkinson's disease. The higher the score the worse the disability | baseline, week 52 | 
| Changes in the activities of daily living questionnaire | The ADL (Activities of Daily Living) evaluation refers to the fundamental activities of daily life in which the subject is dependent: on a scale from 0 to 6 points, the lower the score, the greater the person's need for assistance | baseline, week 52 | 
| Changes in the instrumental activities of daily living questionnaire | The IADL (Instrumental Activities of Daily Living) evaluation refers to the instrumental activities of daily life in which the subject is dependent (eg using telephone, preparing meals, taking medications, etc): on a scale from 0 to 8 points, the lower the score, the greater the person's need for assistance | baseline, week 52 | 
| Changes in patient experience questionnaire | This is a questionnaire assessing patient perception and satisfaction of the quality of health care | baseline, week 26, week 52 | 
| Changes in EuroQOL-5 Dimensions-5 Levels score | This is a useful and validated instrument to measure quality of life in patients with Parkinson's disease | baseline, week 52 | 
| Changes in the Morisky Medical Adherence scale-8 items score | This is an 8-items scale used to investigate patient adherence to the therapy prescribed by the MD specialist | baseline, week 26, week 52 | 
| Changes in the Zarit Burden Interview scale score | This is a scale used to investigate caregiver's burnout | baseline, week 26, week 52 | 
| Number of incident comorbidities | The number of incident comorbidities over the 12.month study period will be assessed using a semistructured interview | baseline, week 26, week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Case Manager, Parkinson Disease Nurse Specialist