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

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

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

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.

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.

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

Patients are followed up by a nurse specialist in parkinsonism (case manager) who interacts with the treating neurologist and a multidisciplinary team

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

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

This is a scale (MDS-UPDRS) used to assess activities of daily living. The higher the score the worse the Disability

This is a scale (MDS-UPDRS) used to assess complications of dopaminergic therapy. The higher the score the worse the disability

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

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

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

This is a useful and validated instrument to measure quality of life in patients with Parkinson's disease

This is an 8-items scale used to investigate patient adherence to the therapy prescribed by the MD specialist

The number of incident comorbidities over the 12.month study period will be assessed using a semistructured interview

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)

Data obtained through this study may be provided to qualified researchers with academic interest on this topic. Data shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party

Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.

Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement. For more information or to submit a request, please contact crc@istituto-besta.it

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