Mobile Decision Support System for Nurse Management of Neuromodulation Therapy

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Parkinson's Disease

Treatments: Device: iPad-Based Clinical Support Care; Other: Standard Clinical Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02474459

IRB # 82859

R01NR014852 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to test the use of a clinical decision support tool for postoperative care of Parkinson's disease patients who are treated using deep brain stimulation (DBS). The central hypothesis is that the use of a DBS clinical decision support system for individual patient management will enable considerable time savings and reduced burden on patients and caregivers.

Full description

The proposed study will evaluate outcomes for Parkinson's disease (PD) patients who are treated with unilateral deep brain stimulation (DBS); patients who consent to the study will be randomized to standard care or the experimental group. The study will occur in two phases.

Phase I:

Both the standard care and experimental groups will be medically evaluated identically, but the programming will be different between the groups as the experimental group will be programmed using the iPad. Patients in the control and experimental groups will be monitored with the same frequency at each participating clinic. Data and safety monitoring is the responsibility of each participating PI and the lead PI as the protocol involves minimal risk or no more than a minor increase over minimal risk. We anticipate that a single nurse at each site will perform DBS programming.

Phase II:

Patients in the experimental group will be evaluated and programmed by home health nurses in the patient's home setting. Neurological exams in the clinic will be performed at the first post-operative DBS programming session and 6 months later (the proposed end of the experimental period for each patient). During the intervening period, DBS programming and patient evaluations will be performed by a home health nurse. during this phase, data and safety monitoring will be conducted by a DSMB, which will meet regularly to review all cases and ensure safety. All subjects will be recruited directly through the participating sites' clinic systems, and all subjects will have oral and written informed consent before participation in the study. We anticipate that up to two home health registered nurses (RNs) will be performing DBS programming in phase 2.

Enrollment: 123 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of idiopathic Parkinson's Disease
• Planning to receive a DBS device at a participating site.
• Had a DBS device implanted, at a participating site, that hasn't been programmed yet

Exclusion criteria

• Had a DBS device implanted at a non-participating site.
• Any previous DBS programming

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

iPad-based Clinical Support Care

Active Comparator group

Description:

Subjects in this treatment arm will receive deep brain stimulation (DBS) programming at regular intervals as part of routine clinical care. DBS stimulation programming will be performed using an iPad-based decision support system. Outcomes will be measured using the Unified Parkinson's Disease Rating Scale (UPDRS), Parkinson's Disease Questionnaire (PDQ-39) and the Multi-Dimensional Caregiver Strain Index (MCSI).

Treatment:

Device: iPad-Based Clinical Support Care

Standard Clinical Care

Active Comparator group

Description:

Subjects in this treatment arm will receive DBS programming at regular intervals as part of routine clinical care. Outcomes will be measured using the Unified Parkinson's Disease Rating Scale (UPDRS), Parkinson's Disease Questionnaire (PDQ-39) and the Multi-Dimensional Caregiver Strain Index (MCSI).

Treatment:

Other: Standard Clinical Care