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A feasibility study of a SDM intervention for the decision making process in advanced Parkinson’s disease

A feasibility study of a SDM intervention for the decision making process in advanced Parkinson’s disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21200
Enrollment
40
Registered
2017-08-28
Start date
2015-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Parkinson's disease Parkinson

Interventions

It is a before- after design. For the pre-intervention group, patients will receive information and decision support as usual. The decision process of an individual patient ends when a preliminary ch

Sponsors

Radboud Institute for Health Sciences, Department of Neurology
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Five hospitals will participate and are selected from our previous studies. Specialised neurology centers and community based hospitals will be represented, because they have differential access to advanced PD treatments. Neurologists in these hospitals will be eligible if they (1) consider at least five PD patients per year for advanced treatment; and (2) collaborate with a PD nurse specialist in the same hospital. We aim for a total of five to ten neurologists, each participating centre may provide more than one neurologist. Moreover, we aim to include professionals with different levels of expertise on the advanced treatment options. Patients may be included if they: 1) are diagnosed with advanced PD and are considered for advanced treatment, judged by their own neurologist; and 2) are eligible for all three treatments at the beginning of the decision-making process.

Exclusion criteria

Exclusion criteria: Exclusion criteria for patients are: Current or previous advanced treatment for Parkinson's Disease

Design outcomes

Primary

MeasureTime frame
This feasibility study will focus on four aspects, being acceptability, level of implementation, small-scale efficacy testing, and evaluation of study procedures, each with their own relevant outcome measures (see secondary outcomes for more detail) In order to increase cross-validation of the data contextual factors will also be measured.

Secondary

MeasureTime frame
1) acceptability is tested by: a)structured questionnaires for patients on items as readibility, comprehensiveness, layout and amount of information b) semi structured interviews with patients, neurologists and PD nurse specialists with items on perceived satisfaction, and perceived strengths and weakneses of the intervention 2) level of implementation is tested by: a) field notes to what extent the intervention was implemented as planned and training was provided as planned b) analysis of audiotapes consultations, logging data of navigation behaviour website, hard copies of value elicitation tool summary: evaluation if all elements of intervention are actually used c) Analysis of audiotapes consultations, logging data of navigation behaviour website to analyse if patients engage in all elements of the intervention d) semi structured interviews on the operceived interaction with the different elements of the intervention e) Analysis of audiotapes consultations, logging data of navigation behaviour website to analyse which professionals and patients in the intervention group actually used the intervention 3) small-scale efficacy testing:level of SDM a) patient and neurologist/PD nurse specialist perceived level of SDM: SDMQ-9,SDM-Q-9-doc, CollaboRATE, actual decision role(CPS) b) researcher observed level of SDM: analysis of audiotaped consultations using OPTION-5 3) small-scale efficacy testing:decision quality a) level of informed choice: measuring knowledge of patients on the advanced treatments in questionnaires at start and end of decision-making process b) decisional conflict in decision-making: structured questionnaires for patients and neurologists/PD nurse specialists using Decisional conflict Scale and PDPAI 4) feasibility of study procedures: a) field notes on study inclusion rate, drop-out rates b) semi structured interviews with neurologists and PD nurse specialists with items such as barriers to recruitment c) analysis of outcome measu

Contacts

Public ContactF. Nijhuis
f.nijhuis@cwz.nl0031-243658335

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)