Research objectives | Components | Methods and instruments |
---|---|---|
Demographic data | Demographic data | Baseline questionnaire with questions on demographics |
Acceptability | 1. Satisfaction with intervention and how intervention is received | 1a. Structured questionnaires for patients on items as readability, comprehensiveness, layout and amount of information 1b. Semi-structured interviews with patients, neurologists and PD nurse specialists with items on perceived satisfaction, and perceived strengths and weaknesses of the intervention |
Level of implementation | 1. To what extent is the intervention implemented as planned 2. To what extent were all components of the intervention used 3. How did participants react to the specific aspects of the intervention and to what extent did patients engage in the intervention 4. What proportion of the included population actually were using the intervention | 1. Field notes to what extent the intervention was implemented as planned and training was provided as planned 2. Analysis of audiotapes consultations, logging data of navigation behaviour website and hard copies of value elicitation tool summary: evaluation if all elements of intervention are actually used 3a. Analysis of audiotapes consultations and logging data of navigation behaviour website to analyse if patients engage in all elements of the intervention 3b. Semi-structured interviews on the perceived interaction with the different elements of the intervention 4. Analysis of audiotapes consultations and logging data of navigation behaviour website to analyse which patients in the intervention group and professionals were using the intervention during the decision process |
Small-scale efficacy testing: - Level of SDM | 1. Patient and neurologist/PD nurse perceived level of SDM 2. Researcher observed level of SDM | 1. Structured questionnaires for patients and neurologists/PD nurse specialists using the following validated scales: SDMQ-9 (patients) and SDMQ-9-doc (neurologists/PD nurse specialists), CollaboRATE (patients) and CPS actual role (patients, neurologists, PD nurse specialists) 2. Analysis of the audiotaped consultations using the validated scale: OPTION-5 |
Small-scale efficacy testing:- Decision quality | 1. Level of informed choice 2. Decisional conflict in decision-making | 1. Measuring knowledge in patients at the start and end of decision-making process using questionnaire with 20 questions on the advanced treatments 2. Structured questionnaires for patients and neurologists/PD nurse specialists using the following validated scales: DCS (patients) and PDPAI (neurologists/PD nurse specialists) |
Feasibility of study procedures | 1. Recruitment 2. Potential outcome indicators 3. Approaches to data collection | 1a. Field notes on study inclusion rate, drop-out rates 1b. Semi-structured interviews with neurologists and PD nurse specialists with items such as barriers to recruitment 2. Analysis of outcome measures from the small-scale efficacy testing with evaluation of conflicting data on outcome measures 3. Semi-structured interviews with patients and neurologists/PD nurse specialists with items on acceptability of the logistics/practicability of the study procedures |
Context | 1. Patient-related factors in the implementation and outcomes 2. Professional-related factors in the implementation and outcomes 3. Organisational context | 1a. Structured questionnaires for patients with items on preferred role in decision-making (CPS), treatment preference, pre-knowledge, health literacy skills (FCHHL) and mood (HADS) 1b. Cognitive testing using MoCA, BSAT, Verbal Fluency, Stroop Color Word Test, National Adult Reading Test, Raven Advanced Progressive Matrices and MMSE 2. Structured questionnaires for neurologists and PD nurse specialists with items on their role in decision-making (CPS), treatment preference and level of experience with treatments 3. Field notes on national consensus of treatment of advanced PD, organisational structure for this specific decision in participating centres |