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Table 3 Phase two (RCT) data collection steps, outcomes, processes measures, and confounding variables

From: Tailoring and evaluating an intervention to improve shared decision-making among seniors with dementia, their caregivers, and healthcare providers: study protocol for a randomized controlled trial

Step Outcomes (measures)
Clinician baseline, at recruitment (t0)
 Clinician, at recruitment • Self-reported sociodemographic characteristics (confounding variables)
• Self-reported interest for each of the topics addressed in the C-DB on a 1–10 visual analogue scale
Clinician, during professional training (only for those allocated to the experimental group)
 Before e-TUDE • Role preference scale [63]
• Perceptions of being able to adopt shared decision-making using the ICanSDM scale
• Intention to engage senior patients living with dementia and their caregivers in decision-making about choosing a health intervention, based on the TPB [37, 38]
 After e-TUDE • Satisfaction with e-TUDE (1–5 smiley face scale)
• e-TUDE usability based on the Technology Acceptance Model (TAM-2) [64,65,66]
 After reception of each C-DB • Satisfaction with DB (1–5 smiley face scale)
• DB usability based on the Technology Acceptance Model (TAM-2) [64,65,66]
• Value of the evidence presented in the P-DB, measured using the clinician version of the IAM [43, 67]
 When training is completed • Role preference scale [63]
• Perceptions of being able to adopt shared decision-making using the ICanSDM scale
• Intention to engage senior patients living with dementia and their caregivers in decision-making about choosing a health intervention, based on the TPB [37, 38]
Patient baseline, before clinical consultation (t0)
 Able patient • Sociodemographic characteristics of the patient: self-reported by the patient (confounding variable)
• Patient empowerment using the Healthcare empowerment questionnaire [47] (patient PRIMARY outcome)
• Patient quality of life using the French-validated QoL-AD [50, 51] (patient outcome)
 Caregiver of able patient • Self-reported sociodemographic characteristics of the caregiver (confounding variable)
• Caregiver empowerment using the Healthcare empowerment questionnaire [47] (caregiver outcome)
• Caregiver burden [48, 49] (caregiver outcome)
• Patient quality of life using QoL-AD [50, 51] (patient outcome)
 Caregiver (and legal representative) of unable patient • Self-reported sociodemographic characteristics of the caregiver (confounding variable).
• Sociodemographic characteristics of the patient (confounding variable)
• Caregiver empowerment using the Healthcare empowerment questionnaire [47] (caregiver outcome)
• Caregiver burden [48, 49] (caregiver outcome)
• Patient quality of life using QoL-AD [50, 51] (patient outcome)
During consultation  
 Audio-recordings of the clinical consultations (OPTION-12) • Patient involvement in decision-making, using the third-observer OPTION-12 scale [44,45,46] (process measure)
After clinical consultation (t1)
 Able patient • Self-reported comfort-level with decision-making measured with the Decisional conflict scale [54, 55] (patient PRIMARY outcome)
• Self-reported perceptions of the decision-making processes using the 3-item Collaborate instrument [52, 53] (process measure)
• Questions about the clinical visit
 Caregiver of able patient • Self-reported comfort-level with decision-making measured with the Decisional conflict scale [54, 55] (caregiver outcome)
• Self-reported perceptions of the decision-making processes using the 3-item Collaborate instrument [52, 53] (process measure)
• Questions about the clinical visit
 Caregiver (and legal representative) of unable patient • Self-reported comfort-level with decision-making measured with the Decisional conflict scale [54, 55] (caregiver outcome)
• Self-reported perceptions of the decision-making processes using the 3-item Collaborate instrument [52, 53] (process measure)
• Questions about the clinical visit
Six months after clinical consultation (t2)
 Able patient • Patient empowerment using the Healthcare empowerment questionnaire [47] (patient PRIMARY outcome)
• Patient quality of life using the QoL-AD [50, 51] (patient outcome)
 Caregiver of able patient • Caregiver burden using a French-validated questionnaire [48, 49] (caregiver outcome)
• Decisional regret [56, 57]
• Patient quality of life as perceived by the caregiver QoL-AD [50, 51] (patient outcome)
• Caregiver empowerment using the Healthcare empowerment questionnaire [47] (patient PRIMARY outcome)
 Caregiver (and legal representative) of unable patient • Caregiver burden using a French-validated questionnaire [48, 49] (caregiver outcome)
• Decisional regret [56, 57]
• Patient quality of life as perceived by the caregiver using the QoL-AD [50, 51] (patient outcome)
• Caregiver empowerment using the Healthcare empowerment questionnaire [47] (patient PRIMARY outcome)
  1. C-DB clinician-decision box, P-DB patient-decision box