Table 3.
Phase two (RCT) data collection steps, outcomes, processes measures, and confounding variables
| 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) [64–66] |
| After reception of each C-DB | • Satisfaction with DB (1–5 smiley face scale) • DB usability based on the Technology Acceptance Model (TAM-2) [64–66] • 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 [44–46] (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) |
C-DB clinician-decision box, P-DB patient-decision box