Skip to main content

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