Skip to main content

Table 3 Outcomes, measurement instruments and timing

From: Facilitating advance care planning in the general practice setting for patients with a chronic, life-limiting illness: protocol for a phase-III cluster-randomized controlled trial and process evaluation of the ACP-GP intervention

  Measurement tool Completed by Timing of measurement
Primary outcome    T0 T1 T2
Level of engagement with ACP ACP Engagement Survey 15-item version [24]
• Reported on an overall average 5-point Likert scale (range 1–5)
Patient X X X
ACP Self-efficacy ACP Self-efficacy Scale (ACP-SE) [25]
• 17 items
• Reported on an overall average 5-point Likert scale (range 1–5)
• 1 additional general item including all advance care planning can be used for comparison to the scale
GP X X X
Secondary outcomes
 Health-related quality of life Short Form Health Questionnaire (SF-12v2) [26]
• Physical Health (PCS) and Mental Health (MCS) summary scores (range 0–100)
Patient X X X
 Anxiety Generalized Anxiety Disorder Questionnaire (GAD-7) [27]
• Sum score (range 0–21)
Patient X X X
 Depression Patient Health Questionnaire (PHQ-9) [28]
• Sum score (range 0–27)
Patient X X X
 Appointment of a substitute decision maker GP report
ACP engagement survey “readiness to sign official papers assigning a SDM” item
Patient
GP
X X X
 Completion of new ACP documents Patient report
GP report
ACP engagement survey “readiness to sign official papers stating medical wishes” item
Patient   X X
 Thinking about ACP 1 self-developed item, 10-point Likert (“How much have you thought about ACP in the last 3 months?”; response categories range from “not at all” to “very much”) Patient X X X
 Communication with the GP 4 self-developed items, 10-point Likert (e.g., “To what extent did the GP listen to your concerns about your future health?”; response categories range from “not at all” to “very much”) Patient X X X
 ACP Practices Next Steps training program questionnaire [29] (4 items)
• 2 items specific to practices with patients with chronic, life-limiting illness (“Which percentage of your patients has a chronic, life-limiting illness” and “With which percentage of your patients with a chronic, life-limiting illness do you conduct ACP conversations?”; 4 response options per item) [25]
• 8 additional items regarding ACP practices (e.g., “Where do the ACP conversations you conduct usually take place?”)
GP X X X
 ACP Attitudes Next Steps training program questionnaire [29]
• 9 items; 5-point Likert scale ranging from “Completely disagree” to “Completely agree”; adapted to the Belgian legal context
GP X X X
 ACP Knowledge Next Steps training program questionnaire [29, 30]
• 10 items; correct/not correct/don’t know; adapted to the Belgian legal context
GP X X X
 Documentation of ACP discussion outcomes Documentation template review GP   X X
 Level of engagement with ACP ACP Engagement Survey, substitute decision maker version [31]
• 17 items; 5-point Likert scales
• 3 domain scores (“Serving as SDM”, “Contemplation”, Readiness”) computed as the unweighted average of items per domain (range 1–5)
SDM X X X
Other measurements
 Demographic information For patients and surrogate decision makers:
• Gender
• Age
• Marital status
• Highest completed education
• Religion
• Patient/SDM relationship
• Whether patient and SDM live together or apart
For patients:
• Previous completion of any advance directives (“wilsverklaringen”)
For surrogate decision makers:
• How long they have known the patient
For GPs:
• Gender
• Age
• Graduation year
• Practice setting(s)
• Years of experience as a GP
• Graduating university
• Working in a palliative home care team (yes/no)
• Working as a “coordinating and advising practitioner” in a residential care facility (yes/no)
• Prior formal ACP education or training (intensive/introductory/none)
• Prior formal palliative care education or training (intensive/introductory/none)
GP
Patient
SDM
X   
Process evaluation
RE-AIM domain Operationalization Measurement
Reach • Comparing the characteristics of participating patients with non-participants • Documentation of the recruitment process by the researchers
• Documentation of reasons given for not participating
• Participant demographics
Efficacy/effectiveness • Primary and secondary outcomes of the RCT • See primary and secondary outcomes above
• Reports of any adverse effects
Adoption • ACP discussion documents uploaded
• Patient use of the work booklet
• Experiences of GPs and patients applying intervention steps
• Changes in GP practice
• Training topic checklist (after each training)
• Questionnaire for GPs regarding their ACP practices and conversations in the last 3 months (T1)
• Questionnaire for patients regarding ACP conversations with their GP in the last 3 months (T1)
• Documentation template review (T1, T2)
• Contents of work booklet from a sample of patients in the intervention group (physical copy or digital scan) (T1, T2)
• Check-in discussions between GPs and trainers (continuous)
• Focus groups with GPs (after T2)
• Semi-structured interviews with patients and SDM (after T2)
Implementation • Fidelity: the extent to which the steps of the intervention were followed as specified in the protocol
• Patient and GP barriers/facilitators to following the steps of the intervention
• Satisfaction of GPs and patients with the intervention components
• Training topic checklist (after each training)
• Check-in discussions between GP and trainers (continuous)
• Audio recordings of ACP consultations between GP and patient (and SDM if present)
• Documentation template review (T1, T2)
• Satisfaction questionnaire for intervention GPs and patients (T1)
• Focus groups with GPs (after T2)
• Semi-structured interviews with patients and SDM (after T2)
Maintenance • GP intention for using the intervention materials in the future
• Recommendations by the GP and patients to improve intervention usability in the future
• Satisfaction questionnaires for intervention GPs and patients (T1)
• Focus groups with GPs (after T2)
• Semi-structured interviews with patients and SDM (after T2)