Chronic, life-limiting illnesses (cancer, heart failure, kidney failure, severe COPD, and mild to severe geriatric frailty) Not Applicable
Conditions
Interventions
An independent statistician not affiliated with the research group will randomize the participating general practitioners (GPs) along with their patient cluster to the intervention or control group. R
Sponsors
Vrije Universiteit Brussel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General practitioners: 1. Dutch-spreaking 2. Working with and caring for patients in Flanders or Brussels, Belgium 3. Able to include at least 3 patients Patients: 1. Adults (>18 years old) 2. Mentally competent as measured by judgment of the GP OR if Mini-Mental State Examination has been conducted, score is >24 3. GP answers "no" to the surprise question, "Would I be surprised if this patient were to die within the next 12 to 24 months?" 4. Diagnosis of a life-limiting illness: 4.1. Locally-advanced unresectable, or metastasized cancer OR 4.2. Organ failure, this being a) heart failure (New York Heart Association stage 3 or stage 4) b) chronic kidney failure or end-stage renal disease (ESRD) (stage 4, eGFR=15-29; or stage 5, eGFR18 years old) 2. Identified by the patient as their surrogate decision-maker OR as a person who may be willing to be their surrogate decision-maker
Exclusion criteria
Exclusion criteria: General practitioners: 1. Participated in Phase-II trial of the intervention 2. Participated in the cognitive testing of intervention materials and translated questionnaires Patients: 1. Unable to speak or understand Dutch 2. Unable to provide consent or complete the questionnaires due to cognitive impairment 3. GP answers "no" to the surprise question, "Would I be surprised if this patient were to die within the next 6 months?" 4. Participated in the phase-II trial of this intervention 5. Participated in the cognitive testing of intervention materials and translated questionnaires Added 13/10/2020: Surrogate decision makers: 1. Unable to speak or understand Dutch 2. Unable to provide informed consent
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 13/10/2020: Patient-level secondary outcome measures: 1. Patient health-related quality of life measured using the 12-item Short-Form Survey (SF-12) at baseline, 3 months, and 6 months 2. Patient anxiety measured using the Generalized Anxiety Disorder (GAD-7) Questionnaire at baseline, 3 months, and 6 months 3. Patient depression measured using the Patient Health Questionnaire (PHQ-9) at baseline, 3 months, and 6 months 4. Appointment of a substitute decision maker will be evaluated by patient report, GP report, and by the response to the ACP engagement survey “readiness to sign official papers assigning a SDM” item, at baseline, 3 months, and 6 months 5. Completion of new advance care planning documents will be evaluated by patient report, GP report, and ACP engagement survey “readiness to sign official papers stating medical wishes” item, at 3 months and 6 months 7. "Thinking about ACP" will be measured using 1 self-developed item, 10-point Likert (“How much have you thought about ACP in the last 3 months?”) at baseline, 3 months, and 6 months 8. Communication with the GP will be measured using 4 self-developed items, 10-point Likert (e.g., “To what extent did the GP listen to your concerns about your future health?”), at baseline, 3 months, and 6 months GP secondary outcome measures: 1. General practitioner knowledge and attitudes regarding advance care planning measured using the Next Steps training program questionnaire at baseline, 3 months, and 6 months 2. ACP practices will be measured using the Next Steps training program questionaire; 2 items specific to practices with patients with chronic, life-limiting illness; 8 additional items regarding ACP practices (e.g., “Where do the ACP conversations you conduct usually take place?”); at baseline, 3 months, and 6 months 3. Documentation of ACP discussion outcomes evaluated through anonymized documentation template review, at 3 months and 6 months SDM secondary outcome m | — |
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 13/10/2020: 1. Level of engagement with advance care planning will be measured using the 15-item version of the ACP Engagement Survey (Dutch translation) at baseline, 3 months, and 6 months 2. The general practitioner primary outcome of advance care planning self-efficacy will be measured using the ACP Self-Efficacy Scale (ACP-SE) at baseline (T0), 3 months (T1), and 6 months (T6). Success on any one of these outcomes at T1 may support a conclusion of effectiveness. The researchers will treat T2 scores on these scales as a secondary outcome. Previous primary outcome measures: 1. Level of engagement with advance care planning will be measured using the 15-item version of the ACP Engagement Survey (Dutch translation) at baseline, 3 months, and 6 months 2. The general practitioner primary outcome of advance care planning self-efficacy will be measured using the ACP Self-Efficacy Scale (ACP-SE) at baseline, 3 months, and 6 months. | — |
Countries
Belgium
Contacts
Public ContactJulie Stevens
Outcome results
None listed