Bleeding and thrombosis symptoms bleedings and symptoms of a bloodcloth in the vessels
Conditions
Interventions
We're evaluating a complex intervention, which includes a comprehensive training program for health care professionals, ensuring continuity of care and the implementation of the CoClarity SDST. We wil
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Criterion A: 18 years or older Use of at least one ATT type, (i.e. Vitamin K antagonists (B01AA), direct oral anticoagulants (B01AE/B01AF), heparins (B01AC), thrombocyte aggregation inhibitors (B01AC)) Have a malignant tumor which cannot or will not be cured A life expectancy of < 1 year identified by using the surprise question: “would I be surprised if this person died within the next 12 months Willing and able to provide informed consent Criterion B: Meet at least one of the specific ATT reconsideration trigger criteria. Decline in performance as observed by a physicianAdmission to a hospice or palliative care unit First visit palliative care team Stop anticancer treatment Initiation of palliative chemotherapyA bleeding event, with no clear indication to either continue or discontinue ATT An advance care planning (ACP) conversation
Exclusion criteria
Exclusion criteria: A potentially included patient who meets any of the following criteria will be excluded from participation in this study:A life expectancy of less than 2 weeks, according to the physician Does not speak the language of the trial country or have other communication issues Inability to use a digital tool, such as patients who have severely impaired vision or patients who have no access to internet connection. Participation in clinical trial testing a new ATT, e.g. FXI. If it is abundantly clear that a patient must continue with the treatment, e.g. ATT indication for a mitral valve.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test the effectiveness of implementation of the CoClarity SDST on bleeding events and symptoms related to TE events.in patients with cancer in the last phase of their lives. The primary outcome will be a composite of a) the occurrence of any new bleeding and b) the occurrence of symptoms attributable to a new TE events. We consider the endpoint to be met if either of these two outcomes occur. | — |
Secondary
| Measure | Time frame |
|---|---|
| To test the effectiveness and efficacy of implementation of the CoClarity SDST on: All visible or symptomatic bleeding events Symptoms related to potential TE events Bleeding severity TE symptoms related severity Fatigue ATT use Overall health related QoL Functioning Frailty Patient involvement in SDM Decisional conflict Survival To study cost-effectiveness of implementing the CoClarity SDST To study impact of implementation of the CoClarity SDST on: Continuation, discontinuation, dose reduction or ATT type switch, including timing of the decision and effectuation into prescribing and actual administration of medication | — |
Countries
Netherlands, Poland, Spain, United Kingdom
Contacts
Public ContactSP Mooijaart
Leids Universitair Medisch Centrum
Outcome results
None listed