Patient Identification
‘COAST’
COORDINATING OPTIONS FOR ACUTE STROKE THERAPY
____ (initial) I have reviewed the COAST fact sheet AND/OR discussed the relevant clinical trial and FDA approval data with my health care provider, and understand the risks and benefits associated with each potential treatment option at each time point.
____ (initial) I understand that this form will be used to guide my treatment and advise my health care provider(s) and/or healthcare surrogate of my wishes for treatment in case I am unable to participate in my care plan at the time of an acute stroke.
____ (initial) I understand that if I am able to express my wishes and opinions at the time of my stroke, or if a healthcare surrogate or DPOA is available to express my wishes for me, those wishes will be considered, over the preferences listed on this COAST form, as a more accurate representation of my opinions regarding treatments. I have been instructed to update my advanced directive to reflect my current wishes and to discuss these choices with my family.
____ (initial) I understand that the preferences I express on this form do not substitute for clinical judgment by my healthcare provider. I realize that the COAST form allows me to express my wishes regarding which treatments, if any, I would prefer in particular circumstances of a stroke.
Attention Providers: This form does NOT take precedence over the patient’s Advanced Directives, Surrogate, DPOA, or personal wishes expressed at time of treatment.
_____________________________________________ Date: ________________Time: ___________ AM / PM
Patient Signature
_____________________________________________ Date: ________________Time: ___________ AM / PM
Surrogate Signature
D3625 (2-18) Page 1 of 4
*D3625*
In the event I have a stroke, if intravenous tissue plasminogen activator (IV r-tPA, alteplase) is a treatment option as stated below, I choose the following:
yes
no I prefer to receive IV r-tPA therapy up to 3 hours (FDA approved) after onset of stroke symptoms, at the discretion of the treating healthcare provider
yes
no I prefer to receive IV r-tPA therapy up to 4.5 hours after onset of stroke symptoms, at the discretion of the treating healthcare provider
yes
no I prefer to receive IV r-tPA therapy at any time point after onset of stroke symptoms, at the discretion of the treating healthcare provider
yes
no I prefer NOT to receive IV r-tPA under any circumstances
yes
no I prefer to receive IV r-tPA therapy, at the discretion of the treating healthcare provider, in the setting of: _____________________________________________________In the event I have a stroke, if Endovascular Therapy (mechanical clot disruption, angioplasty and stenting, mechanical clot retrieval device) is a treatment option as stated below, I choose the following:
yes
no I prefer to receive endovascular therapy up to 6 hours after onset of stroke symptoms, at the discretion of the treating healthcare provider
yes
no I prefer to receive endovascular therapy up to 24 hours after onset of stroke symptoms if there is a favorable neuroimaging pattern, at the discretion of the treating healthcare provider
yes
no I prefer to receive endovascular therapy at any time point after onset of stroke symptoms, at the discretion of the treating healthcare provider
yes
no I prefer NOT to receive endovascular therapy under any circumstances
yes
no I prefer to receive endovascular therapy at the discretion of the treating healthcare provider, in the setting of: ______________________________________________**Unless otherwise specified, if patient selects both tPA and endovascular therapy at a given time, the choice of treatment (including combination therapy) will be at the discretion of the treating provider**
Specific stroke therapy comments/clarifications (optional): ______________________________________
__________________________________________________________________________________________
______________________________________________ Date________________Time___________ AM / PM
Patient Signature
______________________________________________ Date________________Time___________ AM / PM
Surrogate Signature (if applicable)
______________________________________________ Date________________Time___________ AM / PM
Witness Signature
______________________________________________ Date________________Time___________ AM / PM
Interpreter Signature (if applicable)
D3625 (2-18) Page 2 of 4
Patient Identification
‘COAST’
COORDINATING OPTIONS FOR ACUTE STROKE THERAPY
Providers: Please discuss and fill out the COAST-R section with your patients if time and expertise allow.
Completion of the COAST-R section of the form (pages 3-4) may be deferred to another visit or provider, but this should not preclude completion of pages 1 and 2 (clinical therapeutic options) at this time.
Patients: If you would not like to hear about current clinical trials today, there is no need to complete this form. In this case, clinical trial options will still be discussed with you or your surrogate or DPOA at time of any future stroke event in accordance with standard stroke team practices in operation at that time.
______ (initial) I would like to have the relevant research options regarding newly developed stroke therapies presented to me or my surrogate or DPOA today, to determine if I may qualify for any of these clinical trial options.
This COAST-R form details specific clinical research trials available or soon to be available at this center.
This is an individualized section, tailored by stroke specialists at this particular center, with
trial information listed below. By checking ‘yes’ next to the individual trial name and short description, I attest that:
1. All elements of consent have been discussed with me including trial design, potential risks, safety, potential benefits, alternatives, costs and confidentiality concerns.
2. This does not represent my consent to participate in any of these trials listed, but simply my acknowledgement that the presently known data related to the trial has been described to me in full detail.
3. I would be interested in participating in the trial listed if my stroke subtype, timing and other relevant features are appropriate for enrollment at the time I have a stroke.
4. Actual consent for enrollment in any of these trials will still be required to take place at the time of the stroke itself and that published literature, known risks, benefits, and even overall trial options available at the time of my stroke may be different than described to me today.
5. I understand that given clinical trial allocation grids and any present or future trial portfolios at this institution, I may not be offered all or even any of these trials (even those that I answer ‘yes’ to on this form), and am aware that there is no ethical or legal mandate that any or all trials be disclosed to me at the time of the stroke.
6. I have been provided ample opportunity to have all my questions answered regarding potential participation in any of the trials listed below.
7. I understand that all attestations made on page 1 of this COAST document apply to both clinical and research options presented throughout this document.
Attention Providers: This form does NOT take precedence over the patient’s Advanced Directives, Surrogate, DPOA, or personal wishes expressed at time of treatment.
______________________________________________ Date________________Time___________ AM / PM
Patient Signature
______________________________________________ Date________________Time___________ AM / PM
Surrogate Signature (if applicable)
D3625 (2-18) Page 3 of 4
Patient Identification
‘COAST-R’
COORDINATING OPTIONS FOR ACUTE STROKE THERAPY RESEARCH OPTIONS
Clinical research trials available at this facility:
The Table below is to be populated by the stroke practitioner with the relevant trial names and short trial descriptions in an institution-specific manner in advance of potential future stroke event (only listing those trials that might be available to this specific patient). If time or practitioner comfort level with available clinical trials is not adequate, skip this form.
The patient is to check the ‘yes’ or ‘no’ box related to each particular trial to document his/ her interest in being approached for participation in the relevant trial, should he/she qualify at the time of stroke.
In the event I have a stroke, if this hospital facility has stroke-specific Clinical Trial Options available (IRB approved research therapies), I prefer the following:
PREFERENCE TRIAL NAME TRIAL DESCRIPTION
yes
no
yes
no
yes
no
yes
no
yes
no
yes
no
yes
no
yes
no
yes
no
yes
no______________________________________________ Date________________Time___________ AM / PM
Patient Signature
______________________________________________ Date________________Time___________ AM / PM
Surrogate Signature (if applicable)
______________________________________________ Date________________Time___________ AM / PM
Witness Signature
______________________________________________ Date________________Time___________ AM / PM
Interpreter Signature (if applicable)
D3625 (2-18) Page 4 of 4
Patient Identification
‘COAST-R’
COORDINATING OPTIONS FOR ACUTE STROKE THERAPY RESEARCH OPTIONS
