Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT04283994
Eligibility Criteria:
Eligibility criteria apply to three subject groups: 1) seriously ill adult patients; 2) adult surrogate legal next of kin of the patients; and 3) hospital clinicians.
Inclusion Criteria:
PATIENTS. Eligible patients will be those who are: 1) equal to or older than 80 years of age; or 2) equal to or older than 55 years of age with one or more chronic conditions used by the Dartmouth Atlas to study end-of-life care: malignant cancer/leukemia, chronic pulmonary disease, coronary artery disease, heart failure, chronic liver disease, chronic renal disease, dementia, diabetes with end-organ damage, and peripheral vascular disease, 3) English-speaking, 4) admitted for minimum of 12 hours/maximum of 96 hours to participating in-patient services at the participating hospitals, and 5) without documentation in the EHR of a goals-of-care discussion during this admission. Patients without decisional capacity (as documented in the EHR or as identified with a brief six-item screening tool) will be represented by a legal surrogate decision maker/legal next of kin (LNOK) in accordance with Washington State Law RCW 7.70.065.
SURROGATE/FAMILY. Eligible surrogate/family subjects will be those who are 18 years of age or older, English-speaking, involved in the patient's medical care or decision-making.
CLINICIANS (Interview). Eligible clinicians will be those who are 18 years of age or older, English-speaking, employed at a participating hospital, and have been the clinician of record for an enrolled patient in the trial.
Exclusion Criteria:
Reasons for exclusion for any patient in include: restricted status (prisoners or victims of violence); legal or risk management concerns (as determined by the attending physician or via hospital record designation); unable to complete informed consent procedures; and without a legal surrogate to participate for them. Patients who are non-English speaking (and therefore unable to complete survey materials) are excluded. Reasons for exclusion for any surrogate/family subject include: non-English speaking (and therefore unable to complete study materials), legal or risk management concerns (as determined by the attending physician or via hospital record designation); psychological illness or morbidity; and physical or mental limitations preventing ability to complete questionnaires. Patients under COVID precautions will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04283994
Study Brief:
Protocol Section:
NCT04283994