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:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT03569150
Eligibility Criteria:
Inclusion Criteria:
Focus Groups. Aim 1.1: Patient eligibility criteria: 1) Native American; 2) 18 years old or greater; 3) and diagnosis with one or more serious life-limiting illness, such as renal failure, cancer, or heart disease, as defined by the International Statistical Classification of Diseases and Related Health Problems (ICD-10). Caregiver eligibility criteria: 1) 18 years old or greater; 2) primary caregiver of a family member participant. Healthcare Professional eligibility: employment 1 year or more as a nurse, social worker, or primary care provider at Indian Health Service. An Elder is eligible if he/she is Native American and an identified elder in the community. Tribal health leader/representative inclusion criteria: 1) Native American; 2) 18 years old or greater; 3) live in the community; 4) employed by tribal health administration.
Cognitive Interviews. Aim 1.2: The investigators will recontact and reconsent those patients, family caregivers, and Elders who participated in the focus groups (Aim 1.1) (Total of 10; 5 per site) to conduct interviews assessing the culturally-adapted COMFORT Communication Curriculum's cultural relevance and fit.
COMFORT Communication Curriculum Training. Aim 2.1: Healthcare Professionals (nurses, social workers, primary care providers) will be recruited through Indian Health Service nursing and clinic administrators and must be employed for 1 year or more by Rosebud Indian Health Service to participate in the COMFORT Communication Curriculum education (Total of 10). The wait-list control arm (Pine Ridge Healthcare Professionals; total of 10) will receive the education following completion of data collection in the intervention group. Participants will be recruited through Indian Health Service nursing and clinic administrators and must be employed for 1 year or more by Pine Ridge Indian Health Service to participate in the COMFORT Communication Curriculum education.
Cluster-assigned wait-list control Trial. Aims 3.1 and 3.2: The intervention will be applied to Rosebud; Pine Ridge will serve as the control community. We will recruit patients (Total of 30) to the intervention arm (Rosebud Indian Health Service) from the outpatient clinics. For Pine Ridge, the electronic health record will be used to identify 30 participants from the outpatient clinic meeting the same eligibility criteria (Native American, 18 years of age or greater, ICD-10 codes identifying serious life-limiting illness) as the Rosebud participants. Patient eligibility criteria are the same as Aim 1.1. Patient eligibility will be identified by trained project Indian Health Service personnel at both sites.
Cognitive Interviews. Aim 3.3: Participants from the intervention arm (Rosebud) who participated in Aim 3.1 and 3.2 (total of 10 of the 30) will be asked to participate in an interview regarding their Advance Care Planning. Interested participants will provide a contact phone number and be given an information sheet by trained project Indian Health Service personnel regarding the interview purpose. Researchers will contact the participant via phone within 2 business days of visit and if still agreeable, schedule a face-to-face interview within 14 business days of advance care planning, where they will be reconsented.
Exclusion Criteria:
* Participants not meeting the inclusion criteria for the above aims will be excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03569150
Study Brief:
Protocol Section:
NCT03569150