- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03569150
Culturally-Adapting a Communication Intervention to Improve Palliative Care Literacy on Two Native American Reservations
Culturally-Adapting a Communication Intervention to Improve End-of-Life Palliative Care Health Literacy on Two Native American Reservations: An Academic-Tribal Partnership
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Intervention (Rosebud)
The intervention is: Native Americans patients with a serious life-limiting illness will have an advance care planning discussion with an interdisciplinary healthcare professional trained in the culturally-adapted COMFORT Communication Curriculum.
|
The COMFORT Communication Curriculum (CC) will be culturally-adapted for 2 Native American reservation communities.
The investigators will then implement the culturally-adapted COMFORT Communication Curriculum in 2 tribal communities by training interdisciplinary healthcare professionals to conduct culturally-respectful and relevant Advance Care Planning.
The investigators will then conduct a cluster-assigned pilot, wait-list controlled trial of the culturally-adapted COMFORT Communication Curriculum in 2 tribal communities to evaluate feasibility, acceptability, and perceived effectiveness by comparing 30 Native Americans completing Advance Care Planning with a trained healthcare professional and 30 Native Americans receiving usual care.
|
NO_INTERVENTION: Control (Pine Ridge)
In the control group, Native American patients with a serious life-limiting illness will receive usual care.
The healthcare professionals have not undergone training in the culturally-adapted COMFORT Communication Curriculum.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Documentation of advance care planning and advance directive completion
Time Frame: Project Year 02, Quarter 2 and Quarter 3
|
The investigators will evaluate this outcome by measuring the presence or absence of advance care planning documentation and advance directive completion in the patient's electronic health record at both the intervention and control sites.
|
Project Year 02, Quarter 2 and Quarter 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of uncertainty perceived in illness
Time Frame: Project Year 02, Quarter 2 and Quarter 3
|
This will be evaluated by patient report using the validated Mishel Uncertainty in Illness Scale- Community (MUIS-C) pre and post outpatient clinic visit only at the intervention site.
Uncertainty in illness (construct) is often discussed in relationship to health literacy, and for purposes of this study, end of life palliative care health literacy.
This outcome will be evaluated by patient report using the validated MUIS-C, which has been used extensively in cancer, cardiac, and chronic illness patients and in cross-cultural studies.
The MUIS-C is a 23-item Likert-format scale, where patients score items from 1 (strongly disagree) to 5 (strongly agree).
The total score range is 23-115, with higher scores indicating a greater level of uncertainty.
Reported Cronbach's alphas are 0.74 to 0.92.
|
Project Year 02, Quarter 2 and Quarter 3
|
Patient satisfaction with the intervention
Time Frame: Project Year 02, Quarter 2 and Quarter 3
|
The investigators will conduct cognitive interviews with patients that participated in the intervention and completed a MUIS-C, only with intervention participants.
|
Project Year 02, Quarter 2 and Quarter 3
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healthcare Professional Comfort with Palliative and End-of-life Communication
Time Frame: Project Year 02, Quarter 1 and Quarter 2
|
Healthcare professionals participating in the COMFORT Communication Curriculum (CC) training will complete a C-COPE (Comfort with Communication in Palliative and End of Life Care) questionnaire before and after training.
This will be done only at the intervention site.The C-COPE operationalizes the key components within the COMFORT CC and is a 28-item instrument including 2-ranked items and 26 Likert-format items, where healthcare professionals score items from 1 (not difficult) to 5 (very difficult).
The range of possible C-COPE total scores is 26-130, with higher scores indicating less comfort with end of life palliative care communication, while rated items are categorized according to patient, family, and team communication.
Preliminary psychometric analysis of test-retest reliability with ICC > 0.77, internal reliability for total score with Cronbach's alpha = 0.91.
|
Project Year 02, Quarter 1 and Quarter 2
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mary J Isaacson, PhD, South Dakota State University
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SDSU4909
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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