Culturally-Adapting a Communication Intervention to Improve Palliative Care Literacy on Two Native American Reservations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03569150|
Recruitment Status : Not yet recruiting
First Posted : June 26, 2018
Last Update Posted : June 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advance Care Planning||Other: Cultural adaptation/implementation COMFORT CC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||cluster-assigned pilot, wait-list control|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Culturally-Adapting a Communication Intervention to Improve End-of-Life Palliative Care Health Literacy on Two Native American Reservations: An Academic-Tribal Partnership|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||March 31, 2021|
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.
Other: Cultural adaptation/implementation COMFORT CC
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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569150
|Contact: Mary J Isaacson, PhDfirstname.lastname@example.org|
|Contact: Victoria LS Britson, PhDemail@example.com|
|Principal Investigator:||Mary J Isaacson, PhD||South Dakota State University|