Culturally-Adapting a Communication Intervention to Improve Palliative Care Literacy on Two Native American Reservations

NCT03569150 | Withdrawn DMC

• 1 other identifier: SDSU4909
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the feasibility, acceptability, and perceived effectiveness of the culturally-adapted COMFORT Communication Curriculum in two Native American reservation communities. Participants in one community will have an advance care planning conversation with a healthcare professional trained in the the culturally-adapted curriculum. Participants in the other community will receive usual care.

Conditions

Advance Care Planning

Keywords

palliative care; end-of-life care; advance care planning; communication; health literacy; serious life-limiting illness

Outcome Measures

Primary Outcomes (1)

• Documentation of advance care planning and advance directive completion

  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 Outcomes (2)

• Level of uncertainty perceived in illness

  Project Year 02, Quarter 2 and Quarter 3

• Patient satisfaction with the intervention

  Project Year 02, Quarter 2 and Quarter 3

Other Outcomes (1)

• Healthcare Professional Comfort with Palliative and End-of-life Communication

  Project Year 02, Quarter 1 and Quarter 2

Study Arms (2)

Intervention (Rosebud)

OTHER

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

Control (Pine Ridge)

NO INTERVENTION

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.

Interventions

Cultural adaptation/implementation COMFORT CC OTHER

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.

Intervention (Rosebud)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• South Dakota State University: lead
• Southcentral Foundation: collaborator
• Indian Health Service (IHS): collaborator
• Rosebud Sioux Tribe Health Administration: collaborator
• Oglala Sioux Tribe Health Administration: collaborator
• California State University, Los Angeles: collaborator

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Mary J Isaacson, PhD

  South Dakota State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cluster-assigned pilot, wait-list control

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: April 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: March 31, 2021
• Last Updated: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months and ending 5 years following article publication. Person(s) requesting data will complete a data request form.
• Access Criteria: Data access requests will be reviewed first by an Independent Review Panel and if appropriate forwarded onto the tribal entities for final approval.