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

NCT ID: NCT03569150

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-30

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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Advance care planning (ACP) is an important component of palliative care (PC), and is a critical, ongoing dialogue between health care professionals (HCPs), patients, and families; where patients' comprehension of their illness and illness progression, goals of care, and treatment choices are discussed. Essential to ACP is the interdisciplinary team, where each member must be comfortable and confident initiating conversations about quality of life and end-of-life (EOL) care. ACP is often hindered by low health literacy, including PC health literacy, uncertainty regarding illness trajectory and end-of-life palliative care (EOLPC) options, and lack of awareness about ACP among patients. For HCPs, discomfort, lack of EOL communication training, and knowledge of cultural differences are often barriers to ACP. Foundational to ACP is PC health literacy, which necessitates considering semantics, eliminating misconceptions, and recognizing uncertainty. Ensuring access to ACP for patients with serious life-limiting illness requires that all healthcare disciplines receive evidence-based EOLPC communication training. The COMFORT communication curriculum (CC) is an intervention that trains interdisciplinary HCPs to provide patient- and family-centered EOLPC communication. Patient outcomes related to this intervention have not been studied. Moreover, the curriculum's efficacy and fit has not been specifically tested with minority groups. Native Americans (NA) are disproportionately affected by serious life-limiting conditions and life expectancy is 4 years less than all other US races. Despite greater morbidity and mortality, NAs use of PC is largely unknown. Yet, it has been identified that tribal communities are requesting EOLPC services and will participate in ACP when conducted in a culturally-respectful manner. There is an urgent need to develop culturally-relevant communication approaches specific to EOLPC, including ACP, for use with NAs with serious life-limiting illness. The investigators propose a collaborative clinical trial to: 1) Culturally-adapt the COMFORT CC for pilot testing with NA communities; 2) Implement the culturally-adapted COMFORT CC in 2 tribal communities by training 20 interdisciplinary (nurses, social workers, primary care providers) HCPs to conduct culturally-respectful and relevant ACP; 3) Conduct a pilot, wait-list controlled trial of the culturally-adapted COMFORT CC in 2 tribal communities to evaluate feasibility, acceptability, and perceived effectiveness by comparing 30 NAs completing ACP with a trained HCP and 30 NAs receiving usual care. Implementing a culturally-relevant communication intervention to improve EOLPC health literacy is a high priority for the Rosebud and Pine Ridge reservations in South Dakota. This proposed study will culturally-adapt and evaluate the COMFORT CC on these 2 reservations and will provide the foundation for an R01-funded intervention study that could positively impact EOLPC literacy and outcomes among the 566 US federally recognized NA tribes.

Conditions

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Advance Care Planning

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

cluster-assigned pilot, wait-list control
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Cultural adaptation/implementation COMFORT CC

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Southcentral Foundation

OTHER

Sponsor Role collaborator

Indian Health Service (IHS)

FED

Sponsor Role collaborator

Rosebud Sioux Tribe Health Administration

UNKNOWN

Sponsor Role collaborator

Oglala Sioux Tribe Health Administration

UNKNOWN

Sponsor Role collaborator

California State University, Los Angeles

OTHER

Sponsor Role collaborator

South Dakota State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary J Isaacson, PhD

Role: PRINCIPAL_INVESTIGATOR

South Dakota State University

Other Identifiers

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SDSU4909

Identifier Type: -

Identifier Source: org_study_id