Palliative Care Messaging for American Indians

June 26, 2024 updated by: Mary Isaacson, South Dakota State University

Culturally Responsive Palliative Care Messaging for American Indians: An Efficacy Trial

The investigators will be conducting a randomized trial in 3 reservation communities to test the efficacy of the narrative as culture-centric health promotion model for increasing American Indian tribal members' palliative care knowledge and intentions to discuss palliative care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Palliative care is specialized patient-/family-centered care designed to reduce suffering and enhance quality of life for persons with serious illness. Culturally responsive palliative care can ease serious illness burden experienced by American Indians (AIs) and improve seriously ill AIs end-of-life decision-making. However, for seriously ill Northern Plains AIs, specifically those in South Dakota (SD), access to and use of culturally responsive palliative care is severely limited. To address this need, the investigators have formed a multidisciplinary, tribally-driven collaborative team consisting of Great Plains Tribal Leaders Health Board, active AI community advisory boards at the following reservations: Cheyenne River, Rosebud, and Pine Ridge, and South Dakota State University. The research team will conduct a campaign messaging efficacy test using the narrative as culture-centric health promotion model (NCHP) to create and test culture-centric narrative messaging that improves knowledge of palliative care and encourages participants to engage in formal and informal communication about palliative care. The NCHP model is an evidence-based innovative approach to enhance AI's knowledge and intentions to talk formally and informally about palliative care, because it provides guidelines for how to construct culture-centric narratives which identify the features of effective narratives and the mechanisms by which the narratives work to transform cognitive and behavioral outcomes. The investigators have developed a culture-centric narrative health video message and will be conducting a randomized trial to test the efficacy of the NCHP model for increasing AI tribal members' palliative care knowledge and intentions to discuss palliative care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
408

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • South Dakota State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years old or older
  • Self-identify as American Indian
  • Must be able to read and comprehend English
  • Live on or around the Pine Ridge Indian Reservation, Rosebud Indian Reservation, or Cheyenne River Indian Reservation

Exclusion Criteria:

  • Under the age of 18 years
  • Not American Indian
  • Do not live near or on the Pine Ridge Indian Reservation, Rosebud Indian Reservation, or Cheyenne River Indian Reservation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: No Message
Individuals assigned to this arm will take the surveys only and not be exposed to a palliative care message.
Other: No message
Participants will not be exposed to a message in this arm of the intervention.
Other: Culture-centric message
Individuals assigned to this arm will watch a 2 minute culture-centric palliative care video specific for these American Indian communities and then take the surveys after watching the videos.
Other: Culture-centric message
Participants in this arm of the study will watch a 2-minute video on palliative care developed specifically for these American Indian communities.
Other: General message
Individuals assigned to this arm will watch a 2 minute palliative care video created for the general US population and then take the surveys after watching the videos.
Other: General messge
Participants receiving this intervention will watch a 2-minute video developed by the National Hospice and Palliative Care Organization to teach about palliative care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Palliative Care Knowledge Scale (PaCKS)
Time Frame: 2 hours
The 13-item PaCKS measures palliative care knowledge among lay people, using true/false items covering topics like goals of palliative care. We know palliative care awareness is lacking; thus it is important to understand knowledge gaps; hence we will modify the response options to include "I don't know" in addition to true/false.
2 hours
Knowledge of Care Options (KOCO)
Time Frame: 2 hours
The 11-item KOCO measures gaps in knowledge of care options among cancer patients for curative, palliative, and hospice care using true-false options.
2 hours
Hospice and Palliative Care Questionnaire (HPCQ)
Time Frame: 2 hours
The 12-item HPCQ examines attitudes, use, and interest in receiving more information. There are 6 hospice and 6 palliative care questions, that have been used successfully with ethnically diverse populations.
2 hours
Identification and Transportation with Palliative Care Message
Time Frame: 2 hours
Individuals watching either the culture-centric palliative care video or the general video will be asked to ask 5 questions about emotions they felt, how they identified with the main characters in the video, and how focused they were while watching the video
2 hours
Attitudes and Intentions to Discuss Palliative Care
Time Frame: 2 hours
Those watching the culture-centric video or the general message video will be asked to respond to 5 questions about their intentions to discuss pallative care with their family.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
South Dakota State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)
Great Plains Tribal Leaders Health Board

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mary J Isaacson, PhD, RN, South Dakota State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DNZNC466DGR7
  • 1R21NR020383-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are working with Tribal communities that are sovereign nations and we will share their data back with them at the end of the trial. We have to obtain special permission in order to share de-identified data more broadly.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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