Knowledge, Attitudes, PracticeNCT06359392
Palliative Care Messaging for American Indians
A study testing No message, Culture-centric message and General messge in people with Knowledge, Attitudes, Practice, run by South Dakota State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knowledge, Attitudes, Practice
- What is being tested?
- No message, Culture-centric message and General messge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 13 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
South Dakota State University
Rapid City, South Dakota, 57701
About this study
Official title: 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.
Read the 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.
- Conditions
- Knowledge, Attitudes, Practice
- Being tested
- No message, Culture-centric message, General messge
- Keywords
- palliative care, American Indian, hospice, end of life
- Medical subject headings
- Behavior, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No messageOther
Participants will not be exposed to a message in this arm of the intervention.
Culture-centric messageOther
Participants in this arm of the study will watch a 2-minute video on palliative care developed specifically for these American Indian communities.
General messgeOther
Participants receiving this intervention will watch a 2-minute video developed by the National Hospice and Palliative Care Organization to teach about palliative care.
| Study group | Role | What they receive |
|---|---|---|
| No Message | Other | Individuals assigned to this arm will take the surveys only and not be exposed to a palliative care message. Receives: Other: No message |
| Culture-centric message | Other | 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. Receives: Other: Culture-centric message |
| General message | Other | 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. Receives: Other: General messge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palliative Care Knowledge Scale (PaCKS)
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.
Measured: 2 hours
Knowledge of Care Options (KOCO)
The 11-item KOCO measures gaps in knowledge of care options among cancer patients for curative, palliative, and hospice care using true-false options.
Measured: 2 hours
Hospice and Palliative Care Questionnaire (HPCQ)
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.
Measured: 2 hours
Identification and Transportation with Palliative Care Message
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
Measured: 2 hours
Attitudes and Intentions to Discuss Palliative Care
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start29 Apr 2024
- Primary completion13 Jun 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Dakota State University
- Sponsor type
- University, hospital or other
- Collaborators
- Great Plains Tribal Leaders Health Board, National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Mary Isaacson, South Dakota State University
- Investigators
- Mary J Isaacson, PhD, RN, Principal investigator, South Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359392
- Sponsor's protocol ID
- DNZNC466DGR7
- Other IDs
- 1R21NR020383-01
- Status last verified
- Jun 2024
- First submitted
- 29 Mar 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Responsive Palliative Care Messaging for American Indians: An Efficacy Trial
- ClinicalTrials.gov ID
- NCT06359392
- Acronym / sponsor ID
- DNZNC466DGR7
- Conditions
- Knowledge, Attitudes, Practice
- Keywords
- palliative care, American Indian, hospice, end of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- South Dakota State UniversityUniversity, hospital or other
- Collaborators
- Great Plains Tribal Leaders Health Board, National Institute of Nursing Research (NINR)
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Message | Other | Other: No messageIndividuals assigned to this arm will take the surveys only and not be exposed to a palliative care message. |
| Culture-centric message | Other | Other: Culture-centric messageIndividuals 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. |
| General message | Other | Other: General messgeIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No messageParticipants will not be exposed to a message in this arm of the intervention. | Other | No Message |
| Culture-centric messageParticipants in this arm of the study will watch a 2-minute video on palliative care developed specifically for these American Indian communities. | Other | Culture-centric message |
| General messgeParticipants receiving this intervention will watch a 2-minute video developed by the National Hospice and Palliative Care Organization to teach about palliative care. | Other | General message |
Primary outcome
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.
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.
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary J Isaacson, PhD, RN principal investigator
South Dakota State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No message, Culture-centric message and General messge in people with Knowledge, Attitudes, Practice, run by South Dakota State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palliative Care Knowledge Scale (PaCKS) (time frame: 2 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.