Advance Care PlanningNCT03569150
Culturally-Adapting a Communication Intervention to Improve Palliative Care Literacy on Two Native American Reservations
A study testing Cultural adaptation/implementation COMFORT CC in people with Advance Care Planning, run by South Dakota State University.
Trial summary
This study will evaluate the feasibility, acceptability, and perceived effectiveness of the culturally-adapted COMFORT Communication Curriculum in two Native American reservation communities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advance Care Planning
- What is being tested?
- Cultural adaptation/implementation COMFORT CC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to 31 Mar 2021
- 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
- Focus Groups. Aim 1.1: Patient eligibility criteria: 1) Native American; 2) 18 years old or greater; 3) and diagnosis with one or more serious life-limiting illness, such as renal failure, cancer, or heart disease, as defined by the International Statistical Classification of Diseases and Related Health Problems (ICD-10). Caregiver eligibility criteria: 1) 18 years old or greater; 2) primary caregiver of a family member participant. Healthcare Professional eligibility: employment 1 year or more as a nurse, social worker, or primary care provider at Indian Health Service. An Elder is eligible if he/she is Native American and an identified elder in the community. Tribal health leader/representative inclusion criteria: 1) Native American; 2) 18 years old or greater; 3) live in the community; 4) employed by tribal health administration.
- 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.
Who cannot join
- Participants not meeting the inclusion criteria for the above aims will be excluded.
About this study
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
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.
Read the detailed description
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
- Advance Care Planning
- Being tested
- Cultural adaptation/implementation COMFORT CC
- Keywords
- palliative care, end-of-life care, advance care planning, communication, health literacy, serious life-limiting illness
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultural adaptation/implementation COMFORT CCOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Project Year 02, Quarter 2 and Quarter 3
Secondary outcomes (2)
Level of uncertainty perceived in illness
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.
Measured: Project Year 02, Quarter 2 and Quarter 3
Patient satisfaction with the intervention
The investigators will conduct cognitive interviews with patients that participated in the intervention and completed a MUIS-C, only with intervention participants.
Measured: Project Year 02, Quarter 2 and Quarter 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study startApr 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Why it stopped: Study not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance Care PlanningStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- cluster-assigned pilot, wait-list control
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Dakota State University
- Sponsor type
- University, hospital or other
- Collaborators
- Southcentral Foundation, Indian Health Service (IHS), Rosebud Sioux Tribe Health Administration, Oglala Sioux Tribe Health Administration, California State University, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Mary J Isaacson, PhD, Principal investigator, South Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569150
- Sponsor's protocol ID
- SDSU4909
- Status last verified
- Oct 2020
- First submitted
- 14 Jun 2018
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03569150
- Acronym / sponsor ID
- SDSU4909
- Conditions
- Advance Care Planning
- Keywords
- palliative care, end-of-life care, advance care planning, communication, health literacy, serious life-limiting illness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- South Dakota State UniversityUniversity, hospital or other
- Collaborators
- Southcentral Foundation, Indian Health Service (IHS), Rosebud Sioux Tribe Health Administration, Oglala Sioux Tribe Health Administration, California State University, Los Angeles
- Study start
- Apr 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 26 Jun 2018 (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.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cluster-assigned pilot, wait-list control
| Arm | Type | Receives |
|---|---|---|
| Intervention (Rosebud) | Other | Other: Cultural adaptation/implementation COMFORT CCThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Focus Groups. Aim 1.1: Patient eligibility criteria: 1) Native American; 2) 18 years old or greater; 3) and diagnosis with one or more serious life-limiting illness, such as renal failure, cancer, or heart disease, as defined by the International Statistical Classification of Diseases and Related Health Problems (ICD-10). Caregiver eligibility criteria: 1) 18 years old or greater; 2) primary caregiver of a family member participant. Healthcare Professional eligibility: employment 1 year or more as a nurse, social worker, or primary care provider at Indian Health Service. An Elder is eligible if he/she is Native American and an identified elder in the community. Tribal health leader/representative inclusion criteria: 1) Native American; 2) 18 years old or greater; 3) live in the community; 4) employed by tribal health administration.
- 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.
Key exclusion criteria (1 listed)
- Participants not meeting the inclusion criteria for the above aims will be excluded.
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 |
|---|---|---|
| Cultural adaptation/implementation COMFORT CCThe 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. | Other | Intervention (Rosebud) |
Primary outcome
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.
2 secondary outcomes
Level of uncertainty perceived in illness
Time frame: Project Year 02, Quarter 2 and Quarter 3
Patient satisfaction with the intervention
Time frame: Project Year 02, Quarter 2 and Quarter 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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 principal investigator
South Dakota State University
Questions about this trial
What is this clinical trial studying?
A study testing Cultural adaptation/implementation COMFORT CC in people with Advance Care Planning, run by South Dakota State University.
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 5 inclusion and 1 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: withdrawn, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Documentation of advance care planning and advance directive completion (time frame: Project Year 02, Quarter 2 and Quarter 3). 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 28 Oct 2020.