- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03256110
Palliative Care Communication With Alaska Native and American Indian People (PALL)
October 7, 2021 updated by: Jennifer Shaw, Southcentral Foundation
Exploring Palliative Care Communication With Alaska Native and American Indian People at Two Sites
This mixed-methods study is culturally tailoring and evaluating a communication intervention to increase the frequency and quality of advance care planning with diverse American Indian and Alaska Native adults with serious, life-limiting illness in primary care at two sites.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Palliative care is an interdisciplinary field that aims to relieve emotional, spiritual and physical suffering and improve quality of life in patients with serious, life-limiting illness and their families.
Unfortunately, palliative care is often introduced too late in the course of care to maximize its potential benefits, in part because healthcare providers and patients alike lack the knowledge and self-efficacy to initiate conversations about advance care planning (ACP).
ACP is an important component of palliative care in which patients, families and providers discuss and plan for the patient's desired treatment goals, including preferences for care and who can make decisions on the patient's behalf if needed.
Integrating ACP into treatment early, before serious, life-limiting illness advances to a late stage, can improve patient and caregiver quality of life, length of survival, and health care cost.
Primary care is an ideal setting for early integration of ACP, as primary care providers routinely diagnose and care for patients in the early stage of serious, life-limiting conditions, such as chronic obstructive pulmonary disease.
Alaska Native and American Indian (AN/AI) people have disproportionately high prevalence of many serious, life-limiting conditions, including cancer, coronary heart disease, and liver disease.
Yet, AN/AIs use ACP and other palliative care services significantly less than the overall population.
The reasons for this disparity are unclear, and AN/AIs are among the most underrepresented groups in palliative care studies.
Previous research indicates that when given the opportunity, AIs will engage in ACP, and our preliminary data suggest strong support among ANs for developing culturally congruent ACP interventions in primary care settings.
The need for timely and effective ACP is growing in AN/AI communities and there is a pressing need for culturally-congruent, patient-centered palliative care interventions for AN/AIs as tribal health systems manage rising numbers of AN/AI individuals with serious, life-limiting illnesses.
The aims of this collaborative, community-engaged, clinical study are to: 1) conduct focus groups with 40 key stakeholders (patients, caregivers, providers, administrators) in two tribal health systems to tailor an existing ACP communication intervention for AN/AIs with serious, life-limiting illness; 2) evaluate the cultural relevance and usability of the tailored ACP communication intervention among 20 AN/AI patients using cognitive interviews; and 3) compare the impact of the tailored intervention on frequency of ACP discussions, as well as quality of and satisfaction with ACP communication between 30 AN/AI patients receiving individualized information to prompt ACP discussions with providers and 30 AN/AI patients receiving usual care, with information to prompt a discussion.
Implementing effective, appropriate ACP is a high priority at Southcentral Foundation (SCF) and First Nations Community HealthSource (FNCH), two tribal health systems serving large, diverse populations of AN/AI people in Alaska and New Mexico.
This study will develop and evaluate a culturally congruent, patient- centered ACP intervention at these sites and produce evidence for a large, multi-site clinical trial of the intervention that could improve patient and caregiver outcomes in this diverse population of more than 5 million Americans.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- 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 Locations
-
-
Alaska
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Anchorage, Alaska, United States, 99508
- Southcentral Foundation
-
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New Mexico
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Albuquerque, New Mexico, United States, 87108
- First Nations Community HealthSource
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-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Alaska Native and/or American Indian (patients)
- Age 18 or older (patients and providers)
- Employed at least 2 years as a primary care provider at one of the two study sites (providers)
- Have a primary care provider of record at one of the two study sites (patients)
- Have had at least 2 visits with primary care provider in previous 12 months (patients)
- Having at least one serious, life-limiting condition, including metastatic cancer, primary lung cancer, chronic obstructive pulmonary disorder, heart disease, liver disease or cirrhosis, renal failure, or being oxygen dependent. (patients)
Exclusion Criteria:
- Under age 18 (patients and providers)
- Not Alaska Native or American Indian (patients)
- Not having a primary care provider at one of the study sites (patients)
- Not being employed for at least two years as a primary care provider at one of the study sites (providers)
- Not having had at least 2 visits with a primary care providers at one of the study sites in the previous 12 months (patients)
- Not having a serious, life-limiting condition, such as metastatic cancer, primary lung cancer, chronic obstructive pulmonary disorder, heart disease, liver disease or cirrhosis, renal failure, or being oxygen dependent.
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Patients and providers in this arm receive the culturally-tailored Improving Communication about Serious Illness (ICSI) Intervention.
The ICSI involves providing the provider and the patient with an individualized, one-page summary of patient-specific preferences for advance care planning communication that prompts the patient and the provider to have a conversation about advance care planning at the next clinical visit.
|
A one-page summary of patient-specific preferences, barriers and facilitators for engaging in patient-provider communication about advance care planning, provided to patient and provider prior to a clinical encounter with prompts for initiating and/or improving the quality of communication about advance care planning.
|
No Intervention: Control
Patients and providers in this arm receive usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ACP communication occurrence
Time Frame: up to 2 weeks
|
Patient self-report of occurence of advance care planning communication.
|
up to 2 weeks
|
ACP communication quality
Time Frame: up to 2 weeks
|
Patient self-report of quality of advance care planning communication
|
up to 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Advance Directives
Time Frame: up to 1 month
|
Documentation of advance directives (i.e.
health care agent and living will) in electronic health record
|
up to 1 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention feasibility-provider
Time Frame: up to 1 week
|
Provider self-report of ease of using advance care planning communication tool
|
up to 1 week
|
Intervention feasibility-patient
Time Frame: up to 2 weeks
|
Patient self-report of ease of using advance care planning communication tool
|
up to 2 weeks
|
Intervention acceptability-provider
Time Frame: up to 1 week
|
Provider self-report of cultural acceptability of advance care planning communication tool
|
up to 1 week
|
Intervention acceptability-patient
Time Frame: up to 2 weeks
|
Patient self-report of cultural acceptability of advance care planning communication tool
|
up to 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer Shaw, PhD, Southcentral Foundation
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)
January 28, 2019
Primary Completion (Actual)
August 30, 2020
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
August 14, 2017
First Submitted That Met QC Criteria
August 18, 2017
First Posted (Actual)
August 21, 2017
Study Record Updates
Last Update Posted (Actual)
October 11, 2021
Last Update Submitted That Met QC Criteria
October 7, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5R21NR016611 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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