Palliative Care Communication With Alaska Native and American Indian People

NCT03256110 | Completed DMC

• 1 other identifier: 5R21NR016611
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Advance Care Planning

Keywords

Advance Care Planning; Palliative Care; Indians, North American; Alaska Natives; Health Communication; Primary Health Care

Outcome Measures

Primary Outcomes (2)

• ACP communication occurrence

  Patient self-report of occurence of advance care planning communication.

  up to 2 weeks

• ACP communication quality

  Patient self-report of quality of advance care planning communication

  up to 2 weeks

Secondary Outcomes (1)

• Advance Directives

  up to 1 month

Other Outcomes (4)

• Intervention feasibility-provider

  up to 1 week

• Intervention feasibility-patient

  up to 2 weeks

• Intervention acceptability-provider

  up to 1 week

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Improving Communication about Serious Illness-AI/AN

Control

NO INTERVENTION

Patients and providers in this arm receive usual care.

Interventions

Improving Communication about Serious Illness-AI/AN BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southcentral Foundation: lead
• University of Colorado, Denver: collaborator
• University of New Mexico: collaborator
• Washington State University: collaborator
• University of Washington: collaborator

Study Sites (2)

Southcentral Foundation

Anchorage, Alaska, 99508, United States

Location

First Nations Community HealthSource

Albuquerque, New Mexico, 87108, United States

Location

Study Officials

• Jennifer Shaw, PhD

  Southcentral Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Model Details: Cluster-randomized design with providers randomized to intervention or control and patients nested within provider.

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 21, 2017
• Study Start: January 28, 2019
• Primary Completion: August 30, 2020
• Study Completion: July 1, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)