NCT03550404

Brief Summary

This community-driven study features a mixed-method, participatory design to examine help-seeking behavior and healthcare experiences of American Indian elders in New Mexico, in order to develop and evaluate a tailored intervention to enhance knowledge of, access to, and use of insurance and available services to reduce healthcare disparities. This study includes qualitative and quantitative interviews combined with concept mapping and focus groups with American Indian elders and other key stakeholders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
2 years until next milestone

Results Posted

Study results publicly available

July 10, 2024

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

3.3 years

First QC Date

May 15, 2018

Results QC Date

October 24, 2022

Last Update Submit

July 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • User Evaluation Survey

    A semi-structured, in-person interview (or focus group, depending on availability) with AIEs and healthcare providers who interacted with a navigator using the Seasons of Care app to assess experiences with, and effects of, the Seasons of Care app; suggestions to improve the Seasons of Care app

    Once at the end of P2 (Month 8 of 8)

Secondary Outcomes (1)

  • Navigator Pre- and Post-Evaluation Interview

    Month 1 and 4 (of 8) for P1 Navigators; Month 5 and 8 (of 8) for P2 Navigators

Other Outcomes (2)

  • User Evaluation Demographic Survey

    Once at the end of P2 (Month 8 of 8)

  • Feasibility Questionnaire

    Assessed monthly for 4 months; participants' ratings for each category were averaged. Average ratings per participant for each category is reported here.

Study Arms (3)

Navigators

AIE Navigators will use the Seasons of Care app in the context of their everyday outreach work with AIEs over two four-month intervention periods (P1 and P2). Their goal will be to facilitate health literacy to shift attitudes, beliefs, and behaviors to create a "Culture of Coverage" for AIEs at individual, organizational/community, and policy levels. Separated by distance, the AIE Navigators will receive coaching as necessary, using virtual meeting space, to help refine their implementation skills from a member of the research team with experience in AIE health outreach.

Behavioral: Seasons of Care App

American Indian Elders (AIEs)

Elders will be exposed to the Seasons of Care app when they reach out to navigators for assistance navigating the healthcare system.

Behavioral: Seasons of Care App

Healthcare providers/staff

This cohort will be exposed to the Seasons of Care app via navigators and their patients.

Behavioral: Seasons of Care App

Interventions

A web-based mobile application (app) called the Seasons of Care Elder Navigation Guide will assist elders, their families/caregivers, healthcare providers, outreach workers, and other community members in navigating healthcare and insurance systems. The app has the added advantage of being easy to update to respond to future changes in health care and insurance, and sustainable because it is not dependent on intensive training, developing, and retaining of individuals in professional navigation positions.

American Indian Elders (AIEs)Healthcare providers/staffNavigators

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outreach workers from indigenous communities in the southwest United States, and then the American Indian elders, healthcare staff and providers that interact with those outreach workers.

You may qualify if:

  • Working in a health and health insurance outreach
  • Routinely interacting with AIEs as part of their jobs
  • Primary service region includes target AIEs.

You may not qualify if:

  • Not Routinely interacting with AIEs as part of their jobs
  • Not willing to be trained in or use the Seasons of Care app
  • Age 55+
  • Identifying as AI
  • Able to read in English
  • Able to consent and complete study procedures
  • Interacted with Navigator
  • Individuals who have been in contact with a pilot test Navigator
  • Work in a healthcare facility that serves AIEs in one of our 4 regions
  • ● Individuals who have not interacted with a pilot test Navigator or do not work in a healthcare facility serving our primary population, will not be eligible to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pacific Institute for Research and Evaluation

Albuquerque, New Mexico, 87106, United States

Location

Related Publications (1)

  • Willging CE, Sommerfeld DH, Jaramillo ET, Lujan E, Bly RS, Debenport EK, Verney SP, Lujan R. "Improving Native American elder access to and use of health care through effective health system navigation". BMC Health Serv Res. 2018 Jun 18;18(1):464. doi: 10.1186/s12913-018-3182-y.

Limitations and Caveats

Data collection with American Indian Elders and healthcare providers/staff to evaluate their experiences with the Seasons of Care Guide was not possible due to the closure of tribal communities during the COVID-19 pandemic and the infeasibility of collecting data with these participants remotely. These evaluation data are qualitative; future research on the dissemination of the Seasons of Care Guide should prioritize quantitative methods.

Results Point of Contact

Title
Cathleen Willging
Organization
Pacific Institute for Research and Evaluation

Study Officials

  • Cathleen Willging

    Pacific Institute for Research and Evaluation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist/Center Director

Study Record Dates

First Submitted

May 15, 2018

First Posted

June 8, 2018

Study Start

August 1, 2018

Primary Completion

November 30, 2021

Study Completion

June 30, 2022

Last Updated

July 10, 2024

Results First Posted

July 10, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations