ClinicalTrials.gg
CompletedNCT03550404Updated Jul 10, 2024Results posted

Improving Native American Elder Access to and Use of Healthcare

An observational study in Access to Health Care, sponsored by Pacific Institute for Research and Evaluation. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-10.

Sponsored by Pacific Institute for Research and Evaluation · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
16
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This five-year project was developed by investigators from the Behavioral Health Research Center of the Southwest (BHRCS), a center of the Pacific Institute of Research and Evaluation (PIRE), the Health Committee of the New Mexico Indian Council on Aging (NMICoA), and the University of New Mexico (UNM). The project combines qualitative and quantitative interviews with concept-mapping (CM) techniques and focus groups to study insurance coverage, help-seeking behavior, and the healthcare experiences of American Indian Elders (AIEs) in New Mexico (NM). Practical knowledge grounded in the actual perspectives of AIEs and other key stakeholders may improve healthcare practices and policies for a population largely excluded from national and state discussions of health reform. The study data will also inform the adaptation and development of culturally tailored programming to enrich understanding and facilitate negotiation of a changing landscape of healthcare by AIEs. Our four specific aims are to:

  1. Assess how AIEs understand, access, maintain, and use insurance coverage.
  2. Characterize AIE help-seeking and healthcare experiences in dominant service delivery settings, i.e., Indian Health Service (IHS), tribally-run 638 facilities, and managed care programs.
  3. Identify and compare factors that affect AIE access to health care as perceived by multiple stakeholders, i.e., AIEs, outreach workers (OWs), healthcare staff and providers, public sector administrators, and tribal leaders.
  4. Develop and assess implementation feasibility of a structured intervention for OWs that promotes enhanced patient navigation, in addition to healthcare literacy, access, and usage among AIEs.
02

Conditions studied

  • Access to Health Care
03

In context

Lead sponsor

Pacific Institute for Research and Evaluation is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

Eligibility criteria

Navigators

Inclusion Criteria:

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

Exclusion Criteria:

  • Not Routinely interacting with AIEs as part of their jobs
  • Not willing to be trained in or use the Seasons of Care app

American Indian Elders (AIEs) Inclusion

  • Age 55+
  • Identifying as AI
  • Able to read in English
  • Able to consent and complete study procedures
  • Interacted with Navigator

Exclusion ● Individuals who cannot read in English or who have not interacted with a pilot test Navigator will not be eligible to participate

Healthcare Staff/providers Inclusion

  • 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

Exclusion

● 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

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
16 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralSeasons of Care App

    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.

06

What researchers measure

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

    Time frame: Once at the end of P2 (Month 8 of 8)

Secondary outcomes

  1. Navigator Pre- and Post-Evaluation Interview

    A semi-structured, in-person interview comprised of open-ended questions to assess navigator's confidence and experiences with communicating health information to AIEs and healthcare providers; perceptions of the Seasons of Care app

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

Other outcomes

  1. User Evaluation Demographic Survey

    A demographic survey with AIEs and healthcare providers who interacted with a navigator using the Seasons of Care app

    Time frame: Once at the end of P2 (Month 8 of 8)

  2. Feasibility Questionnaire

    A written questionnaire to assess navigator's experiences with, and effects of, Seasons of Care Guide

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

07

Results

Posted Jul 10, 2024
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.

Participant flow

We used reputational case selection to identify potential participants who were individuals who provided healthcare navigation services to Elders as part of their everyday work. We approached individuals or administrators at community organizations, healthcare facilities, and tribal agencies with an email or in-person description of the study and an invitation to participate. We followed up at each site with up to three emails, visits, or phone calls.

Phase 1
Participant flow — Phase 1
MilestoneNavigatorsAmerican Indian Elders (AIEs)Healthcare Providers/Staff
Started800
Completed800
Not completed000
Phase 2
Participant flow — Phase 2
MilestoneNavigatorsAmerican Indian Elders (AIEs)Healthcare Providers/Staff
Started800
Completed400
Not completed400
Withdrew: Unable to complete due to other duties during covid-19 pandemic300
Withdrew: Vacated position100

Outcome measures

PrimaryUser 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

Time frame:
Once at the end of P2 (Month 8 of 8)

No measurements were reported for this outcome.

SecondaryNavigator Pre- and Post-Evaluation Interview

A semi-structured, in-person interview comprised of open-ended questions to assess navigator's confidence and experiences with communicating health information to AIEs and healthcare providers; perceptions of the Seasons of Care app

Time frame:
Month 1 and 4 (of 8) for P1 Navigators; Month 5 and 8 (of 8) for P2 Navigators
Reported as:
Count of participants · Participants
Navigator Pre- and Post-Evaluation Interview
ParticipantsNavigatorsAmerican Indian Elders (AIEs)Healthcare Providers/Staff
Effects of Seasons of Care Guide on Communication with Providers — Improved3——
Effects of Seasons of Care Guide on Communication with Providers — Improved but with some remaining barriers2——
Effects of Seasons of Care Guide on Communication with Providers — No change1——
Effects of Seasons of Care Guide on Communication with Providers — No response6——
Effects of Seasons of Care Guide on Communication with Elders — Improved5——
Effects of Seasons of Care Guide on Communication with Elders — Improved but with some remaining barriers0——
Effects of Seasons of Care Guide on Communication with Elders — No change3——
Effects of Seasons of Care Guide on Communication with Elders — No response4——
Other pre-specifiedUser Evaluation Demographic Survey

A demographic survey with AIEs and healthcare providers who interacted with a navigator using the Seasons of Care app

Time frame:
Once at the end of P2 (Month 8 of 8)

No measurements were reported for this outcome.

Other pre-specifiedFeasibility Questionnaire

A written questionnaire to assess navigator's experiences with, and effects of, Seasons of Care Guide

Time frame:
Assessed monthly for 4 months; participants' ratings for each category were averaged. Average ratings per participant for each category is reported here.
Reported as:
Count of participants · Participants
Feasibility Questionnaire
ParticipantsNavigatorsAmerican Indian Elders (AIEs)Healthcare Providers/Staff
Looks appealing (Average rating: 10=Strongly agree, 1=Strongly disagree) — 104——
Looks appealing (Average rating: 10=Strongly agree, 1=Strongly disagree) — 94——
Looks appealing (Average rating: 10=Strongly agree, 1=Strongly disagree) — 83——
Looks appealing (Average rating: 10=Strongly agree, 1=Strongly disagree) — 71——
Looks appealing (Average rating: 10=Strongly agree, 1=Strongly disagree) — 60——
Looks appealing (Average rating: 10=Strongly agree, 1=Strongly disagree) — 51——
Looks appealing (Average rating: 10=Strongly agree, 1=Strongly disagree) — 40——
Looks appealing (Average rating: 10=Strongly agree, 1=Strongly disagree) — 30——
Looks appealing (Average rating: 10=Strongly agree, 1=Strongly disagree) — 20——
Looks appealing (Average rating: 10=Strongly agree, 1=Strongly disagree) — 10——
Looks appealing (Average rating: 10=Strongly agree, 1=Strongly disagree) — Not rated0——
Can easily navigate on first try (Average rating: 10=Strongly agree, 1=Strongly disagree) — 103——
Can easily navigate on first try (Average rating: 10=Strongly agree, 1=Strongly disagree) — 92——
Can easily navigate on first try (Average rating: 10=Strongly agree, 1=Strongly disagree) — 86——
Can easily navigate on first try (Average rating: 10=Strongly agree, 1=Strongly disagree) — 71——
Can easily navigate on first try (Average rating: 10=Strongly agree, 1=Strongly disagree) — 60——
Can easily navigate on first try (Average rating: 10=Strongly agree, 1=Strongly disagree) — 51——
Can easily navigate on first try (Average rating: 10=Strongly agree, 1=Strongly disagree) — 40——
Can easily navigate on first try (Average rating: 10=Strongly agree, 1=Strongly disagree) — 30——
Can easily navigate on first try (Average rating: 10=Strongly agree, 1=Strongly disagree) — 20——
Can easily navigate on first try (Average rating: 10=Strongly agree, 1=Strongly disagree) — 10——
Can easily navigate on first try (Average rating: 10=Strongly agree, 1=Strongly disagree) — Not rated0——
Can easily re-located info (Average rating: 10=Strongly agree, 1=Strongly disagree) — 103——
Can easily re-located info (Average rating: 10=Strongly agree, 1=Strongly disagree) — 93——
Can easily re-located info (Average rating: 10=Strongly agree, 1=Strongly disagree) — 85——
Can easily re-located info (Average rating: 10=Strongly agree, 1=Strongly disagree) — 71——
Can easily re-located info (Average rating: 10=Strongly agree, 1=Strongly disagree) — 60——
Can easily re-located info (Average rating: 10=Strongly agree, 1=Strongly disagree) — 51——
Can easily re-located info (Average rating: 10=Strongly agree, 1=Strongly disagree) — 40——
Can easily re-located info (Average rating: 10=Strongly agree, 1=Strongly disagree) — 30——
Can easily re-located info (Average rating: 10=Strongly agree, 1=Strongly disagree) — 20——
Can easily re-located info (Average rating: 10=Strongly agree, 1=Strongly disagree) — 10——
Can easily re-located info (Average rating: 10=Strongly agree, 1=Strongly disagree) — Not rated0——
Can find relevant info using "Search" (Average rating: 10=Strongly agree, 1=Strongly disagree) — 105——
Can find relevant info using "Search" (Average rating: 10=Strongly agree, 1=Strongly disagree) — 91——
Can find relevant info using "Search" (Average rating: 10=Strongly agree, 1=Strongly disagree) — 86——
Can find relevant info using "Search" (Average rating: 10=Strongly agree, 1=Strongly disagree) — 70——
Can find relevant info using "Search" (Average rating: 10=Strongly agree, 1=Strongly disagree) — 60——
Can find relevant info using "Search" (Average rating: 10=Strongly agree, 1=Strongly disagree) — 51——
Can find relevant info using "Search" (Average rating: 10=Strongly agree, 1=Strongly disagree) — 40——
Can find relevant info using "Search" (Average rating: 10=Strongly agree, 1=Strongly disagree) — 30——
Can find relevant info using "Search" (Average rating: 10=Strongly agree, 1=Strongly disagree) — 20——
Can find relevant info using "Search" (Average rating: 10=Strongly agree, 1=Strongly disagree) — 10——
Can find relevant info using "Search" (Average rating: 10=Strongly agree, 1=Strongly disagree) — Not rated0——
Can easily find healthcare facilities (Average rating: 10=Strongly agree, 1=Strongly disagree) — 101——
Can easily find healthcare facilities (Average rating: 10=Strongly agree, 1=Strongly disagree) — 95——
Can easily find healthcare facilities (Average rating: 10=Strongly agree, 1=Strongly disagree) — 83——
Can easily find healthcare facilities (Average rating: 10=Strongly agree, 1=Strongly disagree) — 72——
Can easily find healthcare facilities (Average rating: 10=Strongly agree, 1=Strongly disagree) — 62——
Can easily find healthcare facilities (Average rating: 10=Strongly agree, 1=Strongly disagree) — 50——
Can easily find healthcare facilities (Average rating: 10=Strongly agree, 1=Strongly disagree) — 40——
Can easily find healthcare facilities (Average rating: 10=Strongly agree, 1=Strongly disagree) — 30——
Can easily find healthcare facilities (Average rating: 10=Strongly agree, 1=Strongly disagree) — 20——
Can easily find healthcare facilities (Average rating: 10=Strongly agree, 1=Strongly disagree) — 10——
Can easily find healthcare facilities (Average rating: 10=Strongly agree, 1=Strongly disagree) — Not rated0——
AIEs like using it (Average rating: 10=Strongly agree, 1=Strongly disagree) — 101——
AIEs like using it (Average rating: 10=Strongly agree, 1=Strongly disagree) — 92——
AIEs like using it (Average rating: 10=Strongly agree, 1=Strongly disagree) — 83——
AIEs like using it (Average rating: 10=Strongly agree, 1=Strongly disagree) — 71——
AIEs like using it (Average rating: 10=Strongly agree, 1=Strongly disagree) — 61——
AIEs like using it (Average rating: 10=Strongly agree, 1=Strongly disagree) — 51——
AIEs like using it (Average rating: 10=Strongly agree, 1=Strongly disagree) — 41——
AIEs like using it (Average rating: 10=Strongly agree, 1=Strongly disagree) — 32——
AIEs like using it (Average rating: 10=Strongly agree, 1=Strongly disagree) — 21——
AIEs like using it (Average rating: 10=Strongly agree, 1=Strongly disagree) — 10——
AIEs like using it (Average rating: 10=Strongly agree, 1=Strongly disagree) — Not rated0——
Useful for working with AIEs — 103——
Useful for working with AIEs — 93——
Useful for working with AIEs — 82——
Useful for working with AIEs — 72——
Useful for working with AIEs — 61——
Useful for working with AIEs — 51——
Useful for working with AIEs — 41——
Useful for working with AIEs — 30——
Useful for working with AIEs — 20——
Useful for working with AIEs — 10——
Useful for working with AIEs — Not rated0——
Provides info not available elsewhere (Average rating: 10=Strongly agree, 1=Strongly disagree) — 102——
Provides info not available elsewhere (Average rating: 10=Strongly agree, 1=Strongly disagree) — 90——
Provides info not available elsewhere (Average rating: 10=Strongly agree, 1=Strongly disagree) — 85——
Provides info not available elsewhere (Average rating: 10=Strongly agree, 1=Strongly disagree) — 72——
Provides info not available elsewhere (Average rating: 10=Strongly agree, 1=Strongly disagree) — 62——
Provides info not available elsewhere (Average rating: 10=Strongly agree, 1=Strongly disagree) — 52——
Provides info not available elsewhere (Average rating: 10=Strongly agree, 1=Strongly disagree) — 40——
Provides info not available elsewhere (Average rating: 10=Strongly agree, 1=Strongly disagree) — 30——
Provides info not available elsewhere (Average rating: 10=Strongly agree, 1=Strongly disagree) — 20——
Provides info not available elsewhere (Average rating: 10=Strongly agree, 1=Strongly disagree) — 10——
Provides info not available elsewhere (Average rating: 10=Strongly agree, 1=Strongly disagree) — Not rated0——
Useful tool for healthcare providers (Average rating: 10=Strongly agree, 1=Strongly disagree) — 102——
Useful tool for healthcare providers (Average rating: 10=Strongly agree, 1=Strongly disagree) — 91——
Useful tool for healthcare providers (Average rating: 10=Strongly agree, 1=Strongly disagree) — 86——
Useful tool for healthcare providers (Average rating: 10=Strongly agree, 1=Strongly disagree) — 72——
Useful tool for healthcare providers (Average rating: 10=Strongly agree, 1=Strongly disagree) — 60——
Useful tool for healthcare providers (Average rating: 10=Strongly agree, 1=Strongly disagree) — 52——
Useful tool for healthcare providers (Average rating: 10=Strongly agree, 1=Strongly disagree) — 40——
Useful tool for healthcare providers (Average rating: 10=Strongly agree, 1=Strongly disagree) — 30——
Useful tool for healthcare providers (Average rating: 10=Strongly agree, 1=Strongly disagree) — 20——
Useful tool for healthcare providers (Average rating: 10=Strongly agree, 1=Strongly disagree) — 10——
Useful tool for healthcare providers (Average rating: 10=Strongly agree, 1=Strongly disagree) — Not rated0——
Is helping AIEs access care and insurance (Average rating: 10=Strongly agree, 1=Strongly disagree) — 102——
Is helping AIEs access care and insurance (Average rating: 10=Strongly agree, 1=Strongly disagree) — 92——
Is helping AIEs access care and insurance (Average rating: 10=Strongly agree, 1=Strongly disagree) — 84——
Is helping AIEs access care and insurance (Average rating: 10=Strongly agree, 1=Strongly disagree) — 70——
Is helping AIEs access care and insurance (Average rating: 10=Strongly agree, 1=Strongly disagree) — 60——
Is helping AIEs access care and insurance (Average rating: 10=Strongly agree, 1=Strongly disagree) — 51——
Is helping AIEs access care and insurance (Average rating: 10=Strongly agree, 1=Strongly disagree) — 43——
Is helping AIEs access care and insurance (Average rating: 10=Strongly agree, 1=Strongly disagree) — 30——
Is helping AIEs access care and insurance (Average rating: 10=Strongly agree, 1=Strongly disagree) — 20——
Is helping AIEs access care and insurance (Average rating: 10=Strongly agree, 1=Strongly disagree) — 10——
Is helping AIEs access care and insurance (Average rating: 10=Strongly agree, 1=Strongly disagree) — Not rated1——

Adverse events

Collected over Adverse event data were collected from Navigators monthly during Phase 1 and Phase 2. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Navigators0/16 (0%)0/16 (0%)0/16 (0%)
American Indian Elders (AIEs)———
Healthcare Providers/Staff———

Baseline characteristics

Due to complete closure of tribal communities during the COVID-19 pandemic, we were unable to complete baseline measures with any American Indian Elders or healthcare providers/staff

Age, Continuous
Age, Continuous(years)NavigatorsAmerican Indian Elders (AIEs)Healthcare Providers/StaffTotal
Mean36 (21 to 70)——36 (21 to 70)
Sex: Female, Male
Sex: Female, Male(Participants)NavigatorsAmerican Indian Elders (AIEs)Healthcare Providers/StaffTotal
Female12——12
Male4——4
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)NavigatorsAmerican Indian Elders (AIEs)Healthcare Providers/StaffTotal
Hispanic or Latino4——4
Not Hispanic or Latino12——12
Unknown or Not Reported0——0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)NavigatorsAmerican Indian Elders (AIEs)Healthcare Providers/StaffTotal
American Indian or Alaska Native12——12
Asian0——0
Native Hawaiian or Other Pacific Islander0——0
Black or African American0——0
White3——3
More than one race1——1
Unknown or Not Reported0——0
Confidence communicating with Elders
Confidence communicating with Elders(Participants)NavigatorsAmerican Indian Elders (AIEs)Healthcare Providers/StaffTotal
Comfortable communicating with AIEs about health and healthcare issues16——16
Comfortable communicating with AIEs about health insurance11——11
Uncomfortable communicating AIEs about insurance due to lack of knowledge3——3
Experienced language barriers communicating with AIEs5——5
Experienced challenges communicating with AIEs about difficult or taboo topics4——4
Confidence communicating with healthcare providers
Confidence communicating with healthcare providers(Participants)NavigatorsAmerican Indian Elders (AIEs)Healthcare Providers/StaffTotal
Comfortable communicating with healthcare providers due to regular experience doing so12——12
Comfortable communicating with healthcare providers when receiving referrals to help AIEs7——7
Comfort using Seasons of Care Guide
Comfort using Seasons of Care Guide(Participants)NavigatorsAmerican Indian Elders (AIEs)Healthcare Providers/StaffTotal
Comfortable using the Seasons of Care Guide in their work10——10
Confident that they would become comfortable with the Seasons of Care Guide over time5——5
Felt that the Seasons of Care Guide was no different than other resources they already used1——1
08

Study locations

1 site
  • Pacific Institute for Research and Evaluation
    Albuquerque, New Mexico 87106, United States
09

References and documents

Publications

  • 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. PubMed 29914446 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03550404
Lead sponsor
Pacific Institute for Research and Evaluation
Responsible party
Cathleen Willging (Senior Research Scientist/Center Director, Pacific Institute for Research and Evaluation) — Principal investigator
First posted
Jun 8, 2018
Start date
Aug 1, 2018
Primary completion
Nov 30, 2021
Completion
Jun 30, 2022
Results posted
Jul 10, 2024
Last update
Jul 10, 2024

Study contacts

Cathleen Willging
principal investigator · Pacific Institute for Research and Evaluation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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