Access to Health CareNCT03550404
Improving Native American Elder Access to and Use of Healthcare
An observational study of Access to Health Care, run by Pacific Institute for Research and Evaluation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Access to Health Care
- What is being tested?
- Seasons of Care App
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 30 Jun 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
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.
Who may be able to join
- Working in a health and health insurance outreach
- Routinely interacting with AIEs as part of their jobs
- Primary service region includes target AIEs.
Who cannot join
- 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
Show all 13Show fewer
- 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
- ● 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pacific Institute for Research and Evaluation
Albuquerque, New Mexico, 87106
About this study
Official title: Improving Native American Elder Access to and Use of Healthcare Through Effective Health System Navigation
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:
- Assess how AIEs understand, access, maintain, and use insurance coverage.
- 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.
- 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.
- 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.
- Conditions
- Access to Health Care
- Being tested
- Seasons of Care App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seasons of Care AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Seasons of Care App | |
| Healthcare providers/staff | This cohort will be exposed to the Seasons of Care app via navigators and their patients. Receives: Behavioral: Seasons of Care App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Month 1 and 4 (of 8) for P1 Navigators; Month 5 and 8 (of 8) for P2 Navigators
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Aug 2018
- Primary completion30 Nov 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Access to Health CareStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Institute for Research and Evaluation
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, University of New Mexico
- Responsible party
- Principal investigator, Cathleen Willging, Pacific Institute for Research and Evaluation
- Investigators
- Cathleen Willging, Principal investigator, Pacific Institute for Research and Evaluation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550404
- Sponsor's protocol ID
- 0784.01.01
- Status last verified
- Jul 2024
- First submitted
- 15 May 2018
- Last updated
- 10 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Native American Elder Access to and Use of Healthcare Through Effective Health System Navigation
- ClinicalTrials.gov ID
- NCT03550404
- Acronym / sponsor ID
- 0784.01.01
- Conditions
- Access to Health Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Pacific Institute for Research and EvaluationUniversity, hospital or other
- Collaborators
- University of California, San Diego, University of New Mexico
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Posted 10 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Assess how AIEs understand, access, maintain, and use insurance coverage.
- 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.
- 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.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Navigators | – | Behavioral: Seasons of Care AppAIE 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. |
| American Indian Elders (AIEs) | – | Behavioral: Seasons of Care AppElders will be exposed to the Seasons of Care app when they reach out to navigators for assistance navigating the healthcare system. |
| Healthcare providers/staff | – | Behavioral: Seasons of Care AppThis cohort will be exposed to the Seasons of Care app via navigators and their patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Working in a health and health insurance outreach
- Routinely interacting with AIEs as part of their jobs
- Primary service region includes target AIEs.
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Seasons of Care AppA 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. | Behavioural | American Indian Elders (AIEs), Healthcare providers/staff, Navigators |
Primary outcome
User Evaluation Survey
Time frame: Once at the end of P2 (Month 8 of 8)
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
1 secondary outcome
Navigator Pre- and Post-Evaluation Interview
Time frame: Month 1 and 4 (of 8) for P1 Navigators; Month 5 and 8 (of 8) for P2 Navigators
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29914446Willging 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.
- Individual participant dataSharing planned: No
Related trials for Access to Health Care
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Recruiting
Targeted Navigation in Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma, Cholangiocarcinoma
Enrolling by invitation
TimelyCare - A Proactive Primary Care Model: Delivering the Right Care at the Right Time for Individuals at Risk of High Care Consumption
Multimorbidity, Integrated Care
Not yet recruiting
Pilot Study to Co-create and Implement a Multicomponent Intervention to Reduce Mental Health Stigma in Primary Care
Mental Health, Stigma of Mental Illness
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.
Cathleen Willging principal investigator
Pacific Institute for Research and Evaluation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Access to Health Care, run by Pacific Institute for Research and Evaluation at 1 site in United States.
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 3 inclusion and 13 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: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 10 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
User Evaluation Survey (time frame: Once at the end of P2 (Month 8 of 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03550404, which also lists 1 linked publication.
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 10 Jul 2024.