An interventional study of Health Insurance Education Program (HIEP) and Usual Care in Adolescent, Young Adult and Cancer, sponsored by University of Utah. Completed at 3 sites in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by University of Utah · Not applicable, Interventional, and Health services research
This is a test of an existing health insurance education program (HIEP) in adolescent and young adult (AYA) individuals (aged 18-39) diagnosed with cancer. The study will evaluate whether the HIEP delivered by patient navigators improves participants' health insurance and cost-related literacy compared to usual navigation care, which does not include education on insurance and medical costs. The study team hypothesizes that: The HIEP will improve participants' health insurance and cost-related literacy compared to usual navigation care. Specifically, that participants in the intervention arm will report greater 1) health insurance and cost literacy, including confidence with provider communication about costs, 2) familiarity with ACA policies, and 3) improvement in financial distress related to medical costs. Participants will fill out a survey upon enrollment and a follow up survey 3 months after meeting with a patient navigator where they may or may not receive the HIEP.
The goal of this research is to refine and pilot test an existing health insurance education program (HIEP) to improve health insurance and cost-related literacy among adolescent and young adult (AYA) individuals who have recently been diagnosed with cancer. This study will be conducted within the Huntsman-Intermountain Adolescent and Young Adult (HI-AYA) Cancer Care Program, which is a unique collaboration between the Huntsman Cancer Institute and Intermountain Healthcare, the largest oncology providers in Utah. Initially, age-related differences related to health insurance and cost literacy among AYAs diagnosed with cancer ages 18-26 and 27-39 years will be identified, and the HIEP materials will be adapted accordingly. The HIEP delivered by the HI-AYA patient navigators, will be investigated to see if it improves participants' health insurance and cost-related literacy.
Upon enrollment, participants will fill out a survey containing questions about their current health insurance plan, financial status, demographics, health insurance knowledge, and financial toxicity. Participants will then be randomized into separate trial arms after which participants in both groups will meet with a HI-AYA patient navigator. Participants in the interventional arm will receive 4 educational sessions surrounding health insurance use and laws (four sessions total occurring approximately every two weeks). These educational sessions will be conducted, in person, over video conference calls, or over the telephone, and will cover:
Approximately three months after meeting with the patient navigator, participants in both arms of the trial will fill out a second survey, including similar questions to those in the first survey as well as questions surrounding satisfaction with the HIEP and the patient navigator delivery for those who received the HIEP. After the post survey is complete, a small subset of participants in both the intervention and control arm will be randomly selected to complete an interview to better understand satisfaction with patient navigation, the intervention, recommendations for modifications on delivery modality, and recommendations for intervention topics and content modifications to identify components of the HIEP that require refinement prior to potential scaling of the intervention to a larger sample. Another small subset of participants will be randomly selected to complete an interview from the control arm to discuss their satisfaction with their patient navigation and to ask how they found resources concerning health insurance during their treatment.
University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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Exclusion Criteria:
Participants will be randomized to receive the insurance navigation intervention from patient navigators, which includes four, one hour long, educational learning sessions. Randomization will be done by age at diagnosis and site.
Behavioral: Health Insurance Education Program (HIEP)
Participants will be randomized to receive standard navigation provided by patient navigators ("usual care").
Other: Usual Care
\[See arm/group descriptions\]
\[See arm/group descriptions\]
Feasibility Measurement
Comparing total number of individuals enrolled and randomized vs completed study (completion of both surveys for control or both surveys and all of the sessions for intervention.)
Time frame: Post-Assessment survey (Weeks 13 (+/- 2 weeks))
Acceptability - Module Satisfaction
Questions surrounding satisfaction with the HIEP. These will be asked at the post-assessment interview and will consist of participants responses surrounding satisfaction with the HIEP. We will report percentages of participants who did 1 or more session and reported satisfaction with the HIEP.
Time frame: Post-Assessment interview (Weeks 18 (+/- 2 weeks))
Navigator Satisfaction
Validated Patient Satisfaction with Navigator Interpersonal Relationship (PSN-I) measure at post assessment survey. This score ranges from 0-45 with higher scores indicating higher satisfaction. We will report the mean and standard deviation.
Time frame: Post-Assessment survey (Weeks 13 (+/- 2 weeks))
Changes in Efficacy- Health Insurance Literacy
Differences between Health Insurance Literacy Measure (HILM) reported at the intro baseline and exit post-assessment survey. For this study, the last two sections (3\&4) of the HILM were used. Scores range from 9-36 with lower scores indicate lower health insurance literacy and worse outcomes. Differences will be examined by age group and by treatment arm. We report mean and standard deviation. Please note that not all participants, filled out all necessary questions at both timepoints to be assessed.
Time frame: Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))
Changes in Efficacy- Affordable Care Act (ACA) Familiarity
Questions surrounding familiarity with the ACA reported at the baseline and post-assessment survey. Values range from 0 to 28 with higher scores indicating better familiarity with ACA concepts. We will report the mean and standard deviation of the difference in response scores between baseline and post assessment for the control and intervention. Please note that not all participants, filled out all necessary questions at both timepoints to be assessed.
Time frame: Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))
Changes in Efficacy-Financial Distress
Differences between COmprehensive Score for financial Toxicity (COST) reported at the baseline and post-assessment survey. Values range from 0 to 44 where lower COST scores indicate worse financial toxicity. Differences will be examined by age group and by treatment arm. We will report mean and standard deviation. Please note that not all participants, filled out all necessary questions at both timepoints to be assessed.
Time frame: Baseline (Week 0) and Post Assessment survey ( Weeks 13 (+/- 2 weeks))
We decided to overshoot our original target just to have the extra data.
| Milestone | HIEP Intervention | Usual Care |
|---|---|---|
| Started | 45 | 41 |
| Completed | 25 | 39 |
| Not completed | 20 | 2 |
Comparing total number of individuals enrolled and randomized vs completed study (completion of both surveys for control or both surveys and all of the sessions for intervention.)
| Participants | Usual Care | HIEP Intervention |
|---|---|---|
| Feasibility Measurement | 39 | 25 |
Questions surrounding satisfaction with the HIEP. These will be asked at the post-assessment interview and will consist of participants responses surrounding satisfaction with the HIEP. We will report percentages of participants who did 1 or more session and reported satisfaction with the HIEP.
| Participants | HIEP Intervention | Usual Care |
|---|---|---|
| Acceptability - Module Satisfaction | 10 | 0 |
Validated Patient Satisfaction with Navigator Interpersonal Relationship (PSN-I) measure at post assessment survey. This score ranges from 0-45 with higher scores indicating higher satisfaction. We will report the mean and standard deviation.
| score on a scale | HIEP Intervention | Usual Care |
|---|---|---|
| Navigator Satisfaction | 30.84 ± 16.15 | 30.32 ± 12.95 |
Differences between Health Insurance Literacy Measure (HILM) reported at the intro baseline and exit post-assessment survey. For this study, the last two sections (3\&4) of the HILM were used. Scores range from 9-36 with lower scores indicate lower health insurance literacy and worse outcomes. Differences will be examined by age group and by treatment arm. We report mean and standard deviation. Please note that not all participants, filled out all necessary questions at both timepoints to be assessed.
| Score on a scale | HIEP Intervention | Usual Care | Combined |
|---|---|---|---|
| Changes in Efficacy- Health Insurance Literacy | 5.39 ± 6.44 | 2.30 ± 6.06 | 3.84 ± 6.40 |
Questions surrounding familiarity with the ACA reported at the baseline and post-assessment survey. Values range from 0 to 28 with higher scores indicating better familiarity with ACA concepts. We will report the mean and standard deviation of the difference in response scores between baseline and post assessment for the control and intervention. Please note that not all participants, filled out all necessary questions at both timepoints to be assessed.
| Score on a scale | HIEP Intervention | Usual Care | Combined |
|---|---|---|---|
| Changes in Efficacy- Affordable Care Act (ACA) Familiarity | 5.84 ± 6.30 | 2.03 ± 4.89 | 3.93 ± 5.92 |
Differences between COmprehensive Score for financial Toxicity (COST) reported at the baseline and post-assessment survey. Values range from 0 to 44 where lower COST scores indicate worse financial toxicity. Differences will be examined by age group and by treatment arm. We will report mean and standard deviation. Please note that not all participants, filled out all necessary questions at both timepoints to be assessed.
| Score on a scale | HIEP Intervention | Usual Care | Combined |
|---|---|---|---|
| Younger group (18-25) | 3.70 ± 9.59 | 2.89 ± 9.44 | 3.32 ± 9.26 |
| Older group (26-39) | 3.08 ± 8.45 | 0.741 ± 6.42 | 1.87 ± 7.48 |
| Combined (18-39) | 3.25 ± 8.65 | 1.28 ± 7.20 | 2.25 ± 7.95 |
Collected over Adverse events were not monitored for this study;.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HIEP Intervention | — | — | — |
| Usual Care | — | — | — |
Insured cancer patients between the ages of 18-39 who are within their first year of treatment at Huntsman Cancer Institute or the Intermountain Network.
| Age, Categorical(Participants) | HIEP Intervention | Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 45 | 41 | 86 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Years) | HIEP Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 28.96 ± 7.19 | 28.71 ± 6.15 | 28.84 ± 6.68 |
| Age, Customized(Participants) | HIEP Intervention | Usual Care | Total |
|---|---|---|---|
| Younger Group Age 18-25 | 17 | 13 | 30 |
| Older Group Age 26-39 | 28 | 28 | 56 |
| Sex: Female, Male(Participants) | HIEP Intervention | Usual Care | Total |
|---|---|---|---|
| Female | 28 | 31 | 59 |
| Male | 17 | 10 | 27 |
| Ethnicity (NIH/OMB)(Participants) | HIEP Intervention | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 10 | 16 |
| Not Hispanic or Latino | 39 | 30 | 69 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | HIEP Intervention | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 36 | 26 | 62 |
| More than one race | 1 | 2 | 3 |
| Unknown or Not Reported | 6 | 11 | 17 |
| Region of Enrollment(participants) | HIEP Intervention | Usual Care | Total |
|---|---|---|---|
| United States | 45 | 41 | 86 |
| COmprehensive Score for financial Toxicity (COST)(Score on a scale) | HIEP Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 19.72 ± 9.72 | 20.18 ± 12.20 | 19.94 ± 10.90 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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