Improving Cancer Patients' Insurance Choices (I Can PIC)
29. april 2019 oppdatert av: Washington University School of Medicine
Supporting Cancer Survivors' Health Insurance Marketplace Decisions
The goal of this research study is to find out if a decision aid (DA) created by investigators, I Can PIC, is effective in helping cancer patients make decisions about their health insurance.
The investigators will evaluate I Can PIC compared to an attention control condition (existing website created by the American Cancer Society Cancer Action Network).
The study hypothesis is that those randomly assigned to I Can PIC will have higher knowledge about health insurance terms and details, more certainty about the best health insurance plan for them, and more confidence in their health insurance decisions compared to those randomly assigned to the control condition.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
In a prior study, the investigators created a consumer-friendly online tool, Show Me Health Plans (SMHP), for those enrolling in health insurance in the ACA marketplace.
I Can PIC was developed based on SMHP, with input from an advisory board, and incorporating feedback from semi-structured qualitative interviews with cancer survivors.
The investigators created I Can PIC to focus on unique needs of cancer patients and survivors considering health insurance.
In this study, the investigators will examine the effectiveness of I Can PIC by conducting a randomized experiment with 275 participants.
The trial will compare the I Can PIC to an attention control website developed by the American Cancer Society Cancer Action Network.
Primary outcomes include knowledge, decision self-efficacy, certainty about plan choice, and the match between plan choice and preferences.
The investigators will also explore whether financial toxicity, cancer type, and time since diagnosis relate to outcomes.
Studietype
Intervensjonell
Registrering (Faktiske)
263
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Missouri
-
Saint Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 64 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Ability to read English
- Diagnosed with cancer in the past 5 years
- Residing in Missouri or Illinois
Exclusion Criteria:
- Eligible for Medicaid or Medicare in Missouri or Illinois
- Enrolled in the following types of health insurance plans: Medicare, Medicaid, TRICARE or other military healthcare, or Indian Health Services
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: I Can PIC
The I Can PIC website will be provided to participants randomized to the experimental/intervention group.
|
Participants will be shown (on a computer or via email link) a website called I Can PIC.
I Can PIC provides health insurance education, suggests ways to learn about the costs of cancer care and follow-up, shows resources to help offset the high costs of care, and helps individuals estimate (based on national data) how much they might spend on health insurance in the upcoming year.
Andre navn:
|
|
Ingen inngripen: Attention Control
Participants randomized to the attention control group will be provided a link to a website developed by the American Cancer Society Cancer Action Network.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Knowledge Score
Tidsramme: Completed immediately after using I Can PIC
|
The percent correct out of eight questions that were created by the research team based on information that is considered vital to making health insurance decisions.
|
Completed immediately after using I Can PIC
|
|
Decision Self-efficacy
Tidsramme: Completed immediately after using I Can PIC.
|
The validated decision self-efficacy scale will be used.
This 11-item scale measures an individual's self-confidence or belief in their ability to make a decision.
Individuals will be asked to rate how confident they feel taking actions involved in making an informed choice (e.g., gathering information, asking questions, and expressing opinions).
|
Completed immediately after using I Can PIC.
|
|
Certainty about Choice (Decisional Conflict Scale)
Tidsramme: Completed immediately after using I Can PIC
|
The validated, 4-item SURE Test for clinical practice will be used.
This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice, and feel they have enough support to make a choice.
|
Completed immediately after using I Can PIC
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Health Insurance Literacy Measure
Tidsramme: Completed immediately after using I Can PIC
|
Two items from the validated Health Insurance Literacy Measure will be used.
This scale measures consumers' confidence in their ability to estimate their annual health care costs and their understanding of health insurance terms.
|
Completed immediately after using I Can PIC
|
|
Health Insurance Literacy Measure
Tidsramme: 3 month follow-up
|
Two items from the validated Health Insurance Literacy Measure will be used. This scale measures consumers' confidence in their ability to estimate their annual health care costs and their understanding of health insurance terms. This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up. |
3 month follow-up
|
|
Choice of Health Insurance Plan
Tidsramme: Completed immediately after using I Can PIC
|
Participants will be asked what health insurance plan they would choose.
Plan selections will be categorized by the type of plan, e.g., high deductible plan, PPO, silver-tier Marketplace plan, gold-tier Marketplace plan, and will be compared to our algorithmic prediction about good fit plans for users based on estimates of their health care expenses.
|
Completed immediately after using I Can PIC
|
|
Choice of Health Insurance Plan
Tidsramme: 3 month follow-up
|
Participants will be asked what health insurance plan they choose. Plan selections will be categorized by the type of plan, e.g., high deductible plan, PPO, silver-tier Marketplace plan, gold-tier Marketplace plan, and will be compared to our algorithmic prediction about good fit plans for users based on estimates of their health care expenses. This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up. |
3 month follow-up
|
|
Healthcare Utlization
Tidsramme: 3 month follow-up
|
Participants will be asked questions about how often they use healthcare services to see if their plan choice relates to their utilization
|
3 month follow-up
|
|
Knowledge Score
Tidsramme: 3 month follow-up
|
The percent correct out of eight questions that were created by the research team based on information that is considered vital to making health insurance decisions. This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up. |
3 month follow-up
|
|
Certainty about Choice (Decisional Conflict Scale)
Tidsramme: 3 month follow-up
|
The validated, 4-item SURE Test for clinical practice will be used. This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice, and feel they have enough support to make a choice. This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up. |
3 month follow-up
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Mary C Politi, PhD, Washington University School of Medicine
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Housten AJ, Furtado K, Kaphingst KA, Kebodeaux C, McBride T, Cusanno B, Politi MC. Stakeholders' perceptions of ways to support decisions about health insurance marketplace enrollment: a qualitative study. BMC Health Serv Res. 2016 Nov 8;16(1):634. doi: 10.1186/s12913-016-1890-8.
- Politi MC, Barker AR, Kaphingst KA, McBride T, Shacham E, Kebodeaux CS. Show Me My Health Plans: a study protocol of a randomized trial testing a decision support tool for the federal health insurance marketplace in Missouri. BMC Health Serv Res. 2016 Feb 16;16:55. doi: 10.1186/s12913-016-1314-9.
- Politi MC, Kuzemchak MD, Liu J, Barker AR, Peters E, Ubel PA, Kaphingst KA, McBride T, Kreuter MW, Shacham E, Philpott SE. Show Me My Health Plans: Using a Decision Aid to Improve Decisions in the Federal Health Insurance Marketplace. MDM Policy Pract. 2016 Jul;1(1):2381468316679998. doi: 10.1177/2381468316679998. Epub 2016 Nov 16.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
27. juni 2018
Primær fullføring (Faktiske)
28. februar 2019
Studiet fullført (Faktiske)
28. februar 2019
Datoer for studieregistrering
Først innsendt
26. juni 2018
Først innsendt som oppfylte QC-kriteriene
9. juli 2018
Først lagt ut (Faktiske)
19. juli 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. mai 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. april 2019
Sist bekreftet
1. april 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 201704045
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .