Improving Cancer Patients' Insurance Choices (I Can PIC)
29 avril 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
263
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Missouri
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Saint Louis, Missouri, États-Unis, 63110
- Washington University School of Medicine
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 64 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: I Can PIC
The I Can PIC website will be provided to participants randomized to the experimental/intervention group.
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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.
Autres noms:
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Aucune intervention: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Knowledge Score
Délai: Completed immediately after using I Can PIC
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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.
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Completed immediately after using I Can PIC
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Decision Self-efficacy
Délai: Completed immediately after using I Can PIC.
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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).
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Completed immediately after using I Can PIC.
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Certainty about Choice (Decisional Conflict Scale)
Délai: Completed immediately after using I Can PIC
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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.
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Completed immediately after using I Can PIC
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Health Insurance Literacy Measure
Délai: Completed immediately after using I Can PIC
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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.
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Completed immediately after using I Can PIC
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Health Insurance Literacy Measure
Délai: 3 month follow-up
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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
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Choice of Health Insurance Plan
Délai: Completed immediately after using I Can PIC
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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.
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Completed immediately after using I Can PIC
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Choice of Health Insurance Plan
Délai: 3 month follow-up
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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
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Healthcare Utlization
Délai: 3 month follow-up
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Participants will be asked questions about how often they use healthcare services to see if their plan choice relates to their utilization
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3 month follow-up
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Knowledge Score
Délai: 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)
Délai: 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
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Mary C Politi, PhD, Washington University School of Medicine
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
27 juin 2018
Achèvement primaire (Réel)
28 février 2019
Achèvement de l'étude (Réel)
28 février 2019
Dates d'inscription aux études
Première soumission
26 juin 2018
Première soumission répondant aux critères de contrôle qualité
9 juillet 2018
Première publication (Réel)
19 juillet 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 mai 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 avril 2019
Dernière vérification
1 avril 2019
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 201704045
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .