Improving Cancer Patients' Insurance Choices (I Can PIC)
29 aprile 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
263
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Missouri
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Saint Louis, Missouri, Stati Uniti, 63110
- Washington University School of Medicine
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 64 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
Altri nomi:
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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Knowledge Score
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Health Insurance Literacy Measure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 3 month follow-up
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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. 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)
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Mary C Politi, PhD, Washington University School of Medicine
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
27 giugno 2018
Completamento primario (Effettivo)
28 febbraio 2019
Completamento dello studio (Effettivo)
28 febbraio 2019
Date di iscrizione allo studio
Primo inviato
26 giugno 2018
Primo inviato che soddisfa i criteri di controllo qualità
9 luglio 2018
Primo Inserito (Effettivo)
19 luglio 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
1 maggio 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 aprile 2019
Ultimo verificato
1 aprile 2019
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 201704045
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .