Improving Affordability in Cancer Care Through Economic Screening and Support (I-ACCESS) (I-ACCESS)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
In Aim 1, we will interview up to 30 clinical leaders and front-line staff across the two healthcare systems and community-based practices to understand workflows and opportunities for I-ACCESS integration. Assessment constructs will focus on understanding structural characteristics (including information technology infrastructure), available resources, culture, compatibility, relational connections, communications, and access to knowledge. These data will inform the creation of tailored process maps to outline processes and procedures to prepare each site for I-ACCESS implementation and elucidate when, how, and by whom I-ACCESS screening should be done.
In Aim 2, we will implement I-ACCESS as part of routine clinical practice for eight months at each site. Using a pre-/post-approach, we will examine whether I-ACCESS screening increases the number of financial counseling and oncology social work referrals (primary outcome). We will also examine counseling dispositions, receipt of services among those referred to financial support, and the predictive accuracy of the screening tool (secondary outcomes).
In Aim 3, we will analyze approximately 225 patient and 25 clinician surveys, informed by the Practical, Robust, Implementation and Sustainability Model, to gather feedback on I-ACCESS delivery, procedures, and barriers/facilitators to implementation. Based upon survey findings, we will then focus on key implementation determinants and outcomes through in-depth, semi-structured interviews with up to 40 stakeholders. Stakeholders will include patients, caregivers, healthcare providers, financial counselors, clinical support staff, and hospital administration at participating clinical sites.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Brianna Connelly
- Telefonnummer: 919-964-2343
- E-post: brianna_connelly@med.unc.edu
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10016
- Perlmutter Cancer Center
-
Ta kontakt med:
- Brianna Connelly
- Telefonnummer: 919-964-2343
- E-post: brianna_connelly@med.unc.edu
-
Ta kontakt med:
- Bridgette
- Telefonnummer: 646-221-6953
- E-post: Bridgette.Thom@unc.edu
-
-
North Carolina
-
Burlington, North Carolina, Forente stater, 27215
- Cone Health Alamance Regional
-
Ta kontakt med:
- Brianna Connelly
- Telefonnummer: 919-964-2343
- E-post: brianna_connelly@med.unc.edu
-
Ta kontakt med:
- Bridgette Thom
- Telefonnummer: 646-221-6953
- E-post: Bridgette.Thom@unc.edu
-
Chapel Hill, North Carolina, Forente stater, 27599
- University of North Carolina at Chapel Hill
-
Hendersonville, North Carolina, Forente stater, 28791
- UNC Health Pardee
-
Ta kontakt med:
- Brianna Connelly
- Telefonnummer: 919-964-2343
- E-post: brianna_connelly@med.unc.edu
-
Ta kontakt med:
- Bridgette Thom
- Telefonnummer: 646-221-6953
- E-post: Bridgette.Thom@unc.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Patients: Treatment for cancer at study site, over age 18 years, speak/read English or Spanish; Caregivers: Identified caregiver of a patient with cancer offered financial hardship screening, over age 18 years, speak/read English or Spanish; Staff/Clinicians: Involvement with I-ACCESS pilot implementation; over age 18 years, speak/read English or Spanish
Exclusion Criteria:
- Unable to read of speak English or Spanish
- Under the age of 18 years old
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Financial Screener
Determine the effectiveness of the I-ACCESS screening tool in facilitating patient referrals for financial hardship counseling across diverse clinical practice settings.
Patients who meet inclusion criteria will be screened for financial toxicity for financial toxicity using a 2-question screener tool developed from the COST ( a financial toxicity screening measure).
Patients who screen positive for financial toxicity will be appropriately referred to available counseling resources.
|
Patients who screen positive for financial toxicity on the 2-question screener tool, will be referred to available counseling or navigation resources available at each site.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Screening completion
Tidsramme: From enrollment to the end of the intervention at 8 months.
|
Ratio of the number of completed screens to the number of eligible patients
|
From enrollment to the end of the intervention at 8 months.
|
|
Rate of referral assistance
Tidsramme: From enrollment to the end of the intervention at 8 months.
|
Ratio of the number of patients referred to counseling to the number of patients screened positive for financial distress
|
From enrollment to the end of the intervention at 8 months.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Type of referral
Tidsramme: From enrollment to the end of the intervention at 8 months.
|
Count/percent of reason for referral (out-of-pocket costs, non-medical expense, benefit counseling, medication cost, other)
|
From enrollment to the end of the intervention at 8 months.
|
|
Counseling content
Tidsramme: From enrollment to the end of the intervention at 8 months.
|
Count/percent of counseling disposition (general, insurance, external referral, other)
|
From enrollment to the end of the intervention at 8 months.
|
|
Applications for assistance
Tidsramme: From enrollment to the end of the intervention at 8 months.
|
Count/percent of external referrals (including, but not limited to, foundation/charity support, local non-medical expense resources)
|
From enrollment to the end of the intervention at 8 months.
|
|
Referrals to external resources
Tidsramme: From enrollment to the end of the intervention at 8 months.
|
Count/percent of external referrals (including, but not limited to, foundation/charity support, local non-medical expense resources)
|
From enrollment to the end of the intervention at 8 months.
|
|
Predictive accuracy of tool
Tidsramme: From enrollment through the end of data analysis at 12 months
|
Sensitivity, specificity, positive predictive value, and negative predictive value of tool vs. documented bill-paying challenges
|
From enrollment through the end of data analysis at 12 months
|
|
Acceptability of Intervention Measure
Tidsramme: 4-6 months after implementation of I-ACCESS
|
Patient and clinician perception of intervention acceptability
|
4-6 months after implementation of I-ACCESS
|
|
Intervention Appropriateness Measure
Tidsramme: 4-6 months after implementation of I-ACCESS
|
Patient and clinician perception of intervention appropriateness
|
4-6 months after implementation of I-ACCESS
|
|
Feasibility of Intervention Measure
Tidsramme: 4-6 months after intervention completion
|
Patient and clinician perception of intervention feasibility
|
4-6 months after intervention completion
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 25-1413
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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. .