- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07664436
Improving Affordability in Cancer Care Through Economic Screening and Support (I-ACCESS) (I-ACCESS)
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Brianna Connelly
- Numer telefonu: 919-964-2343
- E-mail: brianna_connelly@med.unc.edu
Lokalizacje studiów
-
-
New York
-
New York, New York, Stany Zjednoczone, 10016
- Perlmutter Cancer Center
-
Kontakt:
- Brianna Connelly
- Numer telefonu: 919-964-2343
- E-mail: brianna_connelly@med.unc.edu
-
Kontakt:
- Bridgette
- Numer telefonu: 646-221-6953
- E-mail: Bridgette.Thom@unc.edu
-
-
North Carolina
-
Burlington, North Carolina, Stany Zjednoczone, 27215
- Cone Health Alamance Regional
-
Kontakt:
- Brianna Connelly
- Numer telefonu: 919-964-2343
- E-mail: brianna_connelly@med.unc.edu
-
Kontakt:
- Bridgette Thom
- Numer telefonu: 646-221-6953
- E-mail: Bridgette.Thom@unc.edu
-
Chapel Hill, North Carolina, Stany Zjednoczone, 27599
- University of North Carolina at Chapel Hill
-
Hendersonville, North Carolina, Stany Zjednoczone, 28791
- UNC Health Pardee
-
Kontakt:
- Brianna Connelly
- Numer telefonu: 919-964-2343
- E-mail: brianna_connelly@med.unc.edu
-
Kontakt:
- Bridgette Thom
- Numer telefonu: 646-221-6953
- E-mail: Bridgette.Thom@unc.edu
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Inny: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Screening completion
Ramy czasowe: 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
Ramy czasowe: 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.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Type of referral
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 4-6 months after intervention completion
|
Patient and clinician perception of intervention feasibility
|
4-6 months after intervention completion
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 25-1413
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .