- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07664436
Improving Affordability in Cancer Care Through Economic Screening and Support (I-ACCESS) (I-ACCESS)
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Brianna Connelly
- 전화번호: 919-964-2343
- 이메일: brianna_connelly@med.unc.edu
연구 장소
-
-
New York
-
New York, New York, 미국, 10016
- Perlmutter Cancer Center
-
연락하다:
- Brianna Connelly
- 전화번호: 919-964-2343
- 이메일: brianna_connelly@med.unc.edu
-
연락하다:
- Bridgette
- 전화번호: 646-221-6953
- 이메일: Bridgette.Thom@unc.edu
-
-
North Carolina
-
Burlington, North Carolina, 미국, 27215
- Cone Health Alamance Regional
-
연락하다:
- Brianna Connelly
- 전화번호: 919-964-2343
- 이메일: brianna_connelly@med.unc.edu
-
연락하다:
- Bridgette Thom
- 전화번호: 646-221-6953
- 이메일: Bridgette.Thom@unc.edu
-
Chapel Hill, North Carolina, 미국, 27599
- University of North Carolina at Chapel Hill
-
Hendersonville, North Carolina, 미국, 28791
- UNC Health Pardee
-
연락하다:
- Brianna Connelly
- 전화번호: 919-964-2343
- 이메일: brianna_connelly@med.unc.edu
-
연락하다:
- Bridgette Thom
- 전화번호: 646-221-6953
- 이메일: Bridgette.Thom@unc.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Screening completion
기간: 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
기간: 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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Type of referral
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 4-6 months after intervention completion
|
Patient and clinician perception of intervention feasibility
|
4-6 months after intervention completion
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .