유년기 생존자를 위한 가상 건강 보험 내비게이션 파일럿 프로그램(HINTII) (HINTII)
2025년 10월 31일 업데이트: Elyse Park, PhD, Massachusetts General Hospital
건강 보험 이해력 향상 및 재정적 부담 감소를 위한 가상 내비게이션 개입의 효과 평가: 소아암 생존자 연구 무작위 시험(HINTII)
조사관은 건강 보험 문맹 퇴치 촉진에 있어 HINT-S(동기식)와 강화된 일반 진료(EUC)의 효과를 평가하기 위해 유형 I 하이브리드 효과-구현 시험을 수행하고 있습니다. 소아암 생존자의 치료 및 장기적 결과를 개선하기 위한 의료 비용에.
조사관은 또한 HINT-S를 5개의 HINT-S 내비게이터 세션의 사전 기록된 비동기 버전인 HINT-A(비동기)와 비교할 것입니다.
연구 개요
상세 설명
본 연구는 LTFU(Long-Term Follow-Up) 코호트에서 모집된 소아암 생존자와 함께 건강 보험 탐색 프로그램을 평가하고자 합니다. 소아암 생존자는 모니터링과 지속적인 치료가 필요한 평생 동안 건강 문제에 직면합니다. 이것은 어린 시절 생존자들 사이에서 더 높은 부분 보험 비율, 충족되지 않은 의료 요구 및 치료와 관련된 부담스러운 비용을 갖는 경향으로 인해 더욱 복잡해집니다. 이러한 부담스러운 비용은 또한 생존자들이 돌봄을 제대로 활용하지 못하는 원인이 됩니다. 박 박사와 그녀의 동료들은 LTFU 생존자들이 보험 사용 방법을 이해하는 데 어려움을 겪고 종종 재정 관련 고통을 겪었다는 연구 결과를 발표했습니다. 현재 환경에서 보험 혜택을 이해하고 탐색하는 것은 암 생존자가 필요한 의료 서비스를 얻고 활용하는 데 매우 중요합니다. 이를 염두에 두고 연구 조사관은 동기식 및 비동기식 양식으로 제공되는 LTFU 참가자와의 보험 탐색 개입의 효과를 평가할 것을 제안합니다.
내비게이션 개입은 동기식 그룹(HINT-S)에 대해 HIPAA 준수 화상 회의를 통해 건강 보험 내비게이터가 제공하고 비동기식 그룹(HINT-A)에 대해 사전 녹화된 비디오 세션을 통해 제공됩니다. 참가자는 2개의 내비게이션 중재군(HINT-S 및 HINT-A; 중재군당 약 234명) 또는 강화된 일반 치료군(대조군의 경우 약 52명)으로 무작위 배정됩니다. 실행 가능성 및 수용 가능성 목표를 평가하고 결과의 의미 있는 차이를 탐색할 수 있도록 부문당 샘플 크기를 선택했습니다. 제안된 1차 및 2차 결과를 평가하기 위해 모든 시험 참가자는 기본 및 6개월, 12개월 및 18개월 프로그램 후 추적 조사를 완료합니다.
연구 유형
중재적
등록 (실제)
529
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 등록 당시 18세 이상
- 정보에 입각한 동의를 할 수 있습니다
- 인터넷 접속이 가능한 스마트폰, 컴퓨터 또는 태블릿에 액세스할 수 있습니다.
- 미국에 기반을 둔 건강 보험이 있습니다
- 현재 LTFU 코호트 참가자
- CCSS 환자 포털에 액세스할 수 있습니다.
제외 기준:
- 파일럿 시험 참가자는 자격이 없습니다.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: HINT 동기 개입 그룹(HINT-S)
5개의 HINT-S 네비게이터 세션 + HINT 소책자의 가상 동기 버전
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프로그램은 약 3개월에 걸쳐 내비게이터의 화상회의를 통해 진행되며 5개 세션으로 구성됩니다.
탐색 개입 세션은 다음과 같습니다: 섹션 1 - 보험 계획 기본; 섹션 2 – 정책과 관련된 귀하의 계획; 섹션 3 - 계획 탐색 및 장애물 극복 섹션 4 - 치료 비용 관리; 5- 의료비 이해하기.
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실험적: HINT 비동기 개입 그룹(HINT-A)
5개의 HINT-S 내비게이터 세션 + HINT 소책자의 사전 녹음된 비동기 버전
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프로그램은 약 3개월에 걸쳐 내비게이터의 화상회의를 통해 진행되며 5개 세션으로 구성됩니다.
탐색 개입 세션은 다음과 같습니다: 섹션 1 - 보험 계획 기본; 섹션 2 – 정책과 관련된 귀하의 계획; 섹션 3 - 계획 탐색 및 장애물 극복 섹션 4 - 치료 비용 관리; 5- 의료비 이해하기.
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간섭 없음: 강화된 평소 관리
힌트 소책자
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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기준선에서 6개월까지 건강 보험 이해력의 변화.
기간: 6개월 추적
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검증된 설문조사(Health Insurance Literacy scale; HIL)로 측정한 건강 보험 이해력의 변화를 그룹 간에 비교합니다.
HIL은 용어(예: 공제액, 공동 부담금, 공동 보험) 이해에 대한 참가자의 자가 보고 자신감과 건강 보험 관련 활동을 수행하는 방법을 알고 있는 자신감(예:
코페이 계산, 네트워크 내 의사 찾기).
항목은 총 점수 범위가 16-64인 4점 리커트 척도로 평가됩니다. 높은 점수는 낮은 문해력을 나타냅니다.
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6개월 추적
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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기준선에서 12개월까지의 건강 보험 이해력 변화.
기간: 12개월 추적
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검증된 설문조사(Health Insurance Literacy 척도, HIL)로 측정한 건강 보험 이해력의 변화를 시간 경과에 따라 그룹 간에 비교합니다.
HIL은 용어(예: 공제액, 공동 부담금, 공동 보험) 이해에 대한 참가자의 자가 보고 자신감과 건강 보험 관련 활동(예:
코페이 계산, 네트워크 내 의사 찾기).
항목은 총 점수 범위가 16-64인 4점 리커트 척도로 평가됩니다. 높은 점수는 낮은 문해력을 나타냅니다.
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12개월 추적
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기준선에서 12개월까지 자가 보고한 재정적 어려움의 변화.
기간: 12개월 추적
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시간 경과에 따른 자가 보고된 재정적 어려움의 변화는 그룹 간에 비교되고 재정적 어려움의 3가지 영역을 활용하는 3가지 척도를 사용하여 측정됩니다. /항목이 없습니다; 더 많은 예 점수 = 더 많은 어려움; b) 심리학적, 지난 1년 동안의 의료비로 인한 걱정을 5점 리커트로 측정된 6개 항목으로 평가합니다. 높은 점수는 더 큰 걱정을 반영합니다. c) 8개의 예/아니오 항목으로 지난 1년 동안 의료 비용의 재정적 결과를 평가하는 자료; 더 많은 예 점수 = 더 많은 어려움.
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12개월 추적
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기준선에서 12개월까지 연간 본인 부담 비용의 변화.
기간: 12개월 추적
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본인 부담 연간 비용의 달러 금액 변화는 그룹 간에 시간 경과에 따라 비교됩니다.
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12개월 추적
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기준선에서 12개월까지의 건강 관리 방문 및 절차(의료 이용) 수의 변화.
기간: 12개월 추적
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시간 경과에 따른 환자 의료 이용의 변화는 그룹 간에 시간 경과에 따라 비교됩니다. 건강 관리 이용은 환자가 건강 관리 방문에 대해 예/아니오를 보고하도록 요청하는 11개 항목으로 평가됩니다. 더 많은 예 응답은 더 많은 의료 사용을 반영합니다. |
12개월 추적
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Elyse R Park, Ph.D., MPH, MGH
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2023년 5월 1일
기본 완료 (추정된)
2027년 4월 1일
연구 완료 (추정된)
2027년 4월 1일
연구 등록 날짜
최초 제출
2022년 5월 31일
QC 기준을 충족하는 최초 제출
2022년 9월 1일
처음 게시됨 (실제)
2022년 9월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정된)
2025년 11월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2025년 10월 31일
마지막으로 확인됨
2025년 10월 1일
추가 정보
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