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Understanding and Addressing Patient and Provider Preferences Around Discussions of Cost of Breast Cancer Care

2020년 11월 18일 업데이트: Cindy Matsen, MD, University of Utah

The investigators hypothesize that many cancer patients desire discussions of cost as part of their care, but that preferences for having cost discussions with their physicians vary. Further, the investigators hypothesize that providers can introduce the topic of cost into clinical conversations in a balanced way and that this will improve shared decision making and patient uptake of offers of financial counseling which will lead to improved financial well-being, patient satisfaction with providers, and satisfaction with treatment decisions.

Aim 1: Further understand patient preferences and attendant associations for cost discussions through a patient survey of newly diagnosed breast cancer patients.

Aim 2: Study the influence of provider communication about cost on shared decision making, uptake of financial counseling, financial well-being and satisfaction through an intervention to encourage discussion of cost by breast cancer surgeons with subsequent referral to financial counseling.

연구 개요

상태

완전한

정황

상세 설명

Newly diagnosed breast cancer patients over the age of 18 will be eligible for participation. All stages of disease will be included. Eligible participants will be approached in clinic. Those interested will provide written, informed consent at the time of their clinic visit. All participants will be asked to complete baseline surveys consisting of the InCharge Financial Distress/Financial Well Being scale (IFDFW),[24] the Maximizer-Minimizer Scale,[25] and a three question, 5-point Likert scale survey about desire for cost information (1: How concerned are participants about the cost of their cancer care? 2: How interested are participants in discussing cost of care with their doctors? 3: How interested are participants in meeting with a financial counselor about the costs of their care?) Demographic information including age, race and ethnicity, marital status, number of children, current employment status of self and spouse, and education level will be included. To decrease participant burden and encourage study participation, only the three question survey will be required to be completed prior to the visit. The other survey components (IFDFW and Max-Min Scale) can be completed after the visit, but prior to seeing a financial counselor. Participants will be offered a $10 giftcard of their choice (grocery store, Starbucks, Amazon, or gas) at each survey timepoint ($20 total) for participation.

For this study, the investigators will use a pre and post design with 100 total participants. All visits will be audiorecorded, transcribed, and coded for whether cost was discussed in the control group and whether the intervention was successfully implemented in the intervention group as well as shared decision making using the observer-OPTION scale. The first 50 patients will have usual care with providers conducting the visit in their typical manner.

From our past studies, study team discusses cost in 15% of visits, though these discussion tend to be very superficial. The second group of 50 patients will be the intervention group where the providers will have a discussion of cost emphasizing five points: 1) Cancer care is expensive and it is normal to be concerned about cost. 2) The investigators will recommend treatments for the participants' cancer based on what the investigators think gives them the best chance of doing well, not based on the cost of the treatment. 3) Because of how complex our healthcare system is, it is very hard for their doctors to know what their costs will be, but the investigators will do our best to give participants some general information. 4) The investigators have resources available to help participants get more specific information so that participants can plan appropriately. 5) Do participants have any specific concerns about cost that participants would like to share with me? The investigators will encourage study team to have this discussion at the beginning of the consult, but the exact timing will be according to study team judgment.

After the visit, all patients will complete a patient satisfaction survey and will be offered a referral to a financial counselor at our institution. Financial counseling will take place per our usual institutional protocols either in person or over the phone. Our financial counselors are aware that they may see an increased volume of patients during the study period and the investigators will provide funding to cover the increased need. Volume will be tracked during the study period and compared to the non-study period and between the groups.

At the first three to six-month follow-up visit with the surgeon, participants will again complete the IFDFW, a validated patient satisfaction scale[26], and the Satisfaction with Decision Scale.[27].

Data will have personal health identifiers removed from the data for the analysis portion of the study. PHI will not be reused without first seeking IRB approval.

The investigators will enroll 100 patients in two consecutive groups of 50. This gives us 80% power with a two sided significance level of 0.05 for seeing a 27-30% improvement (0.27-0.3 higher score) in our primary outcome of financial well-being as measured by the IFDFW in the intervention group at 3-6 months after the initial visit; the average pre-score on the IFDFW is 5.52 in past studies with improvements of 0.32-1.18 seen in past studies of education interventions to improve financial well-being.[24] This level of difference may not be achievable with this small study, but will provide data for powering a larger study.

Maximizer-Minimizer status, uptake of financial counseling, patient satisfaction, decision satisfaction, and demographic variables will be evaluated for associations with financial well-being using logistic regression methods.

연구 유형

중재적

등록 (실제)

100

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Utah
      • Salt Lake City, Utah, 미국, 84112
        • University of Utah

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

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Age 18 or older
  • All patients who present to Huntsman Cancer Hospital/University of Utah for a newly diagnosed breast cancer surgical consultation.

Exclusion Criteria:

  • none

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Control
The first 50 patients will have usual care with providers conducting the visit in their typical manner.
실험적: Cost Discussion
The second group of 50 patients will be the intervention group where the providers will have a discussion of cost emphasizing five points: 1) Cancer care is expensive and it is normal to be concerned about cost. 2) We will recommend treatments for your cancer based on what we think gives you the best chance of doing well, not based on the cost of the treatment. 3) Because of how complex our healthcare system is, it is very hard for your doctors to know what your costs will be, but we will do our best to give you some general information. 4) We have resources available to help you get more specific information so that you can plan appropriately. 5) Do you have any specific concerns about cost that you'd like to share with me?
The second group of 50 patients will be the intervention group where the providers will have a discussion of cost emphasizing five points: 1) Cancer care is expensive and it is normal to be concerned about cost. 2) We will recommend treatments for your cancer based on what we think gives you the best chance of doing well, not based on the cost of the treatment. 3) Because of how complex our healthcare system is, it is very hard for your doctors to know what your costs will be, but we will do our best to give you some general information. 4) We have resources available to help you get more specific information so that you can plan appropriately. 5) Do you have any specific concerns about cost that you'd like to share with me?

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
InCharge Financial Distress/Financial Well-being Scale
기간: 3-6 months after visit
The InCharge Financial Distress/Financial Well Being scale, an eight-item self-report subjective measure of financial distress/financial well-being. Sores are numeric 1-10. Higher scores indicate higher financial well-being.
3-6 months after visit

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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

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)

2018년 11월 5일

기본 완료 (실제)

2020년 11월 16일

연구 완료 (실제)

2020년 11월 16일

연구 등록 날짜

최초 제출

2018년 12월 17일

QC 기준을 충족하는 최초 제출

2018년 12월 17일

처음 게시됨 (실제)

2018년 12월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 11월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 11월 18일

마지막으로 확인됨

2020년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 114421

약물 및 장치 정보, 연구 문서

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미국에서 제조되어 미국에서 수출되는 제품

아니

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. .

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