- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01361035
Using Effective Provider-Patient Communication to Improve Cancer Screening Among Low Literacy Patients
What's the purpose of this study? This 4-year study is designed: (1) to teach primary care physicians how to recognize low health literacy patients and effectively counsel them on cancer screening using risk communication and shared decision making and (2) to assess the impact of training on changes in physician communication behavior and changes in low health literacy patients' cancer screening behaviors. This study proposal is based on the hypothesis that physician training in cancer screening guidelines, health literacy, and communication skills will improve provider-patient interactions during encounters dealing with preventive health maintenance especially cancer screening.
How will the proposed study be implemented? Thirty-two physicians in the New Orleans metropolitan area will be recruited and randomly assigned to one of two groups. The unit of randomization will be the health care organization or clinic. The intervention group will receive training in health literacy, cancer screening, risk communication and shared decision-making. The control group will not receive communication training until the end of the study. Physicians in both groups will undergo three clinic visits with standardized patients (actors trained to portray real patients; mystery shoppers) but they will not be aware that they are conducting visits with actors. The visits will occur at study enrollment and at 6 and 12 months. At the end of each clinic visit, the standardized patients will rate the physicians' communication skills. Each physician assigned to the intervention group will receive verbal feedback on communication skills from the standardized patients and complete a web-based tutorial. Physicians in the control group will not have access to the web-based tutorial until the end of the study.
For each physician, 10-15 patients with limited health literacy will be recruited to the study. Each patient will rate his/her perceived involvement with care and global satisfaction with care at study enrollment and annually for three years. Age and gender-appropriate referral rates for breast, cervical and colorectal cancer screening and patients' receipt of such screening will be assessed annually for three years. All study physicians, regardless of group assignment, will receive performance feedback (report cards) on their cancer screening rates among low health literacy patients in their clinic.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Louisiana
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New Orleans, Louisiana, 미국, 70112
- Tulane Communty Health Center at Covenant House
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New Orleans, Louisiana, 미국, 70112
- Tulane Faculty Practice
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New Orleans, Louisiana, 미국, 70114
- EXCELth - Ida Hymel Community Health Center
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New Orleans, Louisiana, 미국, 70117
- DCSNO St Cecelia Medical Center
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New Orleans, Louisiana, 미국, 70118
- DCSNO Carrollton Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Physician
- Physicians who practice at these clinic sites at least one half day per week are eligible to participate in this study.
Patient
- Eligible patients include men and women age 40 to 75, individuals enrolled in the clinic practice for at least one year, and individuals identified as having low or inadequate health literacy via the Rapid Estimate of Adult Literacy in Medicine.
Exclusion Criteria:
Physician
- Any provider planning to leave before the end of 12 months will be excluded.
Patient
- Patients will be excluded if they plan to change primary care provider or site of health plan, have resided in the United States for less than five years, or do not speak English
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: No communication training
Physicians enrolled in the control arm do not undergo training in health literacy, cancer screening and shared decision making
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다른: Cancer risk ommunication skills training
Physicians enrolled in the intervention arm undergo training in health literacy, cancer screening and shared decision making
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Intervention physicians receive training in cancer risk communication and shared decision making (SDM).
At the end of each visit with intervention physicians, standardized patients (SPs) reveal themselves as actors and give structured verbal feedback.
After baseline SP visits, each intervention physician undergoes academic detailing with a communication expert.
Intervention physicians are directed to a web-based communication skills tutorial where SP ratings are hyperlinked to key references for supplemental reading.
Both study groups will receive annual reports detailing their patients' cancer screening status and aggregate ratings of their communication style.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in cervical, breast and colorectal cancer screening rates
기간: 0, 12, 24 months
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Cervical/Breast/Colorectal cancer screening rates will be measured at baseline and annually for 2 years to assess whether screening rates improve over time
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0, 12, 24 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in standardized patient ratings of physician communication behaviors
기간: 0, 6, 12 months
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The mystery shoppers (standardized patients) will rate the physicians' shared decision making and counseling about cancer screening prior to the intervention at baseline and then again at 6-month and 12-month follow up evaluations to assess whether communication behaviors improve over time
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0, 6, 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Eboni Price-Haywood, MD, MPH, Tulane University School of Medicine
간행물 및 유용한 링크
일반 간행물
- Price-Haywood EG, Roth KG, Shelby K, Cooper LA. Cancer risk communication with low health literacy patients: a continuing medical education program. J Gen Intern Med. 2010 May;25 Suppl 2(Suppl 2):S126-9. doi: 10.1007/s11606-009-1211-6.
- Price-Haywood EG, Harden-Barrios J, Cooper LA. Comparative effectiveness of audit-feedback versus additional physician communication training to improve cancer screening for patients with limited health literacy. J Gen Intern Med. 2014 Aug;29(8):1113-21. doi: 10.1007/s11606-014-2782-4. Epub 2014 Feb 4.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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. .
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Queens College, The City University of New York완전한