Increasing Lung Cancer Screening Among Emergency Department Patients - LCS R01
Increasing Lung Cancer Screening Uptake Among Emergency Department Patients - LCS R01
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This randomized clinical trial will evaluate strategies to improve lung cancer screening uptake among emergency department patients who meet lung cancer screening eligibility criteria based on age and smoking history. Participants will be randomized using a 2 by 2 factorial design into one of four groups: basic referral, basic referral plus text messaging, facilitated referral, or facilitated referral plus text messaging.
The basic referral strategy includes verbal referral to the lung cancer screening program and primary care provider, if applicable, along with written contact information for the lung cancer screening program navigator. The facilitated referral strategy includes submission of a lung cancer screening requisition to the lung cancer screening program on behalf of the participant during the emergency department visit.
The text messaging intervention includes a series of theory informed messages designed to increase intention and motivation to complete lung cancer screening. Lung cancer screening uptake will be assessed at 120 days after enrollment using participant follow up and electronic health record review.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Peter Macdowell
- 전화번호: 585-274-1509
- 이메일: peter_macdowell@urmc.rochester.edu
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 50 - 80
- ≥ 20 pack-year smoking history
- current smoker or quit within 15 years
- English/Spanish speaking
- Registered in the Emergency Department as a patient
Exclusion Criteria:
- Non-English/Spanish
- Inability to provide consent (e.g. high clinical acuity, cognitive deficit)
- Lack of text-capable mobile phone and/or inability to use text function
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Basic Referral (enhanced control arm)
Participants assigned to this arm will be notified that they are eligible and meet federal recommendations for lung cancer screening.
They will be verbally referred to a lung cancer screening program and their primary care provider (if they have one) to discuss lung cancer screening.
They will also be provided with written materials that include telephone contact information for the lung cancer screening program navigator.
If contacted, the LCS Program Navigator will conduct a discussion, schedule a screening CT scan at one of the 8 regional American College of Radiology-designated lung cancer screening centers and arrange clinical follow-up as needed.
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Participants are verbally referred to the lung cancer screening program and their primary care provider if applicable.
Written materials with contact information for the lung cancer screening program navigator are provided.
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실험적: Basic Referral plus Text Messaging
Participants assigned to this arm will receive the basic referral as described in the previous arm.
In addition, they will receive a series of text messages, aimed at generating intention and motivation to get lung cancer screening.
Patients will receive a total of 9 messages.
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Participants are verbally referred to the lung cancer screening program and their primary care provider if applicable.
Written materials with contact information for the lung cancer screening program navigator are provided.
Participants receive a series of up to 9 theory informed text messages designed to increase awareness, motivation, and completion of lung cancer screening.
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활성 비교기: Facilitated Referral
Participants assigned to this arm will be notified that they are eligible and meet federal recommendations for lung cancer screening.
Rather than the basic referral received in the arms above, a lung cancer screening requisition form will be submitted to the lung cancer screening program on behalf of the participant during their emergency department visit.
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A lung cancer screening requisition form is submitted to the lung cancer screening program on behalf of the participant during the emergency department visit.
The screening program will contact the participant to discuss screening and schedule a low dose CT scan if appropriate.
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실험적: Facilitated Referral plus Text Messaging
Participants assigned to this arm will receive facilitated referral plus the series of text messages described above.
Among these participants, contact with the lung cancer screening program is likely to occur after receipt of the initial text messages but prior to receipt of all text messages.
|
Participants receive a series of up to 9 theory informed text messages designed to increase awareness, motivation, and completion of lung cancer screening.
A lung cancer screening requisition form is submitted to the lung cancer screening program on behalf of the participant during the emergency department visit.
The screening program will contact the participant to discuss screening and schedule a low dose CT scan if appropriate.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Participants Who Complete Lung Cancer Screening Within 120 Days After Enrollment
기간: Up to 120 Days After Enrollment
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Lung cancer screening uptake is defined as completion of a low dose computed tomography scan for lung cancer screening within 120 days after enrollment.
Screening completion will be confirmed using electronic health record review, lung cancer screening program records, or participant self report obtained during follow up.
The outcome is reported as the proportion of participants who complete screening.
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Up to 120 Days After Enrollment
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Participants Who Participate in Shared Decision Making for Lung Cancer Screening Within 120 Days After Enrollment
기간: Up to 120 Days After Enrollment
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Participation in shared decision making is defined as documentation of a shared decision making discussion regarding lung cancer screening or participant self report of completing such a discussion within 120 days after enrollment.
The outcome is reported as the proportion of participants who participate in shared decision making.
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Up to 120 Days After Enrollment
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Frequency of Reported Barriers to Lung Cancer Screening at 120 Days
기간: 120 Days After Enrollment
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Barriers to lung cancer screening are assessed using participant responses to a structured questionnaire administered at follow up.
The questionnaire includes items on transportation challenges, cost concerns, scheduling difficulties, and fear of screening results.
The outcome is reported as the number and proportion of participants reporting each barrier.
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120 Days After Enrollment
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Acceptability of Emergency Department Based Lung Cancer Screening Interventions at 120 Days
기간: Up to 120 Days After Enrollment
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Acceptability is assessed using participant responses to Likert scale questionnaire items evaluating the degree to which participants find the emergency department based lung cancer screening interventions acceptable.
Each item is scored on a 5 point Likert scale ranging from 1 to 5, with higher scores indicating greater acceptability.
The outcome is reported as summary scores based on participant responses.
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Up to 120 Days After Enrollment
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Appropriateness of Emergency Department Based Lung Cancer Screening Interventions at 120 Days
기간: 120 Days After Enrollment
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Appropriateness is assessed using participant responses to Likert scale questionnaire items evaluating the perceived fit and relevance of emergency department based lung cancer screening interventions.
Each item is scored on a 5 point Likert scale ranging from 1 to 5, with higher scores indicating greater perceived appropriateness.
The outcome is reported as summary scores based on participant responses.
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120 Days After Enrollment
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Frequency of Reported Facilitators to Lung Cancer Screening at 120 Days
기간: 120 Days After Enrollment
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Facilitators to lung cancer screening are assessed using participant responses to a structured questionnaire administered at follow up.
The questionnaire includes items related to factors such as access to care, health literacy, prior healthcare engagement, and presence of a primary care provider.
The outcome is reported as the number and proportion of participants reporting each facilitator.
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120 Days After Enrollment
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- FP00007604
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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