The MyLungHealth Study Protocol: A Pragmatic Patient-Randomized Controlled Trial to Evaluate a Patient-Centered, Electronic Health Record-Integrated Intervention to Enhance Lung Cancer Screening in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31,303
- 试验地点
- 2
- 主要终点
- Study 1 Primary Outcome: Count of Patients Newly Identified as Eligible for Lung Cancer Screening
研究概览
简要总结
Early lung cancer screening (LCS) through low-dose computed tomography (LDCT) is crucial but underused due to various barriers, including incomplete or inaccurate patient smoking data in the electronic health record and limited time for shared decision-making. The objective of this trial is to investigate a patient-centered intervention, MyLungHealth, delivered through the patient portal. The intervention is designed to improve LCS rates through increased identification of eligible patients and informed decision making.
详细描述
MyLungHealth is a multi-site pragmatic trial, involving University of Utah Health and New York University Langone Health primary care clinics. The MyLungHealth intervention was developed using a user-centered design process, informed by patient and provider focus groups and interviews. The intervention's effectiveness will be evaluated through a patient-randomized trial, comparing the combined use of MyLungHealth and DecisionPrecision+ (a provider-focused clinical decision support and shared decision-making intervention) against DecisionPrecision+ alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for both study 1 and study 2:
- •aged 50-79
- •a history of smoking (e.g., current or former tobacco use)
- •seen in a study primary care clinic in the 12 months preceding the start of the trial
排除标准
- •for both study 1 and study 2:
- •>0 but < 10 pack-year smoking history or quit more than 15 years ago
- •No use of the patient portal at least once in the year preceding the start of the study
- •A lung cancer diagnosis at the start of the study
- •LDCT completed in the past 3 years
- •Another chest CT completed in the past year
- •Structured EHR data indicating LCS SDM was provided in the past 3 years
- •Exposed to the intervention during the pilot phase
- •No visit at a study clinic during the trial period when the intervention was available
- •Inclusion criteria for study 1:
- •a 10-19 pack-year smoking history, an unknown pack-year history, unknown quit date for patients who quit smoking, or a 0 pack-year smoking history
- •Inclusion criteria for study 2:
- •at least a 20 pack-year smoking history and are a current smoker or have quit within the last 15 years
研究组 & 干预措施
Study 1 (Study of Patients with Uncertain LCS Eligibility) Control Arm
In Study 1 (Study of Patients with Uncertain LCS Eligibility), patients allocated to the control arm will not be exposed to the project intervention unless their EHR data change during the trial so that they have documented LCS eligibility. In these rare cases, these patients will be exposed to the intervention provided to patients in the control arm of Study 2 but will not be considered participants in Study 2.
Study 1 (Study of Patients with Uncertain LCS Eligibility) Intervention Arm
Patients allocated to the intervention arm of Study 1 will be exposed to the MyLungHealth intervention in addition to usual care. The Study 1 MyLungHealth eligibility questionnaires will consist of pre-visit smoking history questions asked through the EHR patient portal to increase the identification of screening-eligible patients (Figure 2). Patients will be prompted to engage in the intervention through pre-visit questionnaires for primary care visits administered up to 7 days prior to the visits. These questions will ask about the patients' smoking history and determine whether patients meet LCS eligibility criteria. Study 1 patients who meet LCS eligibility criteria will be offered the intervention provided to patients in the intervention arm of Study 2 immediately after confirming eligibility but will not be considered participants in Study 2.
干预措施: MyLungHealth (Behavioral)
Study 2 (Study of Patients with Documented LCS Eligibility) Control Arm
In Study 2 (Study of Patients with Documented LCS Eligibility), patients allocated to the control arm will be exposed to the DecisionPrecision+ intervention because DecisionPrecision+ intervention automatically identifies patients with documented LCS eligibility in the EHR. The DecisionPrecision+ intervention is designed to promote LCS and LCS SDM; the intervention consists of provider-facing EHR preventive care reminders, a provider-facing EHR SDM tool, and simple patient-facing preventive care reminders (only available at UUH). Simple patient-facing preventive care reminders will be available at UUH, but not NYU, because NYU does not use this type of reminders.
干预措施: DecisionPrecision+ (Behavioral)
Study 2 (Study of Patients with Documented LCS Eligibility) Intervention Arm
Patients allocated to the intervention arm will be offered the MyLungHealth education tool in addition to the DecisionPrecision+ intervention. The pre-visit questionnaire will directly invite patients to use the MyLungHealth education app, rather than first asking about smoking history to confirm eligibility. When patients affirm in the patient portal that they were able to successfully open the MyLungHealth education tool, their providers will be notified of their potential interest in LCS through a passive (non-interruptive) prompt in the EHR.
干预措施: MyLungHealth (Behavioral)
Study 2 (Study of Patients with Documented LCS Eligibility) Intervention Arm
Patients allocated to the intervention arm will be offered the MyLungHealth education tool in addition to the DecisionPrecision+ intervention. The pre-visit questionnaire will directly invite patients to use the MyLungHealth education app, rather than first asking about smoking history to confirm eligibility. When patients affirm in the patient portal that they were able to successfully open the MyLungHealth education tool, their providers will be notified of their potential interest in LCS through a passive (non-interruptive) prompt in the EHR.
干预措施: DecisionPrecision+ (Behavioral)
结局指标
主要结局
Study 1 Primary Outcome: Count of Patients Newly Identified as Eligible for Lung Cancer Screening
时间窗: 1 year trial period
In Study 1, the primary outcome was the number of patients newly identified as eligible for lung cancer screening during the 12-month follow-up period, defined as having a smoking history of at least 20 pack-years and being a current smoker or having quit within the past 15 years, based on structured electronic health record data and patient-reported smoking history collected through the MyLungHealth patient portal.
Study 2 Primary Outcome: Count of Participants for Whom LDCT Was Ordered.
时间窗: 1 year trial period
In Study 2, which enrolled participants with documented lung cancer screening eligibility at baseline, the primary outcome was the count of participants for whom a low-dose computed tomography (LDCT) lung cancer screening order was placed during the 12-month follow-up period, as identified from structured electronic health record order data.
次要结局
- Study 1 Secondary Outcome: Count of Participants for Whom LDCT Eligibility Status Became Known.(1 year trial period)
- Study 1 Secondary Outcome: Count of Participants for Whom LDCT Was Ordered.(1 year trial period)
- Study 1 Secondary Outcome: Count of Participants for Whom LDCT Was Completed.(1 year trial period)
- Study 2 Secondary Outcome: Count of Participants for Whom LDCT Was Completed.(1 year trial period)
研究者
Kensaku Kawamoto, MD, PhD, MHS
Associate Chief Medical Information Officer
University of Utah