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| ID | Type | Description | Link |
|---|---|---|---|
| 5K08CA283304 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The goal of this pilot clinical trial is to learn whether the patient and provider support program, called FIX-SDM, helps patients and providers engage in shared decision-making for lung cancer screening during primary care visits and increases the number of patients who complete lung cancer screening. The investigators will also assess the acceptability of the support program and the feasibility of the study protocol to prepare for a future large-scale trial. The main questions this trial aims to answer are:
Primary care provider participants will:
Patient participants will
Facilitation of Information eXchange for Shared Decision Making (FIX-SDM) for lung cancer screening is a multi-strategy implementation program designed to help patients eligible for lung cancer screening and their primary care providers (PCPs) prepare for shared decision-making (SDM). The investigators will conduct a cluster-randomized pilot study of FIX-SDM plus the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility (FIX-SDM arm), compared with the standard e-alert notification alone (usual care comparison arm).
The investigators hypothesized that, compared to the usual care comparison arm, more patients in the FIX-SDM arm will complete lung cancer screening 3 months after the primary care visit. This study will also provide feasibility data and preliminary results to help prepare for a future large-scale trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FIX-SDM | Experimental | Primary care providers (PCPs) will receive a support session and educational materials, in addition to the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility implemented within the healthcare system. Patients will receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit. |
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| Comparator: Usual Care | Active Comparator | PCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice). Patients will receive the usual care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FIX-SDM | Behavioral | Primary care providers (PCPs) will receive a support session and educational materials, in addition to the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility implemented within the healthcare system. Patients receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of Lung Cancer Screening (LCS) within 3 months | The proportion of patients in each arm who completed LCS within 3 months of the index primary care visit | 3 months after the index visit |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of LCS within 6 months | The proportion of patients in each arm who completed LCS within 6 months of the index primary care visit | 6 months after the index visit |
| LCS order | The proportion of patients in each arm who had a LCS order in the electronic health record (EHR) |
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Primary care provider (PCP) participants:
Inclusion criteria
Patient participants
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mayuko Ito Fukunaga, MD, MSc | UMass Chan Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01605 | United States |
With an executed Data Use Agreement, a limited data set may be shared.
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A cluster-randomized pilot study randomized at the PCP level (patient allocation clustered with PCP)
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| Usual Care | Behavioral | PCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice). Patients will receive the usual care |
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| 3 and 6 months after the index visit |
| LCS appointment | The proportion of patients in each arm who had an appointment for LCS scheduled in the EHR | 3 and 6 months after the index visit |
| Patient-reported LCS discussion | The proportion of patients in each arm who had LCS discussions with providers during their visits, assessed by the patient survey items | Within 10 days after the index visit |
| Content of LCS discussion | The mean number of LCS topics discussed during the visits, assessed by the patient survey items in each arm | Within 10 days after the index visit |
| Patient perceived quality of LCS discussion | The mean score of the Patient Assessment of Cancer Communication Experiences (PACE) survey in each arm | Within 10 days after the index visit |
| Patient-reported shared decsion making (SDM) for LCS | The mean score of the SDM Process 4, assessed during the patient survey in each arm | Within 10 days after the index visit. |
| Patient knowledge of LCS | The mean number of LCS knowledge question items answered correctly in each arm, assessed during the patient survey in each arm | Within 10 days after the index visit. |
| Patient decisional conflict | The mean score of the Decisional Conflict Scale in each arm, assessed during the patient survey in each arm | Within 10 days after the index visit and 3 months after the index visit |
| Patient acceptability of FIX-SDM | Acceptability of FIX-SDM among patients in the FIX-SDM arm, assessed by the survey items | Within 10 days after the index visit. |
| Patient decision satisfaction | Patient decision satisfaction in each arm assessed by a 10-point Likert scale | 3 months after the index visit |
| Patient decision regret | Patient decision regret in each arm assessed by the Decision Regret Scale | 3 months after the index visit |
| Patient decision intention to follow-up LCS | Patient decision intention to adhere to follow-up LCS in each arm, assessed by a 5-point Likert scale | 3 months after the index visit |
| Provider acceptability of FIX-SDM | Acceptability of FIX-SDM among providers in the FIX-SDM arm, assessed by provider survey items | Immediately after the PCP intervention |
| Provider report on decision aid use | Frequency of decision aid use measured by a 5-point Likert scale in each arm | 6 months after the provider baseline survey |
| Provider reports on the content of the LCS discussion | Frequency of the content of LCS discussion measured by a 5-point Likert scale in each arm | 6 months after the provider baseline survey |
| Sustainability of shared decision making for LCS | Sustainability of shared decision-making for LCS assessed by the Normalization Measure Development Questionnaire in a provider survey in each arm | 6 months after the provider baseline survey |