Lung Cancer Screening
Conditions
Keywords
Shared Decision Making, Lung Cancer Screening, health informatics
Brief summary
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: * Does the patient and provider support increase the number of patients who complete lung cancer screening? * Does the patient and provider support help patients and health care providers engage more in shared decision-making and improve the quality of the patient's decision regarding lung cancer screening? * Is the study protocol feasible? The investigators will compare the patient and provider support program to usual care to see if the support increases the number of patients who complete lung cancer screening. Primary care provider participants will: * Receive the provider support session and educational materials, or follow usual practice * Answer a baseline survey and a follow-up survey in 6 months * Answer additional survey questions regarding the acceptability of the provider support session if they receive it Patient participants will * Receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit, or receive usual care * Complete the baseline survey and two follow-up surveys, one right after the primary care visit and another 3 months after the visit.
Detailed description
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.
Interventions
BEHAVIORALFIX-SDM
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.
BEHAVIORALUsual Care
PCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice). Patients will receive the usual care
Sponsors
University of Massachusetts, Worcester
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
A cluster-randomized pilot study randomized at the PCP level (patient allocation clustered with PCP)
Eligibility
Sex/Gender
ALL
Age
50 Years to 77 Years
Healthy volunteers
No
Inclusion criteria
Primary care provider (PCP) participants: Inclusion criteria * PCPs (physicians or advanced practitioners) * Who practice in general internal medicine or family medicine clinics in UMass Memorial Health * Who care for more than 5 potentially LCS-eligible patients in their practice
Exclusion criteria
* Participation in the previous study to co-develop the provider intervention (to avoid bias) Patient participants Inclusion Criteria: * Adults between the ages of 50 and 77 * Meets criteria for Lung Cancer Screening (LCS) (Current eligibility includes: An individual who currently smokes or quit smoking within 15 years with at least a 20 pack-year smoking history) * Has a smartphone with texting capability * English-speaking * Has a scheduled PCP visit in the next \~3-6 weeks from study enrollment with one of the PCP participants enrolled in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Lung Cancer Screening (LCS) within 3 months | 3 months after the index visit | The proportion of patients in each arm who completed LCS within 3 months of the index primary care visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion of LCS within 6 months | 6 months after the index visit | The proportion of patients in each arm who completed LCS within 6 months of the index primary care visit |
| LCS order | 3 and 6 months after the index visit | The proportion of patients in each arm who had a LCS order in the electronic health record (EHR) |
| LCS appointment | 3 and 6 months after the index visit | The proportion of patients in each arm who had an appointment for LCS scheduled in the EHR |
| Patient-reported LCS discussion | Within 10 days after the index visit | The proportion of patients in each arm who had LCS discussions with providers during their visits, assessed by the patient survey items |
| Content of LCS discussion | Within 10 days after the index visit | The mean number of LCS topics discussed during the visits, assessed by the patient survey items in each arm |
| Patient perceived quality of LCS discussion | Within 10 days after the index visit | The mean score of the Patient Assessment of Cancer Communication Experiences (PACE) survey in each arm |
| Patient-reported shared decsion making (SDM) for LCS | Within 10 days after the index visit. | The mean score of the SDM Process 4, assessed during the patient survey in each arm |
| Patient knowledge of LCS | Within 10 days after the index visit. | The mean number of LCS knowledge question items answered correctly in each arm, assessed during the patient survey in each arm |
| Patient decisional conflict | Within 10 days after the index visit and 3 months after the index visit | The mean score of the Decisional Conflict Scale in each arm, assessed during the patient survey in each arm |
| Patient acceptability of FIX-SDM | Within 10 days after the index visit. | Acceptability of FIX-SDM among patients in the FIX-SDM arm, assessed by the survey items |
| Patient decision satisfaction | 3 months after the index visit | Patient decision satisfaction in each arm assessed by a 10-point Likert scale |
| Patient decision regret | 3 months after the index visit | Patient decision regret in each arm assessed by the Decision Regret Scale |
| Patient decision intention to follow-up LCS | 3 months after the index visit | Patient decision intention to adhere to follow-up LCS in each arm, assessed by a 5-point Likert scale |
| Provider acceptability of FIX-SDM | Immediately after the PCP intervention | Acceptability of FIX-SDM among providers in the FIX-SDM arm, assessed by provider survey items |
| Provider report on decision aid use | 6 months after the provider baseline survey | Frequency of decision aid use measured by a 5-point Likert scale in each arm |
| Provider reports on the content of the LCS discussion | 6 months after the provider baseline survey | Frequency of the content of LCS discussion measured by a 5-point Likert scale in each arm |
| Sustainability of shared decision making for LCS | 6 months after the provider baseline survey | Sustainability of shared decision-making for LCS assessed by the Normalization Measure Development Questionnaire in a provider survey in each arm |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMayuko Ito Fukunaga, MD, MSc
UMass Chan Medical School
Outcome results
None listed