Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P50CA244688 | U.S. NIH Grant/Contract | View source | |
| NCI-2021-04394 | Other Identifier | CTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| High Plains Research Network | NETWORK |
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
The intervention is aimed to improve adherence to the lung cancer screening (LCS) guidelines and Centers for Medicare and Medicaid Services (CMS) coverage criteria to conduct shared decision-making (SDM) and provide smoking cessation services in rural primary care practices.
The pilot intervention will engage no more than 300 patients using a pragmatic, pre-post design guided by an enhanced RE-AIM/PRISM framework. The primary goal of this intervention is to improve LCS practice by offering a formal SDM process and smoking cessation support aligned with the CMS coverage criteria. The investigators will conduct a type II effectiveness implementation hybrid trial using a pre-post design to evaluate the effectiveness (co-primary outcomes of LCS and decision quality) and implementation at four rural clinics. Space precludes discussion of pragmatic design features, but this study was designed to be pragmatic using the PRECIS-2 criteria and it scores highly on almost all PRECIS-2 dimensions.
Each clinic will recruit the minimum of 9 patients eligible to LCS (based on CMS guidelines) every 2 months for up to 8 months. The first period of 2 months is for baseline data, the second and every other period of 2 months is for intervention (pre-post design). Each patient will receive 2 surveys (one immediately after the doctor's visit and a second one a month later). The intervention will be in the form of patient decision aid (information flyer) the participant receives during a healthcare provider visit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | The control group will consist of each participant and clinic before the intervention (baseline, first 2 months). | |
| Patient decision aid | Active Comparator | The intervention group will consist of each participant and clinic once they move to the intervention phase (after the first 2 months). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient decision aid | Other | Each subject will receive an informational flyer describing lung cancer screening options and smoking cessation from a trained person on the medical staff at each clinic. Staff will lead a shared decision-making discussion with the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants Who's Health Visit Adhered to the LCS Guidelines and CMS Coverage Criteria in Rural Primary Care Practices: Baseline Survey | The adherence to the LCS guidelines and CMS coverage criteria to conduct SDM and provide smoking cessation services in rural primary care practices (is a latent variable) and will be measured as a composite measure using variables in a baseline survey administered immediately after healthcare provider's visit (baseline). A survey tool will be developed and used to count "Yes" response to the following survey questions: Were you given a decision aid during your last clinic visit/call? Was the clinic provider or staff able to go over the decision aid together with you during your last clinic visit/call? Were you recommended for a low-dose CAT scan by your provider during your last clinic visit/call? | Baseline |
| Count of Participants Who's Health Visit Adhered to the LCS Guidelines and CMS Coverage Criteria in Rural Primary Care Practices: Follow-up Survey | The adherence to the LCS guidelines and CMS coverage criteria to conduct SDM and provide smoking cessation services in rural primary care practices (is a latent variable) and will be measured as a composite measure using variables in a baseline survey administered immediately after the healthcare provider's visit (follow-up). A survey tool will be developed and used to count "Yes" response to the following survey questions: Were you given a decision aid during your last clinic visit/call? Was the clinic provider or staff able to go over the decision aid together with you during your last clinic visit/call? Were you recommended for a low-dose computerized axial tomography (CAT) scan by your provider during your last clinic visit/call? | 1 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Knowledge About Lung Cancer | Patient knowledge about lung cancer will be measured by overall knowledge score calculated from 15 survey questions previously used by Lau et al in their peer-reviewed manuscript published in the American Journal of Preventive Medicine titled Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening. The level of knowledge will be assessed based on correct answers to 15 questions. The overall knowledge score will range from 0-15 where 0 is no correct answer (lowest knowledge) and 15 is all correct answers (highest knowledge). More correct answers indicate higher level of knowledge and higher score. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- A patient that does not meet inclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Russell Glasgow, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control (Pre-intervention) | The control group will consist of each participant and clinic before the intervention (baseline, first 2 months). |
| FG001 | Patient Decision Aid (Post-intervention) | The intervention group will consist of each participant and clinic once they move to the intervention phase (after the first 2 months, pre-post study design). Patient decision aid: Each subject will receive an informational flyer describing lung cancer screening options and smoking cessation from a trained person on the medical staff at each clinic. Staff will lead a shared decision-making discussion with the patient. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control (Pre-intervention) | The control group will consist of each participant and clinic before the intervention (baseline, first 2 months). |
| BG001 | Patient Decision Aid (Post-intervention) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Count of Participants Who's Health Visit Adhered to the LCS Guidelines and CMS Coverage Criteria in Rural Primary Care Practices: Baseline Survey | The adherence to the LCS guidelines and CMS coverage criteria to conduct SDM and provide smoking cessation services in rural primary care practices (is a latent variable) and will be measured as a composite measure using variables in a baseline survey administered immediately after healthcare provider's visit (baseline). A survey tool will be developed and used to count "Yes" response to the following survey questions: Were you given a decision aid during your last clinic visit/call? Was the clinic provider or staff able to go over the decision aid together with you during your last clinic visit/call? Were you recommended for a low-dose CAT scan by your provider during your last clinic visit/call? | Posted | Number | participants | Baseline |
|
We did not collect adverse events data because our intervention involved reading a flyer.
We did not collect adverse events data because our intervention involved reading a flyer.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | The control group will consist of each participant and clinic before the intervention (pre-intervention). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dan Mattlock | University of Colorado | (303)724-9941 | daniel.matlock@cuanschutz.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2022 | May 16, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Postcard consent | May 4, 2021 | May 16, 2024 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
A type II effectiveness implementation hybrid trial will be conducted using a pre-post design to evaluate the effectiveness (co-primary outcomes of LCS and decision quality) and implementation at four rural clinics.
Not provided
Not provided
Not provided
Not provided
|
| Baseline |
| Patient Knowledge About Lung Cancer | Patient knowledge about lung cancer will be measured by overall knowledge score calculated from 15 survey questions previously used by Lau et al in their peer-reviewed manuscript published in the American Journal of Preventive Medicine titled Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening. The level of knowledge will be assessed based on correct answers to 15 questions. The overall knowledge score will range from 0-15 where 0 is no correct answer (lowest knowledge) and 15 is all correct answers (highest knowledge). More correct answers indicate higher level of knowledge and higher score. | 1 month follow up |
The intervention group will consist of each participant and clinic once they move to the intervention phase (pre-post design)
Patient decision aid: Each subject will receive an informational flyer describing lung cancer screening options and smoking cessation from a trained person on the medical staff at each clinic. Staff will lead a shared decision-making discussion with the patient.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Patient Decision Aid | The intervention group will consist of each participant and clinic once they move to the intervention phase (post-intervnetion). Patient decision aid: Each subject will receive an informational flyer describing lung cancer screening options and smoking cessation from a trained person on the medical staff at each clinic. Staff will lead a shared decision-making discussion with the patient. |
|
|
| Primary | Count of Participants Who's Health Visit Adhered to the LCS Guidelines and CMS Coverage Criteria in Rural Primary Care Practices: Follow-up Survey | The adherence to the LCS guidelines and CMS coverage criteria to conduct SDM and provide smoking cessation services in rural primary care practices (is a latent variable) and will be measured as a composite measure using variables in a baseline survey administered immediately after the healthcare provider's visit (follow-up). A survey tool will be developed and used to count "Yes" response to the following survey questions: Were you given a decision aid during your last clinic visit/call? Was the clinic provider or staff able to go over the decision aid together with you during your last clinic visit/call? Were you recommended for a low-dose computerized axial tomography (CAT) scan by your provider during your last clinic visit/call? | Posted | Number | participants | 1 month follow-up |
|
|
|
| Secondary | Patient Knowledge About Lung Cancer | Patient knowledge about lung cancer will be measured by overall knowledge score calculated from 15 survey questions previously used by Lau et al in their peer-reviewed manuscript published in the American Journal of Preventive Medicine titled Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening. The level of knowledge will be assessed based on correct answers to 15 questions. The overall knowledge score will range from 0-15 where 0 is no correct answer (lowest knowledge) and 15 is all correct answers (highest knowledge). More correct answers indicate higher level of knowledge and higher score. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Patient Knowledge About Lung Cancer | Patient knowledge about lung cancer will be measured by overall knowledge score calculated from 15 survey questions previously used by Lau et al in their peer-reviewed manuscript published in the American Journal of Preventive Medicine titled Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening. The level of knowledge will be assessed based on correct answers to 15 questions. The overall knowledge score will range from 0-15 where 0 is no correct answer (lowest knowledge) and 15 is all correct answers (highest knowledge). More correct answers indicate higher level of knowledge and higher score. | Posted | Mean | Standard Deviation | score on a scale | 1 month follow up |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Patient Decision Aid | The intervention group will consist of each participant and clinic once they move to the intervention phase (post-intervention). Patient decision aid: Each subject will receive an informational flyer describing lung cancer screening options and smoking cessation from a trained person on the medical staff at each clinic. Staff will lead a shared decision-making discussion with the patient. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |