SAILS-FQHC: Designing an Implementation Strategy for Lung Screening and Smoking Cessation Treatment in Community Health Centers

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05447897

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Tobacco use is the leading preventable cause of death in the US and a major driver of health disparities. Among our tools for reducing the harms of tobacco is lung cancer screening (LCS). This study will combine a review of existing qualitative and quantitative data on barriers to lung cancer screening and smoking cessation in underserved populations, a quantitative analysis of predictors of lung cancer screening and smoking cessation treatment use among Massachusetts Federally Qualified Health Centers (FQHC)s, and a stakeholder advisory group to synthesize these data and select implementation strategies that reflects the critical determinants and the strengths and resource constraints of the Federally Qualified Health Centers (FQHC) context.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Other: Qualitative Group Interviews Other: Stakeholder advisory group	N/A

Detailed Description

Aim 1) To design an implementation strategy that targets critical components in the delivery of SCT or LCS services for patients who smoke.

Aim 2) To assess the acceptability, appropriateness and feasibility of the implementation strategy among community health center staff.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A Systematic Approach to Designing an Implementation Strategy to Increase Lung Cancer Screening and Smoking Cessation Treatment Among Federally Qualified Community Health Center Patients Who Smoke

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Stakeholder Advisory Group To co-design an implementation strategy that targets critical components in the delivery of SCT or LCS services for patients who smoke. Convene a stakeholder advisory group (CHC providers, quality improvement specialists, community engagement staff, and specialty providers) to review the results of the literature review and quantitative analysis of deidentified data in order to select a set of implementation strategies from a menu of strategies to implement. The team will meet with the stakeholder advisory group four times for 1-2 hours each.	Other: Qualitative Group Interviews One time interview, 60-90 minutes Other: Stakeholder advisory group The team will meet with the stakeholder advisory group four times for 1-2 hours each

Arm

Intervention/Treatment

Other: Stakeholder Advisory Group

To co-design an implementation strategy that targets critical components in the delivery of SCT or LCS services for patients who smoke. Convene a stakeholder advisory group (CHC providers, quality improvement specialists, community engagement staff, and specialty providers) to review the results of the literature review and quantitative analysis of deidentified data in order to select a set of implementation strategies from a menu of strategies to implement. The team will meet with the stakeholder advisory group four times for 1-2 hours each.

Other: Qualitative Group Interviews

One time interview, 60-90 minutes

Other: Stakeholder advisory group

The team will meet with the stakeholder advisory group four times for 1-2 hours each

Outcome Measures

Primary Outcome Measures

Feasibility of Intervention Measure [End of study, up to 16 weeks]
Feasibility of Intervention Measure

Secondary Outcome Measures

Acceptability of Intervention Measure [End of study, up to 16 weeks]
Acceptability of Intervention Measure
Intervention appropriateness measure [End of study, up to 16 weeks]
Intervention appropriateness measure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

FQHC implementation team including staff in the intervention FQHCs and their lung screening partners

Exclusion Criteria:

FQHC staff or partners who leave the organization before end of study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Massachusetts General Hospital
National Cancer Institute (NCI)

Investigators

Principal Investigator: Gina Kruse, MD, MPH, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gina Kruse, Principal Investigator, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT05447897

Other Study ID Numbers:

22-215
P50CA244433-03S3

First Posted:

Jul 7, 2022

Last Update Posted:

Jul 7, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 7, 2022