Tailoring Shared Decision Making for Lung Cancer Screening in Persons Living With HIV

Completed

Conditions: Lung Carcinoma

Interventions: Behavioral: Behavioral Intervention
Other: Discussion (focus group)
Other: Discussion (feedback on SDM)
Other: Interview
Other: Survey Administration

Registration Number: NCT04682301

Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary: This study tailors a shared decision making intervention for lung cancer screening in persons living with human immunodeficiency virus (HIV). Information collected in this study may help doctors better understand how to perform lung cancer screening in persons living with HIV, so as to enhance shared decision making in persons living with HIV.

Detailed Description: OUTLINE:

AIM I: Participants attend a focus group over 1-1.5 hours providing feedback on refining potential methods of shared decision making (SDM).

AIM II: Participants receive the SDM intervention developed in Aim I and provide feedback. Participants may attend a telephone interview over 45 minutes 1 month later.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 102

Inclusion Criteria

AIM I: Patients with human immunodeficiency virus (PWH) enrolled in the local UW HIV cohort and primary providers at Madison Clinic and other Seattle-based clinics serving PWH
AIM I: Using proposed United States Preventive Services Task Force (USPSTF) guidelines, participants enrolled in the registry who are current or former smokers, report >= 20 pack-years smoking history, and >= 50 years old (n=165) will be eligible for recruitment
AIM I: Clinicians (medical doctors, physicians assistants and nurse practitioners) who provide primary care for PWH (n=48) will be eligible
AIM II: PWH who are eligible for lung cancer screening (LCS) based on proposed USPSTF criteria

Exclusion Criteria

Those found to be ineligible for LCS on coordinator review
Are non-English speaking or have cognitive dysfunction that would prevent participation in SDM

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aims I-II	Behavioral Intervention	AIM I: Participants attend a focus group over 1-1.5 hours providing feedback on refining potential methods of SDM. AIM II: Participants receive the SDM intervention developed in Aim I and provide feedback. Participants may attend a telephone interview over 45 minutes 1 month later.
Aims I-II	Discussion (focus group)	AIM I: Participants attend a focus group over 1-1.5 hours providing feedback on refining potential methods of SDM. AIM II: Participants receive the SDM intervention developed in Aim I and provide feedback. Participants may attend a telephone interview over 45 minutes 1 month later.
Aims I-II	Survey Administration	AIM I: Participants attend a focus group over 1-1.5 hours providing feedback on refining potential methods of SDM. AIM II: Participants receive the SDM intervention developed in Aim I and provide feedback. Participants may attend a telephone interview over 45 minutes 1 month later.
Aims I-II	Discussion (feedback on SDM)	AIM I: Participants attend a focus group over 1-1.5 hours providing feedback on refining potential methods of SDM. AIM II: Participants receive the SDM intervention developed in Aim I and provide feedback. Participants may attend a telephone interview over 45 minutes 1 month later.
Aims I-II	Interview	AIM I: Participants attend a focus group over 1-1.5 hours providing feedback on refining potential methods of SDM. AIM II: Participants receive the SDM intervention developed in Aim I and provide feedback. Participants may attend a telephone interview over 45 minutes 1 month later.

Primary Outcome Measures

Name	Time	Method
Focus Group Analysis (Aim I)	During focus participation, an average of 1-1.5 hours	All focus groups will be recorded and transcribed. Will use a framework analysis approach which combines both inductive and deductive methods where generated themes are mapped onto an implementation framework, specifically the Tailored Implementation of Chronic Diseases (TICD) checklist. Codes will then be analyzed through a constant comparison method to determine key themes. Will analyze all focus groups in real time to make iterative changes to the focus group guide based on feedback and refining potential methods of shared decision making (SDM). Pre-/post-SDM survey data will be collected via tablet, with a paper option if desired. Effectively, number of participants who complete focus group participation for analysis.
Improvement in Lung Cancer Screening Knowledge (LKS), According to Pre- vs. Post-intervention Scores (Aim II)	During shared decision-making participation, an average of 1 hour	The primary outcome was change in knowledge of LCS after using the tailored decision aid. We used two validated measures of LCS knowledge, the LCS-12 and LKS-7, to evaluate knowledge of risks, benefits, and characteristics of LCS. The LCS-12 includes twelve multiple-choice questions which assess knowledge of lung cancer risk, characteristics of LCS, and benefits and harms of LCS. The LKS-7 uses seven questions assessing understanding of the harms and benefits LCS, incidental findings, and the screening process. Our enrollment target was 40-50 patients to achieve greater than 90% power to observe a difference similar to a prior study in pre- and post-SDM knowledge of screening harms (69% to 93%). Minimum score of 0 for LCS-12 and LKS-7, indicating no improvement from pre- to post-intervention assessment on LCS knowledge; maximum score of 12 for LCS-12 and 7 for LKS-7. Higher score represents better outcome, or greater improvement from pre- to post-intervention on measures of LKS.
Fidelity (Aim II)	During shared decision-making participation, an average of 1 hour	Fidelity summarized as median percent of a 10-item checklist completed. Higher percentages represented a better outcome, or greater fidelity to the intervention/completion of items throughout intervention. Minimum percentage of completion is 0; maximum percentage of completion is 100.
Acceptability of Intervention Measure (AIM) (Aim II)	During shared decision-making participation, an average of 1 hour	The AIM was used to evaluate the acceptability of the intervention for participants. The AIM is a four-item measure to assess the acceptability of a given intervention, in this case the decision aid, producing responses on a scale from 1 (completely disagree) to 5 (completely agree) and higher scores indicating greater acceptability. The score is calculated by taking the mean of the four responses. Scores range from 1-5.
Decision of Cancer Screening (DCS) (Aim II)	During shared decision-making participation, an average of 1 hour	The Decision of cancer screening (DCS) was used to evaluate participants' decisional conflict after SDM visits. The ten-item lower literacy DCS was selected with possible scores ranging from 0 (minimum; no decisional conflict) to 100 (maximum; extremely high decisional conflict), with possible sub-scores for resulting feelings of uncertainty, feeling informed, clarity of values regarding risks and benefits, and feeling supported. Each question has options for yes (0), unsure (2), and no (4); answers are summed, divided by ten, then multiplied by 25 to provide the overall DCS. Lower scores represent a better outcome, or no/low decisional conflict.