A Community Health Intervention to Improve Lung Cancer Screening Uptake in Community Health Centers

Browse trials for

• Lung Neoplasms 5,422
• Tobacco Use 420

Keywords

• lung cancer screening
• tobacco treatment
• community health workers
• community health centers
• Lay navigators

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 120 is above the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.

Lead sponsor

Baystate Medical Center is the lead sponsor of 48 studies on the registry; 8 are open to participants now.

Study arms

• Active comparator
  Enhanced Usual Care

  Partcipants will receive educational materials about lung cancer screening

  Other: Enhanced Usual Care

• Experimental
  Community Health Worker-delivered Intervention

  Participants will receive a four-part intervention delivered by a community health worker to improve lung cancer screening uptake. The intervention includes: 1) patient outreach, 2) patient-centered shared decision-making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers to care.

  Behavioral: Community health worker delivered outreach, shared decision-making, tobacco treatment, and navigation

• Experimental
  Lay Navigator-delivered Intervention

  Participants will receive the same four-part intervention delivered by a trained lay navigator to improve lung cancer screening uptake. The intervention includes: 1) patient outreach, 2) patient-centered shared decision-making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers to care.

  Behavioral: Lay Navigator delivered outreach, shared decision-making, tobacco treatment, and navigation

Interventions

• BehavioralCommunity health worker delivered outreach, shared decision-making, tobacco treatment, and navigation

  The CHW will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) tobacco treatmnet counseling, and 4) navigation of logistical barriers

• BehavioralLay Navigator delivered outreach, shared decision-making, tobacco treatment, and navigation

  The lay navigator will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers

• OtherEnhanced Usual Care

  Participants will receive educational materials about lung cancer screening and usual lung cancer screening care through their primary care provider.

Primary outcomes

1. Feasibility: Number of participants at each stage of the recruitment and retention cascade

   Counts abstracted from the study screening and enrollment log at each of the following stages: approached, screened eligible, consented, randomized, completed baseline data collection, and completed post-intervention follow-up assessment.

   Time frame: once a month until study trial ends, an average one year

2. Feasibility: Percentage of participants at each stage of the recruitment and retention cascade

   Percentages calculated from the study screening and enrollment log. Eligibility rate = number screened eligible divided by number approached. Consent rate = number consented divided by number screened eligible. Randomization rate = number randomized divided by number consented. Baseline completion rate = number completing baseline data collection divided by number randomized. Retention rate = number completing post-intervention follow-up divided by number randomized.

   Time frame: once a month until study trial ends, an average one year

3. Fidelity: Duration in minutes of shared decision making (SDM) counseling per encounter

   Time in minutes spent on SDM, recorded by community health workers (CHWs) and lay navigators in the encounter/call tracking log.

   Time frame: once a month until study trial ends, an average of 1 year

4. Fidelity: Duration in minutes of smoking cessation counseling per encounter

   Time in minutes spent on smoking cessation counseling,recorded by community health workers (CHWs) and lay navigators in the encounter/call tracking log.

   Time frame: once a month until study trial ends, an average of 1 year

5. Fidelity - SDM quality using OPTION Scale Observer OPTION Scale

   Mean total score on the OPTION Scale Observer OPTION Scale scored from audio-recorded SDM encounters; 12 items rated 0 ("not observed") to 4 ("exhibited at a very high standard"), total score 0-48, with higher scores indicating greater SDM competence.

   Time frame: once a month until study trial ends, an average of 1 year

6. Fidelity - Completion of SDM required elements

   Mean count of CMS SDM Elements completed during each encounter: reduced lung cancer mortality, false positive, overdiagnosis, radiation exposure, annual screening, smoking cessation, follow-up testing, and diagnostic procedures.

   Time frame: once a month until study trial ends, an average of 1 year

7. Fidelity: Percentage of participants with documented use of the SDM decision aid

   Proportion of participants for whom the SDM decision aid was used, documented in the CHW and lay navigator encounter log.

   Time frame: Monthly through study completion, an average of 1 year

8. Fidelity: Percentage of participants referred to tobacco treatment services, by type

   Proportion referred to any tobacco treatment service by type (telephone quitline, in-person counseling,), from EHR referral orders and the CHW and lay navigator encounter log.

   Time frame: Monthly through study completion, an average of 1 year

9. Acceptability of the CHW and lay navigator intervention to participants

   Qualitative themes regarding overall experience with the CHW and lay navigator intervention and barriers to lung cancer screening, identified through thematic analyses of semi-structured interviews using a study-specific interview guide. Participants (N=15), \~40-45 minutes, conducted in private at 3-month follow-up;

   Time frame: 3 months post-enrollment (participants) and through study completion, an average of 1 year (navigators)

10. Acceptability of the intervention to CHWs and Lay navigators

    Qualitative themes regarding overall experience with the Naviagtor intervention and barriers to lung cancer screening, identified through thematic analysis of Navigator encounter logs and semi-structured interviews using a study-specific interview guide. Navigators (N=3), one 45-minute interview each after final intervention delivery.

    Time frame: 3 months post-enrollment (participants) and through study completion, an average of 1 year (navigators)

Secondary outcomes

1. Percentage of participants with a lung cancer screening (LCS) referral order

   Proportion of participants with an order placed in the electronic health record referring them to the LCS program, abstracted from EHR order data. Reported overall and by ordering source (community health worker vs. primary care provider).

   Time frame: 3 months post study enrollment

2. Percentage of participants completing low-dose CT lung cancer screening (LCS uptake)

   Proportion of participants with a completed low-dose CT scan documented in the electronic health record, ascertained by EHR chart abstraction

   Time frame: Baseline and post intervention, 3 months post study enrollment

3. Percentage of participants initiating tobacco treatment, by treatment type

   Proportion of participants initiating any tobacco treatment, and proportion by type (telephone quitline, in-person counseling, nicotine replacement therapy, prescription pharmacotherapy), ascertained by EHR chart abstraction and participant self-report at follow-up.

   Time frame: 3 months post study enrollment

4. Duration in weeks of tobacco treatment

   Number of weeks of continuous tobacco treatment received, calculated from EHR pharmacy fill and counseling encounter data supplemented by participant self-report.

   Time frame: 3 months post study enrollment

5. Number of self-reported quit attempts per participant

   Count of quit attempts lasting at least 24 hours, measured by participant self-report at the 3-month follow-up assessment.

   Time frame: 3 months post study enrollment

Other outcomes

1. Mean score on the LCS-12 lung cancer screening knowledge instrument

   The Lung Cancer Screening Knowledge Measure (published as "a brief measure of smokers' knowledge of lung cancer screening with low-dose computed tomography") is a 12-item instrument assessing knowledge of lung cancer screening eligibility, benefits, and harms. One point is awarded per correct response. Total score ranges from 0 (minimum) to 12 (maximum). Higher scores indicate greater knowledge and are a better outcome.

   Time frame: Baseline and at 3 months post-enrollment

2. Mean score on the Perceived Risk of Lung Cancer subscale of the Lung Cancer Screening Health Belief Scales

   The Lung Cancer Screening Health Belief Scales are a 35-item instrument based on the Expanded Health Belief Model. The Perceived Risk of Lung Cancer subscale comprises 3 items rated on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). The subscale score is the mean of the item responses and ranges from 1 (minimum) to 4 (maximum). Higher scores indicate greater perceived personal risk of lung cancer. This construct is not inherently better or worse; higher perceived risk is hypothesized to be associated with greater screening uptake.

   Time frame: At baseline and at 3 months post-enrollment

3. Mean score on the Perceived Benefits of Lung Cancer Screening subscale of the Lung Cancer Screening Health Belief Scales

   The Perceived Benefits subscale comprises 6 items rated on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). The subscale score is the mean of the item responses and ranges from 1 (minimum) to 4 (maximum). Higher scores indicate greater perceived benefit of lung cancer screening and are a better outcome.

   Time frame: At baseline and at 3 months post-enrollment

4. Mean score on the Perceived Barriers to Lung Cancer Screening subscale of the Lung Cancer Screening Health Belief Scales

   The Perceived Barriers subscale comprises 17 items rated on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). The subscale score is the mean of the item responses and ranges from 1 (minimum) to 4 (maximum). Higher scores indicate greater perceived barriers to lung cancer screening and are a worse outcome.

   Time frame: At baseline and at 3 months post-enrollment

5. Mean score on the Self-Efficacy subscale of the Lung Cancer Screening Health Belief Scales

   The Self-Efficacy subscale comprises 9 items rated on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree), assessing patient confidence in the ability to arrange and complete lung cancer screening. The subscale score is the mean of the item responses and ranges from 1 (minimum) to 4 (maximum). Higher scores indicate greater self-efficacy and are a better outcome.

   Time frame: At baseline and at 3 months post-enrollment

6. Mean score on the Trust in Navigator Scale

   Trust in Navigator Scale: 6-item instrument developed to measure interpersonal trust in a patient's navigator, adapted from the trust in physician scale. Items are rated on a 5-point Likert scale. The score is the mean of the 6 item responses and ranges from 1 (minimum) to 5 (maximum) with higher mean scores indicating greater trust.

   Time frame: 3 months post-enrollment

7. Mean score on the SDM Process Survey

   The Shared Decision Making Process Scale (also referred to as the SDM Process Survey; National Quality Forum measure 2962) is a 4-item patient-reported instrument assessing whether the clinical conversation addressed the benefits of the option, addressed the harms of the option, and elicited the patient's preference. Total score ranges from 0 (minimum) to 4 (maximum). Higher scores indicate a more complete shared decision making process and are a better outcome.

   Time frame: 3 months post-enrollment

Individual participant data

Plan to share: No — Sharing qualitative data such as transcriptions from interviews can potentially reveal sensitive information and identify individual participants. The higher level of redaction needed to remove potentially-identifying and sensitive information would substantially reduce the utility of transcripts in future analyses.To ensure this group's participation and honest responses, we will not share transcripts or coding summaries from participant or community health worker interviews. The goal of this pilot trial is to provide preliminary information to support a future fully powered randomized trial to address disparities in lung cancer in Black and Hispanic communities. Given that these community members have historically been subject to unethical research practices, we will limit the potential for further distrust by not sharing de-identified information outside of the study team or its collaborators.