Larch: Multilevel Interventions to Increase Adherence to Lung Cancer Screening

Sponsor
Kaiser Permanente (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05747443
Collaborator
Fred Hutchinson Cancer Center (Other), Hackensack Meridian Health (Other)
1,606
1
4
42.6
37.7

Study Details

Study Description

Brief Summary

Screening for lung cancer has the potential for a profound public health benefit. Repeat annual screening is necessary for early detection of lung cancer. We will test two interventions which include patient education and reminders to improve adherence to lung cancer screening.

Condition or Disease Intervention/Treatment Phase
  • Other: Stepped Reminders
  • Other: Patient Education
N/A

Detailed Description

Screening for lung cancer has the potential for a profound public health benefit.

Successful population-based screening requires continuous monitoring to adherence repeat screening in high risk adults to achieve similar results. Repeat annual screening is necessary for early detection of lung cancer. Baseline or first LDCT scans detect prevalent lung cancer, when subsequent screening detects new nodules. However, adherence to screening is low, ranging at 28-38% from centers nationally.

We developed two novel, patient-centered interventions to address patient education and offering reminders for on-time screening. To address our goals, our specific aims are to: 1) Compare effectiveness of two multilevel interventions relative to usual care in improving (a) rates of adherence to lung cancer screening, (b) patient-centered outcomes; and (c) clinic outcomes; and 2) Determine the patient-, clinician-, and system-level factors that influence changes in adherence to inform lung cancer screening programs.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1606 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Multilevel Interventions to Increase Adherence to Lung Cancer Screening
Actual Study Start Date :
Dec 12, 2022
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patient Video only

About 3 weeks after the index LDCT, the study Medical Assistant (MA) will deliver a link to the Patient Voices Video, an educational video about lung cancer screening.

Other: Patient Education
The Patient Voices Video is an educational video about lung cancer screening.

Experimental: Stepped Reminders only

Prior to patient's next LDCT scan is due, MA begins Stepped Reminders intervention: MA pends LDCT orders to PCP to sign. MA sends reminders to patient when order is placed and follows up by phone if patient has not scheduled LDCT.

Other: Stepped Reminders
Stepped Reminders, which directly reminds providers to order the next LDCT scan and then reminds patients they are due and prompts them to schedule LDCT with Radiology.

Experimental: Patient Video and Stepped Reminders

See above. Those assigned to the Patient Video and Stepped Reminders will receive both interventions, as described above.

Other: Stepped Reminders
Stepped Reminders, which directly reminds providers to order the next LDCT scan and then reminds patients they are due and prompts them to schedule LDCT with Radiology.

Other: Patient Education
The Patient Voices Video is an educational video about lung cancer screening.

No Intervention: Usual Care

Those assigned to the the Usual Care arm will continue to receive usual lung cancer screening care.

Outcome Measures

Primary Outcome Measures

  1. Repeat annual lung cancer screening [9-15 months after index LDCT]

    Electronic health records will be searched for screening low dose CT (LDCT).

Secondary Outcome Measures

  1. Knowledge of lung cancer screening [6-8 weeks after index LDCT]

    Knowledge of lung cancer screening eligibility, time to return and cost on patient reported outcomes survey.

  2. Attitudes and beliefs [6-8 weeks after index LDCT]

    The Lung Cancer Screening Health Beliefs metric.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 78 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

KPWA members Aged 50-78 years Have a negative screening LDCT scan Speak English or Spanish Meet US Preventive Services Task Force guidelines

Exclusion Criteria:

Patients who were previously diagnosed with lung cancer, have a positive scan, or have an indicator for interpreter services, except for Spanish.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaiser Permanente Seattle Washington United States 98101

Sponsors and Collaborators

  • Kaiser Permanente
  • Fred Hutchinson Cancer Center
  • Hackensack Meridian Health

Investigators

  • Principal Investigator: Karen Wernli, PhD, Kaiser Permanente Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT05747443
Other Study ID Numbers:
  • 220-115.001
First Posted:
Feb 28, 2023
Last Update Posted:
Feb 28, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kaiser Permanente
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 28, 2023