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Multilevel Interventions to Increase Adherence to Lung Cancer Screening (Larch)

Primary Purpose

Lung Cancer, Lung Cancer Screening

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stepped Reminders
Patient Education
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lung Cancer focused on measuring Lung Cancer, Low dose CT (LDCT), Lung Cancer Screening, Stepped Reminders, Educational Video, User centered design, Stakeholders, Evaluation, Qualitative, Patient Partners, Adherence

Eligibility Criteria

50 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, Patients who have a positive scan, Patients who have an indicator for interpreter services, except for Spanish

Sites / Locations

  • Kaiser Permanente

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Patient Video only

Stepped Reminders only

Patient Video and Stepped Reminders

Usual Care

Arm Description

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.

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.

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

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

Outcomes

Primary Outcome Measures

Rate of repeat annual lung cancer screening
Electronic health records will be searched for screening low dose CT (LDCT).

Secondary Outcome Measures

Knowledge of lung cancer screening
Knowledge of lung cancer screening eligibility, time to return and cost on patient reported outcomes survey.
Attitudes and beliefs
The Lung Cancer Screening Health Belief Scales: 1) perceived risk of lung cancer (3 items); 2) perceived benefits of lung cancer screening (6 items); (3) perceived barriers to lung cancer screening (17 items); and (4) self-efficacy for lung cancer screening (9 items).

Full Information

First Posted
February 17, 2023
Last Updated
March 6, 2023
Sponsor
Kaiser Permanente
Collaborators
Fred Hutchinson Cancer Center, Hackensack Meridian Health
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1. Study Identification

Unique Protocol Identification Number
NCT05747443
Brief Title
Multilevel Interventions to Increase Adherence to Lung Cancer Screening
Acronym
Larch
Official Title
Multilevel Interventions to Increase Adherence to Lung Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Fred Hutchinson Cancer Center, Hackensack Meridian Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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. The investigators will test two interventions which include patient education and reminders to improve adherence to lung cancer screening.
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. The investigators developed two novel, patient-centered interventions to address patient education and offering reminders for on-time screening. To address these goals, the 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lung Cancer Screening
Keywords
Lung Cancer, Low dose CT (LDCT), Lung Cancer Screening, Stepped Reminders, Educational Video, User centered design, Stakeholders, Evaluation, Qualitative, Patient Partners, Adherence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1606 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient Video only
Arm Type
Experimental
Arm Description
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.
Arm Title
Stepped Reminders only
Arm Type
Experimental
Arm Description
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.
Arm Title
Patient Video and Stepped Reminders
Arm Type
Experimental
Arm Description
See above. Those assigned to the Patient Video and Stepped Reminders will receive both interventions, as described above.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Those assigned to the the Usual Care arm will continue to receive usual lung cancer screening care.
Intervention Type
Other
Intervention Name(s)
Stepped Reminders
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Patient Education
Intervention Description
The Patient Voices Video is an educational video about lung cancer screening.
Primary Outcome Measure Information:
Title
Rate of repeat annual lung cancer screening
Description
Electronic health records will be searched for screening low dose CT (LDCT).
Time Frame
9-15 months after index LDCT
Secondary Outcome Measure Information:
Title
Knowledge of lung cancer screening
Description
Knowledge of lung cancer screening eligibility, time to return and cost on patient reported outcomes survey.
Time Frame
8 weeks after index LDCT
Title
Attitudes and beliefs
Description
The Lung Cancer Screening Health Belief Scales: 1) perceived risk of lung cancer (3 items); 2) perceived benefits of lung cancer screening (6 items); (3) perceived barriers to lung cancer screening (17 items); and (4) self-efficacy for lung cancer screening (9 items).
Time Frame
8 weeks after index LDCT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, Patients who have a positive scan, Patients who have an indicator for interpreter services, except for Spanish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Wernli, PhD
Organizational Affiliation
Kaiser Permanente Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Multilevel Interventions to Increase Adherence to Lung Cancer Screening

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