Saturday, November 23, 2024
11/23/2024
We propose to conduct a multi-level intervention randomized trial in four health systems (Christiana Care Health System (CCHS), Jefferson Health (JH), Lehigh Valley Health Network (LVHN), and PennState Health (PSH)) to test the combined and separate effects of a provider support intervention and a patient outreach intervention on SDM and LCS in primary care practice. Using a mixed methods 2x2 factorial design, we initially will recruit and randomize 28 primary care practices and providers either to a Provider Support Group (N=14) or a Control Group (N=14). Over three years, we will also identify approximately 4,480 patients who are potentially eligible for LCS and have a scheduled primary care visit. On a weekly basis, we will allocate identified patients to cohorts and initiate telephone contact with each cohort to verify screening eligibility, obtain consent, and complete a baseline survey. We will randomize at least 672 patient participants either to a Patient Outreach Group (N=336) or a Control Group (N=336). Thus, the trial will involve a Provider Support + Patient Outreach Group, a Provider Support Group, a Patient Outreach Group, and a Control Group. We will collect health system electronic medical records (EMRs) data, study administrative data, physician and patient survey data, and interview data from physicians, practice staff, health system care coordinators, and health system leaders for use in addressing trial aims. Specific aims of the trial are as follows: Aim 1. Assess intervention impact on Lung Cancer Screening (LCS); Aim 2. Assess intervention impact on Shared Decision Making (SDM); Aim 3. Identify mediators and moderators of screening; and, Aim 4. Assess intervention implementation. We will use health system EMR data, study administrative data, provider baseline and endpoint survey data, and patient baseline and endpoint survey data, focus group data, and health system leader interview data to identify practice-, provider- and patient-level factors that impact intervention effects on screening. In terms of overall impact, this trial will identify effective strategies for increasing SDM and LCS rates in primary care and for implementing effective strategies in health systems. We will disseminate study findings through communication channels in participating health systems and more broadly by reporting results on ClinicalTrials.gov, at health care professional organization meetings, through local, state and regional conferences, and via publications in peer-reviewed journals.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).
