A Pilot Study Testing the Effectiveness, Feasibility, and Fidelity - PowerPoint PPT Presentation

A Pilot Study Testing the Effectiveness, Feasibility, and Fidelity of Implementing a Shared Decision Making Visit for Lung Cancer Screening in the Screening Setting Presenter: Lisa M. Lowenstein, PhD, MPH Co-authors: Myrna Cobos Barco Godoy, MD, PhD; Zineb Zirari; Viola B. Leal, MPH; Ashley J. Housten, OTD; Jeremy J. Erasmus, MD; Robert J. Volk, PhD, and Members of the Lung Cancer Screening Collaborative Group

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 2 Funding and Disclaimers This work was supported by a grant from The University of Texas MD Anderson Cancer Center Duncan Family Institute for Cancer Prevention and Risk Assessment. The authors declare they have not conflicts of interest.

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 3 Background

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 4 Honors patients right to be fully informed of all Honors care options providers’ expert Shared Decision Making knowledge – It’s the Right Thing to Do Honors patients right to be fully informed of the potential harms and benefits Informedmedicaldecisions.org

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 5 Effectiveness of SDM – Cochrane Database of Systematic Reviews: Decision Aids for People Facing Health Treatment or Screening Decisions Added 18 RCTs and dropped 28 because they compared simple vs 117 complex aids 105 86 • 31,043 Subjects No. of RCTs • 10 countries 55 • Screening RCTs: 35 • Prostate (n=14) 17 • Colorectal (n=10) • Breast cancer genetic testing (n=4) 1999 2003 2009 2011 2013 2017 Stacey, Eisenberg Conference 2013; O’Connor, 1999; 2003; 2009; Stacey, 2011; 2013, 2017

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 6 Effectiveness of SDM – Compared to Usual Care, Decision Aids… Greater knowledge (High) Greater participation in decision making (Moderate) More accurate perception of outcome probabilities (Moderate) Increase consultation length by 2.6 minutes Greater congruence between choice and values (Low) No impact on anxiety, health outcomes, or adverse events Feeling more informed (High) Variable impact on choice Feeling clear about values (High) Stacey, Cochrane Database of Systematic Reviews, 2017

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 7 Effectiveness of SDM - Patient Choice Cancer Screening Aid Impact on Patient Choice Prostate cancer screening Reduce (12%) Colorectal cancer Increase (30%) screening Lung cancer screening Unknown Breast cancer screening Unknown Other cancer screening Unknown Volk 2007, 2017

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 8 Lung Cancer Screening: The National Lung Screening Trial Randomized >53,000 heavy smokers to… • Low-dose computed tomography (LDCT) or chest x-ray • 3 annual screens • Followed 6.5 years Benefit: Reduced lung cancer deaths by 16-20% Harms: High false-positive rate, NNS = 320 radiation exposure, overdiagnosis NLST Research Team, NEJM 2011; Bach, Jama 2012; Pinsky, Cancer , 2014.

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 9 Current Lung Cancer Screening Guidelines and Policy (US) U.S. Preventive Services Task Force Centers for Medicare & Medicaid Services • The USPSTF recommends annual screening for lung cancer with low-dose The evidence is sufficient to add lung cancer computed tomography (LDCT): screening counseling and shared decision • aged 55 to 80 years making visit, and for appropriate • 30+ pack-year smoking history beneficiaries, annual screening for lung cancer with low-dose computed tomography • currently smoke or have quit within the past 15 (LDCT) as an additional preventive service years. benefit under the Medicare program. • Screening should be discontinued: • not smoked for 15 years, or February 5, 2015 • develops a health problem that substantially limits life expectancy, or First preventive service policy in US to require • not able or willing to have curative lung shared decision making and the use of surgery. patient decision aids! Released December, 2013

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 10 Implementing SDM for Lung Cancer Screening Potential Barriers • Few people are getting screened (National Health Interview Survey 2015) • In 2015, 5.8% of “eligible” smokers • Some “ineligible” smokers screened • Chest radiography being used for screening ( Not effective for LCS) • Primary care providers are not ready • 28.0% refer patients to high quality “accredited” screening programs • 34.5% identify eligible patients for LCS • 42.7% Engage patients in shared/informed decision making prior to referral Huo, Jama Internal, 2017; Volk, Preventive Medicine Reports, 2015

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 11 Alternative approaches for implementing the SDM visit for lung cancer screening are needed. • RQ 1: Is delivering the SDM visit for lung cancer screening effective and feasible in the screening setting? • RQ2: Can it be done with fidelity to CMS requirements?

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 12 Methods

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 13 Interactive Tablet Application

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 14 Implementation Strategy: Replicating Effective Programs Pre-Condition Pre-Implementation Implementation • Weekly meetings with all • Weekly meetings with all • Weekly meetings with all stakeholders stakeholders stakeholders • Adaptation of the • • Develop clinic workflow Data collection intervention (user-centered) • Patient surveys • Train nurse practitioners • Develop training materials and physician assistants • TMS • Data collection • Patient surveys Note. TMS, time-motion- • TMS studies Lowenstein, Preventive Medicine Reports, 2016; Elwyn, Patient Education Counseling, 2013

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 15 Evaluation Measures Effectiveness (Patient-Level) Feasibility (Organizational) Fidelity (Clinician-level) • Surveyed patients during • Conducted TMS during pre- • Audio-recorded clinical pre-implementation and implementation and encounters during the implementation phase implementation phase implementation phase • Survey assess… • TMS assessed impact on • CMS requirements clinic workflow • Knowledge (5 items) • Reduced mortality • SDM Process –CollaboRATE • 3 clinics • Follow-up testing (3 items) • Overdiagnosis • Radiation exposure • Annual screening • Smoking cessation • Diagnostic procedures Lowenstein, Preventive Medicine Reports, 2016; Elwyn, Patient Education Counseling, 2013

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 16 Data Analysis Descriptive statistics (all measures) Comparisons between Pre-implementation vs Implementation • ANOVA • Knowledge • TMS • Kruskal-Wallis • CollaboRATE

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 17 Results

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 18 Effectiveness, Feasibility, Fidelity Pre-Implementation Implementation p-Value n = 50 n = 30 Effectiveness Knowledge, % correct ± SD 51% ± 21% 75% ± 20% <0.001 CollaboRATE, median score ± SD 12 ± 6 14 ± 3 0.04 Feasibility Total time in minutes, mean ± SD 84.0 ± 18.7 86.1 ± 19.0 0.72 Fidelity CMS requirements, total items* --- 6.4

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 19 Impact on Clinical Workflow – In Detail Pre-Implementation Implementation 140 140 120 120 100 100 Minutes Minutes 80 80 60 60 40 40 20 20 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Observations Observations

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 20 Implications for D&I Research

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 21 Conclusions • Using the REPs was helpful in guiding the implementation • Implementing shared decision-making visit using decision coaching in the screening setting resulted in patients … Trade-off between not having a “true” shared • Being more informed about the potential benefits decision-making visit but leads to patients being better informed about the decision. and harms of lung cancer screening • Having a better shared decision making process • Implementing a shared decision making in the screening setting was feasible

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 22 Limitations • Pilot study within a single organization • Unequal distribution of sample across clinics • Unbalanced sample for comparisons between pre-implementation and implementation phases

MD Anderson SDM Visit for Lung Cancer Screening | @LisaML_PhD 23 Lessons on Local Adaptation Deep knowledge of the organizational structure is necessary • Large organization involves a number of stakeholders with different reporting structures • Radiologist, Radiation Technologists, Nursing, Clinical Operations, Front staff Involvement of clinicians in the adaptation is crucial • Intervention has to be brief • Each clinic had a different workflow More intensive training for clinicians is needed with opportunity for feedback • Clinicians who followed the script did well