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

Feb 09, 2023 290 likes •546 views

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,

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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

A Pilot Study Testing the Effectiveness, Feasibility, and Fidelity of Implementing a Shared Decision Making Visit for Lung Cancer Screening in the Screening Setting

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MD Anderson

Funding and Disclaimers

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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.

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MD Anderson

Background

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MD Anderson 4 SDM Visit for Lung Cancer Screening | @LisaML_PhD

Shared Decision Making – It’s the Right Thing to Do

Honors providers’ expert knowledge

Honors patients right to be fully informed of all care options Honors patients right to be fully informed of the potential harms and benefits

Informedmedicaldecisions.org

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MD Anderson

Effectiveness of SDM – Cochrane Database of Systematic Reviews: Decision Aids for People Facing Health Treatment or Screening Decisions

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17 35 55 86 117 105 1999 2003 2009 2011 2013 2017

  • 31,043 Subjects
  • 10 countries
  • Screening RCTs:
  • Prostate (n=14)
  • Colorectal (n=10)
  • Breast cancer genetic testing (n=4)

Stacey, Eisenberg Conference 2013; O’Connor, 1999; 2003; 2009; Stacey, 2011; 2013, 2017

  • No. of RCTs

Added 18 RCTs and dropped 28 because they compared simple vs complex aids

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MD Anderson

Effectiveness of SDM – Compared to Usual Care, Decision Aids…

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Greater knowledge (High) More accurate perception of outcome probabilities (Moderate) Greater congruence between choice and values (Low) Feeling more informed (High) Feeling clear about values (High) Greater participation in decision making (Moderate) Increase consultation length by 2.6 minutes No impact on anxiety, health outcomes,

  • r adverse events

Variable impact on choice

Stacey, Cochrane Database of Systematic Reviews, 2017

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Effectiveness of SDM - Patient Choice

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Cancer Screening Aid Impact on Patient Choice Prostate cancer screening Reduce (12%) Colorectal cancer screening Increase (30%) Lung cancer screening Unknown Breast cancer screening Unknown Other cancer screening Unknown

Volk 2007, 2017

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MD Anderson

Lung Cancer Screening: The National Lung Screening Trial

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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, radiation exposure, overdiagnosis

NNS = 320

NLST Research Team, NEJM 2011; Bach, Jama 2012; Pinsky, Cancer, 2014.

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MD Anderson

Current Lung Cancer Screening Guidelines and Policy (US)

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U.S. Preventive Services Task Force

  • The USPSTF recommends annual

screening for lung cancer with low-dose computed tomography (LDCT):

  • aged 55 to 80 years
  • 30+ pack-year smoking history
  • currently smoke or have quit within the past 15

years.

  • Screening should be discontinued:
  • not smoked for 15 years, or
  • develops a health problem that substantially

limits life expectancy, or

  • not able or willing to have curative lung

surgery. Released December, 2013

Centers for Medicare & Medicaid Services

The evidence is sufficient to add lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, annual screening for lung cancer with low-dose computed tomography (LDCT) as an additional preventive service benefit under the Medicare program.

February 5, 2015

First preventive service policy in US to require shared decision making and the use of patient decision aids!

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MD Anderson

Implementing SDM for Lung Cancer Screening

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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

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MD Anderson 11 SDM Visit for Lung Cancer Screening | @LisaML_PhD

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?
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MD Anderson

Methods

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Interactive Tablet Application

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MD Anderson

Implementation Strategy: Replicating Effective Programs

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Pre-Condition

  • Weekly meetings with all

stakeholders

  • Adaptation of the

intervention (user-centered)

  • Develop training materials

Pre-Implementation

  • Weekly meetings with all

stakeholders

  • Develop clinic workflow
  • Train nurse practitioners

and physician assistants

  • Data collection
  • Patient surveys
  • TMS

Implementation

  • Weekly meetings with all

stakeholders

  • Data collection
  • Patient surveys
  • TMS
  • Note. TMS, time-motion-

studies

Lowenstein, Preventive Medicine Reports, 2016; Elwyn, Patient Education Counseling, 2013

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Evaluation Measures

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Effectiveness (Patient-Level)

  • Surveyed patients during

pre-implementation and implementation phase

  • Survey assess…
  • Knowledge (5 items)
  • SDM Process –CollaboRATE

(3 items)

Feasibility (Organizational)

  • Conducted TMS during pre-

implementation and implementation phase

  • TMS assessed impact on

clinic workflow

  • 3 clinics

Fidelity (Clinician-level)

  • Audio-recorded clinical

encounters during the implementation phase

  • CMS requirements
  • Reduced mortality
  • Follow-up testing
  • Overdiagnosis
  • Radiation exposure
  • Annual screening
  • Smoking cessation
  • Diagnostic procedures

Lowenstein, Preventive Medicine Reports, 2016; Elwyn, Patient Education Counseling, 2013

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MD Anderson

Data Analysis

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Descriptive statistics (all measures) Comparisons between Pre-implementation vs Implementation

  • ANOVA
  • Knowledge
  • TMS
  • Kruskal-Wallis
  • CollaboRATE
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MD Anderson

Results

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MD Anderson

Effectiveness, Feasibility, Fidelity

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Pre-Implementation n = 50 Implementation n = 30 p-Value Effectiveness Knowledge, % correct ± SD CollaboRATE, median score ± SD 51% ± 21% 12 ± 6 75% ± 20% 14 ± 3 <0.001 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
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Impact on Clinical Workflow – In Detail

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20 40 60 80 100 120 140 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

Minutes Observations

Pre-Implementation

20 40 60 80 100 120 140 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

Minutes Observations

Implementation

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Implications for D&I Research

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Conclusions

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  • Using the REPs was helpful in guiding the

implementation

  • Implementing shared decision-making visit

using decision coaching in the screening setting resulted in patients …

  • Being more informed about the potential benefits

and harms of lung cancer screening

  • Having a better shared decision making process
  • Implementing a shared decision making in the

screening setting was feasible

Trade-off between not having a “true” shared decision-making visit but leads to patients being better informed about the decision.

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MD Anderson

Limitations

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  • Pilot study within a single organization
  • Unequal distribution of sample across clinics
  • Unbalanced sample for comparisons between pre-implementation and implementation

phases

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Lessons on Local Adaptation

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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
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MD Anderson

Collaborators

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Decision Support Lab

  • Robert J. Volk, PhD
  • Alina Bennet, PhD, MPH
  • Laura Covarrubias, MPH
  • Rhodrick Haralson
  • Aubri S. Hoffman, PhD
  • Ashley J. Housten, OTD
  • Viola B. Leal, MPH
  • Luke Robinson
  • Zineb Zirari
  • Vincent Richards

Clinical Partners

  • Myrna Cobos-Barco Godoy, MD, PhD
  • Jeremy J. Erasmus, MD
  • Temitope Adebayo
  • Karen Allen
  • Terrell Evans
  • Joanne Gigstad
  • Morgan Hatchett
  • Anissa Lewis, MBA
  • Mo Salami
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MD Anderson

Thank You!

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Lisa M. Lowenstein, PhD, MPH Assistant Professor LMLowenstein@mdanderson.org