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How to Get Clinicians to Use Your Project. Sue Palsbo, PhD Associate Director NRH-CHDR. Diffusion of New Technologies. Translating research into practice Early adopters Opinion leaders Volume leads to assignment of a CPT code by the American Medical Association “Evidence based practice”.

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How to get clinicians to use your project

How to Get Clinicians to Use Your Project

Sue Palsbo, PhD

Associate Director

NRH-CHDR


Diffusion of new technologies
Diffusion of New Technologies

  • Translating research into practice

  • Early adopters

  • Opinion leaders

  • Volume leads to assignment of a CPT code by the American Medical Association

  • “Evidence based practice”


Get it covered
Get It Covered

  • Definition of “covered” benefits

    • experimental

    • medical necessity (restorative)

  • Medicaid; DoD and VA

  • Private sector (Technology Assessment Centers)

  • Medicare

    • a “leader” or “follower”?


Clinical trials
Clinical Trials

  • Safe

  • Effective

  • Timing

  • Modality

  • Intensity


Building a research team
Building a Research Team

  • Track record and experience

  • “New” investigators

  • Team skill set

  • What they want to see from you

  • Advisors


Agree on the study stage
Agree on the Study Stage

  • Innovation

  • Pilot study

  • Feasibility study

  • Large scale clinical trial


Agree on the methods
Agree on the Methods

  • Define characteristics of the study population

  • Randomization

  • Blinding

    • of treatments

    • of analysis

  • Control group


Agree on the outcome measures and statistical tests
Agree on the Outcome Measures and Statistical Tests

  • Clinical, Satisfaction, Financial

  • Significance

    • Statistical

    • Clinical

  • Locus of control; patient empowerment

  • Valid, reliable assessment tools


Research designs
Research Designs

  • Single-Subject

  • N=1 Randomized Trial

  • Sequential Medical Trial (SMT)


Single subject designs
Single Subject Designs

  • Repeated measures

    • AB

    • Withdrawal (ABAB, etc).

    • Multiple Baseline (subjects, settings)

    • Alternating Treatments

  • Statistics for repeated measures

  • Withdrawing treatments (ABA)

  • Natural recovery; maturation

    multiple baseline


Measures you might see
Measures You Might See

  • FIM=Functional Improvement Measure

  • GMFM=Gross Motor Function Measure

  • ROM=range of motion

  • Ashworth Scale = spasticity

  • COPM=Canadian Occupational Performance Measure

  • MRFA=Medical Rehabilitation Follow Along

  • SIP=Sickness Impact Profile

  • ADL=Activities of Daily Living


Ethical questions
Ethical Questions

  • Is an N=1 trial indicated for this patient?

    • Is the effectiveness really in doubt?

    • If Tx is effective, will it be continued in long term?

    • Is patient eager to collaborate?


Ethical questions1
Ethical Questions

  • Is an N=1 trial feasible in this patient?

    • Rapid onset?

    • Does Tx cease to act soon after it is discontinued?

    • Is an optimal Tx duration feasible?

    • Can clinically relevant targets be measured?

    • Are the criteria for stopping the trial, sensible?

    • Should an unblinded run-in period be conducted?


Practical questions
Practical Questions

  • Is an N=1 trial feasible in the clinician’s practice?

    • Will you be available to help the clinician?

    • Are strategies in place for interpreting the data?

  • Has the study been approved by the IRB?

  • What will happen to the device after the test?

  • Where will the results be

    published?


Funding sources
Funding Sources

  • Public

  • Private


Huzzah my device is covered now what
Huzzah, My Device is Covered -- Now What?

  • Retrospective, fee-for-service

  • Prospective, Medicare

    • Inpatient

    • Outpatient

    • SNF & Nursing homes

    • Home health


Prospective payment system pps
Prospective Payment System (PPS)

(National base rate)

x (local cost of inputs factor)

x (national case or procedure index)

= reimbursement per case or procedure

  • Incentive on facility is to find and use tools that will maximize clinical outcomes while still living within the reimbursement per case


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