NRH Center for Health

and Disability Research

How to Get Clinicians to Use Your Project

Sue Palsbo, PhD

Associate Director

NRH-CHDR

NRH Center for Health

and Disability Research

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”

NRH Center for Health

and Disability Research

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”?

NRH Center for Health

and Disability Research

Clinical Trials

• Safe

• Effective

• Timing

• Modality

• Intensity

NRH Center for Health

and Disability Research

Building a Research Team

• Track record and experience

• “New” investigators

• Team skill set

• What they want to see from you

• Advisors

NRH Center for Health

and Disability Research

Agree on the Study Stage

• Innovation

• Pilot study

• Feasibility study

• Large scale clinical trial

NRH Center for Health

and Disability Research

Agree on the Methods

• Define characteristics of the study population

• Randomization

• Blinding– of treatments– of analysis

• Control group

NRH Center for Health

and Disability Research

Agree on the Outcome Measures and Statistical Tests

• Clinical, Satisfaction, Financial

• Significance– Statistical– Clinical

• Locus of control; patient empowerment

• Valid, reliable assessment tools

NRH Center for Health

and Disability Research

Research Designs

• Single-Subject

• N=1 Randomized Trial

• Sequential Medical Trial (SMT)

NRH Center for Health

and Disability Research

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

NRH Center for Health

and Disability Research

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

NRH Center for Health

and Disability Research

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?

NRH Center for Health

and Disability Research

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?

NRH Center for Health

and Disability Research

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?

NRH Center for Health

and Disability Research

Funding Sources

• Public

• Private

NRH Center for Health

and Disability Research

Huzzah, My Device is Covered -- Now What?

• Retrospective, fee-for-service

• Prospective, Medicare– Inpatient– Outpatient– SNF & Nursing homes– Home health

NRH Center for Health

and Disability Research

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