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”
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 • Safe • Effective • Timing • Modality • Intensity
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 • Innovation • Pilot study • Feasibility study • Large scale clinical trial
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 • Clinical, Satisfaction, Financial • Significance • Statistical • Clinical • Locus of control; patient empowerment • Valid, reliable assessment tools
Research Designs • Single-Subject • N=1 Randomized Trial • Sequential Medical Trial (SMT)
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 • 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 • 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 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 • 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 • Public • Private
Huzzah, My Device is Covered -- Now What? • Retrospective, fee-for-service • Prospective, Medicare • Inpatient • Outpatient • SNF & Nursing homes • Home health
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