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