1. Jim Alaimo CPO PRACTICAL O&P OUTCOMES TO VALIDATE THE EFFICACY OF YOUR CLINICAL INTERVENTION

2. NEED FOR OUTCOMES IN O&P There is a lack in outcomes in the field of Orthotics and Prosthetics A 2006 research paper* published in the JPO study reported in a review of lower limb outcomes from 1995-2005, revealed only 25 studies on LE amputees. Included both evidence based and patient reported outcomes Majority of studies were based on results of a small number of patient subjects or single patient case studies * Lower Limb Prosthetic Outcome Measures: A Review of the Literature 1995 to 2005. Elizabeth Condie, Grad Dip Phys, FCSP Helen Scott, Grad Dip Phys, MCSP Shaun Treweek, BSc, PhD.

3. Copyright 20103 There's a "right" way to do outcome evaluation. What if I don't get it right? Outcomes is a complex. I don't have time to learn it. I always know what my clients need - I don't need outcome evaluation to tell me if I'm really meeting the needs of my clients or not. Outcomes require a whole new set of activities – we don't have the resources COMMON MISCONCEPTIONS REGARDING OUTCOME MEASURES Myth 1 Myth 2 Myth 3 Myth 4

4. STEPS FOR ESTABLISHING OUTCOMES IN YOUR FACILITY As the idea of outcomes becomes important for many O&P facilities, there is a desire to gather as much information as possible. Gathering will not be enough, however. Evaluation of the information will be of critical importance.

5. A successful outcome management program includes a process to measure outcomes plus the use of that information to help manage and improve services and organizational outcomes STEPS FOR ESTABLISHING OUTCOMES IN YOUR FACILITY

6.  Are the outcomes relevant? Are they related to the "core” activities of your business  Are the outcomes useful and meaningful? Will they help you understand whether or not your program is successful?  Are your outcomes achievable? Are they realistic and attainable given the intensity and duration of service you deliver?  Are the outcomes likely feasible and practical to measure? Will you be able to collect data related to them? An outcome is not what you do, but what changes you make to improve the life of the your clients

7. OUTCOME MEASUREMENT CRITERIA Reliability Insure that questions are worded properly and provide consistent results. Cannot be ambiguous or misleading. Validity Be able to measure differences in the performance One facility compared to the entire company Performance of one patient in facility to all the patients in a facility and the company as a whole. Responsiveness Any change would be noted as an improvement or degradation of functional abilities or confidence levels. Patient activity and confidence level collected at 3 different times of their prosthetic care using the same survey; 1.Evaluation 2.2 weeks post delivery 3.90+ days delivery.

8. PLAN AHEAD

9. 9  Identify outcomes that need attention.  Collect data on more than one outcome indicator so that you have enough information to base proposals for change.  Recent findings can be compared to earlier periods.  Identify client groups that need attention. These can include age, gender, race or disability level  Identify service procedures and policies that need improvement. This information can be used to improve procedures, facilities or staff whose outcomes are not as good as others.  Identify possible improvements in service delivery. At the very least, outcomes data can help support proposals to change particular program practices or policies. GLOBAL OBJECTIVES

10. INTERNAL OBJECTIVES Measures the patient’s perception on major functions that take place in your independent practice such as Administrative, and Technical areas.

11. Measure the results of your independent patient care compared to nationally recognized outcomes studies. Measure the patient’s perception on major functions that take place in our independent practice such as Administrative, and Technical areas INTERNAL OBJECTIVES

12. Measure the results of your independent patient care compared to nationally recognized outcomes studies. Measures the patient’s perception on major functions that take place in your independent practice such as Administrative, and Technical areas Design an electronic outcome measurement system that can be sustained and measure intermediate and long term outcomes INTERNAL OBJECTIVES

13. Measure the results of your independent patient care compared to nationally recognized outcomes studies. Measure the patient’s perception on major functions that take place in your independent practice such as Administrative, and Technical areas Design an electronic outcome measurement system that can be sustained and measure intermediate and long term outcomes Establish an automated system that minimizes the burden on the health care provider, patient care facility and end user. INTERNAL OBJECTIVES

14. Obtain demographic information on your patient base. INTERNAL OBJECTIVES

15. Obtain demographic information on our patient base Compare results between facilities INTERNAL OBJECTIVES

16. Obtain demographic information on our patient base Evaluate changes in function during the temporary and definitive timeframe Compare results between facilities

17. INTERNAL OBJECTIVES Obtain demographic information on our patient base Compare results between facilities Respond to 3 rd party payor requests for proof on the efficacy of your prosthetic intervention. Evaluate changes in function during the temporary and definitive timeframe.

18. Copyright 201018 What is the alternative to the intervention (e.g. placebo, different component, technique)? What are the characteristics of the patient or population? What is the condition or disease you are interested in? What do you want to do with this patient (e.g. treat, diagnose, observe)? What are the relevant outcomes (e.g. improved functional abilities, improved standards, new policies or procedures)? Patient, Population or Problem Intervention or exposure Comparison Outcome CONSTRUCT WELL BUILT CLINICAL QUESTIONS USING P. I.C.O Intervention or exposure

19. Age Race Sex Education Marital Status Current User Where They Learned How to Use Their Prosthesis Level of Amputation Assistive Devices Used First Prosthesis Patient demographics can improve the services you provide by allowing you to focus on the type of patient base you currently serve. They also allow you to plan more effectively in the areas you would like your business to grow Copyright 201019 DEMOGRAPHIC QUESTIONS PATIENT DEMOGRAPHICS

20. “Evidenced Based” outcomes tests include fairly simple performance measures such as;  Ten-meter walk test (10mWT)  Six-minute walk test (6MWT)  L-Test “Patient Reported” outcomes test include;  Activities-specific Balance Confidence Scale…0-100% Scale where patients are asked to imagine performing 16 ADL tasks and rate their confidence level in accomplishing those tasks  Socket Comfort Score (SCS) 20Copyright 2010 OUTCOME MEASURES CURRENTLY USED IN O&P

21. MEASUREMENT TESTS “ EVIDENCED BASED” L Test 20 meters, timed event, 2 transfers, 3 turns in both directions

22. MEASUREMENT TESTS “ PATIENT REPORTED” Hanspal Socket Comfort Score (SCS) Patient rate their comfort level within their socket at the present moment 0-10 Scale 0………………...…….………………..10 Least comfort Most comfort Socket Comfort

23. SELECTION OF QUESTIONS Subsets Demographic Health Related Administrative Service Patient Satisfaction Technical Skills Prosthetic Fit Functional Ability

24. HEALTH RELATED QUESTIONS My current physical condition allows me accomplish everyday tasks My current emotional condition allows me accomplish everyday tasks I have a positive image of myself During the past week I have been satisfied with my overall physical health I am able to maintain as active lifestyle as I wish I do not let being an amputee hinder my social life I Can Walk 100’ Farther

25. ADMINISTRATIVE SERVICE RELATED QUESTIONS  I received an appointment with the prosthetist in a reasonable time  I was informed of my financial obligations for my prosthesis  Overall I am satisfied with the services I received from my prosthetic facility and would recommend this company to others Knowing if your front office personnel are doing a proficient job is paramount in providing excellent customer service.

26. PROSTHETIC FIT RELATED QUESTIONS I have overall comfort in my prosthesis  Less than 25% of the time  25-50% of the time  50-75% of the time  More than 75% of the time

27. FUNCTIONAL ABILITY RELATED QUESTIONS I feel balanced while standing with my prosthesis I can walk on uneven ground while using my prosthesis I can easily take off and put on my prosthesis

28. COMPONENTS OF AN OUTCOME SYSTEM Software Requirements Hardware Requirements Data Transfer Evaluation of Data

29. SOFTWARE DIGIVEY Outcomes Software  Ability to compose appropriate questions, scoring, a pleasant look and feel  Ability to have several surveys on one laptop  Ability to analyze data, by individual patient, by all patients in one facility and by all patients in all facilities. Survey Monkey  Web-based survey company which allows you to compose, survey and analyze results  Simple cost effective and quick and easy to use.

30. HARDWARE REQUIREMENTS SIMPLE TO USE  Touch Screen Laptops  Uses a Stylus  Tablet Style  Large Enough Screen for Patients with Poor Eyesight

31. PATIENT SELECTION Lower extremity All patients receiving preparatory prosthesis, new complete prosthesis, or socket change Voluntary participation Ability to complete the survey independently or with assistance

32. PATIENT PREPARATION Make sure everyone in facility understands purpose and instructions Collect data same way every time Lower Limb Amputees Patient Release Form Administrator or family member assisted if necessary in operation of the computer

33. DATA SECURITY  No patient names, use patient identity numbers  Designate an outcomes administrator, employees should not able to view or retrieve data  Data is centrally housed in a separate server  Data uploaded on a consistent basis

34. DATA COLLECTION Three surveys on each patient are collected. All surveys are exactly the same  Initial- @ evaluation or casting  2 week post-delivery or post initiation of PT gait training for new amputees  90 day post delivery within 2 weeks

35. COMPARE DATA WITH ESTABLISHED STUDIES

36. SINGLE PATIENT RESULTS Increase in functional abilities, safety, donning prosthesis and walking

37. WEARING TIMES This graph shows that your patients wear their prosthesis more hours per day once fit by your prosthetist. This allows them to lead a more active lifestyle

38. USE OF ASSISTIVE DEVICE This graph shows there is a significant downward trend of amputees needing an assistive device, 90 or more days past delivery of their prosthesis. Patients that are able to dispense the use of their assistive aide are more functional and active amputees.

39. FUNCTIONAL ABILITY IMPROVEMENT This graph shows an improvement in certain functional tasks from the time they are initially seen to 90 or more days after they received their prosthesis. These tasks are very important for amputees in order to become part of the able bodied population.

40. ESTABLISH BENCHMARKS FacilityABC Score Hours Per Day Usage Walk On Uneven GroundDonning Variable CadenceFalling Accomplish Everyday Tasks Facility 174.34%4.002.633.133.003.381.88 Facility 277.08%10.673.003.673.333.672.67 Facility 385.94%6.673.003.333.003.332.33 Facility 421.56%2.501.503.501.503.501.50 Facility 586.76%9.203.203.803.603.702.40 Facility 648.97%9.202.803.403.00 2.20 Facility 774.48%10.672.673.673.33 2.67 Facility 858.94%8.482.603.253.053.502.05 Facility 976.20%9.542.923.693.003.542.38 Facility 1085.56%10.402.603.803.603.202.40 Company Average69%8.132.693.523.043.412.25

41. MARKETING

42. Customer TypeWhat Outcomes Data Points Will Interest Them Referring Doctors Number of hours wearing prosthesis; Prosthetic function Non-Referring Doctors Number of hours wearing prosthesis; Prosthetic function; Comparison of patient confidence levels (Miller Study) Insurance Companies Prosthetic function; Use of assistive device; Admin and customer service Case Managers Prosthetic function; Comparison of patient confidence levels (Miller study) Patients Prosthetic function; Comparison of patient confidence levels (Miller); Demographic data for targeting purposes Potential Employees/Acquisitions/AcademiaAny/all data points; VA/Hospital/Other Referral Sources Number of hours wearing prosthesis; Prosthetic function; Use of assistive device; Comparison of patient confidence levels (Miller

43. WHAT YOU CAN ACHIEVE THROUGH OUTCOMES DATA COLLECTION  Actual demographic information  High-quality information on the services you provide patients  A reliable, easy to use data collection model  A tool to improve your individual, facility and company performance

44. QUESTIONS? COMMENTS? Jim Alaimo We all know in our heart that we provide good patient care. It important that we statistically prove that we do.