Pure HealthyBack and Ascension Smart Health
Functional Restoration Clinical Outcomes Report February 18, 2016
Measurement Period: October 2015 through January 2016
Report Delivery: February 18, 2016
Table of Contents
- Outcomes Overview
- Outcomes Measures
- Patient–‐reported Outcomes (PROs)
- Clinic–‐based Outcomes (CBOs)
- Outcomes Results: Patient Reported Outcomes (PRO)
- Pain
- Function
- Oswestry Disability Index (ODI)
- Patient Centered Outcome (PCO)
- Assessment of Quality of Life (AQoL)
- Outcomes Results: Clinical Based Outcomes (CBO)
- Lumbar and Cervical Strength/ROM
- Patient Satisfaction Scores
Outcomes Overview
The Pure HealthyBack (PHB) contractual relationship with Ascension SmartHealth began to enroll patients in the third quarter of 2015. Pure HealthyBack is the only company in the United States that provides evidence based, protocol driven spinal functional restoration and integrative wellness. In the era of the Patient Protection and Affordable Care Act, Accountable Care Organizations and the movement toward transparency, the PHB model leads the nation in metric based functional restoration and integrative wellness. As a result, the Ascension SmartHealth relationship with PHB is a comprehensive program that actively treats chronic neck and back pain patients and combines patient reported outcomes (PROs), clinician based outcomes (CBOs) and proactive healthcare coaching. As of January 31, 2016, the Ascension SmartHealth program has 39 patients that have completed the 10- week program. Ascension SmartHealth enrolled patients have exhibited significant clinical improvement as demonstrated by reduction in patient reported outcomes (PROs) of pain (- 48%) and disability (-48%), with increases in function (+114%), quality of life (+10%). In addition, clinician based outcomes (CBOs) representing measured performance improvements in lumbar and cervical strength were +49% and +7% respectively. Improvements in Range of motion values (ROM) in lumbar and cervical were +7% and +27 % respectively. These reported outcome measures demonstrate that the PHB solution continues to be extremely successful in improving pain, disability, quality of life, patient satisfaction, strength and ROM for the enrolled patients of Ascension SmartHealth. Ascension SmartHealth is an elite health healthcare organization with a commitment to their employee’s health and well being. PHB fully supports this commitment through their comprehensive treatment approach for Ascension SmartHealth’s employess suffering with chronic neck and back pain which has demonstrated positive clinical results in both in patient reported and clinic based outcomes.
Outcomes Measures
Patient-Reported Outcomes (PROs)
PROs are patient self-reports based on standardized questionnaires. These questionnaires ask each patient to rate their pain, their ability to perform certain functional tasks, and their quality of life.
Patient-reported Outcomes (PROs) include:
- Pain is measured using the Visual Analog Scale, which asks patients to rank their pain from 0 to 10 with 0 equaling no pain at all and 10 equaling the worst pain possible.
- Function is measured using the Patient-Centered Outcomes questionnaire, which asks patients to rank their abilities to function; 0 means that they are unable to function, and 30 is totally functional.
- Quality of Life is measured using the Assessment of Quality of Life questionnaire, which asks patients to rank their quality of life; 0 indicates no quality of life and 1.0 indicates the best quality of life.
Clinic-based Outcomes (CBOs)
Blue Care Network of Michigan CBOs are obtained by measuring patients’ lumbar or cervical range of motion and spinal strength on Pure HealthyBack’s FDA-registered proprietary medical equipment.
Initial testing creates a baseline of patient performance and is used to develop individualized patient treatment prescriptions and to evaluate changes in the patient function as a result of the treatment program. Testing is safe, effective, and has been successfully utilized in thousands of chronic back/neck patients.
Over the last 25 years, the University of Florida, the University of California at San Diego, and medical institutions around the world have published compelling research showing exceptional results with specific spinal strengthening exercises using the PHB proprietary MedX lumbar and cervical extension machines. Over 75 peer-reviewed medical journal articles have been published affirming MedX’s ability to significantly decrease chronic spine-related pain issues, restore spinal function, improve quality of life and independence, and decrease or eliminate the need for ongoing spinal care or pain management.
Outcomes Results: Patient-reported Outcomes (PROs)
Pain: Patient pain is recorded using a Visual Analog Scale (VAS). Patients are asked before starting treatment to rate their pain from zero—meaning no pain—to 10, for the worst possible pain. Additional VAS scores are recorded after completing treatment and at successive milestone dates as indicted in Figure 1. The avg. overall significant reduction in pain of -51.58% (Figure 2) represents a drop from ‘intense’ to ‘mild’ pain.
Function: Indirect patient function is recorded in two ways through standardized functional questionnaires. Lumbar function is measured using the Oswestry Disability Index and cervical function is measured using the Neck Disability Index. Patient-generated functional goals are measured using the patient-centered outcomes.
Oswestry Disability Index (ODI)
The ODI is a standard functional questionnaire that measures back patients’ perceptions of their disability. The questionnaire asks 10 questions, each providing six possible answers with a maximum disability score of 100 reflecting total disability. Topics include functional activities such as lifting, traveling, walking, and personal care. Patients are given the ODI questionnaire and scored before starting treatment with additional scores recorded after completing treatment and at successive milestone dates as indicted in Figure 3. The avg. reduction in ODI scores of -58.79% (Figure 4) represents a significant drop in patients’ disability.
Neck Disability Index (NDI)
The NDI is the cervical counterpart of the ODI. It is a measure of each neck patient’s perceptions of their disability. The questionnaire asks 10 questions, each having six possible answers with a maximum disability score of 50 reflecting total disability. Topics include functional activities such as lifting, headache, concentration, and driving. Patients are given the NDI questionnaire and scored before starting treatment with additional scores recorded after completing treatment and at successive milestones dates as indicted in Figure 5. The avg. reduction in NDI scores of -53.14% (Figure 6) represents a significant drop in patients’ disability.
Patient Centered Outcomes (PCOs)
It is helpful for each patient to identify specific functional goals that are relevant in their personal lives with examples such as: gardening, lifting grandchildren, getting in and out of the car, and being more active in recreational activities. The PCO questionnaire asks each patient to list three items, each worth 10 points for a total of 30 points. They are asked to rank each item from 0—meaning they are unable to complete these activities—to 10, meaning they are completely able to complete these activities with no restrictions. Patients are given the PCO questionnaire and scored before starting treatment with additional scores recorded after completing treatment and at successive milestone dates as indicted in Figure 7. The avg. increase in PCO scores of +800% (Figure 8) represents a significant increase in patients’ function.
Assessment of Quality of Life (AQoL)
The AQoL is a standardized questionnaire that provides insight into each patient’s quality of life. In addition to reducing pain and increasing function, our goal is to enhance each patient’s life experiences. The AQoL asks about family/community relationships, sleep patterns, hearing, and sight, and has a maximum score of 1.0. Patients are given the AQoL questionnaire and scored before starting treatment with additional scores recorded after completing treatment and at successive milestone dates as indicted in Figure 9. The avg. increase in AQoL scores of 35.68% (Figure 10) represents a significant increase in patients’ quality of life.
Outcomes Results: Clinic–based Outcomes (CBOs)
Clinic–‐based Outcomes are founded on objective measurement of patients’ clinical performance and progress. Baseline measurements are taken of each patient’s lumbar and cervical strength and range of motion using proprietary technology that has been researched and published in medical journals over the past 25 years.
Outcomes Results: Clinic-based Outcomes (CBOs)
Clinic-based Outcomes are founded on objective measurement of patients’ clinical performance and progress. Baseline measurements are taken of each patient’s lumbar and cervical strength and range of motion using proprietary technology that has been researched and published in medical journals over the past 25 years.
Initial testing provides measurements of the lumbar and/or cervical spine functional range of motion (ROM) by isolating the appropriate spinal segments to be treated. Once ROM is determined, strength of the lumbar and/or cervical extensors is measured as a baseline from which an individualized, clinical-strengthening prescription can be given to the patient. Knowing a patient’s initial capacity is critical to providing a program that is both safe and tailored specifically to the needs and limitations of each patient. Isometric testing has been performed on tens of thousands of patients and research documents measured positive changes for patients in strength gains, pain reduction, quality of life, and functional improvement. The following pages present Ascension SmartHealth clinical data on these variables in our patient populations.
Lumbar and Cervical Strength/ROM
The MedX lumbar and cervical patented technology provide objective measurement of spinal strength and range of motion. This data is presented in Figures 11 to 18 respectively along with percentage + /- changes.
Patient Satisfaction Scores
A major component in determining the overall quality and effectiveness of the program includes patient satisfaction survey results. Research has shown that patient satisfaction has a direct correlation to clinical outcomes and overall patient and program successes.
We collect patient satisfaction data in four key areas that directly impact the total patient experience and to provide an overall assessment. Each area has a series of questions with a score of 1.0 indicating “Very Poor” to 5.0, indicating “Very Good”. The Blue Care Network of Michigan program rated on average above 4.7 in every category (as seen below), meaning the program has been rated as “Very Good” overall.
Physician Care Patient Comments
“Overall very good experience”
“Very good experience, very professional staff, friendly staff”
“Very friendly, had a professional and friendly attitude”
“Conservative approach- good”
“Very thorough about program treatment and goals”
“Exudes confidence in programs ability to help me”
“Great experience”
“Pleased”
“Very good. No issues”
“Great!”
“Very good program”
Clinic Operations Patient Comments
“Very good overall”
“Becca is wonderful”
“Overall good experience”
“Very good experience with clinic operations”
“Great experience”
“Front desk was kind and professional”
“Top notch”
“Front desk kind and personable”
“Tells friends about it”
“Thank you fixing my neck, excellent place”
“Runs efficient and friendly”
Which Of Our Providers Made Your Experience Positive
“All of the staff was great and very supportive and friendly”
“Ryan Duva,Jen, Jeanie, Brittany Eric”
“Whole staff was very helpful, smiles on their faces, tone of voice”
“Simon, very interactive Pete, very nice”
“Ryan, Beth, Jamie took their jobs more serious than others”
“Ryan and Pete made experience pleasant and fun, made it go by fast”
“Jenai was very helpful”
“Each staff member took interest in me”
“Took time to share tips on stretching at home and remembered important
details”
“Enjoyed the nutrition seminar”
“Was excited to see massage and yoga were incorporated into program”
“Ryan will greet me and say hi even when not working with me”
“Entire staff was very friendly and went out of their way to greet me”
“Rachel, Pete, Ryan went the extra mile”
“Everyone’s been terrific’
“Everyone was great and everyone was very accommodating”
“Everybody is really nice”
“Everyone goes out of their way to make you comfortable, and see how you are feeling”
“Becca and Jackie were amazing”
“Ryan and Eric are excellent, helped me with the timing”
“Suggestions and how to decrease back pain in the car”
“Sam, Alicia, and Rachel were very patient and helpful”
“I like how you introduce other staff members Eric and Jen”
“Beth is awesome too”
“All were good. Beth and Ryan very good to work with.
“Everybody”
“Simon! Really present & quick to help”
“Ryan& Beth”
“Jackie and Becca are wonderful!”
“Everyone went out of their way to make me get better”
“Very good. Everyone is extremely friendly and caring”
“Good interaction with patients, getting to know them and make them feel welcome”
“You guys did great”
“Always felt welcomed, it was fun, it didn’t feel like a chore and it made it go by fast”
“Was skeptical but the program worked and was pleasantly surprising.
“Gave me control over my back”
“You are very good at catching improper body mechanics during an exercise”
Physical Therapist Patient Comments
“Overall excellent place”
“Overall good experience with all of the therapists”
“Likes Jeanie, and Britney”
“Very good experience”
“Very pleasant calm and warm personality”
“They were good”
“Everyone did a great job”
“Very impressed with the knowledge of the staff”
“Roger helped with a crisis and was fantastic”
“All good”
“Pleased with interest and care”
“Great experience”
“No issues. Everyone was very pleasant and helpful”
“Excellent work”
“Very friendly”
“They really explain everything well”
“Great program. Would recommend to others”
What Have You Learned To Help You Gain Control Over Your
Condition
“Do stretches”
“Stretching and other home exercises helped out a lot”
“Consistency of working out”
“How important it is to become stronger makes everything easier, flexibility”
“Learned contraindications that create flare ups”
“Initial assessment gave the answer to some of the questions about flexion or extension”
“Stretches helped”
“Positions to help ease numbness handouts and meetings with health coach”
“Strengthening is important, more aware of my posture, ability to correct my
posture”
“Continuity is important, maintaining stretching routine”
“Importance of stretching and how sitting too long negatively affects me”
“Home exercises are helpful”
“The exercises I do at home, exercises to relieve the pain”
“When to use heat and cold packs at home”
“Stretching does it all”
“Strengthening and stretching exercises were very helpful”
“Exercising, total health is important to make everything work right”
“Consistency, patient education, follow-up care”
“Home exercises, how important all the exercises are to a healthy back”
“Nice to have reinforcement of machines”
“That maintaining good health is a great benefit. Stretching actually works”
“Maintenance”
“Keeping positive”
“Everything you do affects your back & we need to build up the muscles to support back”
“Taking time to warm up properly”
“Posture”
“The education was great”
“Everyone worked with me to help me get better”
Conclusion
Pure Healthy Back is deeply invested in the collection and use of clinic-based and patientreported outcomes so that we can follow patient results both individually and as a population. We use this information to continuously refine what is already a leading-edge treatment model. As this report demonstrates, we continue to see significant improvements among our Ascension SmartHealth patients with reductions in pain and disability; increases in function and quality of life; outstanding improvements in lumbar and cervical strength and range of motion; and excellent patient satisfaction scores.