Abstract
Objective:
To describe the application and examine the influence of a continuous quality improvement (CQI) intervention, which had a goal of standardizing care to reduce the proportion of patients who do not have a meaningful improvement in patient-reported outcomes following Total Knee Arthroplasty (TKA).
Design:
Continuous Quality Improvement
Methods:
A physical therapy (PT) care guideline was initiated in 2013 for patients following (TKA). The Knee Outcome Survey (KOS-ADL) was measured at every visit and scores were extracted from a clinical outcomes database to calculate the proportion of patients who did not achieve a minimal clinically important difference. Based on logistic regression analysis, we compared the proportion of patients who did not progress on the KOS-ADL in a Non-Care Guideline (NCG) group (2008–2012) to a Care Guideline (CG) group (2014–2019).
Results:
12,355 patients (age 18–92 years) following TKA incurring at least 3 PT visits from 2008–2019 were included. The percentage of patients who did not progress in the NCG group was 25.8% and in the CG group 14.3% (p< 0.001). The relationship between care guideline adherence and lack of progression on the KOS-ADL was statistically significant, X2 (df=1) = 148.7, p < 0.001.
Conclusion:
The percentage of patients who did not achieve meaningful progress on the KOS-ADL declined significantly in the six years after implementing a TKA care guideline without an increase in the number of clinical visits. The standardized care guideline was associated with meaningful improvements for patients following TKA when applied in conjunction with PT access to outcome data, feedback through audits, performance goals, and financial incentives.
Keywords: Patient-reported outcomes, total knee arthroplasty, care guidelines, implementation, quality improvement, rehabilitation
INTRODUCTION
High-quality, evidence-based care guidelines are designed to standardize care and are increasingly common in health care.10,28,44,47,55 There are many challenges to disseminating and implementing guidelines in clinical practice.23,34,40 We define care guidelines broadly to include any published (peer reviewed or by an institution) document that applies evidence with the intent to standardize musculoskeletal health care. Care guidelines have been developed to guide physical therapists in providing evidence based care in many areas, including low back,18 neck,7 shoulder,37 knee,39 and neurologic.30 The expected results after guideline implementation are improved patient outcomes, reduced care use,6 and lower costs.32,33 Only a few studies have examined the impact of implementing care guidelines on rehabilitation outcomes,9,59 and the evidence does not relate to patients following total knee arthroplasty or long-term outcomes beyond one year.
A lack of documented effectiveness of guidelines is related to the difficulties of implementation and diffusion.38,50 Providers are slow to adopt changes in practice15 or may be unaware of the best evidence even though they believe the use of evidence in practice is necessary.35 Incentives and reimbursement are not aligned to reward providers to improve care while reducing health care use.22,27 Physical therapists are not immune from implementation challenges of awareness and behavior change.19 Reports of physical therapist adherence to guideline recommendations with low back pain (LBP) range from less than 50%5,24 to 67%.51
Successfully implementing guidelines often involves a flexible, long-term continuous quality improvement approach.17,49,60 However, more research is needed to study the impact of this approach on outcomes that are meaningful to patients and providers. Continuous Quality Improvement (CQI) is a responsive, deliberate process to provide better quality healthcare and is often recommended to drive the implementation of care guidelines within a health system.16,53
There is a need to determine what is effective in physical therapy adherence to evidence-based care for people with TKA. Interventions that demonstrated a positive effect on therapist adherence following a guideline included: 1) dissemination of clinical practice guidelines, 2) the use of educational meetings, 3) tailored interventions and monitoring of the performance of health care delivery, 4) peer assessment, and 5) local opinion leaders plus educational outreach visits. However, there is a gap in the physical therapy literature examining the impact of a guideline on both variation of care and long-term patient outcomes. One might assume that if physical therapists follow a guideline, patient outcomes would improve, but few studies have evaluated this.24,25
A companion study (Capin et al11) focuses on analyzing variation around visits and outcomes following TKA. The purpose of our study was to describe the application and examine the influence of a CQI intervention16,53 on patient-reported outcomes with a goal of standardizing care to reduce the proportion of patients who did not make a meaningful improvement following TKA.
METHODS
Context
Intermountain Healthcare is a not-for-profit learning health system with an integrated payer spanning all of Utah, southern Idaho, and northern Nevada. Initial studies at Intermountain focused on reducing variation and improving outcomes around clinical processes including transurethral prostatectomy,32 acute respiratory distress syndrome,43 and elective inductions.45 Rehabilitation and other leaders at Intermountain receive training in CQI strategies and have created a culture of measurement and standardization.
In 2002, Intermountain Rehabilitation Outcomes Management System (ROMS) was launched in outpatient physical therapy clinics to collect patient-reported outcomes (PROs). ROMS is an integrated web-based platform within the enterprise data warehouse that leverages patient outcome data and analytics to systematically evaluate quality improvement initiatives. The standard policy is that every patient attending an outpatient physical therapy visit completes a condition-specific PRO. When a minimal clinically important difference (MCID) is not met on the PRO over the episode of physical therapy care it is considered a Failure to Progress. This is a CQI method of measuring defects. Measuring defects has been applied in many manufacturing industries12 including the production of airplanes46 and automobiles.41 In healthcare, defects or failures are measured in areas of infection rates, falls, and wrong site surgery. Failure to Progress is a metric applying this principle to rehabilitation outcomes. By tracking failure rates on PROs following TKA, it was clear in 2012 that a standardized care guideline for TKA was needed. At the same time, the regional not-for-profit integrated payer partnered with Intermountain Rehabilitation to provide financial incentives to therapists from 2012–2018 tied to improved quality of care delivery. The average annual incentive payment was between $500–940 depending on the year and the number of goals achieved (TABLE 1).
TABLE 1.
Description of financial incentive goals each year of the quality improvement initiative.
Year | Goal associated with financial incentive |
---|---|
| |
2012 | 1. ROM measured each week 2. Exercise each visit 3. No sensory electrical stimulation beyond 2 weeks 4. >73.4% outcome collection |
2013 | 1. Patient Satisfaction 4.63/5 2. Failure to progress <17% *Formalized care guideline |
2014 | 1. Statistically significant improvement in failure to progress rate compared to 2013 2. 90% adherence to care guideline |
2015–2017 | No incentive goals for TKA due to focus on other initiatives |
2018 | 1. ≥90% adherence to care guideline 2. Failure to Progress <7.1% for patients with ≥8 visits |
Interventions
In 2012, Intermountain Rehabilitation established goals related to TKA outcome collection and treatment (TABLE 1). Goals and metrics for evaluation evolved each year focusing on either care guideline adherence and/or reducing PRO failure to progress.
Care Guideline Initiated in 2013
The 2012 goals included 3 evidence-based treatment recommendations found through chart reviews to be applied inconsistently: 1) regularly measuring knee range of motion (ROM), 2) exercising at every visit, and 3) discontinuing any sensory electrical stimulation following the first two weeks of treatment.4,48 These metrics served as a rudimentary guide but did not comprehensively cover all evidence-based recommendations for TKA rehabilitation. Therefore, a standardized care guideline was developed and initiated in 2013 with input from content experts in post-operative TKA management. The care guideline document included treatment recommendations for ROM, neuromuscular electrical stimulation (NMES), strengthening, and balance, as well as routine collection of patient-reported outcomes and education on safe kneeling (Supplement 1).
Continuous Quality Improvement
CQI strategies were implemented to improve adherence to the care guideline, including providing the equipment necessary for therapists to treat according to the care guideline. As the clinic transitioned from using sensory electrical stimulation to Neuromuscular Electrical Stimulation (NMES), NMES units were purchased for each clinic.1,2,54,58 Similarly, bags were provided to deliver low load long duration (LLLD) stretching.8,13,42 The care guideline was organized by post-operative phase with each phase containing treatment guidelines, milestones, and adherence metrics.
Clinicians received initial care guideline training in 2013 in a multi-day course led by a national expert, and follow-up continuing education was delivered via 90-minute Clinical Improvement Meetings 1–2x/year. Therapists also had on-demand, customized access to patient outcomes in the ROMS application. We used filters in the dashboard to customize the data selection, including by condition, date, location, therapist, payer, chronicity20, and range of visits to obtain a specific population of interest (FIGURE 1). Additional learning and feedback were provided through systematic chart audits and individualized peer feedback, augmented by incentivized annual performance goals. Furthermore, the electronic health record was modified to align with the guideline making it easier for therapists to follow.
FIGURE 1.
A condensed dashboard image demonstrating the on-demand access to patient outcomes. The two lines represent average PT visits when a minimum of 3 visits were completed (top line) and the average Failure to Progress (FTP) percentage each year (bottom line).
The implementation team consisted of an operations manager, director of quality and outcomes, data analyst, statistician, and quality improvement leaders. Specific goals were developed by the implementation team in partnership with the Medical Director of the regional payer.
Study of the Interventions
As part of standard care delivery, every patient completes a PRO measure every visit using Intermountain ROMS.26 The Knee Outcome Survey (KOS-ADL) is a valid, reliable, and responsive condition-specific PRO that assesses disability for patients with TKA.31,56 The KOS-ADL score ranges from 0–100 with higher scores representing better function. When a 10-point improvement56 on the KOS-ADL was not achieved between evaluation and discharge it was identified as failed to progress.
Included in the analysis were 12,355 patients (18–92 years) from 49 clinic locations following TKA during the years 2008–2019 who had an episode of at least 3 PT visits and were insured by Medicare or a commercial payer. Three or more visits was used as a threshold in previous literature examining guideline adherence in physical therapy to allow time for a plan of care to be established and implemented.25 Excluded were 404 patients from the Non-Care Guideline (NCG) group and 751 patients from the Care Guideline (CG) group who attended only 1 or 2 visits. The care guideline was introduced in 2013; data from this year were excluded. Patients with a prior TKA on either side were also excluded from analysis.36 We compared 2,558 patients prior to implementation of the TKA care guideline (2008–2012), designated the NCG group, to a cohort of 9,797 patients following implementation of the care guideline (2014–2019) designated the CG group.
Analysis
Based on logistic regression analysis, the proportion of failed to progress in the NCG group was compared to the CG group. Age, sex, body mass index, baseline pain score, baseline KOS-ADL, date of surgery, number of PT visits, Area Deprivation Index (ADI), and payer were included as covariates in the model.
Standardized quality chart audits (Supplement 2) were used as a CQI tool to measure adherence to the care guideline in 2018. Individual care guideline components were evaluated for completion at each visit, including ROM, strength progression, balance, and PRO assessment. A few guideline components were considered adherent if they occurred at least once during the episode of care: safe kneeling education, assessing performance measures, and initiating NMES within the first 6 postoperative weeks. Adherence for each item was scored as a 0 if it was not performed or a 1 if it was either performed or justification for not performing the item was documented in the patient’s note. Adherence was quantified as a percentage of the performed items divided by the total number of care guideline items based on the number of PT visits. For 2018, a chi-square test of independence was used to examine the relationship between care guideline adherence and failure to progress.
Ethical Considerations
The care guideline interventions conducted within this health system were done as part of quality improvement and PROs were collected every visit as part of standard care. The Intermountain Institutional Review Board reviewed and approved the retrospective analyses of our interventions in 2020 and issued a waiver of informed consent.
RESULTS
Age, gender, race, ethnicity, and number of visits for the CG and NCG groups are included in TABLE 2. Patients in the NCG (2008–2012) failed to progress on the KOS-ADL at a rate of 25.8%. Following the introduction of the care guideline in 2013, a significantly smaller percentage of patients failed to progress: CG group (2014–2019) = 14.3%, p<.001. The failure to progress rate for each year is included in FIGURE 1. When controlling for the covariates of age, sex, BMI, baseline pain, baseline KOS-ADL, date of surgery, number of PT visits, ADI, and payer, the overall pattern of the model did not change (FIGURE 2).
TABLE 2.
Demographic and baseline characteristics of patients by group.
Variable | All | NCG Group (2008–2012) n = 2558 |
CG Group (2014–2019) n = 9797 |
Excluded NCG ≤ 2 visits n = 404 |
Excluded CG ≤ 2 visits n = 751 |
---|---|---|---|---|---|
Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | |
Age | 63.9 (9.4) | 62.7 (9.5) | 64.2 (9.3) | 64.8 (10.4) | 63.5 (9.9) |
PT Visit Utilization | 10.7 (5.7) | 10.9 (6.1) | 10.6 (5.6) | 1.6 (0.6) | 1.5 (0.5) |
Baseline KOS-ADL | 43.8 (16.7) | 46.7 (15.9) | 43.1 (16.9) | 51.0 (17.5) | 48.2 (18.3) |
Baseline Pain | 5.2 (2.3) | 4.9 (2.3) | 5.3 (2.2) | 4.7 (2.5) | 4.9 (2.5) |
BMI | 32.7 (7.0) | 32.7 (7.3) | 32.7 (6.9) | 33.1 (14.6) | 33.3 (8.6) |
ADI | 94.6 (19.0) | 95.5 (18.1) | 94.3 (19.3) | 98.1 (16.3) | 94.9 (19.8) |
Sex (% Female) | 59.48% | 58.41% | 59.76% | 62.98% | 65.16% |
Payer (% Medicare) | 41.42% | 30.92% | 44.17% | 30.87% | 40.43% |
Race (% Caucasian) | 96.4% | 96.9% | 96.3% | 96.8% | 96.0% |
Ethnicity
(% Hispanic/Latino) |
3.9% | 3.5% | 4.0% | 1.7% | 3.2% |
Abbreviations: NCG, non-care guideline; CG, care process guideline; PT, physical therapy; KOS-ADL, Knee Outcome Survey – Activities of Daily Living; BMI, body mass index; ADI, Area Deprivation Index.
FIGURE 2.
Line graph showing failure to progress (FTP) over time adjusting for covariates. The dotted line indicates 95% confidence intervals.
For patients following TKA, 99.4% (including 99.2% in 2008–2012 and 99.6% in 2014–2019) completed the KOS-ADL at both physical therapy intake and discharge visits.
In 2018, the relationship between care guideline adherence and failure to progress was significant, X2 (df=11) = 148.7, p < 0.001. When the therapist was adherent to the care guideline, patients were more likely to meet an MCID on the KOS-ADL.
TABLE 3 includes a breakdown of demographic and baseline data per year. No variables included appear to differ in a clinically meaningful way across the study period including those that have the potential to substantially account for the change in outcome observed, such as number of PT visits.
TABLE 3.
Demographic and baseline characteristics of patients across all years of the project.
Variable | NCG Group (2008–2012) | CG Group (2014–2019) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
2008 Mean (SD) | 2009 Mean (SD) | 2010 Mean (SD) | 2011 Mean (SD) | 2012 Mean (SD) | 2014 Mean (SD) | 2015 Mean (SD) | 2016 Mean (SD) | 2017 Mean (SD) | 2018 Mean (SD) | 2019 Mean (SD) | |
Age | 61.8 (9.1) | 62.3 (9.3) | 61.8 (9.8) | 63.1 (9.5) | 63.2 (9.3) | 63.5 (9.4) | 63.9 (8.9) | 63.7 (9.6) | 64.4 (9.0) | 64.8 (9.3) | 64.8 (9.4) |
PT Visit Utilization | 11.3 (6.6) | 10.6 (6.2) | 10.2 (5.3) | 10.9 (5.6) | 11.1 (6.1) | 10.5 (5.6) | 10.6 (5.9) | 10.7 (5.6) | 10.5 (5.4) | 11.0 (5.8) | 10.4 (5.8) |
Baseline KOS-ADL | 45.3 (16.3) | 48.0 (15.9) | 47.6 (16.8) | 47.9 (15.5) | 45.3 (15.9) | 46.1 (16.6) | 45.2 (16.7) | 43.2 (16.6) | 42.8 (16.4) | 41.3 (17.1) | 40.7 (17.3) |
Baseline Pain | 5.1 (2.3) | 4.9 (2.2) | 5.1 (2.4) | 4.8 (2.3) | 4.9 (2.2) | 4.9 (2.3) | 5.1 (2.2) | 5.3 (2.2) | 5.3 (2.2) | 5.5 (2.2) | 5.5 (2.3) |
BMI | 32.9 (7.2) | 33.1 (6.9) | 32.6 (6.9) | 32.4 (7.3) | 32.5 (7.0) | 32.8 (7.2) | 32.6 (7.2) | 32.9 (7.2) | 33.0 (7.1) | 32.3 (6.4) | 32.7 (6.3) |
ADI | 96.8 (15.5) | 96.0 (19.0) | 96.3 (15.0) | 95.9 (17.6) | 95.7 (18.0) | 95.9 (17.8) | 94.5 (18.4) | 95.3 (17.9) | 95.1 (17.8) | 93.4 (19.2) | 93.4 (18.7) |
Sex (% Female) | 55.5% | 59.5% | 58.3% | 57.7% | 58.7% | 59.3% | 59.3% | 60.8% | 58.7% | 57.9% | 61.8% |
Race (% Caucasian) | 97.3% | 96.4% | 98.2% | 95.5% | 97.5% | 96.2% | 96.9% | 96.4% | 95.6% | 96.2% | 96.2% |
Ethnicity
(% Hispanic/Latino) |
5.5% | 1.8% | 2.3% | 3.7% | 3.8% | 3.5% | 3.5% | 4.4% | 4.3% | 3.9% | 4.1% |
Abbreviations: NCG, non-care guideline; CG, care process guideline; PT, physical therapy; KOS-ADL, Knee Outcome Survey – Activities of Daily Living; BMI, body mass index; ADI, Area Deprivation Index.
DISCUSSION
After TKA within a large healthcare system, the percentage of patients who did not achieve meaningful progress declined significantly after a TKA care guideline was implemented. Yet, during the 6-year study period, there was not a clinically meaningful change in number of visits. The standardized care guideline, along with PT access to outcome data, feedback through audits, performance goals and financial incentives, was associated with meaningful improvement for patients following TKA. Additionally, other non-financial incentives such as providing NMES units, bags for stretching, continuing education, and clinical improvement meetings may have impacted provider compliance with the CPG.
While the overall trend demonstrates fewer failures since the care guideline was adopted, improvement was not always linear. Years with worsening failure to progress were used as a CQI indicator that adjustments were needed. Following a slight increase in failure to progress in 2017, system-wide chart audits were implemented to measure care guideline adherence. Results from these audits were provided quarterly to each clinic manager to encourage individual improvement activities.
While a CQI approach has limits in generalizability, several key lessons are broadly applicable: 1) a simple set of evidence-based principles was chosen over a formal protocol to encourage adoption, 2) the focus of our interventions was placed on the process rather than the therapists, 3) the electronic health record was modified to align with the care guideline, 4) a careful watch of outcome data was sustained allowing clinical leaders to respond to worsening spikes in outcomes, and 5) a feedback loop of process adherence was implemented with audits. This approach appears to have contributed to both improved outcomes and reduced practice variation.11
Zadro et al59 highlighted several implementation strategies to facilitate the adoption of clinical practice guidelines that were used over the years in our project, including: educational meetings through our clinical improvement series, monitoring delivery performance using the ROMS outcomes database, and peer assessment through audits of guideline adherence. To our knowledge, our project is the first to measure the impact of introducing a care guideline in physical therapy for patients following TKA on patient-reported outcomes beyond 2 years. Outcome measures observed and recorded by providers have the potential to introduce bias. The risk of bias in our results is minimized by collecting patient-reported outcomes at every visit via direct entry into the ROMS database by patients or front desk staff prior to interacting with the therapist. Minimizing bias when performing chart audits to determine adherence with the care guideline was accomplished by using a standard audit form with a limited number of peers trained as auditors.
Several barriers to quality improvement were encountered. The care guideline was scaled to all 49 clinics in the system. Ensuring that all therapists received adequate education and training was a challenge when onboarding new clinics and new hires. This has been alleviated through a system-wide restructuring from 2016–2018. Rehabilitation Services moved away from providers reporting through one of the 23 hospital administrators to a single rehabilitation vice president, opening the door for more unified accountability of the CQI initiatives.
Sustainability was another barrier. Years with specific goals, education, and initiatives related to the TKA care guideline had the largest improvements in outcomes; however, despite the benefit of these initiatives, they were not employed every year because of competing improvement priorities. This highlights the challenge of sustainability in quality improvement efforts in a large healthcare system that treats patients with a wide variety of conditions.29,57,14,53,52 The five most important factors for sustainability52 are: 1) a modifiable program, 2) a champion, 3) alignment with organizational mission, 4) readily perceived benefits, and 5) outside stakeholders providing support. Our project used standard work processes in collecting PROs and modifying the electronic health record. Our ROMS dashboards provided up-to-date process control and each department used performance boards. Our program was modified over the years based on past performance and Intermountain Healthcare’s focus on CQI. We believe this approach contributed to the sustained improvement in outcomes for patients following TKA.
With the growth and merging of physical therapy practices nationally, many organizations now include hundreds of locations over large geographic areas. Reducing unwarranted variation and raising the quality of care at all locations should be a goal of patients, providers, management, and payers. The results of this initiative suggest this may be possible by disseminating a care guideline and measuring the result while providing feedback to therapists and patients.
Limitations
We did not set out to conduct a multi-year study of care guideline implementation. The strategies and scope of this project evolved over the years using quality improvement methodology and in reaction to performance data. The maturing goals and expanding approach are a realistic evolution of quality improvement in a large learning health system but make it challenging to pinpoint the specific action items with the greatest impact. This initiative would have benefited from an implementation science framework, though implementation methodology was still in its infancy at the start of this project.3,21 It is also possible that the outcome improvement we observed may be due to time, monitoring, or other local or national initiatives that were not measured. We do not have information on surgical policies or practice during this time period. We attempted to account for this by reporting that no substantial changes occurred in patient outcomes for 5 years prior to initiating the care guideline (FIGURE 2). Additionally, our dataset is limited to the demographics of Utah and southern Idaho, which includes a significant majority of white individuals, and may impact generalizability.
CONCLUSION
A pragmatic approach to standardizing TKA rehabilitation using a care guideline improved the proportion of patients who reach a clinically meaningful improvement without a change in the number of visits.
Supplementary Material
Patient and Public Involvement:
Staff from Intermountain Rehabilitation Services supported and facilitated the quality improvement initiatives and data collection for this study. Patient involvement included participation in standard outcomes collection and electronic medical record data used in the analysis.
KEY POINTS.
Findings:
In the six years after implementing a TKA care guideline, the percentage of patients who did not have meaningful progress declined significantly without a change in the number of visits. The standardized care guideline, along with PT access to outcome data, feedback through audits, performance goals and financial incentives, was associated with meaningful improvement for patients following TKA.
Implications:
Reducing unwanted variation and raising the quality of care should be a goal of patients, providers, management, and payers. Our results suggest this may be possible by disseminating a care guideline, measuring the result, and providing feedback to therapists and patients.
Caution:
As a quality improvement initiative, the strategies and scope of our project evolved over the years in reaction to performance data, which make it challenging to pinpoint which actions had the greatest impact.
Acknowledgements
JJC’s work was funded by an Advanced Geriatrics Fellowship from the Eastern Colorado VA Geriatric Research Education and Clinical Center (GRECC), the National Institute on Aging (F32-AG066274), and the Academy of Orthopaedic Physical Therapy (Career Development Award). The work is solely the responsibility of the authors and does not necessarily reflect the official views of the funding sources, which played no role in the design, conduct, or reporting of this study.
This project was approved by the Intermountain Healthcare Institutional Review Board.
Footnotes
Financial Disclosure and Conflict of Interest: The authors have no financial affiliation (including research funding) or involvement with any commercial organization that has a direct financial interest in any matter included in this manuscript, except as disclosed in an attachment and cited in the manuscript. Any other conflict of interest (i.e., personal associations or involvement as a director, officer, or expert witness) is also disclosed in an attachment.
Data Sharing:
Aggregate, de-identified data are available upon request to the corresponding author for use in meta-analyses or other reasonable studies, given a methodologically sound proposal and appropriate data use agreements.
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Data Availability Statement
Aggregate, de-identified data are available upon request to the corresponding author for use in meta-analyses or other reasonable studies, given a methodologically sound proposal and appropriate data use agreements.