INTRODUCTION
Postoperative rehabilitation for patients who have undergone lower extremity surgeries has become a major concern in healthcare systems.1) Functional decline during the postoperative period, associated with a lack of comprehensive rehabilitation is a representative area of unmet medical needs. Hip fractures are common in older people and associated with high morbidity and mortality.2) The global incidence of hip fracture was 681.35 per 100,000 population aged 55 years and older in 2019, and this is expected to increase with an aging population.3) Knee arthritis is also prevalent among older adults with a 37% prevalence in the United States.4) Surgical treatments are often required for most hip fractures and advanced knee arthritis in older people.4,5) Among lower extremity surgeries, total hip and knee arthroplasty (THA and TKA) are considered as most successful operations and are increasingly performed worldwide due to the aging population.6-8) In Korea, the numbers of THA and TKA increased by 47% from 2010 to 2018 and by 400% from 2001 to 2010, respectively.9,10) With the rise in lower extremity surgeries, postoperative rehabilitation after lower extremity surgery has become increasingly emphasized to improve physical outcomes and functional recovery.8) Exercise-based multidisciplinary interventions are highly recommended after hip fracture surgeries or major lower extremity joint replacements in clinical practice guidelines.11-14) Multidisciplinary management in the acute phase is essential, followed by subacute rehabilitation through continuous care after discharge. In Europe, postoperative management for fragility fracture is implemented through appropriate care and quality assessment systems, utilizing registries and audits.15) The International Osteoporosis Foundation and Fragility Fracture Network are making significant efforts to promote this standard worldwide.16,17)
Since December 2020, Korea has been implementing the nationwide Rehabilitation at Home Care Pilot Program for patients who have undergone lower extremity surgeries, to facilitate early mobilization and promote continued home-based exercise after discharge.18) The home-based rehabilitation program is a combined effort involving multidisciplinary rehabilitation to facilitate early mobilization after surgeries, as well as tele-rehabilitation to support continued community-based exercise.13,19) The Korean healthcare system has been developed based on the policy of universal health coverage by the National Health Insurance (NHI) system, and the Rehabilitation at Home Care Pilot Program after lower extremity surgeries was launched by the NHI and Ministry of Health and Welfare. The Health Insurance Review and Assessment (HIRA) Agency, an independent governmental organization responsible for reviewing medical claims, plans to conduct an effectiveness and cost-benefit analysis of this pilot program after 3 years in 2023.
This study serves as an interim analysis of the program and aims to compare function and pain severity after program participation of patients who required postoperative rehabilitation after lower extremity surgeries. This finding will provide insights into areas requiring improvement within the pilot program and offer recommendations for enhancing postoperative recovery, particularly for older patients.
MATERIALS AND METHODS
Participants
We collected data from seven teaching hospitals that agreed to share data among the hospitals participating in the pilot program between December 2020 and July 2022. The inclusion criteria were patients who agreed to participate in this pilot education program after undergoing lower extremity surgery and were 19 years of age or older. Exclusion criteria were incomplete demographic or surgery information and inappropriate data. As age is one of the primary prognostic factor of post-orthopedic surgery in lower extremity,20-22) patients were divided into an older-age group (OG; ≥60 years) and a younger-age group (YG; <60 years).23) Data of OG were primarily analyzed with comparison to those of YG. The burden of comorbidities might also affect the recovery process during the postsurgical period.24) Therefore, subgroup analyses were conducted based on the major surgical areas between two groups and the number of comorbidities within each group.
Rehabilitation at Home Care Pilot Program
The pilot program18) was designed to enroll patients who underwent three major joint replacements (hip, knee, or ankle) or surgeries for lower extremity fractures for 90 days postoperatively. This program provides education and counseling regarding postoperative rehabilitation and exercise. Designated hospitals should have home-based rehabilitation teams (HBRTs) consisting of physiatrists, physical therapists, and nurses. Education and counseling sessions were provided to the patients by HBRT while the patients were admitted for surgical treatment and recovery. Further education sessions and monitoring by means of non-face-to-face communication between patients and the HBRT were continued after discharge. The patients should be enrolled within 90 days following lower extremity surgery. Once registered in the project, patients are eligible to receive services offered by the program for 90 days (Fig. 1A). The education is conducted in a hospital by one of the HBRT and covers various topics including the goals of postoperative rehabilitation, how to perform strengthening, flexibility and aerobic exercise, walking and stair-climbing methods, the use of gait aids such as axillary crutches, canes or walkers, fall prevention, pain management, when to seek medical attention. Education counseling can be provided by a physiatrist or other HBRT members. The physiatrist explains the condition, discusses the treatment approach and provides specialized education and counseling for patients and their caregivers. The education service is limited to two sessions within 90 days after program participation. Other HBRT members, such as physical therapists or nurses, also provide health information to them with this service similarly limited to three sessions within the same period. After discharge, non-face-to-face communication was conducted via messaging on a smartphone app or phone calls (Fig. 1B).
Rehabilitation at Home Care Pilot Program has three subcategories within the medical fee system: education and training charge 1 and 2 (ETC1 and ETC2), and patient monitoring charge (PMC). These subcategories are priced according to the services the patients receive and the medical professionals or providers who deliver those services (Table 1, Supplement A). ETC1 is the fee for service reimbursed when a physiatrist of the HBRT provides educational services to patients and oversees the education program. ETC2 and PMC are the fees reimbursed if those services are provided to the patients by any member of the HBRT. The PMC is designed for coordinator nurses in charge of patient education and monitoring to monitor the conditions and activities of patients and provide further education on call or online after hospital discharge.
Outcomes
The Berg Balance Scale (BBS) score, weight-bearing status (1, full weight; 2, partial weight; 3, toe-touch; and 4, no weight bearing), walking aids for physical function (1, independent walking; 2, cane; 3, axillary crutch; 4, walker; and 5, etc.), Numerical Rating Scale (NRS) for pain intensity (0–10), and the level of understanding of the education (1, very high; 2, high; 3, average; 4, low; and 5, very low) were collected to assess the outcomes after surgery based on data from ETC1. The BBS is used to assess balance function and fall risk, with a higher score indicating better balance function (range 0–56) (Supplement B).25) These assessment tools were selected as outcome variables to assess physical function and pain following surgical treatment by the HIRA through discussions with medical experts in the field of musculoskeletal medicine.
A greater number of comorbidities was associated with poorer outcomes in lower extremity surgeries such as THA, hip fracture surgery or TKA.20,26,27) The number of comorbidities were collected from the ETC1 document. HBRT team members should verify whether the patient has concurrent conditions affecting cardiovascular, endocrinologic, respiratory, nephrological, neurologic or musculoskeletal systems and record this information in the ETC1 document (Supplement A).
Ethics Statement
All patients provided informed consent prior to participation in the service. To register patients who participated in this government pilot program, patient education and monitoring documents were submitted to the HIRA website, which is responsible for managing Korean healthcare resources. These documents were developed by HBRT based on medical records, and an independent ethics committee approved this retrospective chart review (Approval No. 2022-08-046).
Statistical Analysis
Statistical analyses were performed using MedCalc (version 20.211; MedCalc Software Ltd., Ostend, Belgium). A paired t-test was used to test the significance of differences between two time points. The two groups were compared using an independent t-test. Categorical variables were analyzed using the chi-squared test. Quantitative results are presented as mean±standard error. Statistical significance was defined as p<0.05.
RESULTS
Study Cohort and Overall Information on Lower Extremity Surgeries
We collected data from 890 patients in seven tertiary hospitals (Fig. 2, Table 2, Supplement C). The total sample was categorized into OG (n=801; mean age, 73.9 years) and YG (n=71; mean age, 49.6 years) after exclusion (n=18). In the OG, the number of female patients was four times greater than that of male patients (female 648, male 153) and there was no significant difference in age between the sexes (female 74.1 years, male 73.4 years). The YG had similar numbers of female (n=37) and male (n=34) patients (Table 3).
The OG received most knee joint surgery (63.7%), followed by hip joint (28.3%) and femur surgery (7.9%). Meanwhile, in the YG, hip joint (77.5%) surgery was the most common surgery, followed by knee joint (18.3%) and femur (4.2%) surgery.
The duration between the date of surgery and enrollment in the pilot program differed between the OG and YG as 4.4 days and 3.2 days, respectively. In dominant surgeries such as the hip and knee joints, it took more days for patients who had undergone hip joint surgery to begin the program in the OG than YG (4.3 days vs. 2.7 days). For knee joint surgery it took the OG 3.4 days to begin the program compared to the 2.2 days it took for the YG.
In OG, hip and knee joint replacements comprised majority of surgical procedures. Among these two, total knee replacement was the most common surgical treatment (63.0%) performed. In terms of hip joint replacements, the proportions of total hip replacement and hemiarthroplasty accounted for 17.6% and 10.7% of all lower extremity surgeries, respectively. In the YG, the primary surgical procedures were also hip and knee joint replacements (94.3%). Among which hip joint replacement was the most common surgery overall (70.4%), followed by knee joint replacement (23.9%).
Outcomes following Surgeries in OG vs. YG
Physical function
In the OG, there was a significant increase in BBS by 23.3 (14.5→37.7) over a duration of 20.3 days (n=384) (p<0.0001) (Fig. 3A). In the subgroup analysis for the two major surgeries—hip joint replacements (total hip and hemiarthroplasty, n=79) and knee replacements (n=296), BBS increased by 19.7 (9.8→29.5) (p<0.0001) for the hip joint replacement and by 24.5 for knee replacements (16.0→40.5) (p<0.0001). However, patients who underwent femur fixation showed a non-significant increase in BBS by 9.1 (n=9) (Fig. 3A). Similarly, in the YG, BBS also increased by 31.9 (11.6→43.5) (p<0.0001) (Fig. 3B). The OG showed less improvement in BBS scores than the YG for all surgeries (23.3 vs. 31.9; p=0.0148) and hip joint surgery (19.8 vs. 33.5; p=0.0018). There was no significant difference in knee joint surgery between the OG and YG (Fig. 3C). In the analysis of the impact of comorbidity burden on OG, it was observed that patients with a higher number of comorbidities (≥3; n=17) showed less balanced improvements compared to those with fewer comorbidities (<3; n=62) in the hip joint replacement group (p=0.0028). However, these findings were not observed in the knee joint surgery group (Fig. 3D). Weight-bearing status was categorized into four categories based on the level of weight bearing on the affected limb: full weight (FW), partial weight (PW), toe-touch (TT), and no weight (NW) bearing. The use of walking aids, such as walkers, axillary crutches, canes, or no walking aids, was also recorded. The ratios of weight-bearing in OG changed from FW (1.9%→28.8%), PW (57.1%→56.4%), TT (38.8%→13.5%), and NW (2.1%→1.2%). YG also showed higher weight-bearing status: FW (5.4%→43.2%), PW (48.6%→43.2%), TT (45.9%→13.5%), and NW (0%→0%) (p<0.0001). As patients became more independent of walking aids, their weight-bearing status progressively advanced to higher levels of weight-bearing (p<0.0001) (Fig. 4A, 4B). These results were also consistent with those in YG (Fig. 4A, 4B).
Pain
In OG, pain intensity, measured on the NRS, decreased by 0.96±0.09 for all available patients (n=413) (p<0.0001). In the subgroup analysis of the two major surgeries, pain intensity decreased by 1.02±0.18 for hip joint surgeries (p<0.0001) and by 0.97±0.11 for knee joint surgeries (p<0.0001). Similarly, the YG showed lower pain intensity for total and hip joint surgery. The pain severity did not change in the YG knee joint surgery group (Fig. 5).
Education target
The educational services were provided either to the patients alone or to both the patients and their caregivers. In approximately one fifth of the cases (22.9% in OG, 21.1% in YG), these educational services were provided to the caregivers in conjunction with the patients. The most common type of caregiver who received these educational services was the patient’s descendants in OG (49.2%) and spouses in YG (61.5%). In all other cases, only the patients received instruction on exercise and managing their daily activities.
Degree of Education Understanding with the Pilot Program
The substantial proportions of program understanding after educational services on postoperative rehabilitation were provided as “very high” or “high” for the 1st ETC program (73.1%) and for the 2nd ETC program (70.6%) in the OG. The same categories of “very high” or “high” were also higher in YG (80.0%, 76.7%) (Supplement D).
DISCUSSION
This interim analysis of the Rehabilitation at Home Care Pilot Program, conducted as part of a multicenter trial for patients who underwent lower extremity surgeries, showed significant improvements in mobility function and pain reduction. The program provides patients or their caregivers with early education on postoperative rehabilitation. Additionally, HBRT provides guidance for patients and caregivers to continue exercising after discharge in a home-based setting and dealing with possible postoperative complications under the observation of the HBRT.28)
Early rehabilitation is strongly recommended to commence within 48 hours following hip surgeries.29,30) The National Institute for Health and Care Excellence guidelines recommend initiating rehabilitation on the same day for hip or knee replacement surgeries to enhance recovery.31) A more organized multidisciplinary approach can facilitate earlier intervention in the rehabilitation process.32) This can be achieved through integrated orthogeriatric care.33,34) Models of orthogeriatric services can be categorized into various forms by the contribution of orthopedists and geriatricians. Integrated care, where orthopedic surgeons and geriatricians manage patients from admission with multiple professionals, is recognized as the most sophisticated model.34,35) In our data, the average time interval between the first education and surgery was 4.4 days in the OG, longer than in the YG (3.2 days). Delayed enrollment in this pilot program compared to the global standard might indicate less structured orthogeriatric care.
In the current study, we focused on OG, patients who are 60 years and older (n=801) compared to YG (<60 years; n=71). Older patients showed less improvement in BBS (23.2 vs. 31.9) than younger patients. Age is inversely related to functional improvement in hip and knee joint replacements.20,26) Multiple preoperative comorbidities, 3 or more were associated with increased mortality in older patients with hip fracture.36) After total knee arthroplasty, comorbidities were also one of risk factor for 1-year mortality with old age.20) Old patients with more comorbidities (≥3) showed less mobility improvement for hip surgeries. This finding supports the notion that postoperative care is particularly crucial for older people undergoing hip surgeries as they are more likely to experience frailty and prolonged medical instability.37)
The operating area also differed between the two age groups. In older patient group, knee was the most common surgical area for replacement, consistent with the epidemiologic study of Korea and the United States.20,38) Total knee arthroplasty is considered as the most successful orthopedic surgery and the number has been growing substantially in people with end-stage degenerative knee arthritis.39) Hip was the most prevalent surgical area in frequency in YG. YG represented middle-aged patients (mean age, 49.6 years) and hip fracture increased substantially after 50 years in Korea.40)
In this program, HBRT members should use common documents of ETC1, ETC2, and PMC regarding surgical information and report what they provide to patients. These documents serve as a type of common dataset. A common dataset is required to establish a registry and a form of real-world evidence.41) They provide the ability to compare with compatibility and generalize each hospital’s practice for health care improvements.42)
This nationwide program for rehabilitation at home after lower extremity surgery is in progress because of a lack of rehabilitation support after discharge. Patients undergoing lower extremity surgeries who need medical services for functional recovery can receive early and proper rehabilitation according to their medical conditions during admission and after discharge under the guidance of HBRT. By improving recovery and reducing comorbidities, hospital stay would decrease, and patients would be provided with education to continue their exercise after discharge. These positive effects can contribute to the formation of organized medical care links among hospitalization, discharge, and home care. To achieve an organized multidisciplinary approach, non-surgeons must learn more about surgeries, surgeons should cooperate with other professionals for more organized communication.5) The government should pay attention to the reimbursement and policy supporting integrated acute and long-term care from hospitals to home-based settings that are essential for patients.43) Postoperative rehabilitation is essential from early post-surgery and is highly recommended as home-based exercise after discharge.44) The Rehabilitation at Home Care Pilot Program can also be an initiative to pay attention to the Fracture Liaison Service (FLS) program. FLS provides a multidisciplinary approach to manage bone health after fragility fractures and includes case finding, patient assessment, osteoporosis treatment, falls prevention, education and exercise.45)
The interim analysis of this pilot program showed positive effects. However, the present study has some limitations. First, the improvement in physical function shown in our analysis could not be solely attributed to this educational program. The results specifically highlighted changes in BBS and pain severity just among patients who participated in post-operational rehabilitation education. When considering the minimal clinically important difference (MCID) for BBS in older adults with hip fractures, which was 11.5 point, our data (19.7 in OG hip subgroup in Fig. 2A) surpassed the MCID.46) However, many confounding factors might have influenced the results. Second, we defined the older people who are aged 60 or above to include more older patients of our data into OG. In this study, we classified patients by age at 60 rather than the threshold of 65 years, as the cause of lower extremity surgeries is likely to be closely associated with accelerated degenerative changes. The age cutoff for older people can vary as 65 or 75.47) When our data were reanalyzed after dividing into OG and YG by age of 65 or 75, the general trend were similar to the current results comparing OG and YG by age of 60: less improvement of BBS in OG than YG and OG with more comorbidities (Supplements E, F, G). Third, the data did not include information on the reasons why the patients underwent lower extremity surgeries and whether the surgeries were primary or revision surgeries. We postulate that most knee arthroplasties may be elective surgeries. However, the outcomes of hip surgeries can vary according to the underlying etiologies, such as hip fracture or hip arthritis. Hip fracture surgery is associated with less favorable outcomes than elective surgery.48) Prognosis also differs between primary and revision surgeries, with revision surgeries generally having less favorable outcomes.7) Fourth, although the sample size was not small, the data did not cover the full scope of the nationwide pilot program, in which 66 hospitals participated, nor did it represent all surgical trends. In our study, for hip area surgeries, total hip replacement was more prevalent than hemiarthroplasty in both OG and YG. However, hemiarthroplasty is the most commonly performed hip surgery in Korea.49) It could be a potential bias due to the different cohort characteristics of a single hospital (Supplement A). In addition, changes in physical function and pain were calculated only for patients who were evaluated at two timepoints, depending on their motivation. The discrepancy between the initial sample sizes of the OG and YG and the number of patients with recorded outcome results indicate low adherence, as shown in the sample size table (Fig. 2). This high rate of missing follow-up evaluations may be due to insufficient monitoring to ensure patients continue their learned exercise and postoperative management. Inconsistent follow-up intervals between assessments should also be considered a potential source of bias. Since the OG and YG differ in terms of sex ration, age, registration duration after surgery and surgery types, it is important to account for these differences when interpreting combined data (Table 2). Fifth, the lack of programs to educate and train physicians, physical therapists, or coordinators in HBRT in each hospital is also an important issue to be considered when implementing this pilot program in clinical settings across the country.
Based on the identification of the limitations of our study, we propose the following suggestions. First, although the pilot program might play a role when compared with the MCID, a more well-designed study is necessary to substantiate its effects, while controlling for confounding factors such as internal determinants (age, sex, personality, comorbidities, etiologies, severity, etc.) and external determinants (surgical technique, type of implant, etc.).50) Second, the documents of this program should be revised to include more detailed information about the etiologies of lower extremity injuries, such as low-energy trauma (e.g., slipping down), high-energy trauma (e.g., accident, falling down), or degenerative change (e.g., advanced arthritis). Additionally, information regarding comorbidities should be more specific, including the disease diagnosis as the current documents only describe the affected organ systems such as cardiovascular, endocrine, pulmonary, renal, neurological, and musculoskeletal systems (Supplement A). Third, future efforts should prioritize the development of structured programs that incorporate ongoing support and communication among healthcare providers, enabling better monitoring of patient adherence and expanding support beyond initial education. Lastly, after discharge, the patients are currently monitored only via telephone or online messaging. Integrating a more efficient practice of tele-rehabilitation would be beneficial.
In conclusion, we analyzed the data from seven hospitals participating in a nationwide Rehabilitation at Home Care Pilot Program for patients undergoing lower extremity orthopedic surgeries. The postoperative rehabilitation education program appeared to be effective in improving physical function and reducing pain severity, though the improvement was less obvious in older patients who may require a more comprehensive approach compared to younger patients.
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