Multiple linear regression analysis did not find a significant relationship between improvement in FIM and comorbidity tier or being consistent with the 3-hour requirement (P = 0.546) or sex (P = 0.302). Improvement in FIM correlated with age (P < 0.001) and with admission FIM score (P < 0.001). The coefficient of age at admission was −0.1105 change in FIM/year of age. Thus, for every 10 years of age, there was a 1.1 point less improvement in FIM score. The coefficient of admission FIM score was −0.3259 change in FIM/unit FIM on admission. For every 10-point increase in FIM score improvement in FIM was reduced by 3.26 points. The only diagnosis with a significant relationship to improvement in FIM was total joint replacement (P = .029). Patients in the joint replacement group had significantly more improvement than patients in the other 8 diagnostic groups.
A regression analysis of FIM change per day versus minutes per day showed that patients in orthopedic, joint replacement, and complex medical/surgical group had a trend to have more positive change in FIM per minute per day than did the patients in the stroke group but results did not reach significance (Fig. 4).
The staff of the IRF made every effort to make sure that each patient was offered and scheduled for an adequate and intensive program of therapy. The difference in the therapy time of the patients in the consistent and not consistent groups was 18.5 minutes/day. This study like the study of Johnston and Miller did not find 3 hours per day or 900 minutes per week of therapy to be a threshold necessary or associated with improvement in function. Multiple linear regression analysis showed that age, admission FIM score, and the diagnosis of total joint replacement were significantly related to improvement in FIM. Younger age is associated with better outcomes from illness and from IRF. There is a ceiling effect on improvement in FIM. When patients reach an adequate level of function, they are discharged to home. Therefore, properly selected patients at a lower level of function may make more improvement than patients admitted with a higher FIM score. Total joint replacement is a procedure with a very high rate of good outcomes.
Regression analysis showed that patients in nonconsistent group had shorter LOS and more improvement in FIM/day. The R2 was small indicating that the variation was likely due to factors other than therapy time. There was a higher percent of patients in the non-consistent group who went to IRF after total joint replacement (8.7 vs 4.3). There was a trend (P = .08) for the patients in the nonconsistent group to have a lower admission FIM score (67.9 vs 70.1). These factors likely contributed to the difference in outcomes between the consistent and nonconsistent groups.
There were more patients in the consistent group than non- consistent group with a diagnosis of stroke (30.5% vs 13.6%). There were significantly more patients in the consistent group with stroke compared to complex medical/surgical and joint replacement (P = .001) (Table 2). There was a trend for patients in the stroke group to have less FIM change per day versus minutes per day than patients in those 2 groups (Fig. 4). This also likely contributed to the difference in outcome between the consistent and nonconsistent groups.
The literature is consistent with the idea that exercise is good medicine. Exercise is important in improving strength, endurance, coordination, and the ability to perform functional tasks. Wade and de Jong report that there are no studies that indicate the minimum amount of therapy time necessary to help a patient or the maximum amount of time beyond which therapy is not helpful. Keith, PhD, reviewed the literature of treatment strength in rehabilitation and reported that evidence for a direct relationship between treatment intensity and outcome is mixed. There are studies that show that increased therapy time leads to reduced LOS and improved level of function. Roach et al reviewed the records of 177 patients admitted to an acute care hospital with orthopedic problems that impaired the patients’ ability to walk. They found a significant relationship between minutes of PT and functional status at discharge. Kirk-Sanchez and Roach reviewed the records of 116 patients admitted to an IRF after orthopedic surgery. They found that increased therapy time was related to improved level of function at time of discharge. DiSotto-Monastero et al reported the results of increasing therapy services at an IRF from five days per week to 7 days per week. The study population was 3500 patients admitted with a diverse set of problems. LOS was reduced from 20.3 days to 19.3 days, but there was no change in improvement in function. Hughes et al compared patients who received 5 day per week and patients who received 7 day per week therapy after total joint replacement and found reduced LOS in the 7 day per week group. Rapoport and Judd-Van Eerd reported that patients at a community hospital with stroke and orthopedic problems had shorter LOS if they had therapy 7 days per week than if they had therapy 5 days per week. Qu et al discussed data available in the National Spinal Cord Injury data base (SCI). Review of the records of 1974 patients admitted 2000 to 2004 showed a significant relationship between therapy time and improvement in function. Dumas et al reviewed the records of 80 children and adolescents admitted to an IRF with traumatic brain injury (TBI) and found a significant relationship between the amount of therapy provided and improvement in function. Slade et al randomly assigned 141 patients with neurologic problems to a usual care group and an enhanced therapy group. Patients in both groups made the same amount of improvement in function as measured by the Barthel's Index, but the patients in the enhanced therapy group had a significantly shorter LOS. Spivak et al reviewed the records of 95 patients admitted to an IRF with TBI and found a significant relationship between the amount of therapy provided and improvement in function. Peiris et al randomly assigned 996 patients admitted to 2 IRFs in Australia, to groups that received therapy 5 days per week and 7 days per week. The patients in the 7 day per week therapy group made significantly more improvement in function and had significantly shorter LOS. Cifu et al reviewed records of 491 patients admitted to IRFs participating in the Model TBI System and reported that increased therapy time was significantly related to improved motor function but not to improved cognitive function or LOS.
There are also studies that show no significant relationship between increased therapy time and improved outcome. Ruff et al assigned patients admitted to an IRF after stroke to groups that received therapy 6 days per week and 7 days per week. There was no difference in improvement in function or LOS. Horn et al reviewed the records of 2130 patients in the Model Traumatic Brain Injury System and found that the number of minutes of therapy provided contributed minimally to the outcome of the patient. Heinemann et al reviewed the records of 140 patients with TBI and 106 patients with SCI. The study did not show a significant relationship between the time spent with therapy and improvement in function. Keren et al collected data from 50 patients admitted to an IRF after stroke and found no significant relationship between therapy minutes and improved function.
There are many differences between the IRF at the institution where this study took place and subacute units. Appropriate physicians and diagnostic technologies for any unresolved medical issues or new problems are available on site. This level of physician care is generally not available at a subacute rehabilitation unit. An IRF has a higher ratio of nurses to patients and a higher ratio of registered nurses to total nurses than does a subacute rehabilitation unit. Studies have shown that patient outcomes are improved by increased ratios of nurses to patients and increased ratio of registered nurses to patients. Evaluation and counseling by psychiatrists, psychologists, and clinical nurse specialists to help the patient understand or change behaviors that cause the patient to refuse therapy may be more available at the IRF than a subacute unit.
Different patients may have varying needs for different members of the rehabilitation team. For many patients, the amount of time spent in gym with PT and OT is the most important factor in their recovery. Other patients’ improvement may depend upon the availability of a comprehensive medical staff to manage complicated problems. Some patients need nurses with great expertise in management of skin care, bowel and bladder problems, or behavioral issues. Some patients may need counseling. It is easy to document the amount of time that a patient spends with PT, OT, and SLP. It is very difficult to quantify the value of the physician and nursing services that are more available at an IRF than at a subacute rehabilitation unit.
Decisions as to where patients go for post-acute care are often determined in large part by the 60% rule and the 3-hour rule. The 60% rule is a regulation-based entirely upon opinion. There have been only 3 studies evaluating the 3-hour rule. Neither this study nor the study of Johnston and Miller found that patients whose treatments are consistent with the 3-hour rule have better outcomes than patients who receive a little less therapy time than is required by the rule. Wang et al found that patients whose treatments were consistent with the 3-hour regulation had better outcomes than patients whose therapy was not consistent with the rule. This study and the study of Johnston and Miller included all admissions to an IRF. The study of Wang et al included only patients with stroke. This possibly accounts for the different conclusions. The patients in the study of Wang and colleagues received an average of 34 minutes per day of SLP. Patients with stroke are more likely than patients in other diagnostic groups such as hip fracture or amputation to require speech therapy so the groups are not exactly comparable.
The courts have ruled that it is not appropriate for a patient to be denied access to an IRF based on the requirement for 3 hours per day of therapy. In the case of Hooper versus Sullivan, a federal court judge ruled that carriers cannot deny admission to an IRF based upon the 3-hour. Admission to an IRF should be considered necessary if the patient receives a coordinated program of multiple services at a level that cannot be provided at home or in a skilled nursing facility. On February 23,2018 CMS informed Medicare contractors that they cannot deny reimbursement based upon any threshold of therapy time.
The main conclusion of the study and the review of the literature are in agreement with the ruling in the federal court district of Connecticut. There is not sufficient evidence to support 3 hours per day of therapy as a criterion for admission or continued stay on an IRF. Each patient needs to be evaluated based on diagnosis, level of function, age, comorbidities, and need for medical, and nursing services that might not be available at a lower level of care. The study highlights the fact that the 3-hour rule applies the same requirement for treatment to patients with very different problems.
A limitation of this study is that it is a retrospective study and it was performed at 1 IRF. Ethical and regulatory issues will make randomized prospective studies of different therapy times difficult to perform. Medical complexity was controlled for using the comorbidity tiers developed by CMS for IRF. The study also uses admission FIM. Shih et al have shown that admission FIM score is as good or better than comorbidity indices for predicting medical stability. A study with a more concentrated focus on the need for therapy time by patients receiving 2 therapies as opposed to 3 therapies would be helpful. A study concentrated on therapy time needed by patients with different diagnosis would be helpful.
Conceptualization: George P Forrest.
Formal analysis: George P Forrest.
Investigation: George P Forrest, Alycia Horn, Mina Kodsi.
Methodology: George P Forrest.
Project administration: George P Forrest.
Software: Mina Kodsi, Joshua Smith.
Writing – original draft: George P Forrest, Joshua Smith.
Writing – review & editing: George P Forrest, Mina Kodsi.
George P Forrest orcid: 0000-0002-3648-417X.
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Keywords:Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc.
inpatient rehabilitation facilities; outcomes; three -hour rule