Archives of Physical Medicine and Rehabilitation

journal homepage: www.archives-pmr.org Archives of Physical Medicine and Rehabilitation 2013;94:17-22

FEATURED ARTICLE

Effect of a Safe Patient Handling Program on Rehabilitation Outcomes

Marc Campo, PT, PhD,a Mariya P. Shiyko, PhD,b Heather Margulis, PT, MS,c Amy R. Darragh, OTR/L, PhDd
From the aSchool of Health and Natural Sciences, Mercy College, Dobbs Ferry, NY; bDepartment of Counseling and Applied Educational Psychology, Northeastern University, Boston, MA; cHebrew Rehabilitation Center, Boston, MA; and dDivision of Occupational Therapy, School of Health and Rehabilitation Sciences, The Ohio State University, Columbus, OH.

Abstract Objective: To evaluate the effect of a safe patient handling (SPH) program on rehabilitation mobility outcomes. Design: Retrospective cohort study. Setting: A rehabilitation unit in a hospital system. Participants: Consecutive patients (NZ1291) over a 1-year period without an SPH program in place (nZ507) and consecutive patients over a 1year period with an SPH program in place (nZ784). Interventions: The SPH program consisted of administrative policies and patient handling technologies. The policies limited manual patient handling. Equipment included ceiling- and oor-based dependent lifts, sit-to-stand assists, ambulation aides, friction-reducing devices, motorized hospital beds and shower chairs, and multihandled gait belts. Main Outcome Measures: The mobility subscale of the FIM. Results: Patients rehabilitated in the group with SPH achieved similar outcomes to patients rehabilitated in the group without SPH. A signicant difference between groups was noted for patients with initial mobility FIM scores of 15.1 and higher after controlling for initial mobility FIM score, age, length of stay, and diagnosis. Those patients performed better with SPH. Conclusions: SPH programs do not appear to inhibit recovery. Fears among therapists that the use of equipment may lead to dependence may be unfounded. Archives of Physical Medicine and Rehabilitation 2013;94:17-22 2013 by the American Congress of Rehabilitation Medicine

In health care settings, manual patient handling tasks (such as transferring a patient) result in excessive physical loads that can lead to injury.1,2 Manual patient handling has been associated with injuries to health care providers such as nurses, physical An audio podcast accompanies this article. Listen at www.archives-pmr.org.
Presented to the Safe Patient Handling and Movement Conference of the Veterans Administration Sunshine Health Network, March 18e22, 2012, Orlando, FL; presented as a poster to the Combined Sections Meeting of the American Physical Therapy Association, February 8e11, 2012, Chicago, IL. Supported by the Agency for Healthcare Research and Quality (Small Research Award, grant no. R03 HS020723-01). No commercial party having a direct nancial interest in the results of the research supporting this article has or will confer a benet on the authors or on any organization with which the authors are associated.

therapists, and occupational therapists.3-5 In response to high rates of injuries of health care providers and patient falls, hospitals across the United States have implemented safe patient handing (SPH) programs.6-8 These programs limit the manual handling of patients through a combination of policies and patient handling technologies.6,9-11 The primary focus of most programs is on policies and equipment that are designed to reduce the physical loads associated with common patient handling tasks such as transfers, repositioning, ambulation, and arresting falls.11-13 Settings for SPH programs include acute care, rehabilitation, and long-term care, where patient lifting is common. SPH programs have reduced the incidence of provider injuries and patient falls.6-8,14-16 They also have decreased lost work time and reduced workers compensation costs.17 However, the effects of these programs on patient recovery and rehabilitation are relatively unknown.

0003-9993/13/$36 - see front matter 2013 by the American Congress of Rehabilitation Medicine http://dx.doi.org/10.1016/j.apmr.2012.08.213

18 Rehabilitation services, in particular, are substantially impacted by SPH programs.18,19 In traditional rehabilitation settings, nurses, physical therapists, and occupational therapists provide assistance with patient functional mobility (eg, ambulation and transfers), retraining patients to walk and transfer by lifting them and guarding them manually. In rehabilitation settings with SPH programs, they use advanced patient handling equipment to support or lift the patient while they guide these activities, particularly when patients are very heavy and/or dependent.19,20Although therapists are at high risk for injuries and work-related pain,3,4 opinions on SPH programs in rehabilitation are mixed. Among therapists, a belief persists that using patient handling equipment in rehabilitation may impede recovery.18 These devices were designed primarily for passive patient movement and not rehabilitation,21 potentially limiting their usefulness as rehabilitative tools. A study of standassist devices, for example, found that equipment-assisted transfers were preferable to a poorly executed manual transfer but still did not promote normal movement patterns. The same study also found that equipment may promote passive participation in the transfer.22 Arnold et al23 reported positive effects of SPH equipment on rehabilitation. They found that patients with stroke who underwent rehabilitation under an SPH program had greater improvements in mobility FIM scores than did patients with stroke who underwent rehabilitation without the program. The study, however, was based on a small sample of patients (nZ94) with a single diagnosis. In our own qualitative work examining the use of SPH equipment in rehabilitation, therapists in facilities with established SPH programs described advantages to using the equipment during patient care.18,19 In addition to increased staff and patient safety, therapists reported that patients demonstrated increased participation and activity, and therapists were able to mobilize bariatric and medically complex patients earlier in the rehabilitation process.19 However, they also identied important limitations of the devices (eg, sling design and equipment maneuverability) as well as limitations in device usage (depending on patient, environment, and activity characteristics). These initial studies provide some evidence for the usefulness of SPH programs in rehabilitation, particularly for addressing functional mobility and for mobilizing patients who require the most assistance. However, given the design and sample size limitations of these studies, more formal evaluations, based on larger and representative samples, are warranted. The number and scope of SPH programs are increasing. The Veterans Administration, for example, has recently implemented a large-scale initiative to implement SPH programs in all the Veterans Administration inpatient facilities.24 In addition, as of 2012, 10 states had enacted some form of SPH legislation, with some requiring full SPH programs in facilities.25 Other laws were demonstration initiatives designed to promote SPH programs and increase adoption. Considering the number and scope of SPH programs, and the fact that they fundamentally alter patient care, there is an urgent need to examine the effect of SPH programs on patient functional mobility in rehabilitation. The purpose of this study was to determine the effect of an SPH program on patient functional mobility outcomes, as measured by the FIM.

M. Campo et al

Methods
Study participants
This was a retrospective cohort study of patient rehabilitation outcomes before and after the implementation of an SPH program. We obtained data from the electronic medical records of 1315 patients admitted to the rehabilitation unit of a large hospital center in Massachusetts. Any patients who died during rehabilitation or who had a stay of 2 days or fewer on the rehabilitation unit were excluded from the study. The purpose of excluding patients with short stays was to eliminate unstable patients who were likely transferred out of the recuperative services unit shortly after admission. Based on this criterion, 23 patients were excluded (10 in 1 group and 13 in the other group). An additional patient was dropped from the analysis because of an unusually prolonged hospital stay (140 days, z scoreZ9.3). The nal sample comprised 1291 patients. The materials and methods of this project were approved by the institutional review boards of Hebrew Rehabilitation Center, Mercy College, and The Ohio State University.

Intervention
Intervention (SPH) and comparison groups (No-SPH) occurred historically within the same hospital at 2 different time periods. The comparison group was composed of 507 patients admitted to rehabilitation between July 2005 and July 2006, prior to the implementation of the SPH program. The intervention group was composed of 784 patients admitted to rehabilitation between April 2008 and April 2009. We did not consider any patients admitted between August 2006 and March 2008 to allow the program to be fully implemented. This provided therapists with time to become comfortable with the equipment and allowed them to fully transition into the work environment with new practices and standards. The SPH program consisted of administrative policies, equipment, and a decision-making algorithm. Under this program, patients with a body mass index (BMI) >35 required a preadmission consultation to select bariatric lift equipment. For all patients admitted, regardless of BMI, all staff members except physical and occupational therapists were required to use patient handling equipment with 2 exceptions: patients could be manually handled if they required only close supervision or contact guard or in the event of emergencies. For physical and occupational therapists, the requirement was to use equipment if a task required >15.9 kilograms (35 pounds) of effort or if a patient required anything more than minimal assistance. A level of 15.9 kilograms was based on recommendations from the National Institute of Occupational Safety and Health.26 The program was designed to give therapists more latitude when working on rehabilitation activities while still reducing the risk from excessive loading. Equipment included oor- and ceiling-based dependent patient lifts, sit-to-stand assists, motorized hospital beds, ambulation aides, multihandled gait belts, and powered shower chairs. Therapy staff members were trained in the use of equipment upon hiring and were required to pass competency evaluations. Therapy units had peer leaders who were available for consultation.

List of abbreviations:
BMI body mass index SPH safe patient handling

Outcome measure
The outcome measure was the functional status of patients as determined by the mobility portion of the FIM. Admission FIM www.archives-pmr.org

Safe patient handling effects on rehabilitation scores were determined by the lowest score observed by any interdisciplinary member of the care team in the rst 3 days following admission. Discharge FIM scores were determined by a similar algorithm in the 3 days prior to discharge. The FIM measure consists of 18 items, each rated on a 7-point scale by health care professionals (usually physical therapists, occupational therapists, and speech pathologists), where a score of 1 indicates total dependence and a score of 7 indicates complete independence. The FIM categories and individual items are described in gure 1. In the current study, we dened the mobility FIM as the total of the 2 locomotion and the 3 transfer subscales. These subscales were chosen because function in these activities was the most likely to be affected by the use of SPH devices in rehabilitation. The FIM has demonstrated good reliability. In a metaanalysis including 11 studies, Ottenbacher et al27 found pooled median reliability coefcients of .95 for both interrater and testretest statistics. In a systematic review, Glenny and Stolee28 found internal consistency values for the total FIM ranging from .88 to .97 and values for the motor domain of the FIM ranging from .86 to .98. The FIM has also demonstrated good construct29 and criterion validity.30,31 Therapy staff members were trained in FIM administration and were certied upon hiring. They were retrained every 2 years thereafter.

19 regression model. The primary predictor was group, coded as a dummy variable (0ZNo-SPH, 1ZSPH), and the outcome was discharge mobility FIM scores. We considered baseline mobility FIM scores, age (in years), length of stay (in days), and impairment codes (diagnosis) as potential confounders and effect modiers. The FIM includes 17 impairment/diagnostic codes, with each having several subcategories. We recoded impairments into 1 of the following diagnostic groups: orthopedic, neurologic, cardiopulmonary, and medical complexity/debility impairments. The largest group (complexity/debility) was designated as the reference group. All continuous predictors were mean centered. Regression assumptions, including linearity, homogeneity of variance, homoscedasticity, normality, and absence of multicollinearity, were assessed graphically and statistically. Heteroscedasticity was noted in plots of residuals and statistical tests (Breusch-Pagan/CookWeisberg; P<.01). To account for the departure from the homoscedasticity assumption, we used the robust SEs to calculate P values, SEs, and condence intervals (HC3).32 Multivariate outliers were assessed through the plots of residuals and Cooks distance. We considered an interaction between group and baseline mobility FIM scores to assess a potential differential effect of treatment for patients admitted to the hospital at different levels of initial function. Plausible interactions between SPH group and age, group and length of stay, and group and diagnosis were also evaluated. Based on a signicant interaction between group and baseline mobility FIM scores (PZ.02), the Johnson-Neyman technique was used to determine regions of signicance.33 Specically, we wanted to identify levels of baseline mobility FIM scores that were associated with differential effects of the SPH program on the discharge scores.

Statistical analysis
Statistical analyses were conducted using SPSS Statistics v. 19a and Intercooled STATA v. 12.b We examined univariate statistics, distributional plots, and outliers for all variables. To establish between-group equivalence, we compared the intervention and control groups on a number of demographic characteristics, including age, length of stay, and diagnosis. Group equivalence was evaluated with independent sample t tests for continuous variables and chi-square tests of association for categorical variables. To evaluate the main research question of the effect of the SPH program on patient outcomes in rehabilitation, we used a linear

Results
Demographic characteristics by group are described in table 1. The groups were comparable in their admission mobility FIM scores. The groups differed in terms of age (tZ2.67; PZ.01) and length of stay (tZ2.11; PZ.03). The distribution of impairment codes was different between the groups (c2Z23.81; dfZ3; P<.01). The No-SPH group had a greater proportion of patients with neurologic (c2Z14.0; dfZ1; P<.01) and cardiopulmonary impairments (c2Z4.4; dfZ1; PZ.04). The SPH group had a greater proportion of patients with medical complexity and/or debility impairments (c2Z11.7; dfZ1; P<.01). Both groups had roughly equal proportions of patients with orthopedic impairments. Figure 2 represents a graphical summary of mean mobility scores for each group at admission and discharge. No signicant difference was noted in the change in mobility FIM score from admission to discharge between the groups (tZ.75; PZ.45). Based on our regression model (table 2), there were no statistically signicant differences between the groups in discharge mobility FIM scores, except for patients who had high admission mobility scores. Those patients performed better with SPH. The Johnson-Neyman signicance region for admission mobility was 15.1 and higher (No-SPH: nZ107; SPH: nZ138). This translates to a signicant difference between the No-SPH and SPH groups when admission mobility scores were 15.1 or higher but not when admission mobility scores were lower. For example, for subjects with admission mobility FIM scores of 16, the predicted mean difference in discharge mobility FIM scores was .85, with subjects in the SPH group scoring higher after controlling for covariates (BZ.85; 95% condence intervalZ.11e1.57).

Fig 1 The FIM categories. The FIM includes 6 categories and 18 individual items, each rated from 1 to 7 by rehabilitation staff. The mobility FIM is the sum of all the transfer and locomotion items.

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Table 1 Factor Number of subjects (n) Number of excluded subjects (n) Age (y) Mean SD Median (IQR) Length of stay (d) Mean SD Median (IRQ) Mobility FIM at admission Mean SD Median (IQR) Impairment group, n (%) Orthopedic Neurologic Cardiopulmonary Medical complexity/ debility Demographic and baseline factors No-SPH 507 10 784 14 SPH P

M. Campo et al

82.39.1 80.910.7 <0.01* 84 (78e89) 83 (75e88) 20.911.6 19.412.9 18 (14e26) 16 (11e24) 12.44.3 12.43.6 12 (10e15) 12 (11e14) 188 54 94 171 (37.1) (10.7) (18.5) (33.7) 294 40 111 339 (37.5) (5.1) (14.2) (43.2) 0.03*

0.67*

0.88y <0.01y 0.04y <0.01y

Abbreviation: IQR, interquartile range. * Independent samples t test (unequal variances). y c2 test of association.

Fig 2 Mean mobility FIM scores at admission and discharge by group. The bars represent the mean mobility FIM scores at admission and discharge by group. The error bars represent 95% condence intervals (CI) of the mean mobility FIM scores.

Discussion
The purpose of this study was to determine the effect of the SPH program on rehabilitation mobility outcomes in a large and diverse sample of patients. Our main nding was that for the majority of patients, both patient handling practices yielded similar functional mobility outcomes. Differences emerged for a subgroup of patients with high mobility FIM scores at admission. Higher functioning patients appeared to do better with SPH. The difference in discharge mobility FIM scores between groups for patients with high admission mobility FIM scores was close to 1 point. We are unaware of any studies of the minimum clinically important difference for the mobility FIM. Studies using the motor FIM (which includes all the 13 mobility and self-care categories) have found minimum clinically important difference values of 11 points and 17 points.34,35 The 1-point difference found in the present study refers only to the mobility FIM scores, for which a total score of 35 is possible. Clinically, a 1-point difference in the overall score may not be meaningful. The difference could potentially result from measurement error or other sources of variation. For the majority of the patients in this study, the SPH program resulted in similar or even slightly better mobility outcomes. This may mitigate concerns of therapists who fear that SPH programs may lead to dependency and interfere with recovery of functional mobility. Very small group differences may have been missed. However, our model was powered adequately to detect even small clinically relevant differences. In our previous research, therapists expressed concerns that the use of equipment may be a hindrance to rehabilitation, especially for higher functioning patients.18 In the current study, the SPH program did not demonstrate an adverse impact on mobility. The focus of the current study was on an SPH program. Future research should evaluate the equipment itself and the efcacy of specic pieces of equipment in rehabilitation. Our previous work also suggested that SPH programs may be particularly useful for complex and low-functioning patients.18,19

Therapists in these previous studies reported that SPH equipment increased the options for therapeutic activities and allowed them to mobilize patients earlier. We found no evidence of an advantage for this subgroup of patients. Outcomes for patients with lower admission mobility scores were similar in both groups. An unanticipated nding is that comparable functional outcomes for the SPH group may have been achieved in a shorter length of a hospital stay. Length of stay was not the primary analysis, however, and there were important group differences that may have inuenced these results. More research should be conducted to determine the potential impact of SPH programs on length of stay. The ndings of the current study contrast with those of Arnold,23 who found that an SPH program resulted in better mobility outcomes for patients with stroke. Although our study found an improvement with SPH for a subgroup of patients, for the majority of patients, there were no statistically or clinically relevant differences. There were many differences in study methods and populations that may have accounted for the difference. The equipment and policies in the individual programs were different. In addition, in the current study, we looked at a much larger, broader patient population with a variety of diagnoses.

Study limitations
To the best of our knowledge, this is the rst study to evaluate the efcacy of the SPH program in a large and diverse sample of patients from a large urban hospital. Analyses of individual rather than aggregated data allowed us to account for important personal characteristics, such as age, length of stay, and diagnosis that have direct implications on functional outcomes and can interfere with effects of the SPH practices. Further studies should include multiple hospital sites to ensure that effects are equivalent across different hospital settings. Another strength of the study related to the setting and the program implementation. This program included clear guidelines for equipment use. The program at this facility was implemented www.archives-pmr.org

Safe patient handling effects on rehabilitation

Table 2 Variables Admission mobility FIM Group Age (y) Length of stay (d) Diagnosis Medical complexity/debility Orthopedic diagnosis Neurologic diagnosis Cardiopulmonary diagnosis Linear regression model of discharge mobility FIM scores Format Mean centered 0ZNo-SPH, 1ZSPH Mean centered Mean centered Reference 0ZNo, 1ZYes 0ZNo, 1ZYes 0ZNo, 1ZYes Unstandardized B 0.87 0.10 0.08 0.03 P <0.01 0.76 <0.01 0.12 95% CI* 0.74 to 1.01 0.53 to 0.73 0.12 to 0.05 0.01 to 0.06

21

Standardized b 0.49 0.01 0.12 0.05

2.63 1.17 0.21

<0.01 0.11 0.65

1.94 to 3.33 2.61 to 0.27 0.71 to 1.13

0.19 0.04 0.01

Abbreviation: CI, condence interval. * CIs generated with robust SEs (HC3).

relatively quickly, and no elements of the program were available for patients in the No-SPH group. All elements of the program were available in the SPH group. Despite these strengths, a number of limitations should be considered to aid interpretation of the results. The facility conrmed that no major changes in stafng qualications, major hospital policies, or health insurance reimbursement practices were instituted following the rst period of data collection, other than the SPH program. However, more subtle changes that we have not considered might have taken place and should be considered when interpreting the results. Another important limitation was our inability to determine the extent of equipment use in the SPH group. While specic guidelines and training were provided, we do not have data that would indicate how closely the guidelines were followed. Although equipment was mandated for levels of assistance more than 15.9 kilograms or anything greater than minimal assistance, therapists estimated the level of assistance and we had no way to determine how accurate they actually were. In addition, equipment was used by the other hospital staff, including nursing. The effect of equipment use outside of therapy could not be determined but may have played a role in the results. There were important differences between the groups in certain patient characteristics. For example, our demographic analysis revealed that patients in the SPH group had more medical complexity diagnoses. These differences were controlled for in our regression model. It is possible, however, that the difference in case mix inuenced the results in a way that the regression model did not capture. Data on other factors that may have inuenced the results were unavailable. For example, we had no data on BMI. One of the primary motivations for using SPH is the ability to work with heavier and more complex patients. BMI may play a role in mobility progress,36-38 and SPH equipment may be particularly useful for obese patients.19 Moving forward, we recommend additional studies that account for BMI and the effect it may have on patient outcomes with and without SPH. Use of the FIM as the primary outcome measure has limitations that should be considered. Although it is widely accepted as a reliable, valid, and responsive assessment of patient function,39 it is limited by the potential for inconsistent and inaccurate scoring, particularly when multiple raters are involved or when equipment is used. In addition, scoring guidelines can result in an inaccurate picture of a patients abilities.40 Other performancebased measures such as the 6-minute walk test and timed up and go test or other measures such as the Barthel Index might be useful additions to studies such as these to increase the overall measurement reliability. www.archives-pmr.org

Clinical implications
Based on the current ndings, it appears that mobility outcomes are similar or slightly better with SPH than with traditional rehabilitation. Therefore, concerns about SPH and functional progress voiced by physical and occupational therapists may be unwarranted. Considering the high rate of injuries in health care workers overall and in therapists specically,3,4 these programs could potentially play a large role in preventing injuries while allowing for effective rehabilitation. More research, however, is needed to determine the effect of SPH programs denitively. Other functional outcomes beyond mobility, such as self-care, are important to examine as well. Studies with larger sample sizes and multiple settings are also warranted. As related laws and initiatives related to SPH continue to evolve, rehabilitation professionals are more likely to nd themselves working in facilities with SPH programs. It is therefore imperative that they embrace SPH, contribute to the evolution of equipment and programs, and learn to use equipment in ways that maximize rehabilitative potential.

Conclusions
To the best of our knowledge, this is the rst study to evaluate the effect of an SPH program on functional mobility outcomes across the full range of rehabilitation diagnoses. Patients who participated in rehabilitation with an SPH program in place achieved similar or slightly better outcomes than did patients who participated in rehabilitation without an SPH program.

Suppliers
a. SPSS Statistics v. 19; SPSS: An IBM Company, IBM Corp, 1 New Orchard Rd, Armonk, NY 10504. b. STATA IC v. 12.1; StataCorp LP, 4905 Lakeway Dr, College Station, TX 77845.

Keywords
Moving and lifting patients; Occupational therapy; Physical therapy techniques; Rehabilitation

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Corresponding author
Marc Campo, PT, PhD, School of Health and Natural Sciences, Mercy College, 555 Broadway, Dobbs Ferry, NY 10522. E-mail address: mcampo@mercy.edu.
18. 19.

20.

Acknowledgments
We thank Karen Drake, PT, GCS (Hebrew Rehabilitation Center), for her assistance with data acquisition; Lena L. Deter, RN, MPH, CSPHP, Clinical Program Specialist (Hebrew Senior Life), for providing information about the safe patient handing program; and Susan E. White, PhD, CHDA (The Ohio State University), for statistical consultation.
21. 22. 23.

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