Traumatic Brain Injury-Practice Based Evidence Study: Design and Patients, Centers, Treatments, and Outcomes.

OBJECTIVES: To describe study design, patients, centers, treatments, and outcomes of a traumatic brain injury (TBI) practice-based evidence (PBE) study and to evaluate the generalizability of the findings to the U.S. TBI inpatient rehabilitation population. DESIGN: Prospective, longitudinal, observational study. SETTING: Ten inpatient rehabilitation centers. PARTICIPANTS: Patients (N=2130) enrolled between October 2008 and September 2011 and admitted for inpatient rehabilitation after an index TBI injury. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Return to acute care during rehabilitation, rehabilitation length of stay, FIM at discharge, residence at discharge, and 9 months postdischarge rehospitalization, FIM, participation, and subjective well-being. RESULTS: The level of admission FIM cognitive score was found to create relatively homogeneous subgroups for the subsequent analysis of best treatment combinations. There were significant differences in patient and injury characteristics, treatments, rehabilitation course, and outcomes by admission FIM cognitive subgroups. TBI-PBE study patients were overall similar to U.S. national TBI inpatient rehabilitation populations. CONCLUSIONS: This TBI-PBE study succeeded in capturing naturally occurring variation in patients and treatments, offering opportunities to study best treatments for specific patient impairments. Subsequent articles in this issue report differences between patients and treatments and associations with outcomes in greater detail.

Effects of Patient Preinjury and Injury Characteristics on Acute Rehabilitation Outcomes for Traumatic Brain Injury.

OBJECTIVE: To examine associations of patient and injury characteristics with outcomes at inpatient rehabilitation discharge and 9 months postdischarge for patients with traumatic brain injury (TBI). DESIGN: Prospective, longitudinal observational study. SETTING: Inpatient rehabilitation centers. PARTICIPANTS: Consecutive patients (N=2130) enrolled between 2008 and 2011, admitted for inpatient rehabilitation after index TBI, and divided into 5 subgroups based on rehabilitation admission FIM cognitive score. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Rehabilitation length of stay, discharge to home, and FIM at discharge and 9 months postdischarge. RESULTS: Severity indices increased explained variation in outcomes beyond that accounted for by patient characteristics. FIM motor scores were generally the most predictable. Higher functioning subgroups had more predictable outcomes then subgroups with lower cognitive function at admission. Age at injury, time from injury to rehabilitation admission, and functional independence at rehabilitation admission were the most consistent predictors across all outcomes and subgroups. CONCLUSIONS: Findings from previous studies of the relations among patient and injury characteristics and rehabilitation outcomes were largely replicated. Discharge outcomes were most strongly associated with injury severity characteristics, whereas predictors of functional independence at 9 months postdischarge included both patient and injury characteristics.

Patient Effort in Traumatic Brain Injury Inpatient Rehabilitation: Course and Associations With Age, Brain Injury Severity, and Time Postinjury.

OBJECTIVE: To describe patients' level of effort in occupational, physical, and speech therapy sessions during traumatic brain injury (TBI) inpatient rehabilitation and to evaluate how age, injury severity, cognitive impairment, and time are associated with effort. DESIGN: Prospective, multicenter, longitudinal cohort study. SETTING: Acute TBI rehabilitation programs. PARTICIPANTS: Patients (N=1946) receiving 138,555 therapy sessions. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Effort in rehabilitation sessions rated on the Rehabilitation Intensity of Therapy Scale, FIM, Comprehensive Severity Index brain injury severity score, posttraumatic amnesia (PTA), and Agitated Behavior Scale (ABS). RESULTS: The Rehabilitation Intensity of Therapy Scale effort ratings in individual therapy sessions closely conformed to a normative distribution for all 3 disciplines. Mean Rehabilitation Intensity of Therapy Scale ratings for patients' therapy sessions were higher in the discharge week than in the admission week (P<.001). For patients who completed 2, 3, or 4 weeks of rehabilitation, differences in effort ratings (P<.001) were observed between 5 subgroups stratified by admission FIM cognitive scores and over time. In linear mixed-effects modeling, age and Comprehensive Severity Index brain injury severity score at admission, days from injury to rehabilitation admission, days from admission, and daily ratings of PTA and ABS score were predictors of level of effort (P<.0001). CONCLUSIONS: Patients' level of effort can be observed and reliably rated in the TBI inpatient rehabilitation setting using the Rehabilitation Intensity of Therapy Scale. Patients who sustain TBI show varying levels of effort in rehabilitation therapy sessions, with effort tending to increase over the stay. PTA and agitated behavior are primary risk factors that substantially reduce patient effort in therapies.

Enteral Nutrition for Patients With Traumatic Brain Injury in the Rehabilitation Setting: Associations With Patient Preinjury and Injury Characteristics and Outcomes.

OBJECTIVE: To determine the association of enteral nutrition (EN) with patient preinjury and injury characteristics and outcomes for patients receiving inpatient rehabilitation after traumatic brain injury (TBI). DESIGN: Prospective observational study. SETTING: Nine rehabilitation centers. PARTICIPANTS: Patients (N=1701) admitted for first full inpatient rehabilitation after TBI. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: FIM at rehabilitation discharge, length of stay, weight loss, and various infections. RESULTS: There were many significant differences in preinjury and injury characteristics between patients who received EN and patients who did not. After matching patients with a propensity score of >40% for the likely use of EN, patients receiving EN with either a standard or a high-protein formula (>20% of calories coming from protein) for >25% of their rehabilitation stay had higher FIM motor and cognitive scores at rehabilitation discharge and less weight loss than did patients with similar characteristics not receiving EN. CONCLUSIONS: For patients receiving inpatient rehabilitation after TBI and matched on a propensity score of >40% for the likely use of EN, clinicians should strongly consider, when possible, EN for ≥25% of the rehabilitation stay and especially with a formula that contains at least 20% protein rather than a standard formula.

Readmission to an Acute Care Hospital During Inpatient Rehabilitation for Traumatic Brain Injury.

OBJECTIVE: To assess the incidence of, causes for, and factors associated with readmission to an acute care hospital (RTAC) during inpatient rehabilitation for traumatic brain injury (TBI). DESIGN: Prospective observational cohort. SETTING: Inpatient rehabilitation. PARTICIPANTS: Individuals with TBI admitted consecutively for inpatient rehabilitation (N=2130). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: RTAC incidence, RTAC causes, rehabilitation length of stay (RLOS), and rehabilitation discharge location. RESULTS: A total of 183 participants (9%) experienced RTAC for a total of 210 episodes. Of 183 participants, 161 patients experienced 1 RTAC episode, 17 had 2, and 5 had 3. The mean time from rehabilitation admission to first RTAC was 22±22 days. The mean duration in acute care during RTAC was 7±8 days. Eighty-four participants (46%) had ≥1 RTAC episodes for medical reasons, 102 (56%) had ≥1 RTAC episodes for surgical reasons, and 6 (3%) participants had RTAC episodes for unknown reasons. Most common surgical RTAC reasons were neurosurgical (65%), pulmonary (9%), infection (5%), and orthopedic (5%); most common medical reasons were infection (26%), neurological (23%), and cardiac (12%). Any RTAC was predicted as more likely for patients with older age, history of coronary artery disease, history of congestive heart failure, acute care diagnosis of depression, craniotomy or craniectomy during acute care, and presence of dysphagia at rehabilitation admission. RTAC was less likely for patients with higher admission FIM motor scores and education less than high school diploma. RTAC occurrence during rehabilitation was significantly associated with longer RLOS and smaller likelihood of discharge home. CONCLUSIONS: Approximately 9% of patients with TBI experienced RTAC episodes during inpatient rehabilitation for various medical and surgical reasons. This information may help inform interventions aimed at reducing interruptions in rehabilitation for RTAC. RTACs were associated with longer RLOS and discharge to an institutional setting.

Institutional Variation in Traumatic Brain Injury Acute Rehabilitation Practice.

OBJECTIVE: To describe institutional variation in traumatic brain injury (TBI) inpatient rehabilitation program characteristics and evaluate to what extent patient factors and center effects explain how TBI inpatient rehabilitation services are delivered. DESIGN: Secondary analysis of a prospective, multicenter, cohort database. SETTING: TBI inpatient rehabilitation programs. PARTICIPANTS: Patients with complicated mild, moderate, or severe TBI (N=2130). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Mean minutes; number of treatment activities; use of groups in occupational therapy, physical therapy, speech therapy, therapeutic recreation, and psychology inpatient rehabilitation sessions; and weekly hours of treatment. RESULTS: A wide variation was observed between the 10 TBI programs, including census size, referral flow, payer mix, number of dedicated beds, clinician experience, and patient characteristics. At the centers with the longest weekday therapy sessions, the average session durations were 41.5 to 52.2 minutes. At centers with the shortest weekday sessions, the average session durations were approximately 30 minutes. The centers with the highest mean total weekday hours of occupational, physical, and speech therapies delivered twice as much therapy as the lowest center. Ordinary least-squares regression modeling found that center effects explained substantially more variance than patient factors for duration of therapy sessions, number of activities administered per session, use of group therapy, and amount of psychological services provided. CONCLUSIONS: This study provides preliminary evidence that there is significant institutional variation in rehabilitation practice and that center effects play a stronger role than patient factors in determining how TBI inpatient rehabilitation is delivered.

Occupational, Physical, and Speech Therapy Treatment Activities During Inpatient Rehabilitation for Traumatic Brain Injury.

OBJECTIVE: To describe the use of occupational therapy (OT), physical therapy (PT), and speech therapy (ST) treatment activities throughout the acute rehabilitation stay of patients with traumatic brain injury. DESIGN: Multisite prospective observational cohort study. SETTING: Inpatient rehabilitation settings. PARTICIPANTS: Patients (N=2130) admitted for initial acute rehabilitation after traumatic brain injury. Patients were categorized on the basis of admission FIM cognitive scores, resulting in 5 fairly homogeneous cognitive groups. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Percentage of patients engaged in specific activities and mean time patients engaged in these activities for each 10-hour block of time for OT, PT, and ST combined. RESULTS: Therapy activities in OT, PT, and ST across all 5 cognitive groups had a primary focus on basic activities. Although advanced activities occurred in each discipline and within each cognitive group, these advanced activities occurred with fewer patients and usually only toward the end of the rehabilitation stay. CONCLUSIONS: The pattern of activities engaged in was both similar to and different from patterns seen in previous practice-based evidence studies with different rehabilitation diagnostic groups.

Psychotropic Medication Use During Inpatient Rehabilitation for Traumatic Brain Injury.

OBJECTIVE: To describe psychotropic medication administration patterns during inpatient rehabilitation for traumatic brain injury (TBI) and their relation to patient preinjury and injury characteristics. DESIGN: Prospective observational cohort. SETTING: Multiple acute inpatient rehabilitation units or hospitals. PARTICIPANTS: Individuals with TBI (N=2130; complicated mild, moderate, or severe) admitted for inpatient rehabilitation. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Not applicable. RESULTS: Most frequently administered were narcotic analgesics (72% of sample), followed by antidepressants (67%), anticonvulsants (47%), anxiolytics (33%), hypnotics (30%), stimulants (28%), antipsychotics (25%), antiparkinson agents (25%), and miscellaneous psychotropics (18%). The psychotropic agents studied were administered to 95% of the sample, with 8.5% receiving only 1 and 31.8% receiving ≥6. Degree of psychotropic medication administration varied widely between sites. Univariate analyses indicated younger patients were more likely to receive anxiolytics, antidepressants, antiparkinson agents, stimulants, antipsychotics, and narcotic analgesics, whereas those older were more likely to receive anticonvulsants and miscellaneous psychotropics. Men were more likely to receive antipsychotics. All medication classes were less likely administered to Asians and more likely administered to those with more severe functional impairment. Use of anticonvulsants was associated with having seizures at some point during acute care or rehabilitation stays. Narcotic analgesics were more likely for those with history of drug abuse, history of anxiety and depression (premorbid or during acute care), and severe pain during rehabilitation. Psychotropic medication administration increased rather than decreased during the course of inpatient rehabilitation in each of the medication categories except for narcotics. This observation was also true for medication administration within admission functional levels (defined by cognitive FIM scores), except for those with higher admission FIM cognitive scores. CONCLUSIONS: Many psychotropic medications are used during inpatient rehabilitation. In general, lower admission FIM cognitive score groups were administered more of the medications under investigation compared with those with higher cognitive function at admission. Considerable site variation existed regarding medications administered. The current investigation provides baseline data for future studies of effectiveness.

Predictors of Agitated Behavior During Inpatient Rehabilitation for Traumatic Brain Injury.

OBJECTIVE: To identify predictors of the severity of agitated behavior during inpatient traumatic brain injury (TBI) rehabilitation. DESIGN: Prospective, longitudinal observational study. SETTING: Inpatient rehabilitation centers. PARTICIPANTS: Consecutive patients enrolled between 2008 and 2011, admitted for inpatient rehabilitation after index TBI, who exhibited agitation during their stay (n=555, N=2130). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Daytime Agitated Behavior Scale scores. RESULTS: Infection and lower FIM cognitive scores predicted more severe agitation. The medication classes associated with more severe agitation included sodium channel antagonist anticonvulsants, second-generation antipsychotics, and gamma-aminobutyric acid-A anxiolytics/hypnotics. Medication classes associated with less severe agitation included antiasthmatics, statins, and norepinephrine-dopamine-5 hydroxytryptamine (serotonin) agonist stimulants. CONCLUSIONS: Further support is provided for the importance of careful serial monitoring of both agitation and cognition to provide early indicators of possible beneficial or adverse effects of pharmacologic interventions used for any purpose and for giving careful consideration to the effects of any intervention on underlying cognition when attempting to control agitation. Cognitive functioning was found to predict agitation, medications that have been found in previous studies to enhance cognition were associated with less agitation, and medications that can potentially suppress cognition were associated with more agitation. There could be factors other than the interventions that account for these relations. In addition, the study provides support for treatment of underlying disorders as a possible first step in management of agitation. Although the results of this study cannot be used to draw causal inferences, the associations that were found can be used to generate hypotheses about the most viable interventions that should be tested in future controlled trials.

Traumatic Brain Injury Patient, Injury, Therapy, and Ancillary Treatments Associated With Outcomes at Discharge and 9 Months Postdischarge.

OBJECTIVE: To examine associations of patient and injury characteristics, inpatient rehabilitation therapy activities, and neurotropic medications with outcomes at discharge and 9 months postdischarge for patients with traumatic brain injury (TBI). DESIGN: Prospective, longitudinal observational study. SETTING: Inpatient rehabilitation centers. PARTICIPANTS: Consecutive patients (N=2130) enrolled between 2008 and 2011, admitted for inpatient rehabilitation after an index TBI injury. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Rehabilitation length of stay, discharge to home, and FIM at discharge and 9 months postdischarge. RESULTS: The admission FIM cognitive score was used to create 5 relatively homogeneous subgroups for subsequent analysis of treatment outcomes. Within each subgroup, significant associations were found between outcomes and patient and injury characteristics, time spent in therapy activities, and medications used. Patient and injury characteristics explained on average 35.7% of the variation in discharge outcomes and 22.3% in 9-month outcomes. Adding time spent and level of effort in therapy activities and percentage of stay using specific medications explained approximately 20% more variation for discharge outcomes and 12.9% for 9-month outcomes. After patient, injury, and treatment characteristics were used to predict outcomes, center differences added only approximately 1.9% additional variance explained. CONCLUSIONS: At discharge, greater effort during therapy sessions, time spent in more complex therapy activities, and use of specific medications were associated with better outcomes for patients in all admission FIM cognitive subgroups. At 9 months postdischarge, similar but less pervasive associations were observed for therapy activities, but not classes of medications. Further research is warranted to examine more specific combinations of therapy activities and medications that are associated with better outcomes.

Rehospitalization During 9 Months After Inpatient Rehabilitation for Traumatic Brain Injury.

OBJECTIVE: To assess the frequency of, causes for, and factors associated with acute rehospitalization during 9 months after discharge from inpatient rehabilitation for traumatic brain injury (TBI). DESIGN: Multicenter observational cohort. SETTING: Community. PARTICIPANTS: Individuals with TBI (N=1850) admitted for inpatient rehabilitation. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Occurrences of proxy or self-report of postrehabilitation acute care rehospitalization, as well as length of and causes for rehospitalizations. RESULTS: A total of 510 participants (28%) had experienced 775 acute rehospitalizations. All experienced 1 admission (510 participants [66%]), whereas 154 (20%) had 2 admissions, 60 (8%) had 3, 23 (3%) had 4, 27 had between 5 and 11, and 1 had 12. The most common rehospitalization causes were infection (15%), neurological (13%), neurosurgical (11%), injury (7%), psychiatric (7%), and orthopedic (7%). The mean time from rehabilitation discharge to first rehospitalization was 113 days. The mean rehospitalization duration was 6.5 days. Logistic regression analyses revealed that older age, history of seizures before injury or during acute care or rehabilitation, history of brain injuries, and non-brain injury medical severity increased the risk of rehospitalization. Injury etiology of motor vehicle collision and high motor functioning at discharge decreased rehospitalization risk. CONCLUSIONS: Approximately 28% of patients with TBI were rehospitalized within 9 months of TBI rehabilitation discharge owing to various medical and surgical reasons. Future research should evaluate whether some of these occurrences may be preventable (such as infections, injuries, and psychiatric disorders) and should evaluate the extent to which persons at risk may benefit from additional screening, surveillance, and treatment protocols.

A predictive model for pressure ulcer outcome: the Wound Healing Index.

PURPOSE: The purpose of this learning activity is to provide information regarding the creation of a risk-stratification system to predict the likelihood of the healing of body and heel pressure ulcers (PrUs). TARGET AUDIENCE: This continuing education activity is intended for physicians and nurses with an interest in skin and wound care. OBJECTIVES: After participating in this educational activity, the participant should be better able to:1. Explain the need for a PrU risk stratification tool.2. Describe the purpose and methodology of the study.3. Delineate the results of the study and development of the Wound Healing Index. OBJECTIVE: : To create a validated system to predict the healing likelihood of patients with body and heel pressure ulcers (PrUs), incorporating only patient- and wound-specific variables. DESIGN: The US Wound Registry data were examined retrospectively and assigned a clear outcome (healed, amputated, and so on). Significant variables were identified with bivariate analyses. Multivariable logistic regression models were created based on significant factors (P < .05) and tested on a 10% randomly selected hold-out sample. SETTING: Fifty-six wound clinics in 24 states PATIENTS: : A total of 7973 body PrUs and 2350 heel PrUs were eligible for analysis. INTERVENTION: Not applicable MAIN OUTCOME MEASURE: : Healed PrU MAIN RESULTS:: Because of missing data elements, the logistic regression development model included 6640 body PrUs, of which 4300 healed (64.8%), and the 10% validation sample included 709 PrUs, of which 477 healed (67.3%). For heel PrUs, the logistic regression development model included 1909 heel PrUs, of which 1240 healed (65.0%), and the 10% validation sample included 203 PrUs, of which 133 healed (65.5%). Variables significantly predicting healing were PrU size, PrU age, number of concurrent wounds of any etiology, PrU Stage III or IV, evidence of bioburden/infection, patient age, being nonambulatory, having renal transplant, paralysis, malnutrition, and/or patient hospitalization for any reason. CONCLUSIONS: Body and heel PrU Wound Healing Indices are comprehensive, user-friendly, and validated predictive models for likelihood of body and heel PrU healing. They can risk-stratify patients in clinical research trials, stratify patient data for quality reporting and benchmarking activities, and identify patients most likely to require advanced therapeutics to achieve healing.

Development of a wound healing index for patients with chronic wounds.

Randomized controlled trials in wound care generalize poorly because they exclude patients with significant comorbid conditions. Research using real-world wound care patients is hindered by lack of validated methods to stratify patients according to severity of underlying illnesses. We developed a comprehensive stratification system for patients with wounds that predicts healing likelihood. Complete medical record data on 50,967 wounds from the United States Wound Registry were assigned a clear outcome (healed, amputated, etc.). Factors known to be associated with healing were evaluated using logistic regression models. Significant variables (p < 0.05) were determined and subsequently tested on a holdout sample of data. A different model predicted healing for each wound type. Some variables predicted significantly in nearly all models: wound size, wound age, number of wounds, evidence of bioburden, tissue type exposed (Wagner grade or stage), being nonambulatory, and requiring hospitalization during the course of care. Variables significant in some models included renal failure, renal transplant, malnutrition, autoimmune disease, and cardiovascular disease. All models validated well when applied to the holdout sample. The "Wound Healing Index" can validly predict likelihood of wound healing among real-world patients and can facilitate comparative effectiveness research to identify patients needing advanced therapeutics.

Comparison of medication safety systems in critical access hospitals: Combined analysis of two studies.

PURPOSE: The role of pharmacist transcription, onsite pharmacist dispensing, use of automated dispensing cabinets (ADCs), nurse-nurse double checks, or barcode-assisted medication administration (BCMA) in reducing medication error rates in critical access hospitals (CAHs) was evaluated. METHODS: Investigators used the practice-based evidence methodology to identify predictors of medication errors in 12 Nebraska CAHs. Detailed information about each medication administered was recorded through direct observation. Errors were identified by comparing the observed medication administered with the physician's order. Chi-square analysis and Fisher's exact test were used to measure differences between groups of medication-dispensing procedures. RESULTS: Nurses observed 6497 medications being administered to 1374 patients. The overall error rate was 1.2%. The transcription error rates for orders transcribed by an onsite pharmacist were slightly lower than for orders transcribed by a telepharmacy service (0.10% and 0.33%, respectively). Fewer dispensing errors occurred when medications were dispensed by an onsite pharmacist versus any other method of medication acquisition (0.10% versus 0.44%, p = 0.0085). The rates of dispensing errors for medications that were retrieved from a single-cell ADC (0.19%), a multicell ADC (0.45%), or a drug closet or general supply (0.77%) did not differ significantly. BCMA was associated with a higher proportion of dispensing and administration errors intercepted before reaching the patient (66.7%) compared with either manual double checks (10%) or no BCMA or double check (30.4%) of the medication before administration (p = 0.0167). CONCLUSION: Onsite pharmacist dispensing and BCMA were associated with fewer medication errors and are important components of a medication safety strategy in CAHs.

A Predictive Model for Diabetic Foot Ulcer Outcome: The Wound Healing Index.

Objective: To develop a healing index for patients with diabetic foot ulcers (DFUs) for use in clinical practice, research analysis, and clinical trials. Approach: U.S. Wound Registry data were examined retrospectively and assigned a clear outcome (healed, amputated, etc.). Significant variables were identified with bivariate analyses. A multivariable logistic regression model was created based on significant factors (p < 0.05) and tested on a hold-out sample of data. Out of 13,266 DFUs from the original dataset, 6,440 were eligible for analysis. The logistic regression model included 5,239 ulcers, of which 3,462 healed (66.1%). The 10% validation sample utilized 555 ulcers, of which 377 healed (67.9%). Results: Variables that significantly predicted healing were as follows: wound age (duration in days), wound size, number of concurrent wounds of any etiology, evidence of bioburden/infection, patient age, Wagner grade, being nonambulatory, renal dialysis, renal transplant, peripheral vascular disease, and patient hospitalization for any reason. Innovation: We present a validated stratification system, previously described as the Wound Healing Index (WHI), which predicts healing likelihood of patients with DFUs, incorporating patient- and wound-specific variables. Conclusion: The DFU WHI is a comprehensive and user-friendly validated predictive model for DFU healing. It can risk stratify patients enrolled in clinical research trials, stratify patient data for quality reporting and benchmarking activities, and identify patients most likely to require costly therapy to heal.