Effectiveness of Community-Based Rehabilitation After Traumatic Brain Injury for 489 Program Completers Compared With Those Precipitously Discharged

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1 ORIGINAL ARTICLE Effectiveness of Community-Based Rehabilitation After Traumatic Brain Injury for 489 Program Completers Compared With Those Precipitously Discharged Irwin M. Altman, PhD, MBA, Shannon Swick, MA, Devan Parrot, BS, James F. Malec, PhD, ABPP-Cn, Rp P ABSTRACT. Altman IM, Swick S, Parrot D, Malec JF. OSTACUTE BRAIN INJURY rehabilitation typically consists of an individualized program of rehabilitation therapies Effectiveness of community-based rehabilitation after traumatic brain injury for 489 program completers compared with delivered in an integrated fashion by an interdisciplinary team. those precipitously discharged. Arch Phys Med Rehabil 2010; PABIR programs are designed to remediate or develop compensation techniques for impairments and disabilities, but also may 91: focus on changing the physical, social, and family environments Objective: To evaluate outcomes of home- and communitybased postacute brain injury rehabilitation (PABIR). on everyday functioning and community participation. (for instance, see High et al 1 ) to minimize the impact of disability Design: Retrospective analysis of program evaluation data Evidence-based reviews 2-4 of brain injury rehabilitation generally have reported positive findings for this type of multi- for treatment completers and noncompleters. Setting: Home- and community-based PABIR conducted in modal interdisciplinary rehabilitation, but noted a dearth of 7 geographically distinct U.S. cities. rigorously controlled trials. In arguably the most rigorously Participants: Patients (N 489) with traumatic brain injury designed study, Cicerone et al 5 conducted a practical RCT of who completed the prescribed course of rehabilitation (completed-course-of-treatment [CCT] group) compared with 114 compared with standard outpatient rehabilitation (n 34). The intensive outpatient holistic brain injury rehabilitation (n 34) who were discharged precipitously before program completion intensive treatment resulted in greater improvements in community integration, quality of life, and self-efficacy than stan- (precipitous-discharge [PD] group). Intervention: PABIR delivered in home and community dard care. A randomized trial 6 conducted in Britain compared settings by certified professional staff on an individualized community-based brain injury rehabilitation (n 46) with a control group receiving only educational materials (n 48). basis. The treatment group showed greater gains on Barthel Index, Main Outcome Measures: Mayo-Portland Adaptability Functional Independence/Assessment Measure, and Brain Injury Community Rehabilitation Outcome-39 scores than con- Inventory (MPAI-4) completed by means of professional consensus on admission and at discharge; MPAI-4 Participation Index at 3- and 12-month follow-up through tele- although blinding was described as imperfect. trols. Outcomes were assessed by an independent evaluator, phone contact. Other studies of PABIR have been less rigorously controlled. High 1 conducted a nonrandomized cohort study of a Results: Analysis of covariance (CCT vs PD group as between-subjects variable, admission MPAI-4 score as covariate) community reentry rehabilitation program. Outcomes were examined for 3 chronicity groups consisting of those entering the showed significant differences between groups at discharge on the full MPAI-4 (F 82.25; P.001), Ability Index (F 50.24; program (1) within 6 months of injury (n 115), (2) within 6 to P.001), Adjustment Index (F 81.20; P.001), and Participation Index (F 59.48; P.001). A large portion of the sam- (n 29). All groups showed reduced disability and improved 12 months (n 23), and longer than 12 months postinjury ple was lost to follow-up; however, available data showed that independence and productivity from before to after the program and maintained these gains at 5 to 12 months of follow- group differences remained statistically significant at follow-up. up. The group entering rehabilitation within 6 months of injury Conclusions: Results provided evidence of the effectiveness continued to show gains between discharge and follow-up. of home- and community-based PABIR and that treatment Seale et al 7 described positive changes on the Community effects were maintained at follow-up. Key Words: Brain injuries; Rehabilitation by the American Congress of Rehabilitation List of Abbreviations Medicine ANCOVA analysis of covariance CARF Commission on Accreditation of Rehabilitation Facilities CCT completed-course-of-treatment GCS Glasgow Coma Scale From the Gentiva Rehab Without Walls, Phoenix, AZ (Altman); Gentiva Rehab Without Walls, Marshall, MI (Swick); Rehabilitation Hospital of Indiana (Parrot, Malec); and Indiana University School of Medicine (Malec), Indianapolis, IN. No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated. Reprint requests to James F. Malec, PhD, ABPP-Cn, Rp, Rehabilitation Hospital of Indiana, 4141 Shore Dr, Indianapolis, IN 46254, jmalec@rhin.com /10/ $36.00/0 doi: /j.apmr LOC LOS MPAI-4 PABIR PD PTA RCT TBI loss of consciousness length of stay Mayo-Portland Adaptability Inventory postacute brain injury rehabilitation precipitous-discharge posttraumatic amnesia randomized controlled trial traumatic brain injury 1697

2 1698 EFFECTIVENESS OF COMMUNITY-BASED REHABILITATION, Altman Integration Questionnaire for 87 adults with brain injury who participated in a community integration rehabilitation program. Those entering the program within 1 year postinjury showed greater improvement than those entering 1 to 5 years postinjury. Pace et al 8 studied 77 patients with brain injury; most (68%) were children and adolescents. Through a course of home- and community-based services, participants achieved 77% of their goals at discharge and maintained these gains at 6 and 12 months of follow-up. A number of factors frustrate rigorous experimental investigation of PABIR. 9 The individualized nature of PABIR makes it difficult to deliver manualized treatment without restricting the composition of the sample to the point at which the sample no longer represents a typical community-based referral group. The extensiveness and interactive nature of the treatment discourages single blinding, precludes double blinding, and interferes with developing believable sham control conditions. Ethical concerns also arise because despite limitations in the scientific evidence supporting PABIR, most providers and consumer groups believe that patients have a right to such treatment after brain injury. An additional concern about RCTs in many areas of medicine is that results of these highly controlled experimental trials with highly selected samples may not generalize to community populations. Many of these same concerns have been raised in other areas of health care delivery and have led to alternative methods of investigation, such as observational and community-based trials. 10 In clinical medicine research generally, observational trials typically included more representative patient samples and have yielded conclusions similar to RCTs. 11 What large-number naturalistic community-based observational trials lack in scientific rigor may be offset to a degree by the potential to generalize findings to community populations. For these reasons, we believe there is value in reporting results of observational community-based trials of PABIR, particularly with large samples. In this study, we report results of the retrospective analysis of program evaluation data for more than 600 patients with TBI using the MPAI-4 as the outcome measure. In assessing objective outcomes, most prior studies of PABIR have used more circumscribed measures or indicators that focused on independent living and vocational outcomes. MPAI-4 ratings also were available for a group of patients for whom treatment was terminated before completion. Although not a rigorous control condition, this PD group provides a comparison group that was assessed as appropriate for the intervention under study, but did not receive the benefit of the entire planned rehabilitation program. Before data analyses, the following hypotheses were developed for this study: (1) that patients who completed a planned program of community-based PABIR would show greater changes on the MPAI-4 from before to after the rehabilitation program than those for whom treatment was terminated prematurely, and (2) that positive changes for program completers would be maintained at follow-up 3 months and 1 year after discharge from the program. METHODS Participants The study sample consisted of consecutive admissions with TBI for community-based rehabilitation with admission and discharge MPAI-4 data; 489 completed the prescribed rehabilitation program (CCT group) and 114 were discharged before program completion (PD group). Participants were admitted using the following admission criteria: (1) medically stable enough to participate in rehabilitation and had medical supports Table 1: Demographic and Injury-Related Variables by Group Variable CCT (n 489) PD (n 114) Men (%) Age (y) t 0.34 Chronicity (d) t 2.00* Mild Moderate Severe Unknown 9 11 LOS (d) t 5.04 *.05;.001. in place to maintain stability in the proposed living environment, (2) potential to achieve specified rehabilitation goals in the home and community setting, (3) reside in a safe and accessible environment with adequate supervision and support so that they are not at risk when therapists are not on site, (4) behaviors are manageable in the proposed treatment environment, and (5) able to consent by self or proxy to admission/ treatment. A potential participant s ability to meet these criteria was determined by means of a preadmission screening assessment conducted by a qualified evaluator generally through face-to-face interview and review of available medical records. Participants or their proxies signed consent forms on admission to allow their data to be included in this study. Although consent for data use was obtained from each participant, data collection originally was planned for only program evaluation purposes, in other words, this was not a prospective research study. Approval through the Indiana University Institutional Review Board for retrospective analysis of these data was obtained prior to data acquisition. At discharge, participants were classified as CCT or PD according to the following definitions. Completed course of treatment. The participant received services as initially targeted toward 1 or more functional outcome goals (eg, independent living status, independence in personal activities of daily living) with at least 2 clinical disciplines other than clinical coordination. Precipitous discharge. Any discharge that allowed less than 1 week of preparation time before discharge or was unanticipated. This included situations in which the participant, family, physician, payer, and/or program staff decided to discharge before reaching the agreed-on outcome goals in the plan of treatment. However, if the discharge was planned for and goals were set accordingly, it was not considered a PD even if goals were not met. The program was discontinued at the request of patient or significant others in 57% of the PD group; at the request of the payer in 29% of cases, on the recommendation of the patient s physician in 10%, and for unspecified reasons in 4%. There was no difference between the group for which the PD decision was made by patient or significant other compared with other cases for age (t 1.11; P.271), sex (Fisher exact test.83; P.454), injury severity ( ; P.275), chronicity (t 1.18; P.239), LOS (t.81, P.418), admission MPAI-4 total score (t.82; P.412), or MPAI-4 discharge total score with admission score covaried (F.54; P.466). Demographic and injury-related variables for both groups are listed in table 1. comparisons between groups found no significant differences between the CCT and PD

3 EFFECTIVENESS OF COMMUNITY-BASED REHABILITATION, Altman 1699 groups at enrollment for age (t.34; P.963), sex ( 2.69; P.406), or injury severity ( ; P.725). Chronicity (ie, time since injury) was significantly longer in the CCT group than the PD group (t 2.00; P.011). As expected, the CCT group had a longer LOS in the program (t 5.04; P.008). Measures Mayo-Portland Adaptability Inventory. The primary outcome measure was the MPAI-4 completed at program admission and discharge by consensus of the rehabilitation team working with the participant. The current version of the MPAI is the product of almost 20 years of evaluation and refinement and has satisfactory internal consistency and construct validity, 12,13 as well as concurrent 14 and predictive validity. The MPAI is sensitive to change in studies of rehabilitation interventions. 15,18 The MPAI-4 Participation Index provides a measure of community participation and also has well-established psychometric properties. 19,20 The Participation Index score correlates highly with the full MPAI score. 21 The Participation Index measures initiation, social contact, leisure, selfcare, residence, transportation, employment, and money management. The Participation Index was completed 3 and 12 months after discharge through telephone follow-up with either the participant or a significant other. Injury severity. Injury severity was calculated using GCS scores, length of PTA, and coma length using the following algorithm: severe indicates GCS score less than 9, LOC longer than 24 hours, or PTA longer than 1 week; moderate indicates GCS score of 9 to 12, LOC of 30 minutes to 24 hours, or PTA of 24 hours to 1 week; and mild indicates GCS score higher than 12, LOC less than 30 minutes, or PTA less than 24 hours. If more than 1 indicator was present and differed in level of severity, the most severe level was assigned. Of the total sample, 17% had mild brain injury; 19%, moderate; and 54%, severe. Ten percent had insufficient data for classification. Procedures All study participants were actively involved in a postacute home- and community-based rehabilitation program. Therapy services were provided by CARF-accredited home- and community-based rehabilitation programs in 7 geographically diverse states owned by a single rehabilitation corporation (Gentiva Rehab Without Walls). Quality assurance mechanisms are in place to maintain treatment consistency across sites within this system. Home- and community-based rehabilitation is defined by CARF as a program that provides integrated, casemanaged, and outcomes-focused rehabilitation. Services were developed from a comprehensive needs assessment and focus on the expectations and outcomes identified by the person served and the program. All therapeutic interventions were conducted by licensed or certified clinicians and/or assistants according to each individual state s practice act in a variety of settings, including the client s home, community locations, public facilities, and work/school sites. Participants received a variety of rehabilitation therapies based on individual need and physician prescription. Therapies included at least 2 of the following: occupational therapy, physical therapy, speech language therapy, psychological intervention, social work, therapeutic recreation, and case coordination. On admission to the program, clinical evaluations were conducted by each discipline for which a physician s order was present. These assessments were provided within the first 2 weeks after admission. After the initial assessment period, the treatment team met to complete the admission MPAI-4 assessment based on professional consensus. Other patient data also were collected at this time. Staff at the various clinical locations who were engaged in outcomes data collection were provided with written materials regarding the process of data collection, form completion, and manuals for the clinical outcomes tools used. These materials are reviewed annually to determine whether processes need to be altered for changes in the work environments. Staff also were provided with a presentation that details the process. With respect to the MPAI-4, each clinician was instructed to refer to the MPAI-4 manual 22 for detailed rating instructions for each and every item and to not rely on the simplified rating scale on the questionnaire itself. It continuously was stressed that referring to the manual was especially important to ensure interrater reliability, which aids in determining the consensus of the professional team. During this initial treatment team meeting, individual interdisciplinary treatment goals were established for each participant. Treatment goals generally focused on improved ability to perform activities of daily living, decreased need for supervision, and improved cognitive functioning and may or may not have included return to work or school. At the time of discharge from the home- and community-based rehabilitation program or postclinical intervention, participants again were rated through professional consensus on the MPAI-4. Rating clinicians were blinded to participants classification as PD or CCT and were not aware of a study analyzing differences between the 2 groups. data were collected for only the Participation Index of the MPAI-4 by means of telephone. Of the 202 CCT cases contacted for follow-up at 3-months, information relevant to completing the Participation Index was obtained from 141 (70%) participants themselves and from a significant other in an additional 60 (30%); respondent type was not recorded in 1 case. Information was obtained from 31 (69%) participants and 14 (31%) significant others in the 45 PD cases contacted at the 3-month follow-up. For the 112 CCT cases contacted at the 12-month follow-up, 78 (64%) participants and 31 (28%) significant others provided information; respondent type was not recorded in 3 cases. For the 20 cases in the PD group at the 12-month follow-up, 12 (60%) participants and 8 (40%) significant others provided information. RESULTS Admission MPAI-4 No significant differences were found between groups on the MPAI-4 total score at enrollment (t 1.07; P.101) or subscale scores: Ability Index (t.73; P.109), Adjustment Index (t 1.52; P.217), and Participation Index (t.23; P.273). Outcome Posttreatment ANCOVA was used to analyze MPAI-4 total raw scores and all subscale raw scores at discharge. Group (CCT vs PD) was used as the between-subjects variable and MPAI-4 score at baseline was used as the covariate. Significant differences between groups were present at discharge for the full MPAI-4 (F 82.25; P.001), Ability Index (F 50.24; P.001), Adjustment Index (F 81.20; P.001), and Participation Index scores (F 59.48; P.001). Effect sizes were moderate; partial 2 for total score was.12; for Ability Index,.08; for Adjustment Index,.12; and for Participation Index,.09. Partial 2 describes the percentage of variance on the dependent measure that is independently accounted for by an independent variable. 23 Using Cohen s 24 guidelines, variance accounted in approximately 1% is a small effect size and greater than 25% is a large effect size, with moderate effects in between.

4 1700 EFFECTIVENESS OF COMMUNITY-BASED REHABILITATION, Altman discharge. In contrast, the change for the PD group was only about one-half an SD. Figure 2 shows changes from admission to discharge for each MPAI-4 index score. As shown, the magnitude of changes on the MPAI-4 index scores mirrors that of the total score. Fig 1. MPAI-4 total standard score by group at admission and discharge. Because groups differed for chronicity and LOS (see table 1), we also analyzed results using these factors as additional covariates. These analyses also showed significant differences between the groups at discharge for the full MPAI-4 (F 89.30; P.001), Ability Index (F 51.95; P.001), Adjustment Index (F 92.05; P.001), and Participation Index scores (F 64.00; P.001). Chronicity contributed significantly to the prediction of total (F 21.17; P.034), Ability Index (F 16.02; P.001), Adjustment Index (F 13.25; P.001), and Participation Index scores (F 15.68; P.001). LOS did not account for additional independent variance in the regression model. Effect sizes again were moderate; partial 2 for total score was.13; for Ability Index score,.08; for Adjustment Index score,.13; and for Participation Index score,.10. Figure 1 shows changes in total MPAI-4 score from baseline to posttreatment for each group. Raw scores were used in all statistical tests of MPAI-4 scores. However, to better illustrate the magnitude of change, T scores are reported in the figures using the baseline mean SD for all subjects to accomplish this conversion. These T scores were computed so that higher scores indicate better outcomes. As shown, the CCT group on average changed a little more than 1SD from admission to at 3 Months A large percentage of subjects were lost to follow-up primarily because follow-up was conducted using limited clinical resources without specific funding for this activity. At the 3-month follow-up, 202 (41%) of 489 CCT participants and 45 (39%) of 114 PD participants were contacted. Nonetheless, because the number of CCT participants contacted at follow-up was relatively large, these data are reported. We looked for systematic bias related to demographic and injury-related variables by contrasting those who completed follow-up with those who did not in both the CCT and PD groups (tables 2 and 3). CCT subjects with 3-month follow-up data (n 202) did not differ from CCT subjects without 3-month follow-up (n 287) for sex ( ; P.281), chronicity (t 1.89; P.060), or MPAI-4 total raw score on admission (t.24; P.809) or discharge (t.68; P.499) and were about at threshold for significance or slightly above for age (t 1.93; P.054), LOS (t 1.93; P.054), and injury severity ( ; P.042). Inspection of table 2 shows a small preponderance of severe cases in the CCT group with 3-month follow-up data. There were no significant differences between those in the PD group with (n 45) and without 3-month follow-up (n 69) for sex ( 2.75; P.386), age (t.58; P.563), chronicity (t 1.16; P.253), injury severity ( ; P.686), or LOS (t.42; P.679). However, the PD group with follow-up had less impaired (lower) MPAI-4 total scores on both admission (t 2.84; P.005) and discharge (t 2.39; P.019). Notably, although the PD group with follow-up was less impaired on admission, this group did not differ from the PD group without follow-up in degree of change from admission to discharge. Figure 3 shows T scores (converted based on baseline values) for the Participation Index at each assessment point. As noted, the Participation Index was extracted from the full MPAI-4 completed by consensus at admission and discharge; follow-up data were obtained by means of telephone from the participant, if possible, or a significant other. As shown in Table 2: Demographic and Injury-Related Variables for the CCT Group With and Without 3-Month Data Variable CCT With (n 202) CCT Without (n 287) Men (%) Age (y) t 1.93 Chronicity (d) t * Mild Moderate Severe Unknown 5 12 LOS (d) t 1.93 Raw MPAI-4 total score Admission t 0.24 Discharge t 0.68 *.05. Table 3: Demographic and Injury-Related Variables for PD Group With and Without 3-Month Data Variable PD With (n 45) PD Without (n 69) Men (%) Age (y) t 0.58 Chronicity (d) t Mild Moderate Severe Unknown 7 13 LOS (d) t 0.42 Raw MPAI-4 total score Admission t 2.84* Discharge t 2.39 *.01;.05.

5 EFFECTIVENESS OF COMMUNITY-BASED REHABILITATION, Altman 1701 Table 4: Demographic and Injury-Related Variables for CCT Group With and Without 12-Month Data Variable CCT With (n 112) CCT Without (n 377) Men (%) Age (y) t 1.32 Chronicity (d) t Mild Moderate Severe Unknown 5 11 LOS (d) t 1.64 Raw MPAI-4 total score Admission t 0.17 Discharge t 1.66 Table 5: Demographic and Injury-Related Variables for the PD Group With and Without 12-Month Data Variable PD With Follow-Up (n 20) PD Without Follow-Up (n 94) Men (%) Age (y) t 1.23 Chronicity (d) t Mild Moderate 5 18 Severe Unknown LOS (d) t 1.06 Raw MPAI-4 total score Admission t 0.75 Discharge t 1.16 figure 3, outcomes trended toward improvement after discharge for both groups. However, the CCT group continued to show outcomes superior to those of the PD group. ANCOVA with MPAI-4 Participation Index score at 3-month follow-up as the dependent measure, group as the between-subjects variable, and admission score on the Participation Index as the covariate confirmed a significant difference between groups (F 7.40; P.001). However, the effect size was small (partial 2.03). Because of possible variation between groups for age, chronicity, LOS, and injury severity, analysis was repeated using these additional covariates. A significant effect for group again was apparent (F 13.59; P.001), with a somewhat larger effect size (partial 2.06). Chronicity (F 6.83; P.010), injury severity (F 7.04; P.009), and LOS (F 10.03; P.002) accounted for independent variance on the outcome measure, but age did not. 12-Month Additional participants were lost to follow-up at 12 months. Only 112 (23%) of the original 489 CCT subjects and 20 of the original 114 (18%) PD subjects were contacted at this time. Differences in demographic and injury-related variables between those with and without 12-month follow-up data were examined (tables 4 and 5). There were no significant differences between CCT participants with (n 112) and without 12-month follow-up (n 377) for sex ( ; P.139), age (t 1.32; P.187), chronicity (t.48; P.629), injury severity ( ; P.139), LOS (t 1.64; P.145), or MPAI-4 total raw score on admission (t.17; P.927) or discharge (t 1.66; P.131). Similarly, there were no significant differences between PD subjects completing (n 20) and not completing follow-up (n 94) for sex ( ; P.077), age (t 1.23; P.290), chronicity (t.20; P.840), injury severity ( ; P.512), LOS (t 1.06; P.290), or MPAI-4 total raw score on admission (t.75; P.456) or discharge (t 1.16; P.248). Outcomes at 12 months continued to trend up for both groups (see fig 3), but remained superior for the CCT group. ANCOVA with MPAI-4 Participation Index score at 12-month follow-up as the dependent measure, group as the betweensubjects variable, and admission score on the Participation Index as the covariate confirmed a significant difference between groups (F 3.99; P.048) with a small effect size (partial 2.03). Those who completed follow-up did not appear to Fig 2. T Scores for MPAI-4 indexes at admission and discharge by group.

6 1702 EFFECTIVENESS OF COMMUNITY-BASED REHABILITATION, Altman Fig 3. MPAI-4 Participation Index standard score by group on admission, discharge, and 3- and 12-month follow-up (numbers in graph indicate numbers of participants at each time). Fig 4. MPAI-4 total standard score for chronic cases (time since injury >1y) by group at admission and discharge. differ from those who did not for demographic or injury-related variables; hence, we controlled for only possible differences in chronicity and LOS (as suggested by original group contrasts) (see table 1) in additional ANCOVA. Results documented a significant effect for group (F 6.67; P.011) with a larger effect size (partial 2.05). Both chronicity (F 3.93; P.050) and LOS (F 7.45; P.007) accounted for independent variance for the outcome variable. Subanalyses of Long Term Cases To address the possibility that spontaneous recovery contributed markedly to changes recorded for the PD group, we conducted analyses similar to those reported previously, limiting the sample to cases admitted to the program more than a year postinjury. Our assumption was that spontaneous recovery would be a less prominent effect in these more long-term cases. Because, consistent with recommended practice, early intervention is part of the philosophy of the rehabilitation system providing treatment, numbers of long-term cases were much smaller than the total sample, reducing the power of statistical tests. Only 94 CCT and 20 PD cases were admitted to the program more than 1 year after injury. Nonetheless, results for this more long-term group were consistent with those obtained for the entire sample. Consistent with our assumption of less evidence of spontaneous recovery in these long-term patients, the PD group showed minimal improvement on the total MPAI-4 score from admission (mean T score 50.70) to discharge (mean T score 51.44). In contrast, the mean score for the long-term CCT group improved from on admission to on discharge (fig 4). ANCOVA on MPAI-4 score at discharge with group as the between-subjects variable and admission MPAI-4 score as the covariate showed significant differences for group on the full MPAI-4 (F 17.92; P.001; partial 2.139), Ability Index (F 8.61; P.004; partial 2.072), Adjustment Index (F 20.58; P.001; partial 2.156), and Participation Index scores (F 8.60; P.004; partial 2.072). At the 3-month follow-up, 42 participants remained in the CCT group and 11 remained in the PD group. ANCOVA of MPAI-4 Participation Index score at the 3-month follow-up with group as the between-subjects variable and MPAI-4 Participation Index score as the covariate did not find a significant a difference between groups (F 2.43; P.125). Because there were only 19 long-term cases in the CCT group and 5 in the PD group at 1 year of follow-up, analysis at this time was judged inappropriate. DISCUSSION Based on retrospective analysis of program evaluation data, this large observational study indicates that PABIR delivered in the home and community settings resulted in substantial positive changes in physical and cognitive abilities, adjustment, and community participation, assessed by using the MPAI-4. CCT participants who completed the planned courses of rehabilitation made significant gains on the MPAI-4 relative to the comparison PD participants who did not complete the treatment course. Changes for the CCT group (see figs 1 3) amounted to more than 1-SD difference from admission to discharge, representing moderate effects. To control to a degree for spontaneous recovery, we conducted subanalyses of a group of more long-term cases admitted more than 1 year postinjury. Because the philosophy of the rehabilitation system that provided treatment, as well as many payors, endorses early intervention, the sample size for the long-term group was substantially decreased and analyses, particularly at follow-up, were underpowered. Nonetheless, a spontaneous recovery effect was not apparent in the more long-term PD group (see fig 4). By comparison, the long-term CCT group showed significantly superior improvement from pre- to posttreatment. The change for the long-term intervention group was less than that for the full sample, which was composed mostly of patients admitted within 1 year of injury. Other research 25 also has shown that greater chronicity has a negative impact on rehabilitation outcome. However, it also should be noted that effect sizes (compared with no change for the PD group) remained in the moderate range. These results support our primary hypothesis of the effectiveness of this model of PABIR. Data were gathered from 7 programs in 7 distinct sites across the United States. Although information was not available to show that this sample is representative of all patients with TBI, the size and geographic diversity of the sample suggest that findings are generalizable to U.S. residents with persistent disabilities after TBI. The large size and diversity of the sample and associated potential for generalization to community populations is a strength of this study and of observational studies of this type. There was substantial loss of cases at 3 and 12 months of follow-up. Informal communications with staff involved in follow-up data collection suggest that lack of follow-up pri-

7 EFFECTIVENESS OF COMMUNITY-BASED REHABILITATION, Altman 1703 marily was caused by limited staff time for this activity. Nonetheless, available data suggest that the CCT group continued to make gradual progress in community participation after discharge from rehabilitation (see fig 3), supporting our secondary hypothesis that gains in the program would be maintained at follow-up. An essential part of the community-based rehabilitation program was training family and significant others to support continued therapeutic work after the formal therapy program was discontinued. Continued self- and family-directed therapy may have contributed to continuing improvement during follow-up. The CCT and PD groups differed for chronicity and LOS (see table 1), and age, injury severity, and admission MPAI-4 score distinguished those lost to follow-up at 3 months (see tables 2 and 3). Although greater severity for the CCT group and less disability for the PD group at the 3-month follow-up suggest bias in favor of enhanced outcome for the PD group, the CCT group continued to show statistically superior outcomes at the 3-month follow-up. Consistent with bias in favor of the PD group, including these variables as covariates magnified the group treatment effect. The PD group does not represent a rigorous control condition because assignment to this group was not done prospectively in a random or unbiased way. In this retrospective study, it was not possible to determine precisely why patients, their families, or their physicians decided to terminate the program precipitously. In many cases, discharge appeared to occur precipitously because of factors beyond the participant s control, such as lack of funding, transportation, changes in living situation, or family ability to provide support. It is possible that in some cases, those precipitously discharged were less engaged in treatment or had more dysfunctional behaviors that interfered with treatment. However, the lack of difference between the CCT and PD groups on the Adjustment Index score suggests that the groups did not differ in such characteristics as anxiety, depression, irritability, self-awareness, or inappropriate interpersonal behavior. Therefore, although we cannot exclude the possibility that the PD comparison group was in some undiscovered way substantially different from the CCT group, there is little evidence of a difference between groups that would favor a better outcome for the CCT group. In the end, it is reasonable to conclude that a group of patients with TBI who complete a planned course of home- and community-based PABIR improve more in ability, adjustment, and community participation than those who for whatever reason do not complete the planned rehabilitation program. Study Limitations As described, limitations of this study include the absence of a randomly selected control condition and the possibility of selective recidivism on follow-up. Another limitation is that information for making ratings on the Participation Index at follow-up was gathered over the telephone from participants or a significant other, whereas the Participation Index at admission and discharge was rated by means of professional consensus based on evaluations and interviews with participants and significant others, as well as all other available information. A previous study showed that MPAI-4 ratings made by professionals, patients with brain injury, and their significant others generally agreed. 19 However, the equivalency of the quality of Participation Index data obtained in this study at admission, discharge, and follow-up cannot be assumed. CONCLUSIONS In summary, this retrospective analysis of a large program evaluation data set for a multisite home- and community-based PABIR program showed significant positive changes from admission to discharge for participants who completed the prescribed course of rehabilitation compared with those who were discharged precipitously. Available follow-up data suggest that gains were maintained 3 and 12 months after discharge. Although this observational study lacked the experimental rigor of an RCT, there are numerous obstacles to successfully conducting an RCT in this type of setting. These obstacles include difficulty blinding providers and participants to the treatment condition, difficulty formulating a credible control condition, and bleedover of active treatment elements to the control condition during an extended intervention period. Additionally, there is an absence of funding mechanisms for a large-scale outpatient rehabilitation RCT that, even if successful, would not yield a product that would generate sufficient revenue in the current reimbursement environment to make investment in this type of research financially attractive. Thus, large-scale observational studies of the type reported here are believed to be of value in identifying PABIR practices likely to result in substantial improvements in abilities, adjustment, and community participation. Future study is planned in an attempt to identify statistical models, based on participants demographic, injury, and disability characteristics, for predicting which participants are likely to benefit most from this type of rehabilitation. References 1. High WM Jr, Roebuck-Spencer T, Sander AM, Struchen MA, Sherer M. Early versus later admission to postacute rehabilitation: impact on functional outcome after traumatic brain injury. 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