Several studies have shown that early symptoms of emotional distress are common after physical trauma, including major limb trauma.1–8 Despite this knowledge, too often attention is focused on surgical management and physical recovery without acknowledging the psychosocial needs of patients and their families. If negative emotions and maladaptive responses are not recognized and proactively managed early in the recovery process, they can result in anxiety, posttraumatic stress disorder (PTSD), and depression which, in turn, can impact long-term functional outcomes, return to usual major activity and quality of life.9–13 Patient- and family-centered programs that address mental health and social needs, with appropriate screening in the trauma center and provision of required services, widen the focus of attention from the patient's medical needs to the needs of the patient as a whole.
In this article, one such program is described together with the design of a national study to evaluate the program's effectiveness for improving outcomes after major orthopaedic trauma. The baseline characteristics of the study population for the evaluation are described with attention paid to differences in patients treated at the intervention and control (usual care) sites.
BACKGROUND: THE TRAUMA COLLABORATIVE CARE PROGRAM
The design of the Trauma Collaborative Care (TCC) program was based on the principles of well-established models of collaborative care that emphasize the importance of “informed, activated” patients interacting with “prepared, proactive practice teams.”14 Empowering patients to take charge of their recovery by increasing self-efficacy and activation is a central component of these models. An increasing body of literature suggests that 2 approaches are particularly helpful in promoting these traits: (1) cognitive–behavioral-based self-management programs15–17 and (2) peer support and peer visitation programs,18,19 and the emphasis on these skills is a commonality between collaborative care models. Providers, in turn, receive coaching in how to support patient engagement and ensure a continuum of care in response to patient needs. The use of nonphysician support to ensure providers and patients establish and follow a mutually determined treatment plan also seems critical to the success of this model.14,20
The centerpiece of the TCC program is the Trauma Survivors Network (TSN) (http://www.traumasurvivorsnetwork.org), developed by the American Trauma Society with the goal of connecting trauma survivors with one another and increasing their self-efficacy, support network, and self-management skills.21–23 The TSN is a suite of services trauma centers provide to their patients that includes the following: (1) access to the TSN website and receipt of the Trauma Patient and Family Handbook; (2) peer visitation in the hospital; (3) family education classes, (4) peer support groups, and (5) self-management classes (offered both online and in person). The TCC program enhances the effectiveness of the TSN within the context of a collaborative care model by training providers to proactively screen for risk and protective factors and reinforce the referral to and the use of TSN programs and additional services as needed. The TCC program uses TSN Coordinators to conduct individualized Recovery Assessments, provide feedback to the patient and provider, and link patients to the TSN and community resources. The TSN Coordinators also provide targeted coaching during the early phases of recovery. Resources of the TCC program are made available early during the initial hospitalization and then for several months after discharge on an as needed basis. These resources are described below.
Resources Available During Initial Hospitalization
During the initial hospitalization, the TSN Coordinator visits the patients and families, provides an overview of the TSN and a copy of the Handbook for Trauma Patients and Their Families. The Handbook, customized for individual hospitals, provides general information about traumatic injuries, the hospital experience, the roles of the professionals providing care, medical terminology, and practical information for families navigating the hospital stay and the discharge process. Patients and their families are also introduced to the TSN website and encouraged to register as members. The website is a resource for connecting survivors with one another, learning about trauma and its consequences, and finding out what programs are available to them through the TSN and the trauma center.
The TSN Coordinator also offers 2 important services to patients and their families while they are still in the hospital: peer visitation and family support. Each patient is offered an opportunity to receive a visit from a peer, someone who has been through a similar trauma and can offer support and a personal perspective on the recovery process. All peer visitors are trained specifically for the TSN. Visits focus on (1) offering the patient an opportunity to share his/her experience; (2) providing encouragement and communicating empathy; and (3) answering questions and offering a perspective from someone who has “been there”.
TSN Family Support Classes are designed to help prepare family members for the caregiving role by providing resources and information. Classes are typically offered once per week and provide an opportunity for family members to connect with others who are experiencing similar emotions and have similar questions about the recovery process.
Early Phase of Recovery: First 6 Weeks
The TSN Coordinator contacts participants at 2 and 4 weeks after discharge to check on their recovery and promote referral to the TSN and other resources. At 6 weeks, when the patient returns for a routine follow-up clinical assessment, the TSN Coordinator meets with the patient to complete a Recovery Assessment. The Recovery Assessment is a 35-item questionnaire the patient completes using an iPad while waiting to see his or her surgeon. It takes 10–15 minutes to complete and assesses 5 risk factors for poor outcome and 3 positive assets known to facilitate recovery. Risk factors include the following: (1) pain (using a numeric 11-point rating of pain intensity)24; (2) depression [using the Patient Health Questionnaire (PHQ-9)],25 (3) PTSD Checklist (PCL),26 (4) alcohol use (NIAAA 2-item screening assessment),27 and (5) tobacco use (any current use). Protective factors include (1) resilience (Connor-Davidson Resilience Scale),28 (2) social support (Behavioral Risk Factor Surveillance System single-item scale),29 and (3) self-efficacy (two ten-point self-efficacy scales for return to usual activity and managing the financial demands associated with recovery).
Results of the Recovery Assessment are automatically summarized in a 1-page printout and reviewed with the patient by the surgeon and the TSN Coordinator. Based on this review, the surgeon completes a Recovery Prescription which provides specific recommendations for further services including medical, rehabilitative, mental health, and TSN services. A Recovery Plan is then developed by the TSN Coordinator together with the patient and his or her family. The TSN Coordinator assists patients in identifying health professionals and provides access to relevant community, vocational/educational, military, or veterans' resources that assist with return to work, school, or other usual activity. Referral to the TSN programs and services is also incorporated into the patient's Recovery Plan and providers are trained to recommend the services during patient follow-ups.
Services made available to patients include peer support groups and self-management training, both of which are designed to improve self-efficacy and promote patient activation. Support groups are semistructured, facilitated meetings of trauma survivors, where members are able to share and manage emotional stress in a safe, supportive space. Interactions between survivors normalize the experience of recovery and increase the survivor's self-efficacy through education and resource sharing. The Next Steps Program is an evidence-based self-management program designed to address the needs of trauma survivors.17 Self-management places an emphasis on the individual taking responsibility for his or her health care.15 The Next Steps Program teaches problem solving and communication skills, in addition to self-monitoring, in an effort to encourage participants to become more proactive and take control of their care. The program is offered in person and online (http://nextstepsonline.org) by a specially trained facilitator.
Ongoing Support and Referrals: After the First 6 Weeks
The TSN Coordinator continues to engage with patients and links patients with services needed for optimal recovery. Specifically, the TSN Coordinator monitors and coaches patients on their Recovery Plan recommendations and goals including adherence to medical treatments and rehabilitation therapies and uses motivational interviewing to help overcome barriers to behavior change. Participants are encouraged to make use of the peer support groups and engage in a Next Steps' self-management class. At 6 months, the TSN Coordinator repeats the Recovery Assessment and provides feedback and continues coaching activities as needed for up to 12 months. Most follow-ups are by telephone.
METHODS: EVALUATION OF THE TCC PROGRAM
The effectiveness of the TCC program was evaluated by comparing outcomes of patients treated at 6 trauma centers that implemented the TCC program (intervention sites) with outcomes of patients treated at 6 trauma centers where care was delivered as usual (control sites). The list of participating centers can be found at the Appendix 1. Compared with standard treatment alone, it is hypothesized that access to the TCC program plus standard treatment will result in lower rates of poor function, depression, and/or PTSD. The study was also designed to (1) determine participant satisfaction with the TCC program; (2) measure the impact of the program on provider confidence in the ability to manage psychosocial factors influencing trauma outcomes; (3) estimate the cost and cost effectiveness of the TCC program relative to standard of care; and (4) develop patient profiles that identify individuals at the highest risk of poor outcome. The study protocol, including the written informed consent, was approved by the Johns Hopkins Bloomberg School of Public Health [location of the Major Extremity Trauma Research Consortium (METRC) Coordinating Center], the Department of Defense (DoD) Human Research Protection Office (study sponsor), and the local institutional review boards at each participating center. Each site was required to obtain DoD Human Research Protection Office approval of local institutional review board documents and certification by the Coordinating Center to ensure proper training on study procedures and data collection before the initiation of the study.
Site Selection and Study Population
This study was conducted by the METRC, a clinical research network of military and civilian trauma centers dedicated to improving the outcomes of service members and civilians who sustain major limb trauma.30 The intervention and control sites were selected from among the core civilian centers and the larger satellite centers, all of which are large, urban level I trauma centers with established academic orthopaedic trauma programs. Random assignment of centers to the intervention or control group, although desirable, was not possible because of the variability in volume and patient populations across sites and the experience some centers already had with implementing components of the TSN. Instead, centers were surveyed for their willingness to participate as either an intervention or control site. Of the 12 centers that responded favorably, 3 centers were assigned to the intervention group because of their prior experience with implementation of components of the TSN. The remaining sites were ranked on size and patient case mix, and then assigned to the treatment or control group with an eye toward achieving balance in the volume of major orthopaedic trauma, case mix, and percent uninsured or on Medicaid.
The study population consisted of patients with major orthopaedic injuries sustained as a result of high-energy trauma and requiring surgical intervention. Specific inclusion and exclusion criteria are listed in Table 1. Eligible patients were approached by the study research coordinator as soon as feasible after stabilization and provided with a description of the study and what would be expected of them if they decided to participate. For those interested in participating, informed consent was obtained, and a baseline interview conducted. The METRC has adopted a comprehensive informed consent process for all of its studies that involves the treating surgeon, the clinical site research coordinator, and material and resources for patients and family members to facilitate informed decision making about participation (see Figure 1, Supplemental Digital Content 1, http://links.lww.com/BOT/A853 describes the METRC consenting procedures). At the control sites, no further contact was initiated in the hospital after consent. At intervention sites, the TSN Coordinator approached enrolled patients to introduce them to the TSN and engaged with them as described above.
Data Collection and Outcome Assessments
All patients were interviewed at baseline (during the initial hospitalization) and at 6 and 12 months after injury (by telephone) (see Table 1, Supplemental Digital Content 1, http://links.lww.com/BOT/A854). As discussed above, an important element of the TCC is a 6-week in-person Recovery Assessment with feedback provided to both patients and providers. The Recovery Assessment was also administered to the control patients (by telephone), but no feedback was provided (except in circumstances where patients were perceived to be at significant risk of self-harm). Provider surveys at both treatment and control sites were performed before initiating the TCC program and then again at the close of study enrollment.
The primary outcome of the study is a binary composite outcome based on the following: (1) patient-reported function as measured by the Short Musculoskeletal Functional Assessment;31 (2) depression, measured using the 9-item depression scale of the PHQ-9;25 and (3) PTSD, measured using the standard PCL, civilian version.26 Impairment in any 1 domain is considered to be a negative outcome and is defined using cutoffs derived from the literature: a PCL score greater than 35, a PHQ-9 score greater than 9,32 and a Short Musculoskeletal Functional Assessment score greater than 27 (ie, greater than 1 SD from the normative population mean).31
Secondary outcomes include the following: (1) pain using the Brief Pain Inventory;33 (2) return to usual major activity and, if working, measures of absenteeism and presentism using the Work Productivity and Activity Impairment Questionnaire;34 (3) health-related quality of life assessed by Veterans RAND 12-Item Health Survey (VR-12)35 and its preference-based derivative, the VR-6D;36 (4) rehospitalizations and emergency department visits ascertained through self-report; and (5) patient satisfaction with overall treatment and with TCC-specific services. Self-efficacy for managing complications and returning to preinjury activity after trauma is included as an additional outcome and is measured using the modified self-efficacy scale,37 a 6-item questionnaire designed to measure patients' perceived self-efficacy to cope with the consequences of trauma.
Objectives of the economic analysis include (1) documenting costs to implement and operate a trauma care coordination program from the hospital perspective and (2) estimating cost-effectiveness of the TCC study (TCCS) model intervention from a societal perspective. Costs of the TCC program are determined by accounting data from participating institutions, including salary of the coordinator and program-related expenses such as office equipment, meeting space, education and training material, and communication. The cost-effectiveness analysis also requires estimating direct medical expenses and value of changes in employment and productivity. Because no actual billing records are collected, direct medical costs are estimated by applying a medical service unit cost to the patient-reported use of medical care services (eg, inpatient hospital stay, ambulatory surgery, or emergency department visit). The medical service unit cost is derived by matching TCCS patients to a sample in a large national insurance claims database (Truven MarketScan) using clinical and patient characteristics and then calculating the sample's unit cost for various medical care services. Changes in work loss and productivity are determined through comparison of baseline (preinjury) and end-of-study employment status. Valuation will reflect average national wages.
Several baseline characteristics of the injury and the patient known to affect function and psychosocial outcomes were collected. These data will be used to assess whether patients are similar in the intervention and control groups and, where differences exist, to adjust for these differences in the analysis. These data will also be used to identify subgroups of the patient population who may differentially respond to the intervention (see Table 1, Supplemental Digital Content 1, http://links.lww.com/BOT/A854).
Assuring Treatment Fidelity and Measuring Exposure to the Intervention
Inconsistent delivery of the intervention across study sites could affect internal and external validity, and reduce the statistical power of the study to detect a treatment effect.38,39 To help ensure treatment fidelity, the TSN Coordinators received standardized training together with a manual of operations to guide the implementation of the TCC at their site. Before enrolling any patients into the study, the TSN Coordinators were required to confirm the completion of several tasks such as organizing a Grand Rounds presentation about the TCC program, providing in-service education to nurses on the trauma floor, developing a list of community resources for patients and their families, and recruiting and training peer volunteers. Importantly, the investigators and TSN Coordinators worked closely with hospital leadership to ensure that all key constituents understood the goals of the program and what role they played in assuring its successful implementation. A national TSN Coordinator provided ongoing support in the form of biweekly conference calls for all coordinators. The coordinators also participated in 2 additional “booster” training sessions to provide additional training in targeted areas and share best practices.
As patients were enrolled, the TSN Coordinators maintained a log documenting all interactions between the patient and the TSN. In addition, participants were asked (as part of the 6- and 12-month interviews) to identify the TSN services they had used in the previous 6 months. By combining information on program utilization from more than one source, an indicator of “treatment dose” will be developed and used as a covariate in analyzing variability in treatment outcomes.
Sample Size and Analysis Plan
A simulation study was conducted to evaluate the power of the study design to detect differences in the main binary outcome as described above. Based on data from the National Study on Costs and Outcomes of Trauma Care,40 a distribution of level I trauma center–stratified prevalence of the outcome, measured 1 year after injury, was derived (mean prevalence of 56%; SD of 10.5%); the prevalence for control sites was drawn from this distribution for the simulation study. Assuming the effect of the intervention is to multiplicatively reduce the prevalence by 34%, and that the data will be analyzed using hierarchical models and a Bayesian formalism with noninformative previous distributions, simulations suggested that complete 1-year outcome data on 360 patients from each of the intervention and control groups would provide an 80% chance of rejecting the null hypothesis that there is no difference in the main binary outcome. Assuming a 15% loss to follow-up, the target sample size was set at 900 patients (450 from the intervention hospitals and 450 from the control hospitals) with roughly equal numbers contributed by each hospital.
To estimate the effect of the TCC model intervention on the primary and secondary outcomes, an analytic approach that accounts for clustering within trauma centers will be used. The primary statistical analyses will follow the intent-to-treat paradigm and use hierarchical regression models; estimates of treatment effects will be reported along with 95% confidence intervals. Secondary statistical analyses will be conducted to estimate effects had all intervention patients availed themselves of the full TCC program.
As the study design does not guarantee probabilistic balance of the distribution of potential confounding factors between the intervention and control groups, it is important to test for imbalances in baseline characteristics and, as necessary, make the appropriate covariate adjustments. Comparisons in baseline characteristics were made using permutation tests that account for clustering of individuals within centers.
STUDY RECRUITMENT AND BASELINE CHARACTERISTICS
Figure 1 summarizes the screening, enrollment, and follow-up of patients into the TCCS. A total of 4,498 patients were screened for eligibility over an 18-month period, of whom 1,496 (33.3%) met all inclusion and no exclusion criteria. Major reasons for ineligibility included lengths of stay less than 3 days without a planned readmission and type or severity of injury that did not meet the inclusion criterion. Of those eligible, 900 patients were enrolled (481 in the intervention arm and 419 in the control arm). The percent enrolled of those eligible was significantly higher (65.5%) in the control arm compared with the intervention arm (56.2%, P < 0.05). The number enrolled varied by site from 47 to 114 in the intervention sites and 34 to 119 in the control sites. The average number enrolled by site was higher in intervention (80.2) versus control (69.8) sites. In both groups, 87% of participants completed the 12-month follow-up.
The study sample is described in Tables 2–4. It is demographically diverse in composition: 31% were Hispanic or non-Hispanic, nonwhite; 47% had no education after high school, and 21% had no insurance at the time of the injury. Sixty five percent of study participants were males, and the average age was 38.2 years. Nearly 3 quarters (72%) of participants were working at the time of the injury, and of those working, 57% reported that their jobs involved very or somewhat physically demanding tasks.
Most sustained moderate-to-severe injuries to multiple body regions with more than a third (37.8%) having an Injury Severity Score greater than 17. Average length of stay in the initial hospital was 12.1 days (10.5 SD) and 39% spent one or more days in the intensive care unit.
The majority (87%) rated their health before the injury as excellent, very good, or good, although the percentages who were obese (38% with body mass index ≥30) and extremely obese (19% with body mass index ≥40) were somewhat higher than the general population of adults greater than 20 years (35.7% obese and 6.3% extremely obese).41 Also, the percentage who were current smokers is higher (38%) compared with the general population (21.3%).42 Nearly one-half (49%) had 1 or more comorbidities.
One-half of patients indicated that they had strong support systems as measured by how likely they felt that friends and/or family would help them out with specific needs. In terms of the patient activation levels, 16% of the respondents were classified as at the lowest 2 levels (disengaged or becoming aware but still struggling), 44% were taking action, and 39% were maintaining behaviors and pushing further. The mean Patient Activation Measure score was 68.2 (SD: 14.2), a level consistent with national samples of patients with and without chronic illness.43,44
After adjusting for clustering effects, there were few significant differences in any of the baseline characteristics between the intervention and control groups. For only one comparison was the adjusted P value less than 0.05; participants in the control group were somewhat more educated than those in the intervention group (60% of the controls had some college vs. 44% in the intervention group).
Data suggest that a more patient-centered, multidisciplinary, and collaborative care approach to managing acute trauma would be beneficial and lead to an improvement in long-term outcomes. Large randomized trials have established the effectiveness of collaborative care models that integrate care management, evidence-based medicine, and cognitive behavior therapy approaches in primary care patients with depressive and anxiety disorders.45–48 Only recently are these care models being applied in the trauma setting. Zatzick et al20 developed a “stepped care approach” based on these models and in a clinical trial, in which 120 patients were randomized, the stepped collaborative care intervention showed reduced PTSD symptoms and improved functioning over the course of a year post injury. Browne et al49 piloted the utility of screening and delivery of an early multidisciplinary intervention for reducing PTSD, depression, and postinjury pain and also found encouraging results. These data suggest that screening and an initial reliance on lower intensity treatments embedded within care management procedures can yield positive outcomes in trauma populations.
The prospective study described in this article will provide data on the feasibility of a multimodal collaborative care model in a trauma setting and examine whether this class of interventions can improve outcomes after orthopaedic trauma. The TCC program was successfully implemented in 6 trauma centers and the inclusion of multiple control sites, all in a relatively wide geographic distribution, helps insure generalizability of findings. The overall target sample size was met, although the numbers of patients enrolled across sites and between treatment and control arms were uneven. Follow-up and data collection were standardized across sites and resulted in high follow-up rates and few missing data.
Because the TCC was conceptualized as an intervention at the level of the trauma center where programmatic changes were necessary for successful implementation of the program, randomization of individuals was not possible. Instead, a cluster design was used with the hope that, overall, participants in the 2 treatment arms of the study would be comparable, which seems to be largely achieved. However, the lack of randomization at the site level is a threat to the internal validity of the study. Appropriate statistical adjustments will be made to account for differences in patient characteristics; however, this will not control for unmeasured site-level differences that may influence outcomes. In addition, it is possible that the TCC intervention may impact some individuals more than others. While the overall number of enrolled participants was large, the identification of differential effects across subgroups of participants will be limited.
Finally, unlike some treatment studies where participants follow an established treatment protocol to insure utilization of key treatment components, this study only referred patients to services based on their Recovery Assessment. While the Recovery Coach and providers were trained in motivating patients to use recommended services, ultimately the choice to engage was left to the participants. This “light touch approach,” which emphasized patient choice, may affect the ability to detect overall treatment effects. However, the extent to which services were used will be documented, so that treatment effects can be estimated under full uptake and for patient subgroups.
Previous research suggests that the care of injured civilians and service members may be more effective by including early screening and management of emotional distress and psychological comorbidity. There is a need for well-designed studies to demonstrate efficacy and cost-effectiveness of interventions to address these risk factors and promote protective factors. This study was designed to address this gap.
APPENDIX 1. CORPORATE AUTHORS
Participating Centers:Carolinas Medical Center: Michael J. Bosse, MD, Christine Churchill, MA, Eileen M. Flores, MSW, LCSW, Joseph R. Hsu, MD, Madhav A. Karunakar, MD, Rachel B. Seymour, PhD, and Stephen H. Sims, MD; Denver Health and Hospital Authority: David J. Hak, MD, MBA, FACS, Hannah J. Gissel, BA (now at New York Medical College), Corey E. Henderson, MS; Cyril Mauffrey, MD, FACS, FRCS, and Philip F. Stahel, MD; Hennepin County Medical Center: Andrew H. Schmidt, MD, Gudrun E. Mirick, MD, Jerald R. Westberg, BA, and David Templeman, MD; Inova Fairfax Hospital: Robert A. Hymes, MD, Elena Lita, BS, Christy S. Lormel, MPH, A. Stephen Malekzadeh, MD, Anna B. Newcomb, PhD, LCSW, Melissa A. Porrey, LPC, NCC, Lolita Ramsey, PhD, RN, CCRC, and Jeff E. Schulman, MD; Methodist Hospital: Anthony T. Sorkin, MD and Walter W. Virkus, MD; MetroHealth Medical Center: Heather A. Vallier, MD, Mary A. Breslin, BA, and Sarah B. Hendrickson, MEd; Orthopaedic Associates of Michigan: Clifford B. Jones, MD and Debra L. Sietsema, PhD (currently at The CORE Institute, MORE Foundation); University of Maryland R Adams Cowley Shock Trauma Center: Robert V. O'Toole, MD, Andrea L. Howe, Katherine Ordonio, A.N.P., MD, Andrew N. Pollak, MD, and Timothy J. Zerhusen Jr, BS; University of Texas Health Science Center at Houston: Milton Lee (Chip) Routt Jr, MD, Joshua L. Gary, MD, Andrew Choo, MD, Kathy Franco, BSN, CCRC, and Matthew C. Galpin, CCRC; Vanderbilt University Medical Center: Kristen R. Archer, PhD, DPT, Eduardo J. Burgos, MD, A. Alex Jahangir, MD, MMHC, William T. Obremskey, MD, MPH, MMHC, Rajesh R. Tummuru, MBBS, and Manish K. Sethi, MD; Wake Forest Baptist Medical Center: Eben A. Carroll, MD, J. Brett Goodman, MBA, Jason J. Halvorson, MD, Martha B. Holden, AAS, AA, and Anna N. Miller, MD, FACS (now at Washington University in St. Louis School of Medicine); METRC Coordinating Center at Johns Hopkins Bloomberg School of Public Health: Ellen J. MacKenzie, PhD, Lauren E. Allen, MA, Jeromie M. Ballreich, MHS, Anthony R. Carlini, MS, Renan C. Castillo, PhD, Susan Collins MSc, Gregory de Lissovoy, PhD, Katherine P. Frey, RN, MPH, Yanjie Huang, ScM, Daniel O. Scharfstein, ScD, Stephen T. Wegener, PhD, and Elizabeth Wysocki, MS.
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