Abstract
BackgroundOrthopedic trauma injury impacts nearly 2.8 million people each year. Despite surgical improvements and excellent survivorship rates, many patients experience poor quality of life (QOL) outcomes years later. Psychological distress commonly occurs after injury. Distressed patients more frequently experience rehospitalizations, pain medication dependence, and low QOL. This study was developed to test whether an integrative care approach (IntCare; ten-step program of emotional support, education, customized resources, and medical care) was superior to usual care (UsCare). The primary aim was to assess patient functional QOL (objective and patient-reported outcomes) with secondary objectives encompassing emotional wellbeing and hospital outcomes. The primary outcome was the Lower Extremity Gain Scale score.Methods/designA single-blinded, single-center, repeated measures, randomized controlled study is being conducted with 112 orthopedic trauma patients aged 18–85 years. Patients randomized to the IntCare group have completed or are receiving a guided ten-step support program during acute care and at follow-up outpatient visits. The UsCare group is being provided the standard of care. Patient-reported outcomes and objective functional measures are collected at the hospital and at weeks 2, 6, and 12 and months 6 and 12 post surgery. The main study outcomes are changes in Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires of Physical Function quality of life, Satisfaction with Social Roles, and Positive-Illness Impact, Post-Traumatic Stress Disorder Check List, and the Tampa Scale of Kinesiophobia-11 from baseline to month 12. Secondary outcomes are changes in objective functional measures of the Lower Extremity Gain Scale, handgrip strength, and range of motion of major joints from week 2 to month 12 post surgery. Clinical outcomes include hospital length of stay, medical complications, rehospitalizations, psychological measures, and use of pain medications. A mixed model repeated measures approach assesses the main effects of treatment and time on outcomes, as well as their interaction (treatment × time).DiscussionThe results from this study will help determine whether an integrative care approach during recovery from traumatic orthopedic injury can improve the patient perceptions of physical function and emotional wellbeing compared to usual trauma care. Additionally, this study will assess the ability to reduce the incidence or severity of psychological distress and mitigate medical complications, readmissions, and reduction of QOL after injury.Trial registrationClinicalTrials.gov, NCT02591472. Registered on 28 October 2015.
Highlights
Orthopedic trauma injury impacts nearly 2.8 million people each year
The results from this study will help determine whether an integrative care approach during recovery from traumatic orthopedic injury can improve the patient perceptions of physical function and emotional wellbeing compared to usual trauma care
At present, there is a lack of rigorous, high-quality, comparative effectiveness research to determine whether a comprehensive care approach for both physical and emotional health produces greater improvements in the key outcomes functional quality of life (QOL) and emotional wellbeing
Summary
Orthopedic trauma injury impacts nearly 2.8 million people each year. Despite surgical improvements and excellent survivorship rates, many patients experience poor quality of life (QOL) outcomes years later. Distressed patients more frequently experience rehospitalizations, pain medication dependence, and low QOL. Medical advances have dramatically improved survivorship, these injuries result in poor quality of life (QOL)-related outcomes in otherwise healthy people [4]. One exacerbating factor for this pattern is that patients are typically not provided comprehensive support and resources that are necessary to successfully cope with psychological distress [8]. This is a serious issue because high distress levels predict poor physical function, use of pain medications and low QOL [9, 10]. The lack of psychosocial support contributes to injury reoccurrence, injury recidivism, [16] rehospitalizations and longer hospitalization, [17] and higher personal and societal healthcare costs [18]
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