An integrated-delivery-of-care approach to improve patient reported physical function and mental wellbeing after orthopedic trauma: study protocol for a randomized controlled trial

Laura Zdziarski-Horodyski, MaryBeth Horodyski, Kalia K Sadasivan, Jennifer Hagen, Terrie Vasilopoulos, Matthew Patrick, Robert Guenther, Heather K Vincent, Laura Zdziarski-Horodyski, MaryBeth Horodyski, Kalia K Sadasivan, Jennifer Hagen, Terrie Vasilopoulos, Matthew Patrick, Robert Guenther, Heather K Vincent

Abstract

Background: 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. 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/design: A 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).

Discussion: 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. 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 registration: ClinicalTrials.gov, NCT02591472 . Registered on 28 October 2015.

Keywords: Emotional wellbeing; Orthopedic trauma; Physical function; Psychosocial.

Conflict of interest statement

Ethics approval and consent to participate

Before any study-related procedures occurred, the IRB for the protection of human rights at the University of Florida approved the study protocol (study number 201500753). Additionally, informed consent was obtained from every participant before randomization into the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flow diagram following the CONSORT guidelines for randomized controlled trials with the Patient-Reported Outcomes extension
Fig. 2
Fig. 2
The ten steps of the Transformative Coaching Program. The order of the steps may be adjusted as needed based on the status of the patient
Fig. 3
Fig. 3
Images of trifold patient folder containing the 10-step program, goal setting space, pre-discharge checklist, space for customized resources and space for paper and pen
Fig. 4
Fig. 4
Schedule of study enrollment, interventions, and assessments

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