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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

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

Published in: Trials | Issue 1/2018

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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.
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Laura Zdziarski-Horodyski
MaryBeth Horodyski
Kalia K. Sadasivan
Jennifer Hagen
Terrie Vasilopoulos
Matthew Patrick
Robert Guenther
Heather K. Vincent
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2430-5

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