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
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...
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| Format: | Article |
| Language: | English |
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BMC
2018-01-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2430-5 |
| _version_ | 1811328499229655040 |
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| author | Laura Zdziarski-Horodyski MaryBeth Horodyski Kalia K. Sadasivan Jennifer Hagen Terrie Vasilopoulos Matthew Patrick Robert Guenther Heather K. Vincent |
| author_facet | Laura Zdziarski-Horodyski MaryBeth Horodyski Kalia K. Sadasivan Jennifer Hagen Terrie Vasilopoulos Matthew Patrick Robert Guenther Heather K. Vincent |
| author_sort | Laura Zdziarski-Horodyski |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T15:26:11Z |
| format | Article |
| id | doaj.art-f392f96fc343421792b1b7cb4bdeba96 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T15:26:11Z |
| publishDate | 2018-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-f392f96fc343421792b1b7cb4bdeba962022-12-22T02:41:30ZengBMCTrials1745-62152018-01-0119111210.1186/s13063-017-2430-5An integrated-delivery-of-care approach to improve patient reported physical function and mental wellbeing after orthopedic trauma: study protocol for a randomized controlled trialLaura Zdziarski-Horodyski0MaryBeth Horodyski1Kalia K. Sadasivan2Jennifer Hagen3Terrie Vasilopoulos4Matthew Patrick5Robert Guenther6Heather K. Vincent7Departments of Orthopaedics and Rehabilitation, University of FloridaDepartments of Orthopaedics and Rehabilitation, University of FloridaDepartments of Orthopaedics and Rehabilitation, University of FloridaDepartments of Orthopaedics and Rehabilitation, University of FloridaDepartments of Orthopaedics and Rehabilitation, University of FloridaDepartments of Orthopaedics and Rehabilitation, University of FloridaDepartments of Clinical Psychology, University of FloridaDepartments of Orthopaedics and Rehabilitation, University of FloridaAbstract 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.http://link.springer.com/article/10.1186/s13063-017-2430-5Orthopedic traumaPsychosocialPhysical functionEmotional wellbeing |
| spellingShingle | Laura Zdziarski-Horodyski MaryBeth Horodyski Kalia K. Sadasivan Jennifer Hagen Terrie Vasilopoulos Matthew Patrick Robert Guenther Heather K. Vincent 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 Trials Orthopedic trauma Psychosocial Physical function Emotional wellbeing |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | integrated delivery of care approach to improve patient reported physical function and mental wellbeing after orthopedic trauma study protocol for a randomized controlled trial |
| topic | Orthopedic trauma Psychosocial Physical function Emotional wellbeing |
| url | http://link.springer.com/article/10.1186/s13063-017-2430-5 |
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