Ignite Creation Date:
2024-05-06 @ 7:46 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02591472
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2015-10-28
Brief Title:
An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes Safety Well-Being After Orthopaedic Trauma
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes Safety Well-Being After Orthopaedic Trauma
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Orthopedic trauma is an unforeseen life-changing event Nearly 28 million Americans sustain traumatic orthopedic injuries such as major fractures or amputation each year Injury is treated in the hospital by physicians who medically stabilize and reconstruct the patient Upon completion of their hospital stay patients are discharged to begin their reintegration back into home and community activities Despite high surgical success and survivorship rates these injuries often result in poor quality of life QOL-related outcomes in otherwise healthy people Fifty to ninety percent of patients develop severe psychological distress such as post-traumatic stress syndrome depression or anxiety Patients are often not provided the comprehensive support care and resources that are necessary to cope successfully with psychological stress and reintegrate into purposeful living This is a major problem because high distress levels predict poor physical function use of pain medications and low QOL Survivors often cannot return to work have persistent pain and experience social isolation Distress worsens the self-perceptions of functional gain and efficacy and decreases personal fulfillment Lingering psychological distress contributes to the development of other health problems and rebuilding of life is negatively impacted The lack of psychosocial support contributes to injury re-occurrence injury recidivism re-hospitalizations and longer hospitalization stays and higher personal and societal health care costs
There is currently a lack of comparative efficacy research to determine which delivery approach produces greater improvements in the outcomes that are most desired by patients specifically functional QOL and emotional well-being The proposed research will directly compare these delivery-of-care approaches and measure the patient-reported outcomes that are considered important to patients
There is currently a lack of comparative efficacy research to determine which delivery approach produces greater improvements in the outcomes that are most desired by patients specifically functional QOL and emotional well-being The proposed research will directly compare these delivery-of-care approaches and measure the patient-reported outcomes that are considered important to patients
Detailed Description:
The research study will determine whether the Usual Care or Integrated Care which is Usual Care plus emotional support and educationinformation during the hospital stay helps patients feel better about their physical function and emotional well-being
Participants with serious musculoskeletal injury being treated at to the University of Floridas UF Orthopaedic Trauma service at UF Health at Shands Hospital will be randomized like tossing a coin between the two groups
Usual Care will follow all the highest standards for injury treatment
Integrated Care will include medical care and emotional support Study Staff are trained to provide emotional support and teach patients the skills for goal setting taking ownership of journey establishing lifelines mobilizing resources and reducing stressors
In addition questionnaires and simple functional tests will be collected at the hospital and at normal follow-up visits at weeks 2 6 and 12 and months 6 and 12
Participants with serious musculoskeletal injury being treated at to the University of Floridas UF Orthopaedic Trauma service at UF Health at Shands Hospital will be randomized like tossing a coin between the two groups
Usual Care will follow all the highest standards for injury treatment
Integrated Care will include medical care and emotional support Study Staff are trained to provide emotional support and teach patients the skills for goal setting taking ownership of journey establishing lifelines mobilizing resources and reducing stressors
In addition questionnaires and simple functional tests will be collected at the hospital and at normal follow-up visits at weeks 2 6 and 12 and months 6 and 12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None