Brief Summary

Orthopedic trauma is an unforeseen life-changing event. Nearly 2.8 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7 years study duration

First Submitted

Initial submission to the registry

October 28, 2015

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed

2 months until next milestone

Study Start

First participant enrolled

January 11, 2016

Completed

7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

October 28, 2024

Completed

Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

7 years

First QC Date

October 28, 2015

Results QC Date

November 29, 2023

Last Update Submit

October 24, 2024

Conditions

Musculoskeletal Injury Trauma

Outcome Measures

Primary Outcomes (1)

Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups.
Survey questionnaire measures the perception of Physical Function. Physical Function Average: t score = 50±10 Min: 10 Max: 90 A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Functional T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
Change from baseline at weeks 2, 6 and 12

Secondary Outcomes (3)

Change From Baseline at Weeks 6 and 12 on the Lower Extremity Gain Scale (LEGS) Between the Groups.
Change from baseline at weeks 6 and 12
Change From Baseline at Weeks 2, 6 and 12 on the Tampa Scale of Kinesiophobia-11 (TSK-11) Between the Groups.
Change from baseline at weeks 2, 6 and 12
Absolute Hand Grip Scores at Weeks 2, 6 and 12 on the Hand-held Hydraulic Dynamometer to Measure Handgrip Strength Between the Groups.
Absolute hand grip scores at weeks 2, 6 and 12

Study Arms (2)

Usual Care (UsCare)

ACTIVE COMPARATOR

This group will receive UsCare for orthopedic trauma involves surgical intervention, acute care therapies, post-acute rehabilitation and follow-up clinic visits after discharge. Additionally, the following test will be performed: Lower Extremity Gain Scale (LEGS), dynamometer isometric handgrip strength, Active Range of Motion (AROM), Posttraumatic Stress Disorder (PTSD), Beck Depression Inventory-II, State-Trait Anxiety Inventory (STAI), Tampa Scale of Kinesiophobia-11 (TSK-11), and Patient-Reported Outcomes Measurement Information System (PROMIS).

Procedure: Usual Care (UsCare)Other: Patient-Reported Outcomes Measurement Information SystemOther: Lower Extremity Gain Scale (LEGS)Other: DynamometerOther: Active Range of Motion (AROM)Other: Posttraumatic Stress Disorder (PTSD)Other: Beck Depression Inventory-IIOther: State-Trait Anxiety Inventory (STAI)Other: Tampa Scale of Kinesiophobia-11 (TSK-11)

Integrated Care (ICare)

EXPERIMENTAL

This group will receive ICare for orthopedic trauma involves surgical intervention, acute care therapies, post-acute rehabilitation and follow-up clinic visits after discharge, plus simultaneous psychosocial support via the Transform-10 Program.. Additionally, the following test will be performed: Lower Extremity Gain Scale (LEGS), dynamometer isometric handgrip strength, Active Range of Motion (AROM), Posttraumatic Stress Disorder (PTSD), Beck Depression Inventory-II, State-Trait Anxiety Inventory (STAI), Tampa Scale of Kinesiophobia-11 (TSK-11), and Patient-Reported Outcomes Measurement Information System (PROMIS).

Procedure: Integrated care (ICare)Other: Patient-Reported Outcomes Measurement Information SystemOther: Lower Extremity Gain Scale (LEGS)Other: DynamometerOther: Active Range of Motion (AROM)Other: Posttraumatic Stress Disorder (PTSD)Other: Beck Depression Inventory-IIOther: State-Trait Anxiety Inventory (STAI)Other: Tampa Scale of Kinesiophobia-11 (TSK-11)

Interventions

Integrated care (ICare)PROCEDURE

The Integrated Care approach provides Usual Care processes plus simultaneous psychosocial support via the Transform-10 Program. The Transform-10 Program will include information regarding emotional well-being, social support, and provides opportunity for the patient to openly discuss their thoughts and concerns regarding their recovery. The patient's normal clinical care usually includes a hospital stay, a 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.

Also known as: ICare

Integrated Care (ICare)

Usual Care (UsCare)PROCEDURE

Usual Care includes radiographic imaging and administration of pain medication and antibiotics, skin care and range of motion of the injured area. The patient's normal clinical care usually includes a hospital stay, a 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit. At the end of the study all of the materials that make up the Transform-10 Program will be provided.

Also known as: UsCare

Usual Care (UsCare)

Patient-Reported Outcomes Measurement Information SystemOTHER

Questionnaires of Physical Functional quality of life and Emotional Well-being will be performed during the hospital stay, a 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.

Also known as: PROMIS