Trial Outcomes & Findings for An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes, Safety, Well-Being After Orthopaedic Trauma (NCT NCT02591472)

Last Updated: 2024-10-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

88 participants

Primary outcome timeframe

Change from baseline at weeks 2, 6 and 12

Results posted on

2024-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care (UsCare) This group will receive UsCare for orthopedic trauma involves surgical intervention, acute care therapies, post-acute rehabilitation and follow-up clinic visits. Usual Care (UsCare) includes radiographic imaging and administration of pain medication and antibiotics, skin care and range of motion of the injured area. Normal clinical care usually includes a hospital stay, a 2 week, 6 week, and 12 week follow up visits. At the end of the study the materials for the Transform-10 Program will be provided. Additionally, the following tests will be performed: Patient-Reported Outcomes Measurement Information System: Questionnaires of Physical Functional quality of life and Emotional Well-being will be done during the 2 week, 6 week,12 week follow up visits. Lower Extremity Gain Scale (LEGS) consists of a 3-meter walk, putting on sock, putting on shoe, rising from a chair, stepping up/ down stairs, getting on/off the toilet, reaching from a sitting position to an object on the ground. This will be performed at the 6 week and 12 week follow up visits. Dynamometer: Isometric handgrip strength will be measured with a hand-held hydraulic dynamometer. This test will be performed at the 2 week, 6 week and 12 week follow up visits. Tampa Scale of Kinesiophobia-11 (TSK-11) will be used to assess pain-related fear in orthopaedic trauma. This will be performed at the 2 week, 6 week and 12 week follow up visits.	Integrated Care (ICare) This group will receive ICare for orthopedic trauma involves surgical intervention, acute therapies, post-acute rehabilitation and follow-up clinic visits and simultaneous psychosocial support via the Transform-10 Program. Integrated care (ICare):This approach provides Usual Care plus the Transform-10 Program that includes information for emotional well-being, social support and opportunity for the patient to discuss thoughts and concerns with recovery. Patient's normal clinical care usually includes a hospital stay, a 2 week, 6 week, and 12 week follow up visits. Additionally, the following test will be performed: Patient-Reported Outcomes Measurement Information System: Questionnaires of Physical Functional quality of life and Emotional Well-being will be done during the 2 week, 6 week,12 week follow up visits. Lower Extremity Gain Scale (LEGS) consists of a 3-meter walk, putting on sock, putting on shoe, rising from a chair, stepping up/ down stairs, getting on/off the toilet, reaching from a sitting position to an object on the ground. This will be performed at the 6 week and 12 week follow up visits. Dynamometer: Isometric handgrip strength will be measured with a hand-held hydraulic dynamometer. This test will be performed at the 2 week, 6 week and 12 week follow up visits. Tampa Scale of Kinesiophobia-11 (TSK-11) will be used to assess pain-related fear in orthopaedic trauma. This will be performed at the 2 week, 6 week and 12 week follow up visits.
Overall Study STARTED	50	38
Overall Study COMPLETED	50	38
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes, Safety, Well-Being After Orthopaedic Trauma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care (UsCare) n=50 Participants This group will receive UsCare for orthopedic trauma involves surgical intervention, acute care therapies, post-acute rehabilitation and follow-up clinic visits. Usual Care (UsCare) includes radiographic imaging and administration of pain medication and antibiotics, skin care and range of motion of the injured area. Normal clinical care usually includes a hospital stay, a 2 week, 6 week, and 12 week follow up visits. At the end of the study the materials for the Transform-10 Program will be provided. Additionally, the following tests will be performed: Patient-Reported Outcomes Measurement Information System: Questionnaires of Physical Functional quality of life and Emotional Well-being will be done during the 2 week, 6 week,12 week follow up visits. Lower Extremity Gain Scale (LEGS) consists of a 3-meter walk, putting on sock, putting on shoe, rising from a chair, stepping up/ down stairs, getting on/off the toilet, reaching from a sitting position to an object on the ground. This will be performed at the 6 week and 12 week follow up visits. Dynamometer: Isometric handgrip strength will be measured with a hand-held hydraulic dynamometer. This test will be performed at the 2 week, 6 week and 12 week follow up visits. Tampa Scale of Kinesiophobia-11 (TSK-11) will be used to assess pain-related fear in orthopaedic trauma. This will be performed at the 2 week, 6 week and 12 week follow up visits.	Integrated Care (ICare) n=38 Participants This group will receive ICare for orthopedic trauma involves surgical intervention, acute therapies, post-acute rehabilitation and follow-up clinic visits and simultaneous psychosocial support via the Transform-10 Program. Integrated care (ICare):This approach provides Usual Care plus the Transform-10 Program that includes information for emotional well-being, social support and opportunity for the patient to discuss thoughts and concerns with recovery. Patient's normal clinical care usually includes a hospital stay, a 2 week, 6 week, and 12 week follow up visits. Additionally, the following test will be performed: Patient-Reported Outcomes Measurement Information System: Questionnaires of Physical Functional quality of life and Emotional Well-being will be done during the 2 week, 6 week,12 week follow up visits. Lower Extremity Gain Scale (LEGS) consists of a 3-meter walk, putting on sock, putting on shoe, rising from a chair, stepping up/ down stairs, getting on/off the toilet, reaching from a sitting position to an object on the ground. This will be performed at the 6 week and 12 week follow up visits. Dynamometer: Isometric handgrip strength will be measured with a hand-held hydraulic dynamometer. This test will be performed at the 2 week, 6 week and 12 week follow up visits. Tampa Scale of Kinesiophobia-11 (TSK-11) will be used to assess pain-related fear in orthopaedic trauma. This will be performed at the 2 week, 6 week and 12 week follow up visits.	Total n=88 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants	35 Participants n=7 Participants	83 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	43.2 years STANDARD_DEVIATION 15.3 • n=5 Participants	41.25 years STANDARD_DEVIATION 18.1 • n=7 Participants	42.23 years STANDARD_DEVIATION 16.4 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	21 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	32 Participants n=7 Participants	63 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	38 participants n=7 Participants	88 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline at weeks 2, 6 and 12

Outcome measures

Outcome measures
Measure	Usual Care (UsCare) n=50 Participants This group will receive UsCare for orthopedic trauma involves surgical intervention, acute care therapies, post-acute rehabilitation and follow-up clinic visits. Usual Care (UsCare) includes radiographic imaging and administration of pain medication and antibiotics, skin care and range of motion of the injured area. Normal clinical care usually includes a hospital stay, a 2 week, 6 week, and 12 week follow up visits. At the end of the study the materials for the Transform-10 Program will be provided. Additionally, the following tests will be performed: Patient-Reported Outcomes Measurement Information System: Questionnaires of Physical Functional quality of life and Emotional Well-being will be done during the 2 week, 6 week,12 week follow up visits. Lower Extremity Gain Scale (LEGS) consists of a 3-meter walk, putting on sock, putting on shoe, rising from a chair, stepping up/ down stairs, getting on/off the toilet, reaching from a sitting position to an object on the ground. This will be performed at the 6 week and 12 week follow up visits. Dynamometer: Isometric handgrip strength will be measured with a hand-held hydraulic dynamometer. This test will be performed at the 2 week, 6 week and 12 week follow up visits. Tampa Scale of Kinesiophobia-11 (TSK-11) will be used to assess pain-related fear in orthopaedic trauma. This will be performed at the 2 week, 6 week and 12 week follow up visits.	Integrated Care (ICare) n=38 Participants This group will receive ICare for orthopedic trauma involves surgical intervention, acute therapies, post-acute rehabilitation and follow-up clinic visits and simultaneous psychosocial support via the Transform-10 Program. Integrated care (ICare):This approach provides Usual Care plus the Transform-10 Program that includes information for emotional well-being, social support and opportunity for the patient to discuss thoughts and concerns with recovery. Patient's normal clinical care usually includes a hospital stay, a 2 week, 6 week, and 12 week follow up visits. Additionally, the following test will be performed: Patient-Reported Outcomes Measurement Information System: Questionnaires of Physical Functional quality of life and Emotional Well-being will be done during the 2 week, 6 week,12 week follow up visits. Lower Extremity Gain Scale (LEGS) consists of a 3-meter walk, putting on sock, putting on shoe, rising from a chair, stepping up/ down stairs, getting on/off the toilet, reaching from a sitting position to an object on the ground. This will be performed at the 6 week and 12 week follow up visits. Dynamometer: Isometric handgrip strength will be measured with a hand-held hydraulic dynamometer. This test will be performed at the 2 week, 6 week and 12 week follow up visits. Tampa Scale of Kinesiophobia-11 (TSK-11) will be used to assess pain-related fear in orthopaedic trauma. This will be performed at the 2 week, 6 week and 12 week follow up visits.
Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. 2 weeks	18.65 percentage of change from baseline Standard Deviation 26	17.6 percentage of change from baseline Standard Deviation 31.9
Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. 6 weeks	25.8 percentage of change from baseline Standard Deviation 28.3	30.45 percentage of change from baseline Standard Deviation 33.05
Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. 12 weeks	47.65 percentage of change from baseline Standard Deviation 37.9	41.35 percentage of change from baseline Standard Deviation 31.1

SECONDARY outcome

Timeframe: Change from baseline at weeks 6 and 12

LEGS consists combined score taken of a 3-meter walk, putting on a sock, putting on a shoe, rising from an armless chair, stepping up and down stairs, getting on and off the toilet, reaching from a sitting position to an object on the ground. Best score 27 Minimum score 0 Normal scores not available

Outcome measures

Outcome measures
Measure	Usual Care (UsCare) n=50 Participants This group will receive UsCare for orthopedic trauma involves surgical intervention, acute care therapies, post-acute rehabilitation and follow-up clinic visits. Usual Care (UsCare) includes radiographic imaging and administration of pain medication and antibiotics, skin care and range of motion of the injured area. Normal clinical care usually includes a hospital stay, a 2 week, 6 week, and 12 week follow up visits. At the end of the study the materials for the Transform-10 Program will be provided. Additionally, the following tests will be performed: Patient-Reported Outcomes Measurement Information System: Questionnaires of Physical Functional quality of life and Emotional Well-being will be done during the 2 week, 6 week,12 week follow up visits. Lower Extremity Gain Scale (LEGS) consists of a 3-meter walk, putting on sock, putting on shoe, rising from a chair, stepping up/ down stairs, getting on/off the toilet, reaching from a sitting position to an object on the ground. This will be performed at the 6 week and 12 week follow up visits. Dynamometer: Isometric handgrip strength will be measured with a hand-held hydraulic dynamometer. This test will be performed at the 2 week, 6 week and 12 week follow up visits. Tampa Scale of Kinesiophobia-11 (TSK-11) will be used to assess pain-related fear in orthopaedic trauma. This will be performed at the 2 week, 6 week and 12 week follow up visits.	Integrated Care (ICare) n=38 Participants This group will receive ICare for orthopedic trauma involves surgical intervention, acute therapies, post-acute rehabilitation and follow-up clinic visits and simultaneous psychosocial support via the Transform-10 Program. Integrated care (ICare):This approach provides Usual Care plus the Transform-10 Program that includes information for emotional well-being, social support and opportunity for the patient to discuss thoughts and concerns with recovery. Patient's normal clinical care usually includes a hospital stay, a 2 week, 6 week, and 12 week follow up visits. Additionally, the following test will be performed: Patient-Reported Outcomes Measurement Information System: Questionnaires of Physical Functional quality of life and Emotional Well-being will be done during the 2 week, 6 week,12 week follow up visits. Lower Extremity Gain Scale (LEGS) consists of a 3-meter walk, putting on sock, putting on shoe, rising from a chair, stepping up/ down stairs, getting on/off the toilet, reaching from a sitting position to an object on the ground. This will be performed at the 6 week and 12 week follow up visits. Dynamometer: Isometric handgrip strength will be measured with a hand-held hydraulic dynamometer. This test will be performed at the 2 week, 6 week and 12 week follow up visits. Tampa Scale of Kinesiophobia-11 (TSK-11) will be used to assess pain-related fear in orthopaedic trauma. This will be performed at the 2 week, 6 week and 12 week follow up visits.
Change From Baseline at Weeks 6 and 12 on the Lower Extremity Gain Scale (LEGS) Between the Groups. week 6	34.55 percentage of change in LEGS score Standard Deviation 35.55	46.8 percentage of change in LEGS score Standard Deviation 54.15
Change From Baseline at Weeks 6 and 12 on the Lower Extremity Gain Scale (LEGS) Between the Groups. week 12	87.6 percentage of change in LEGS score Standard Deviation 66.45	232.25 percentage of change in LEGS score Standard Deviation 267.35

SECONDARY outcome

Timeframe: Change from baseline at weeks 2, 6 and 12

Survey questionnaire given assess the pain-related fear of movement in orthopaedic trauma and the Tampa Scale of Kinesiophobia-11 (TSK-11) will be used. Best Score: 11 Min: 11 Max: 44

Outcome measures

Outcome measures
Measure	Usual Care (UsCare) n=50 Participants This group will receive UsCare for orthopedic trauma involves surgical intervention, acute care therapies, post-acute rehabilitation and follow-up clinic visits. Usual Care (UsCare) includes radiographic imaging and administration of pain medication and antibiotics, skin care and range of motion of the injured area. Normal clinical care usually includes a hospital stay, a 2 week, 6 week, and 12 week follow up visits. At the end of the study the materials for the Transform-10 Program will be provided. Additionally, the following tests will be performed: Patient-Reported Outcomes Measurement Information System: Questionnaires of Physical Functional quality of life and Emotional Well-being will be done during the 2 week, 6 week,12 week follow up visits. Lower Extremity Gain Scale (LEGS) consists of a 3-meter walk, putting on sock, putting on shoe, rising from a chair, stepping up/ down stairs, getting on/off the toilet, reaching from a sitting position to an object on the ground. This will be performed at the 6 week and 12 week follow up visits. Dynamometer: Isometric handgrip strength will be measured with a hand-held hydraulic dynamometer. This test will be performed at the 2 week, 6 week and 12 week follow up visits. Tampa Scale of Kinesiophobia-11 (TSK-11) will be used to assess pain-related fear in orthopaedic trauma. This will be performed at the 2 week, 6 week and 12 week follow up visits.	Integrated Care (ICare) n=38 Participants This group will receive ICare for orthopedic trauma involves surgical intervention, acute therapies, post-acute rehabilitation and follow-up clinic visits and simultaneous psychosocial support via the Transform-10 Program. Integrated care (ICare):This approach provides Usual Care plus the Transform-10 Program that includes information for emotional well-being, social support and opportunity for the patient to discuss thoughts and concerns with recovery. Patient's normal clinical care usually includes a hospital stay, a 2 week, 6 week, and 12 week follow up visits. Additionally, the following test will be performed: Patient-Reported Outcomes Measurement Information System: Questionnaires of Physical Functional quality of life and Emotional Well-being will be done during the 2 week, 6 week,12 week follow up visits. Lower Extremity Gain Scale (LEGS) consists of a 3-meter walk, putting on sock, putting on shoe, rising from a chair, stepping up/ down stairs, getting on/off the toilet, reaching from a sitting position to an object on the ground. This will be performed at the 6 week and 12 week follow up visits. Dynamometer: Isometric handgrip strength will be measured with a hand-held hydraulic dynamometer. This test will be performed at the 2 week, 6 week and 12 week follow up visits. Tampa Scale of Kinesiophobia-11 (TSK-11) will be used to assess pain-related fear in orthopaedic trauma. This will be performed at the 2 week, 6 week and 12 week follow up visits.
Change From Baseline at Weeks 2, 6 and 12 on the Tampa Scale of Kinesiophobia-11 (TSK-11) Between the Groups. week 2	26.1 score on a scale Standard Deviation 7.45	26.65 score on a scale Standard Deviation 5.37
Change From Baseline at Weeks 2, 6 and 12 on the Tampa Scale of Kinesiophobia-11 (TSK-11) Between the Groups. week 6	24.5 score on a scale Standard Deviation 6.69	25 score on a scale Standard Deviation 6.48
Change From Baseline at Weeks 2, 6 and 12 on the Tampa Scale of Kinesiophobia-11 (TSK-11) Between the Groups. week 12	23.15 score on a scale Standard Deviation 6.19	26 score on a scale Standard Deviation 7.45

SECONDARY outcome

Timeframe: Absolute hand grip scores at weeks 2, 6 and 12

Isometric handgrip strength is a valid predictor of mobility and will be measured using a hand-held hydraulic dynamometer. Average: 39 kg Range: 33-45 kg This is an estimated range for normal healthy subject. However, some of the patients in this study did not fall within this estimated range. The Unit of Measure is kilograms (kg). Subsequently all values presented are in kilograms (kg).

Outcome measures

Outcome measures
Measure	Usual Care (UsCare) n=50 Participants This group will receive UsCare for orthopedic trauma involves surgical intervention, acute care therapies, post-acute rehabilitation and follow-up clinic visits. Usual Care (UsCare) includes radiographic imaging and administration of pain medication and antibiotics, skin care and range of motion of the injured area. Normal clinical care usually includes a hospital stay, a 2 week, 6 week, and 12 week follow up visits. At the end of the study the materials for the Transform-10 Program will be provided. Additionally, the following tests will be performed: Patient-Reported Outcomes Measurement Information System: Questionnaires of Physical Functional quality of life and Emotional Well-being will be done during the 2 week, 6 week,12 week follow up visits. Lower Extremity Gain Scale (LEGS) consists of a 3-meter walk, putting on sock, putting on shoe, rising from a chair, stepping up/ down stairs, getting on/off the toilet, reaching from a sitting position to an object on the ground. This will be performed at the 6 week and 12 week follow up visits. Dynamometer: Isometric handgrip strength will be measured with a hand-held hydraulic dynamometer. This test will be performed at the 2 week, 6 week and 12 week follow up visits. Tampa Scale of Kinesiophobia-11 (TSK-11) will be used to assess pain-related fear in orthopaedic trauma. This will be performed at the 2 week, 6 week and 12 week follow up visits.	Integrated Care (ICare) n=38 Participants This group will receive ICare for orthopedic trauma involves surgical intervention, acute therapies, post-acute rehabilitation and follow-up clinic visits and simultaneous psychosocial support via the Transform-10 Program. Integrated care (ICare):This approach provides Usual Care plus the Transform-10 Program that includes information for emotional well-being, social support and opportunity for the patient to discuss thoughts and concerns with recovery. Patient's normal clinical care usually includes a hospital stay, a 2 week, 6 week, and 12 week follow up visits. Additionally, the following test will be performed: Patient-Reported Outcomes Measurement Information System: Questionnaires of Physical Functional quality of life and Emotional Well-being will be done during the 2 week, 6 week,12 week follow up visits. Lower Extremity Gain Scale (LEGS) consists of a 3-meter walk, putting on sock, putting on shoe, rising from a chair, stepping up/ down stairs, getting on/off the toilet, reaching from a sitting position to an object on the ground. This will be performed at the 6 week and 12 week follow up visits. Dynamometer: Isometric handgrip strength will be measured with a hand-held hydraulic dynamometer. This test will be performed at the 2 week, 6 week and 12 week follow up visits. Tampa Scale of Kinesiophobia-11 (TSK-11) will be used to assess pain-related fear in orthopaedic trauma. This will be performed at the 2 week, 6 week and 12 week follow up visits.
Absolute Hand Grip Scores at Weeks 2, 6 and 12 on the Hand-held Hydraulic Dynamometer to Measure Handgrip Strength Between the Groups. 2 weeks	31.35 kilograms Standard Deviation 16.6	30.1 kilograms Standard Deviation 19.15
Absolute Hand Grip Scores at Weeks 2, 6 and 12 on the Hand-held Hydraulic Dynamometer to Measure Handgrip Strength Between the Groups. 6 weeks	35.3 kilograms Standard Deviation 15.8	30.9 kilograms Standard Deviation 13.1
Absolute Hand Grip Scores at Weeks 2, 6 and 12 on the Hand-held Hydraulic Dynamometer to Measure Handgrip Strength Between the Groups. 12 weeks	35.9 kilograms Standard Deviation 15.45	33.95 kilograms Standard Deviation 12.8

Adverse Events

Usual Care (UsCare)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Integrated Care (ICare)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

MaryBeth Horodyski, EdD

University of Florida

Phone: 352-273-7074

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place