Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes, Safety, Well-Being After Orthopaedic Trauma
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.


Options:
A: Arm Label: Prolonged Exposure (CBT); Type: EXPERIMENTAL; Interventions: Procedure: Cognitive Behavioral Therapy | Arm Label: Cognitive Therapy; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Cognitive Therapy | Arm Label: SSRI (escitalopram); Type: EXPERIMENTAL; Interventions: Drug: Escitalopram | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: Waiting List; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Cognitive Behavioral Therapy; Assigned to Arm(s): Prolonged Exposure (CBT) | Intervention Type: PROCEDURE; Name: Cognitive Therapy; Assigned to Arm(s): Cognitive Therapy | Intervention Type: DRUG; Name: Escitalopram; Assigned to Arm(s): SSRI (escitalopram) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Usual Care (UsCare); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Usual Care (UsCare), Other: Patient-Reported Outcomes Measurement Information System, Other: Lower Extremity Gain Scale (LEGS), Other: Dynamometer, Other: Active Range of Motion (AROM), Other: Posttraumatic Stress Disorder (PTSD), Other: Beck Depression Inventory-II, Other: State-Trait Anxiety Inventory (STAI), Other: Tampa Scale of Kinesiophobia-11 (TSK-11) | Arm Label: Integrated Care (ICare); Type: EXPERIMENTAL; Interventions: Procedure: Integrated care (ICare), Other: Patient-Reported Outcomes Measurement Information System, Other: Lower Extremity Gain Scale (LEGS), Other: Dynamometer, Other: Active Range of Motion (AROM), Other: Posttraumatic Stress Disorder (PTSD), Other: Beck Depression Inventory-II, Other: State-Trait Anxiety Inventory (STAI), Other: Tampa Scale of Kinesiophobia-11 (TSK-11) | Intervention Type: PROCEDURE; Name: Integrated care (ICare); Assigned to Arm(s): Integrated Care (ICare) | Intervention Type: PROCEDURE; Name: Usual Care (UsCare); Assigned to Arm(s): Usual Care (UsCare) | Intervention Type: OTHER; Name: Patient-Reported Outcomes Measurement Information System; Assigned to Arm(s): Integrated Care (ICare), Usual Care (UsCare) | Intervention Type: OTHER; Name: Lower Extremity Gain Scale (LEGS); Assigned to Arm(s): Integrated Care (ICare), Usual Care (UsCare) | Intervention Type: OTHER; Name: Dynamometer; Assigned to Arm(s): Integrated Care (ICare), Usual Care (UsCare) | Intervention Type: OTHER; Name: Active Range of Motion (AROM); Assigned to Arm(s): Integrated Care (ICare), Usual Care (UsCare) | Intervention Type: OTHER; Name: Posttraumatic Stress Disorder (PTSD); Assigned to Arm(s): Integrated Care (ICare), Usual Care (UsCare) | Intervention Type: OTHER; Name: Beck Depression Inventory-II; Assigned to Arm(s): Integrated Care (ICare), Usual Care (UsCare) | Intervention Type: OTHER; Name: State-Trait Anxiety Inventory (STAI); Assigned to Arm(s): Integrated Care (ICare), Usual Care (UsCare) | Intervention Type: OTHER; Name: Tampa Scale of Kinesiophobia-11 (TSK-11); Assigned to Arm(s): Integrated Care (ICare), Usual Care (UsCare)
C: Arm Label: Discussion with nurse; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: ICU Diary; Type: EXPERIMENTAL; Interventions: Other: ICU Diary | Intervention Type: OTHER; Name: ICU Diary; Assigned to Arm(s): ICU Diary
D: Arm Label: 1; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Behavioral: Prolonged Exposure (PE) Therapy | Intervention Type: BEHAVIORAL; Name: Prolonged Exposure (PE) Therapy; Assigned to Arm(s): 2

Answer: B