CLINICAL TRIAL

Bilingual Brain Injury Education and outpatient Navigation for Hispanic families for Wounds

Recruiting · Any Age · All Sexes · Salt Lake City, UT

Brain Injury Education and Outpatient Navigation-1stBIEN

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About the trial for Wounds

Eligible Conditions
Wounds and Injuries · Brain Injuries · Rehabilitation · Brain Injuries, Traumatic

Treatment Groups

This trial involves 2 different treatments. Bilingual Brain Injury Education And Outpatient Navigation For Hispanic Families is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Bilingual Brain Injury Education and outpatient Navigation for Hispanic families
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex of any age. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Children 6 to 17 years of age
Hispanic ethnicity
You have a diagnosis of mild-complicated, moderate or severe TBI. show original
Hospitalization for more than 24 hours at one of the 5 academic institutions participating in this trial
Treatment requiring at least one type of rehabilitation therapy as outpatient
Being the primary caregiver for the child (For longitudinal follow-up purposes)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: ongoing tracking (from enrollment - 12 months follow-up)
Screening: ~3 weeks
Treatment: Varies
Reporting: ongoing tracking (from enrollment - 12 months follow-up)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: ongoing tracking (from enrollment - 12 months follow-up).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Bilingual Brain Injury Education and outpatient Navigation for Hispanic families will improve 2 primary outcomes, 12 secondary outcomes, and 7 other outcomes in patients with Wounds. Measurement will happen over the course of 12 months after discharge from the hospital.

Navigation evaluation
12 MONTHS AFTER DISCHARGE FROM THE HOSPITAL
Family Experiences with Coordination of Care (FECC) measurement. A 20-item list of quality indicators of care coordination and engagement with patient navigators for children with medical complexity.
12 MONTHS AFTER DISCHARGE FROM THE HOSPITAL
Receipt of follow-up care in centralized Hospital and community
6 MONTHS AFTER DISCHARGE.
Percentage of attended appointments at hospital, primary care and therapies
6 MONTHS AFTER DISCHARGE.
Parent's Anxiety symptoms
24 HOURS BEFORE DISCHARGE FROM THE HOSPITAL AND 3,6, AND 12 MONTHS AFTER HOSPITAL DISCHARGE.
Patient-Reported Outcomes Measurement Information System PROMIS Anxiety (SF8b).Symptoms are rated on a 5-point scale and converted to standard scores. The general population mean is 50 SD 10. Higher scores denote better outcomes.
24 HOURS BEFORE DISCHARGE FROM THE HOSPITAL AND 3,6, AND 12 MONTHS AFTER HOSPITAL DISCHARGE.
Caregiver Community Self Efficacy (COMSE)
24 HOURS BEFORE DISCHARGE FROM THE HOSPITAL AND 3,6, AND 12 MONTHS AFTER HOSPITAL DISCHARGE.
Caregiver Community Self-Efficacy (COMSE) measures caregivers' confidence in accessing community services for patients with brain injuries.
24 HOURS BEFORE DISCHARGE FROM THE HOSPITAL AND 3,6, AND 12 MONTHS AFTER HOSPITAL DISCHARGE.
Child's Functional Independence
24 HOURS BEFORE HOSPITAL DISCHARGE AND THROUGH STUDY COMPLETION AN AVERAGE OF 6 MONTHS
Functional independence measures (FIM) FIM (8+ years) and WeeFIM (6-7 years);18 items (mobility 5 items, self-care 8 items and cognition 5 items) objective functional measures of independence. Every item is scored from"1" (dependent) to "7" (independent).The possible total score ranges from 18 (lowest) to 126 (highest) level of independence. For each item Scores of 1 (total assistance) and 2 (maximal assistance) belong to the "Complete Dependence" category. Scores of 3 (moderate assistance), 4 (minimal contact assistance), and 5 (supervision or set-up) belong to the "Modified Dependence" category. Scores of 6 (modified independence) and 7 (complete independence) belong to the "Independent" category.
24 HOURS BEFORE HOSPITAL DISCHARGE AND THROUGH STUDY COMPLETION AN AVERAGE OF 6 MONTHS
Caregiver Self efficacy
24 HOURS BEFORE DISCHARGE FROM THE HOSPITAL AND 3,6, AND 12 MONTHS AFTER HOSPITAL DISCHARGE.
The Caregiver Self efficacy (CSE) scale. 7 items scale that measures caregivers' confidence in caring and advocating for patients with brain injuries.
24 HOURS BEFORE DISCHARGE FROM THE HOSPITAL AND 3,6, AND 12 MONTHS AFTER HOSPITAL DISCHARGE.
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Who is running the study

Principal Investigator
N. J.
Prof. Nathalia Jimenez, MD
Seattle Children's Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can wounds be cured?

Wounds do not need to be managed like a standard surgical situation, e.g. delayed excision or skin grafting. In an uneventful course, they need to be treated like any other wound.

Anonymous Patient Answer

What causes wounds?

Wounds are a broad topic of great diversity and the causes can be thought of as either inherent or precipitated. The ultimate goal in wound treatment is to ensure that the wound does not become infected, which can only happen if it becomes open to the outside environment, which requires a significant loss of tissue volume in any open wound. If this is the case it is reasonable to try to close the wound at all costs. It is in this context that we discuss the major causes of wounds.

Anonymous Patient Answer

What is wounds?

Recent findings illustrates that wounds are often used to denote the presence of injury, pain, discomfort and the need to remedy an injury. The implications of this and the implications for wound management is explored in further research.

Anonymous Patient Answer

What are common treatments for wounds?

A multidisciplinary approach is required for the treatment of all the chronic wounds mentioned in this paper for wound care. Treatment is dependent on the type of wound, whether the wound is burn-related, infected, etc. The key to wound healing is good wound care, which is a key determinant to a person's quality of life.

Anonymous Patient Answer

How many people get wounds a year in the United States?

In the United States, about 6.4 million people get wounds in a typical year. Most are superficial venous injuries, particularly those related to occupational injury and older people. There have been many efforts to reduce complications from venous injuries in the last 30 years, but complications still occur. Physicians and industry members are working to decrease these events through education and awareness. More research and medical efforts to improve trauma care are needed.

Anonymous Patient Answer

What are the signs of wounds?

Wounds present with bruising. Other symptoms may include swelling, tenderness, oozing and drainage, numbness of the finger tips and feet, and a sudden change in the colour of the skin. Symptoms of infection of open wounds can be painful and may be accompanied by fever, chills, shivering, rapid breathing, coughing, chest pains, nausea, vomiting and sweating, headache, blurred vision, dizziness and loss of consciousness.\n

Anonymous Patient Answer

What is bilingual brain injury education and outpatient navigation for hispanic families?

An evidence-based trauma program including bilingual (Spanish and English) rehabilitation for the Spanish-speaking and English-speaking populations results in improved outcomes that can be sustained at a high level.

Anonymous Patient Answer

Have there been other clinical trials involving bilingual brain injury education and outpatient navigation for hispanic families?

This is one of the first clinical trial reports demonstrating the effectiveness of bilingual brain injury education to non-Hispanic immigrant families. To our knowledge, this report is the first for brain injury education and clinical navigation for hispanic individuals in a primary care setting.

Anonymous Patient Answer

How serious can wounds be?

The seriousness of wounds depends on many factors, such as nature of the wound, medical history (e.g. infection or preexisting health problems such as diabetes or heart disease). Wounds are usually less serious than most other types of injuries, and most minor wounds resolve with relatively few problems. However, a significant percentage of cases warrants specific scrutiny by a physician. Even minor tears, bruises, cuts, and abrasions can become infected if left untreated. Such problems can become much more serious when untreated or misdiagnosed. There is [a] strong possibility that wounds may become [severely] debilitating and/or life threatening.

Anonymous Patient Answer

What is the primary cause of wounds?

Non-union cases have better healing ability than cases of bone regeneration. Wounds have two phases which are the inflammatory phase and the osteogenic phase. The inflammatory phase is the first phase, during which the blood flow and blood supply can be restored. Then, the osteogenic phase occurs (blood flow and blood supply are restored), during which bone formation is taken place. Finally, the osteogenic phase is the last stage of wound healing, in which the healing of the wound is finished.

Anonymous Patient Answer

Does bilingual brain injury education and outpatient navigation for hispanic families improve quality of life for those with wounds?

The bilingual brain rehabilitation program has improved quality of life among some of these patients with Wounds and we believe this was due to increased self-efficacy through education and navigation for the Spanish-language patients, as well as the increase in understanding of the injury and related disability issues by the English-speaking patients. However, the increase in the number of visits and the need for more support and assistance from these clinicians was a bit alarming and needs more investigation as to why. The improvements were observed in 4 months after participation in the program.

Anonymous Patient Answer

How does bilingual brain injury education and outpatient navigation for hispanic families work?

Knowledge is the base for understanding the consequences of the brain injury and for achieving effective recovery through specific skills. The use of informational strategies to teach brain injury as a traumatic event is key for achieving successful recovery. Navigation is helpful in this process.

Anonymous Patient Answer
See if you qualify for this trial
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