Clinical trial NCT04551157: Impact of Psychoeducational Video on Adjustment to Open Fracture.
Official title: Early Adjustment Following Open Fracture: the Impact of Viewing Psychoeducational Video Material.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Major Trauma
Keywords: major trauma
open fracture
intervention
appearance
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomised to intervention group (video-viewing) or treatment-as-usual (control) group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The multi-disciplinary team involved in the care of major trauma patients with open fractures has developed two novel patient information videos. They include practical advice from staff about the recovery process, images of the wound throughout the healing process and ways to cope with the range of emotional responses that patients report following an open fracture. The experiences of previous patients are also included. The aim of this project is to evaluate the impact of viewing these videos on patients' ability to follow treatment recommendations made by the team, as well as their psychological and social functioning, as measured by standardised questionnaire responses. Additionally, the patient's experience of viewing the videos, in terms of how relevant and useful they found them, will be evaluated.

Detailed description: High levels of psychological difficulty are often reported by patients with an open fracture. These patients frequently describe feeling distressed by the initial appearance of their scars and can struggle to adjust and prepare for the challenges they face on discharge from hospital. Patients' expectations about the appearance of their wounds and their role in the recovery process may be aided with access to visual material that the patient and their family can revisit as often as is helpful to them.

Therefore, the multi-disciplinary team involved in the care of these patients has developed two novel patient information videos. They include practical advice from staff about the recovery process, images of the wound throughout the healing process and ways to cope with the range of emotional responses that patients report following an open fracture. The experiences of previous patients are also included. The aim of this project is to evaluate the impact of viewing these videos on patients' ability to follow treatment recommendations made by the team, as well as their psychological and social functioning, as measured by standardised questionnaire responses. Additionally, the patient's experience of viewing the videos, in terms of how relevant and useful they found them, will be evaluated.

All adult patients with an open fracture attending the John Radcliffe Hospital Major Trauma Centre will be eligible to take part (unless they have a diagnosis of dementia, active delirium or traumatic brain injury). Participation will involve completing questionnaires whilst in hospital (within the first week and prior to discharge) and at a routine 3-month follow-up appointment. Patients will be randomly selected to either view the videos or receive treatment as usual. The questionnaire responses of patients in these two groups will be compared to help evaluate the videos.

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Fluent in English.
* Diagnosed with an open fracture.
* Inpatient stay of \>72 hours.

Exclusion Criteria:

* Participant has a diagnosis of dementia.
* Participant is experiencing delirium.
* Participant has a complete spinal fracture.
* Participant has a traumatic brain injury with a clinically significant presentation.
* Participant is unable to provide written consent.

Primary outcomes:
measure: Clinical Outcomes Routine Evaluation 10 (CORE-10)
timeFrame: 3-7 days after hospital admission (Timepoint 1 - baseline)
measure: Clinical Outcomes Routine Evaluation 10 (CORE-10)
timeFrame: 7-14 days after admission (Timepoint 2 - prior to discharge)
measure: Clinical Outcomes Routine Evaluation 10 (CORE-10)
timeFrame: 3-months post-injury (Timepoint 3 - follow-up)
measure: Appearance-Related Psychosocial Distress Scale
timeFrame: 3-7 days after hospital admission (Timepoint 1 - baseline)
measure: Appearance-Related Psychosocial Distress Scale
timeFrame: 7-14 days after admission (Timepoint 2 - prior to discharge)
measure: Appearance-Related Psychosocial Distress Scale
timeFrame: 3-months post-injury (Timepoint 3 - follow-up)
measure: Trauma Screening Questionnaire (TSQ)
timeFrame: 3-7 days after hospital admission (Timepoint 1 - baseline)
measure: Trauma Screening Questionnaire (TSQ)
timeFrame: 7-14 days after admission (Timepoint 2 - prior to discharge)
measure: Trauma Screening Questionnaire (TSQ)
timeFrame: 3-months post-injury (Timepoint 3 - follow-up)
measure: General Adherence Measure
timeFrame: 3-7 days after hospital admission (Timepoint 1 - baseline)
measure: General Adherence Measure
timeFrame: 7-14 days after admission (Timepoint 2 - prior to discharge)
measure: General Adherence Measure
timeFrame: 3-months post-injury (Timepoint 3 - follow-up)
measure: Condition specific statements about treatment and scarring
timeFrame: 3-7 days after hospital admission (Timepoint 1 - baseline)
measure: Condition specific statements about treatment and scarring
timeFrame: 7-14 days after admission (Timepoint 2 - prior to discharge)
measure: Condition specific statements about treatment and scarring
timeFrame: 3-months post-injury (Timepoint 3 - follow-up)
Secondary outcomes:
measure: Intervention acceptability and feasibility measure
timeFrame: 7-14 days after admission (Timepoint 2 - prior to discharge)
measure: Intervention acceptability and feasibility measure
timeFrame: 3-months post-injury (Timepoint 3 - follow-up)
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxfordshire
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: May Quarmby, D Clin
role: PRINCIPAL_INVESTIGATOR
References: