Impact of Psychoeducational Video on Adjustment to Open Fracture.
Primary Purpose
Major Trauma
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Video Viewing
Sponsored by
About this trial
This is an interventional supportive care trial for Major Trauma focused on measuring major trauma, open fracture, intervention, appearance
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.
Sites / Locations
- John Radcliffe Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Video Viewing
Treatment as usual
Arm Description
Participants will receive the intervention where they will view two patient information videos. The first video will be viewed within the first week of their inpatient stay and the second video will be viewed just before discharge.
No change to routine care.
Outcomes
Primary Outcome Measures
Clinical Outcomes Routine Evaluation 10 (CORE-10)
The CORE-10 is a brief, generic and easy-to-use measure of psychological distress. It is a self-report questionnaire with ten items about how the respondent has been feeling over the last week, with a 5-point Likert scale (Not at all/Only occasionally/Sometimes/Often/Most of the time). These items cover symptoms (depression, anxiety, trauma, physical problems), functioning (general, social and close relationships sub-domains) and risk to self. All items are summed (items 2 and 3 are reversed scored). The minimum score is 0 and the maximum score is 40, with higher scores indicating higher levels of psychological distress. The clinical cut-off score for general psychological distress is 11.0. The clinical cut-off for depression is 13.0 (sensitivity and specificity values of .92 and 0.72 respectively).
Clinical Outcomes Routine Evaluation 10 (CORE-10)
The CORE-10 is a brief, generic and easy-to-use measure of psychological distress. It is a self-report questionnaire with ten items about how the respondent has been feeling over the last week, with a 5-point Likert scale (Not at all/Only occasionally/Sometimes/Often/Most of the time). These items cover symptoms (depression, anxiety, trauma, physical problems), functioning (general, social and close relationships sub-domains) and risk to self. All items are summed (items 2 and 3 are reversed scored). The minimum score is 0 and the maximum score is 40, with higher scores indicating higher levels of psychological distress. The clinical cut-off score for general psychological distress is 11.0. The clinical cut-off for depression is 13.0 (sensitivity and specificity values of .92 and 0.72 respectively).
Clinical Outcomes Routine Evaluation 10 (CORE-10)
The CORE-10 is a brief, generic and easy-to-use measure of psychological distress. It is a self-report questionnaire with ten items about how the respondent has been feeling over the last week, with a 5-point Likert scale (Not at all/Only occasionally/Sometimes/Often/Most of the time). These items cover symptoms (depression, anxiety, trauma, physical problems), functioning (general, social and close relationships sub-domains) and risk to self. All items are summed (items 2 and 3 are reversed scored). The minimum score is 0 and the maximum score is 40, with higher scores indicating higher levels of psychological distress. The clinical cut-off score for general psychological distress is 11.0. The clinical cut-off for depression is 13.0 (sensitivity and specificity values of .92 and 0.72 respectively).
Appearance-Related Psychosocial Distress Scale
This is an 8-item self-report scale where respondents are asked to disagree or agree to 8 statements about their appearance using a 4-point likert scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). The minimum score is 8 and the maximum is 32, which higher scores indicating higher levels of appearance-related psychosocial distress. Klassen and colleagues (2016) used Rasch Measurement Theory (RMT) analysis to assess the psychometric properties of the measure. Person Separation Index (analogous to a reliability index) and Cronbach alpha values were 0.81 and 0.89 respectively. Convergent and predictive validity of this scale have not yet been assessed.
Appearance-Related Psychosocial Distress Scale
This is an 8-item self-report scale where respondents are asked to disagree or agree to 8 statements about their appearance using a 4-point likert scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). The minimum score is 8 and the maximum is 32, which higher scores indicating higher levels of appearance-related psychosocial distress. Klassen and colleagues (2016) used Rasch Measurement Theory (RMT) analysis to assess the psychometric properties of the measure. Person Separation Index (analogous to a reliability index) and Cronbach alpha values were 0.81 and 0.89 respectively. Convergent and predictive validity of this scale have not yet been assessed.
Appearance-Related Psychosocial Distress Scale
This is an 8-item self-report scale where respondents are asked to disagree or agree to 8 statements about their appearance using a 4-point likert scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). The minimum score is 8 and the maximum is 32, which higher scores indicating higher levels of appearance-related psychosocial distress. Klassen and colleagues (2016) used Rasch Measurement Theory (RMT) analysis to assess the psychometric properties of the measure. Person Separation Index (analogous to a reliability index) and Cronbach alpha values were 0.81 and 0.89 respectively. Convergent and predictive validity of this scale have not yet been assessed.
Trauma Screening Questionnaire (TSQ)
The TSQ is a 10-item self-report questionnaire with items covering the different reactions that sometimes occur after a traumatic event. Respondents are asked to endorse Yes/No to whether or not they have experienced any of the following at least twice in the last week. Predictive validity of respondents who endorsed at least six of the re-experiencing or arousal items (in any combination) was excellent. Sensitivity was 0.86 and specificity was 0.93. Other research by Brewin, Fuchkan, Huntley & Scragg (2010) has indicated low specificity in non-white samples. Specificity was also low if the TSQ was administered early after the trauma but this improved in the eighteen months following the event.
Trauma Screening Questionnaire (TSQ)
The TSQ is a 10-item self-report questionnaire with items covering the different reactions that sometimes occur after a traumatic event. Respondents are asked to endorse Yes/No to whether or not they have experienced any of the following at least twice in the last week. Predictive validity of respondents who endorsed at least six of the re-experiencing or arousal items (in any combination) was excellent. Sensitivity was 0.86 and specificity was 0.93. Other research by Brewin, Fuchkan, Huntley & Scragg (2010) has indicated low specificity in non-white samples. Specificity was also low if the TSQ was administered early after the trauma but this improved in the eighteen months following the event.
Trauma Screening Questionnaire (TSQ)
The TSQ is a 10-item self-report questionnaire with items covering the different reactions that sometimes occur after a traumatic event. Respondents are asked to endorse Yes/No to whether or not they have experienced any of the following at least twice in the last week. Predictive validity of respondents who endorsed at least six of the re-experiencing or arousal items (in any combination) was excellent. Sensitivity was 0.86 and specificity was 0.93. Other research by Brewin, Fuchkan, Huntley & Scragg (2010) has indicated low specificity in non-white samples. Specificity was also low if the TSQ was administered early after the trauma but this improved in the eighteen months following the event.
General Adherence Measure
This is a general measure of patient's adherence to treatment, where respondents are asked how often they were able to adhere to their treatment. It has 5-items and a 6-point Likert response scale (None of the time/A little of the time/Some of the time/A good bit of the time/Most of the time/All of the time). The minimum score is 5 and the maximum score is 24, with higher scores indicating better adherence to treatment. The internal consistency of the measure has been found to be acceptable with a Cronbach's alpha of 0.81 (Hays, n.d).
General Adherence Measure
This is a general measure of patient's adherence to treatment, where respondents are asked how often they were able to adhere to their treatment. It has 5-items and a 6-point Likert response scale (None of the time/A little of the time/Some of the time/A good bit of the time/Most of the time/All of the time). The minimum score is 5 and the maximum score is 24, with higher scores indicating better adherence to treatment. The internal consistency of the measure has been found to be acceptable with a Cronbach's alpha of 0.81 (Hays, n.d).
General Adherence Measure
This is a general measure of patient's adherence to treatment, where respondents are asked how often they were able to adhere to their treatment. It has 5-items and a 6-point Likert response scale (None of the time/A little of the time/Some of the time/A good bit of the time/Most of the time/All of the time). The minimum score is 5 and the maximum score is 24, with higher scores indicating better adherence to treatment. The internal consistency of the measure has been found to be acceptable with a Cronbach's alpha of 0.81 (Hays, n.d).
Condition specific statements about treatment and scarring
This includes 4 statements about the patient's treatment and 10 about their scarring, written by the chief investigator and based on clinical experience. The items address how the patient feels about their treatment, their expectations about ongoing treatment and healing and their role in the recovery process. The items focus on the patient's emotional responses to their scars and their perceptions about the impact the scars may have on their quality of life. These items are on a 4-point agreement scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). For the treatment section, the minimum score is 4 and the maximum score is 16, with higher scores indicating better understanding of treatment. and better adjustment/more positive attitudes towards scarring respectively. For the scarring section, the minimum score is 10 and the maximum score is 40, with higher scores indicating better adjustment/more positive attitudes towards scarring respectively.
Condition specific statements about treatment and scarring
This includes 4 statements about the patient's treatment and 10 about their scarring, written by the chief investigator and based on clinical experience. The items address how the patient feels about their treatment, their expectations about ongoing treatment and healing and their role in the recovery process. The items focus on the patient's emotional responses to their scars and their perceptions about the impact the scars may have on their quality of life. These items are on a 4-point agreement scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). For the treatment section, the minimum score is 4 and the maximum score is 16, with higher scores indicating better understanding of treatment. and better adjustment/more positive attitudes towards scarring respectively. For the scarring section, the minimum score is 10 and the maximum score is 40, with higher scores indicating better adjustment/more positive attitudes towards scarring respectively.
Condition specific statements about treatment and scarring
This includes 4 statements about the patient's treatment and 10 about their scarring, written by the chief investigator and based on clinical experience. The items address how the patient feels about their treatment, their expectations about ongoing treatment and healing and their role in the recovery process. The items focus on the patient's emotional responses to their scars and their perceptions about the impact the scars may have on their quality of life. These items are on a 4-point agreement scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). For the treatment section, the minimum score is 4 and the maximum score is 16, with higher scores indicating better understanding of treatment. and better adjustment/more positive attitudes towards scarring respectively. For the scarring section, the minimum score is 10 and the maximum score is 40, with higher scores indicating better adjustment/more positive attitudes towards scarring respectively.
Secondary Outcome Measures
Intervention acceptability and feasibility measure
This is a 10-item measure developed specifically for the purpose of this study by the chief investigator. Patients are asked to respond to 6 statements on a 4-point agreement scale (Definitively disagree/Somewhat disagree/Somewhat agree/Definitely agree). This includes items such as 'the videos contained information that was relevant to me' and 'I found the videos upsetting to watch'. The minimum score is 6 and the maximum score is 24, with higher scores indicating higher acceptability and feasibility of the intervention. There are an additional 2 items asking the patient whether the time that they viewed video 1 and video 2 respectively was too soon after the injury, about right or too late after the injury.
Intervention acceptability and feasibility measure
This is a 10-item measure developed specifically for the purpose of this study by the chief investigator. Patients are asked to respond to 6 statements on a 4-point agreement scale (Definitively disagree/Somewhat disagree/Somewhat agree/Definitely agree). This includes items such as 'the videos contained information that was relevant to me' and 'I found the videos upsetting to watch'. The minimum score is 6 and the maximum score is 24, with higher scores indicating higher acceptability and feasibility of the intervention. There are an additional 2 items asking the patient whether the time that they viewed video 1 and video 2 respectively was too soon after the injury, about right or too late after the injury.
Full Information
NCT ID
NCT04551157
First Posted
September 3, 2020
Last Updated
January 12, 2023
Sponsor
Oxford University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT04551157
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit during Covid & funding no longer available
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford University Hospitals NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Trauma
Keywords
major trauma, open fracture, intervention, appearance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants randomised to intervention group (video-viewing) or treatment-as-usual (control) group.
Masking
None (Open Label)
Masking Description
Participants will be made aware at the time of informed consent that they will be randomised to either view the videos or receive treatment-as-usual
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video Viewing
Arm Type
Experimental
Arm Description
Participants will receive the intervention where they will view two patient information videos. The first video will be viewed within the first week of their inpatient stay and the second video will be viewed just before discharge.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
No change to routine care.
Intervention Type
Other
Intervention Name(s)
Video Viewing
Intervention Description
Two patient information videos containing 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.
Primary Outcome Measure Information:
Title
Clinical Outcomes Routine Evaluation 10 (CORE-10)
Description
The CORE-10 is a brief, generic and easy-to-use measure of psychological distress. It is a self-report questionnaire with ten items about how the respondent has been feeling over the last week, with a 5-point Likert scale (Not at all/Only occasionally/Sometimes/Often/Most of the time). These items cover symptoms (depression, anxiety, trauma, physical problems), functioning (general, social and close relationships sub-domains) and risk to self. All items are summed (items 2 and 3 are reversed scored). The minimum score is 0 and the maximum score is 40, with higher scores indicating higher levels of psychological distress. The clinical cut-off score for general psychological distress is 11.0. The clinical cut-off for depression is 13.0 (sensitivity and specificity values of .92 and 0.72 respectively).
Time Frame
3-7 days after hospital admission (Timepoint 1 - baseline)
Title
Clinical Outcomes Routine Evaluation 10 (CORE-10)
Description
The CORE-10 is a brief, generic and easy-to-use measure of psychological distress. It is a self-report questionnaire with ten items about how the respondent has been feeling over the last week, with a 5-point Likert scale (Not at all/Only occasionally/Sometimes/Often/Most of the time). These items cover symptoms (depression, anxiety, trauma, physical problems), functioning (general, social and close relationships sub-domains) and risk to self. All items are summed (items 2 and 3 are reversed scored). The minimum score is 0 and the maximum score is 40, with higher scores indicating higher levels of psychological distress. The clinical cut-off score for general psychological distress is 11.0. The clinical cut-off for depression is 13.0 (sensitivity and specificity values of .92 and 0.72 respectively).
Time Frame
7-14 days after admission (Timepoint 2 - prior to discharge)
Title
Clinical Outcomes Routine Evaluation 10 (CORE-10)
Description
The CORE-10 is a brief, generic and easy-to-use measure of psychological distress. It is a self-report questionnaire with ten items about how the respondent has been feeling over the last week, with a 5-point Likert scale (Not at all/Only occasionally/Sometimes/Often/Most of the time). These items cover symptoms (depression, anxiety, trauma, physical problems), functioning (general, social and close relationships sub-domains) and risk to self. All items are summed (items 2 and 3 are reversed scored). The minimum score is 0 and the maximum score is 40, with higher scores indicating higher levels of psychological distress. The clinical cut-off score for general psychological distress is 11.0. The clinical cut-off for depression is 13.0 (sensitivity and specificity values of .92 and 0.72 respectively).
Time Frame
3-months post-injury (Timepoint 3 - follow-up)
Title
Appearance-Related Psychosocial Distress Scale
Description
This is an 8-item self-report scale where respondents are asked to disagree or agree to 8 statements about their appearance using a 4-point likert scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). The minimum score is 8 and the maximum is 32, which higher scores indicating higher levels of appearance-related psychosocial distress. Klassen and colleagues (2016) used Rasch Measurement Theory (RMT) analysis to assess the psychometric properties of the measure. Person Separation Index (analogous to a reliability index) and Cronbach alpha values were 0.81 and 0.89 respectively. Convergent and predictive validity of this scale have not yet been assessed.
Time Frame
3-7 days after hospital admission (Timepoint 1 - baseline)
Title
Appearance-Related Psychosocial Distress Scale
Description
This is an 8-item self-report scale where respondents are asked to disagree or agree to 8 statements about their appearance using a 4-point likert scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). The minimum score is 8 and the maximum is 32, which higher scores indicating higher levels of appearance-related psychosocial distress. Klassen and colleagues (2016) used Rasch Measurement Theory (RMT) analysis to assess the psychometric properties of the measure. Person Separation Index (analogous to a reliability index) and Cronbach alpha values were 0.81 and 0.89 respectively. Convergent and predictive validity of this scale have not yet been assessed.
Time Frame
7-14 days after admission (Timepoint 2 - prior to discharge)
Title
Appearance-Related Psychosocial Distress Scale
Description
This is an 8-item self-report scale where respondents are asked to disagree or agree to 8 statements about their appearance using a 4-point likert scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). The minimum score is 8 and the maximum is 32, which higher scores indicating higher levels of appearance-related psychosocial distress. Klassen and colleagues (2016) used Rasch Measurement Theory (RMT) analysis to assess the psychometric properties of the measure. Person Separation Index (analogous to a reliability index) and Cronbach alpha values were 0.81 and 0.89 respectively. Convergent and predictive validity of this scale have not yet been assessed.
Time Frame
3-months post-injury (Timepoint 3 - follow-up)
Title
Trauma Screening Questionnaire (TSQ)
Description
The TSQ is a 10-item self-report questionnaire with items covering the different reactions that sometimes occur after a traumatic event. Respondents are asked to endorse Yes/No to whether or not they have experienced any of the following at least twice in the last week. Predictive validity of respondents who endorsed at least six of the re-experiencing or arousal items (in any combination) was excellent. Sensitivity was 0.86 and specificity was 0.93. Other research by Brewin, Fuchkan, Huntley & Scragg (2010) has indicated low specificity in non-white samples. Specificity was also low if the TSQ was administered early after the trauma but this improved in the eighteen months following the event.
Time Frame
3-7 days after hospital admission (Timepoint 1 - baseline)
Title
Trauma Screening Questionnaire (TSQ)
Description
The TSQ is a 10-item self-report questionnaire with items covering the different reactions that sometimes occur after a traumatic event. Respondents are asked to endorse Yes/No to whether or not they have experienced any of the following at least twice in the last week. Predictive validity of respondents who endorsed at least six of the re-experiencing or arousal items (in any combination) was excellent. Sensitivity was 0.86 and specificity was 0.93. Other research by Brewin, Fuchkan, Huntley & Scragg (2010) has indicated low specificity in non-white samples. Specificity was also low if the TSQ was administered early after the trauma but this improved in the eighteen months following the event.
Time Frame
7-14 days after admission (Timepoint 2 - prior to discharge)
Title
Trauma Screening Questionnaire (TSQ)
Description
The TSQ is a 10-item self-report questionnaire with items covering the different reactions that sometimes occur after a traumatic event. Respondents are asked to endorse Yes/No to whether or not they have experienced any of the following at least twice in the last week. Predictive validity of respondents who endorsed at least six of the re-experiencing or arousal items (in any combination) was excellent. Sensitivity was 0.86 and specificity was 0.93. Other research by Brewin, Fuchkan, Huntley & Scragg (2010) has indicated low specificity in non-white samples. Specificity was also low if the TSQ was administered early after the trauma but this improved in the eighteen months following the event.
Time Frame
3-months post-injury (Timepoint 3 - follow-up)
Title
General Adherence Measure
Description
This is a general measure of patient's adherence to treatment, where respondents are asked how often they were able to adhere to their treatment. It has 5-items and a 6-point Likert response scale (None of the time/A little of the time/Some of the time/A good bit of the time/Most of the time/All of the time). The minimum score is 5 and the maximum score is 24, with higher scores indicating better adherence to treatment. The internal consistency of the measure has been found to be acceptable with a Cronbach's alpha of 0.81 (Hays, n.d).
Time Frame
3-7 days after hospital admission (Timepoint 1 - baseline)
Title
General Adherence Measure
Description
This is a general measure of patient's adherence to treatment, where respondents are asked how often they were able to adhere to their treatment. It has 5-items and a 6-point Likert response scale (None of the time/A little of the time/Some of the time/A good bit of the time/Most of the time/All of the time). The minimum score is 5 and the maximum score is 24, with higher scores indicating better adherence to treatment. The internal consistency of the measure has been found to be acceptable with a Cronbach's alpha of 0.81 (Hays, n.d).
Time Frame
7-14 days after admission (Timepoint 2 - prior to discharge)
Title
General Adherence Measure
Description
This is a general measure of patient's adherence to treatment, where respondents are asked how often they were able to adhere to their treatment. It has 5-items and a 6-point Likert response scale (None of the time/A little of the time/Some of the time/A good bit of the time/Most of the time/All of the time). The minimum score is 5 and the maximum score is 24, with higher scores indicating better adherence to treatment. The internal consistency of the measure has been found to be acceptable with a Cronbach's alpha of 0.81 (Hays, n.d).
Time Frame
3-months post-injury (Timepoint 3 - follow-up)
Title
Condition specific statements about treatment and scarring
Description
This includes 4 statements about the patient's treatment and 10 about their scarring, written by the chief investigator and based on clinical experience. The items address how the patient feels about their treatment, their expectations about ongoing treatment and healing and their role in the recovery process. The items focus on the patient's emotional responses to their scars and their perceptions about the impact the scars may have on their quality of life. These items are on a 4-point agreement scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). For the treatment section, the minimum score is 4 and the maximum score is 16, with higher scores indicating better understanding of treatment. and better adjustment/more positive attitudes towards scarring respectively. For the scarring section, the minimum score is 10 and the maximum score is 40, with higher scores indicating better adjustment/more positive attitudes towards scarring respectively.
Time Frame
3-7 days after hospital admission (Timepoint 1 - baseline)
Title
Condition specific statements about treatment and scarring
Description
This includes 4 statements about the patient's treatment and 10 about their scarring, written by the chief investigator and based on clinical experience. The items address how the patient feels about their treatment, their expectations about ongoing treatment and healing and their role in the recovery process. The items focus on the patient's emotional responses to their scars and their perceptions about the impact the scars may have on their quality of life. These items are on a 4-point agreement scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). For the treatment section, the minimum score is 4 and the maximum score is 16, with higher scores indicating better understanding of treatment. and better adjustment/more positive attitudes towards scarring respectively. For the scarring section, the minimum score is 10 and the maximum score is 40, with higher scores indicating better adjustment/more positive attitudes towards scarring respectively.
Time Frame
7-14 days after admission (Timepoint 2 - prior to discharge)
Title
Condition specific statements about treatment and scarring
Description
This includes 4 statements about the patient's treatment and 10 about their scarring, written by the chief investigator and based on clinical experience. The items address how the patient feels about their treatment, their expectations about ongoing treatment and healing and their role in the recovery process. The items focus on the patient's emotional responses to their scars and their perceptions about the impact the scars may have on their quality of life. These items are on a 4-point agreement scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). For the treatment section, the minimum score is 4 and the maximum score is 16, with higher scores indicating better understanding of treatment. and better adjustment/more positive attitudes towards scarring respectively. For the scarring section, the minimum score is 10 and the maximum score is 40, with higher scores indicating better adjustment/more positive attitudes towards scarring respectively.
Time Frame
3-months post-injury (Timepoint 3 - follow-up)
Secondary Outcome Measure Information:
Title
Intervention acceptability and feasibility measure
Description
This is a 10-item measure developed specifically for the purpose of this study by the chief investigator. Patients are asked to respond to 6 statements on a 4-point agreement scale (Definitively disagree/Somewhat disagree/Somewhat agree/Definitely agree). This includes items such as 'the videos contained information that was relevant to me' and 'I found the videos upsetting to watch'. The minimum score is 6 and the maximum score is 24, with higher scores indicating higher acceptability and feasibility of the intervention. There are an additional 2 items asking the patient whether the time that they viewed video 1 and video 2 respectively was too soon after the injury, about right or too late after the injury.
Time Frame
7-14 days after admission (Timepoint 2 - prior to discharge)
Title
Intervention acceptability and feasibility measure
Description
This is a 10-item measure developed specifically for the purpose of this study by the chief investigator. Patients are asked to respond to 6 statements on a 4-point agreement scale (Definitively disagree/Somewhat disagree/Somewhat agree/Definitely agree). This includes items such as 'the videos contained information that was relevant to me' and 'I found the videos upsetting to watch'. The minimum score is 6 and the maximum score is 24, with higher scores indicating higher acceptability and feasibility of the intervention. There are an additional 2 items asking the patient whether the time that they viewed video 1 and video 2 respectively was too soon after the injury, about right or too late after the injury.
Time Frame
3-months post-injury (Timepoint 3 - follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
May Quarmby, D Clin
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Radcliffe Hospital
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Psychoeducational Video on Adjustment to Open Fracture.
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