Impact of Psychoeducational Video on Adjustment to Open Fracture.

NCT04551157 | Terminated

• 1 other identifier: 263694
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Trauma

Keywords

major trauma; open fracture; intervention; appearance

Outcome Measures

Primary Outcomes (15)

• 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).

  3-7 days after hospital admission (Timepoint 1 - baseline)

• 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).

  7-14 days after admission (Timepoint 2 - prior to discharge)

• 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).

  3-months post-injury (Timepoint 3 - follow-up)

• 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.

  3-7 days after hospital admission (Timepoint 1 - baseline)

• 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.

  7-14 days after admission (Timepoint 2 - prior to discharge)

• 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.

  3-months post-injury (Timepoint 3 - follow-up)

• 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.

  3-7 days after hospital admission (Timepoint 1 - baseline)

• 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.

  7-14 days after admission (Timepoint 2 - prior to discharge)

• 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.

  3-months post-injury (Timepoint 3 - follow-up)

• 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).

  3-7 days after hospital admission (Timepoint 1 - baseline)

• 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).

  7-14 days after admission (Timepoint 2 - prior to discharge)

• 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).

  3-months post-injury (Timepoint 3 - follow-up)

• 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.

  3-7 days after hospital admission (Timepoint 1 - baseline)

• 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.

  7-14 days after admission (Timepoint 2 - prior to discharge)

• 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.

  3-months post-injury (Timepoint 3 - follow-up)

Secondary Outcomes (2)

• Intervention acceptability and feasibility measure

  7-14 days after admission (Timepoint 2 - prior to discharge)

• Intervention acceptability and feasibility measure

  3-months post-injury (Timepoint 3 - follow-up)

Study Arms (2)

Video Viewing

EXPERIMENTAL

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.

Other: Video Viewing

Treatment as usual

NO INTERVENTION

No change to routine care.

Interventions

Video Viewing OTHER

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.

Video Viewing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Fractures, Open

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• May Quarmby, D Clin

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: Participants randomised to intervention group (video-viewing) or treatment-as-usual (control) group.

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 16, 2020
• Study Start: December 3, 2020
• Primary Completion: August 1, 2021
• Study Completion: November 1, 2021
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)