Effectiveness of Psycho-emotional Support in Acute Spinal Cord Injury. ESPELMA Project

Study Overview
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Brief Summary
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The purposes of the ESPELMA project are twofold: 1) To increase acute spinal cord injury patients' satisfaction with treatment while hospitalization and 2) To increase mastery among rehabilitation professionals with regard to the clinical management of patients' psychological distress. For these purposes, a tailored training for professionals will be designed and offered. It is hypothesized that building capacity among professionals will serve to better management of patients' distress and a greater ability to commit them to the rehabilitation process. Thus, it is expected to lead to better and faster functional recovery and consequently to higher perceived satisfaction with treatment.

Detailed Description
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Background: Acute spinal cord injury leaves patients severely impaired and consequently, generates high levels of psychological distress among them and their families. This psychological distress can cause patients and their families to take a less active role in rehabilitation, which leads to lower and slower levels of functional recovery and to less perceived satisfaction with the results. In addition, rehabilitation professionals that deal with this psychological distress could ultimately experience higher stress and more risk of burnout. The aim of ESPELMA project is to train rehabilitation professionals in the clinical management of acute spinal cord injury associated psychological distress, and to measure the impact of this training on the patients' perceived satisfaction with treatment. It is hypothesized that rehabilitation professionals trained in psychological distress management will foster greater psychological well-being during hospitalization among acute spinal cord injury patients and their families, and will secure greater commitment from them to participate in the rehabilitation process. Thus, it is expected to lead to better and faster functional recovery and consequently to higher perceived satisfaction with treatment. Methods/Design: The study follows a pre-post control group design. Participants are a sample of acute spinal cord injury patients consecutively admitted to a tertiary hospital spinal cord injury unit, their relatives, and the spinal cord injury unit staff. All participants completed a baseline survey before the intervention. Training of rehabilitation professionals comprises biweekly 6-hour sessions followed by 6-months of optional on-demand coaching. Contents of the training are customized according to focus groups. Once the training sessions end, all participants are assessed again. Discussion: To our knowledge, no studies have yet evaluated the effectiveness of training professionals to manage psychological distress of acute spinal cord injury patients by means of motivational interviewing principles. If this training proves to be effective, several benefits could be achieved: e.g. higher job content and less burnout among professionals, as well as better patient compliance and satisfaction with treatment. Keywords Acute Spinal Cord Injury; Patient Satisfaction; Psychological Distress; Rehabilitation; Training Professionals; Burnout; Job Content.

Official Title
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Effectiveness of Psycho-emotional Support in Acute Spinal Cord Injury. ESPELMA Project.

Conditions
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Spinal Cord Injury, Acute, Professional-Patient Relations, Sensitivity Training Groups, Patient Non-Compliance, Satisfaction

Intervention / Treatment
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* Behavioral: Training for professionals (Spinal Cord Injury Unit staff).


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for patients are: To be 15 years old or older. To be admitted to the SCI Unit and suffering from ASCI, regardless of neurological level cervical, thoracic, lumbar or sacral) or ASIA classification (A, B, C or D). Exclusion criteria for patients are: Etiology of the injury as an acute non-traumatic SCI. Age younger than 15 years old and 3) Traumatic Brain Injury hampering comprehension during assessments. One relative or main caregiver per patient is assessed. Finally, all SCI Unit staff (rehabilitative doctors, nurses, assistant nurses, physiotherapists, physical activity instructors, the occupational therapist, social workers and hospital attendants)is also assessed.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-intervention group.<br>The initial assessment includes pre-intervention measures (baseline) for the patient, his/her relative (or main caregiver) and the rehabilitation staff. Patients are assessed during the first week (or ≥ 10 days of SCI Unit admission) and at discharge (an expected average of 8 weeks). At the time of each patient's discharge, their family or main caregiver is also surveyed. Lastly, rehabilitation team members are also assessed across the pre-intervention phase. | |
| Other: Post-intervention group.<br>Once intervention and coaching period for professionals has ended, post-intervention sample (patients, family and professionals) is assessed with the same time criteria than the pre-intervention sample. | Behavioral: Training for professionals (Spinal Cord Injury Unit staff).<br>* Prior to the training, separate focus groups for professionals, patients & families are conducted to determine each party's needs and worries. Tailored training for professionals (customized according to focus groups contents) consists of 12 hours distributed in 2 days (1 day per week). It includes theoretical and practical exercises on early detection of PD, communication skills, management of psycho-emotional reactions, family interventions and teamwork alternatives. Standard motivational interviewing techniques for improving empathy skills and communication styles are employed. Additionally, optional on-demand small group or individual coaching sessions (after training) will be offered (50-60 minutes per session) during a 6-months period.<br>* Other names: - Coaching.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Picker Patient Experience Questionnaire (PPE-33) | Satisfaction with care received, the main outcome measure of the study, is evaluated with the Spanish version of the Picker Patient Experience Questionnaire (PPE). | At discharge (an expected average of 8 weeks after admission). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resilience Scale (RS-25) | Resilience is evaluated with the Spanish version of the Resilience Scale (RS-25). | At discharge (an expected average of 8 weeks after admission). | 
| WHOQoL-BREF (26 items) | Quality of life is evaluated with the WHOQOL-BREF test developed by the World Health Organization. | At discharge (an expected average of 8 weeks after admission). | 
| Biomedical and demographics | Medical and demographical data of patients is collected according to standard procedures. | Within the first week of admission and updated at discharge (an expected average of 8 weeks after admission). | 
| SCIM-III Questionnaire | Patient functional status is measured with the third version of the Spinal Cord Independence Measure (SCIM-III) questionnaire. | Within the first week of admission. | 
| ASIA Classification | International Standards for Neurological Classification of SCI, developed by the American Spinal Injury Association. | Within the first week of admission. | 
| HADS | Psychological distress (anxiety and depression) is evaluated using the Hospital Anxiety and Depression Scale. | Within the first week of admission (plus 7-10 days). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Spinal Cord Injury, Patient Satisfaction, Psychological Distress, Rehabilitation, Training Professionals, Burnout, Job Content