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

Satisfaction Clinical Trial

— ESPELMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01889940
• Other study ID #: ESPELMA
• Secondary ID: ESPELMA
• Status: Completed
• Phase: N/A
• First received: May 27, 2013
• Last updated: June 15, 2015
• Start date: February 2012
• Est. completion date: February 2015

Study information

• Verified date: June 2015
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Training for professionals (Spinal Cord Injury Unit staff).
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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Fundació La Marató de TV3

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Consultation-Liaison Psychiatry in a Spinal Cord Injury Unit: Theoretical Elements [Interconsulta y Psiquiatría de Enlace en una Unidad de Lesión Medular: Aspectos teóricos] Lusilla-Palacios, P., Castellano-Tejedor, C., Navarro-Marfisis, M.C., González-Viejo, M. A. Cuadernos de Medicina Psicosomática y Psiquiatría de Enlace, 2013, 106, (accepted).

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	VAS for family/caregivers' satisfaction with care.	Family/caregivers' satisfaction is assessed according to the relative who acts as the main caregiver of the patient. It is rated using a 4-point Likert scale (scoring from 1 [very unsatisfied] to 4 [very satisfied]). On open question to add any other relevant information with regard to satisfaction with care is also administered.	At discharge (an expected average of 8 weeks after admission); (tool for family/caregivers).	No
Other	Resilience Scale (RS-25)	Family/caregivers' resilience.	At discharge (an expected average of 8 weeks after admission); (tool for family/caregivers).	No
Other	Jefferson Scale for Professionals Empathy (JSPE)	Rehabilitation professionals' empathy skills is rated with the Jefferson Scale for Professionals Empathy (JSPE).	Baseline (during the first year of the project, months 6 to 10) and post-intervention measure (during the third year of the project, months 6 to 10); (tool for professionals).	No
Other	Maslach Burn-out Inventory (MBI-22)	Burn-out is rated with the Maslach Burnout Inventory (MBI).	Baseline (during the first year of the project, months 6 to 10) and post-intervention measure (during the third year of the project, months 6 to 10); (tool for professionals).	No
Other	Resilience Scale (RS-25).	Resilience is evaluated with the Spanish version of the Resilience Scale (RS-25).	Baseline (during the first year of the project, months 6 to 10) and post-intervention measure (during the third year of the project, months 6 to 10); (tool for professionals).	No
Other	Job Content Questionnaire (JCQ).	Job Content was assessed with the Spanish version of the Job Content Questionnaire.	Baseline (during the first year of the project, months 6 to 10) and post-intervention measure (during the third year of the project, months 6 to 10); (tool for professionals).	No
Primary	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).	No
Secondary	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).	No
Secondary	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).	No
Secondary	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).	No
Secondary	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.	No
Secondary	ASIA Classification	International Standards for Neurological Classification of SCI, developed by the American Spinal Injury Association.	Within the first week of admission.	No
Secondary	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).	No