Clinical trial NCT01889940: Effectiveness of Psycho-emotional Support in Acute Spinal Cord Injury. ESPELMA Project
Official title: Effectiveness of Psycho-emotional Support in Acute Spinal Cord Injury. ESPELMA Project.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury, Acute
Professional-Patient Relations
Sensitivity Training Groups
Patient Non-Compliance
Satisfaction
Keywords: Acute Spinal Cord Injury
Patient Satisfaction
Psychological Distress
Rehabilitation
Training Professionals
Burnout
Job Content
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Fundació La Marató de TV3
First posted: 2013-07-01
Enrollment: 90
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Picker Patient Experience Questionnaire (PPE-33)
timeFrame: At discharge (an expected average of 8 weeks after admission).
Secondary outcomes:
measure: Resilience Scale (RS-25)
timeFrame: At discharge (an expected average of 8 weeks after admission).
measure: WHOQoL-BREF (26 items)
timeFrame: At discharge (an expected average of 8 weeks after admission).
measure: Biomedical and demographics
timeFrame: Within the first week of admission and updated at discharge (an expected average of 8 weeks after admission).
measure: SCIM-III Questionnaire
timeFrame: Within the first week of admission.
measure: ASIA Classification
timeFrame: Within the first week of admission.
measure: HADS
timeFrame: Within the first week of admission (plus 7-10 days).
Other outcomes:
measure: VAS for family/caregivers' satisfaction with care.
timeFrame: At discharge (an expected average of 8 weeks after admission); (tool for family/caregivers).
measure: Resilience Scale (RS-25)
timeFrame: At discharge (an expected average of 8 weeks after admission); (tool for family/caregivers).
measure: Jefferson Scale for Professionals Empathy (JSPE)
timeFrame: 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).
measure: Maslach Burn-out Inventory (MBI-22)
timeFrame: 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).
measure: Resilience Scale (RS-25).
timeFrame: 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).
measure: Job Content Questionnaire (JCQ).
timeFrame: 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).
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Hospital Universitari Vall d'Hebron de Barcelona, Spain
name: Pilar Lusilla-Palacios, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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).
citation: Lusilla-Palacios P, Castellano-Tejedor C. Training a Spinal Cord Injury Rehabilitation Team in Motivational Interviewing. Rehabil Res Pract. 2015;2015:358151. doi: 10.1155/2015/358151. Epub 2015 Dec 6.
citation: Lusilla-Palacios P, Castellano-Tejedor C. Spinal cord injury and substance use: a systematic review. Adicciones. 2015 Dec 15;27(4):294-310. English, Spanish.
citation: Lusilla-Palacios P, Castellano-Tejedor C, Lucrecia-Ramirez-Garceran, Navarro-Sanchis JA, Rodriguez-Urrutia A, Parramon-Puig G, Valero-Ventura S, Cuxart-Fina A. Training professionals' communication and motivation skills to improve spinal cord injury patients' satisfaction and clinical outcomes: Study protocol of the ESPELMA trial. J Health Psychol. 2015 Oct;20(10):1357-68. doi: 10.1177/1359105313512351. Epub 2013 Dec 5.