Satisfaction Clinical Trial
— ESPELMAOfficial title:
Effectiveness of Psycho-emotional Support in Acute Spinal Cord Injury. ESPELMA Project.
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.
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitari Vall d'Hebron | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari Vall d'Hebron Research Institute | Fundació La Marató de TV3 |
Spain,
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).
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 |
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