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

NCT01889940 | Completed

• 1 other identifier: ESPELMA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Resilience Scale (RS-25)

  At discharge (an expected average of 8 weeks after admission).

• WHOQoL-BREF (26 items)

  At discharge (an expected average of 8 weeks after admission).

• Biomedical and demographics

  Within the first week of admission and updated at discharge (an expected average of 8 weeks after admission).

• SCIM-III Questionnaire

  Within the first week of admission.

• ASIA Classification

  Within the first week of admission.

Other Outcomes (6)

• VAS for family/caregivers' satisfaction with care.

  At discharge (an expected average of 8 weeks after admission); (tool for family/caregivers).

• Resilience Scale (RS-25)

  At discharge (an expected average of 8 weeks after admission); (tool for family/caregivers).

• 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).

Study Arms (2)

Pre-intervention group.

NO INTERVENTION

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.

Post-intervention group.

OTHER

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).

Interventions

Training for professionals (Spinal Cord Injury Unit staff). BEHAVIORAL

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.

Also known as: - Focus groups., - Training., - Coaching.

Post-intervention group.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Fundació La Marató de TV3: collaborator

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (4)

• 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).

  BACKGROUND

• 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.

  PMID: 26770827 DERIVED

• 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.

  PMID: 26706812 DERIVED

• 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.

  PMID: 24311743 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Patient Compliance; Personal Satisfaction; Patient Satisfaction; Burnout, Psychological

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Stress, Psychological; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Pilar Lusilla-Palacios, MD, PhD

  Hospital Universitari Vall d'Hebron de Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: July 1, 2013
• Study Start: February 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: February 1, 2015
• Last Updated: June 16, 2015

Record last verified: 2015-06

Locations

ES (1)