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Trial record 13 of 662 for:    Spinal Cord Injury

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Hospital Universitari Vall d'Hebron Research Institute
Sponsor:
Collaborator:
Fundació La Marató de TV3
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01889940
First received: May 27, 2013
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Spinal Cord Injury, Acute
Professional-Patient Relations
Sensitivity Training Groups
Patient Non-Compliance
Satisfaction
Behavioral: Training for professionals (Spinal Cord Injury Unit staff).

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness of Psycho-emotional Support in Acute Spinal Cord Injury. ESPELMA Project.

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Picker Patient Experience Questionnaire (PPE-33) [ Time Frame: At discharge (an expected average of 8 weeks after admission). ] [ Designated as safety issue: No ]
    Satisfaction with care received, the main outcome measure of the study, is evaluated with the Spanish version of the Picker Patient Experience Questionnaire (PPE).


Secondary Outcome Measures:
  • Resilience Scale (RS-25) [ Time Frame: At discharge (an expected average of 8 weeks after admission). ] [ Designated as safety issue: No ]
    Resilience is evaluated with the Spanish version of the Resilience Scale (RS-25).

  • WHOQoL-BREF (26 items) [ Time Frame: At discharge (an expected average of 8 weeks after admission). ] [ Designated as safety issue: No ]
    Quality of life is evaluated with the WHOQOL-BREF test developed by the World Health Organization.

  • Biomedical and demographics [ Time Frame: Within the first week of admission and updated at discharge (an expected average of 8 weeks after admission). ] [ Designated as safety issue: No ]
    Medical and demographical data of patients is collected according to standard procedures.

  • SCIM-III Questionnaire [ Time Frame: Within the first week of admission. ] [ Designated as safety issue: No ]
    Patient functional status is measured with the third version of the Spinal Cord Independence Measure (SCIM-III) questionnaire.

  • ASIA Classification [ Time Frame: Within the first week of admission. ] [ Designated as safety issue: No ]
    International Standards for Neurological Classification of SCI, developed by the American Spinal Injury Association.

  • HADS [ Time Frame: Within the first week of admission (plus 7-10 days). ] [ Designated as safety issue: No ]
    Psychological distress (anxiety and depression) is evaluated using the Hospital Anxiety and Depression Scale.


Other Outcome Measures:
  • VAS for family/caregivers' satisfaction with care. [ Time Frame: At discharge (an expected average of 8 weeks after admission); (tool for family/caregivers). ] [ Designated as safety issue: No ]
    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.

  • Resilience Scale (RS-25) [ Time Frame: At discharge (an expected average of 8 weeks after admission); (tool for family/caregivers). ] [ Designated as safety issue: No ]
    Family/caregivers' resilience.

  • Jefferson Scale for Professionals Empathy (JSPE) [ Time Frame: 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). ] [ Designated as safety issue: No ]
    Rehabilitation professionals' empathy skills is rated with the Jefferson Scale for Professionals Empathy (JSPE).

  • Maslach Burn-out Inventory (MBI-22) [ Time Frame: 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). ] [ Designated as safety issue: No ]
    Burn-out is rated with the Maslach Burnout Inventory (MBI).

  • Resilience Scale (RS-25). [ Time Frame: 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). ] [ Designated as safety issue: No ]
    Resilience is evaluated with the Spanish version of the Resilience Scale (RS-25).

  • Job Content Questionnaire (JCQ). [ Time Frame: 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). ] [ Designated as safety issue: No ]
    Job Content was assessed with the Spanish version of the Job Content Questionnaire.


Estimated Enrollment: 90
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Pre-intervention group.

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.
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).

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.

Other Names:
  • - Focus groups.
  • - Training.
  • - Coaching.

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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01889940

Contacts
Contact: Pilar Lusilla-Palacios, Md, PhD +34934894830 plusilla@vhebron.net
Contact: Carmina Castellano-Tejedor, PhD +34934893455 ccastellano@vhebron.net

Locations
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Pilar Lusilla-Palacios, MD, PhD    +34934894830    plusilla@vhebron.net   
Contact: Carmina Castellano-Tejedor, PhD    +34934893452    ccastellano@vhebron.net   
Principal Investigator: Pilar Lusilla-Palacios, MD, PhD         
Sub-Investigator: Carmina Castellano-Tejedor, PhD         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Fundació La Marató de TV3
Investigators
Principal Investigator: Pilar Lusilla-Palacios, MD, PhD Hospital Universitari Vall d'Hebron de Barcelona, Spain
  More Information

No publications provided

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01889940     History of Changes
Other Study ID Numbers: ESPELMA, ESPELMA
Study First Received: May 27, 2013
Last Updated: June 28, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Acute Spinal Cord Injury
Patient Satisfaction
Psychological Distress
Rehabilitation
Training Professionals
Burnout
Job Content

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014