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

Primary Purpose

Spinal Cord Injury, Acute, Professional-Patient Relations, Sensitivity Training Groups

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Training for professionals (Spinal Cord Injury Unit staff).
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injury, Acute focused on measuring Acute Spinal Cord Injury, Patient Satisfaction, Psychological Distress, Rehabilitation, Training Professionals, Burnout, Job Content

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitari Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Pre-intervention group.

Post-intervention group.

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Resilience Scale (RS-25)
Resilience is evaluated with the Spanish version of the Resilience Scale (RS-25).
WHOQoL-BREF (26 items)
Quality of life is evaluated with the WHOQOL-BREF test developed by the World Health Organization.
Biomedical and demographics
Medical and demographical data of patients is collected according to standard procedures.
SCIM-III Questionnaire
Patient functional status is measured with the third version of the Spinal Cord Independence Measure (SCIM-III) questionnaire.
ASIA Classification
International Standards for Neurological Classification of SCI, developed by the American Spinal Injury Association.
HADS
Psychological distress (anxiety and depression) is evaluated using the Hospital Anxiety and Depression Scale.

Full Information

First Posted
May 27, 2013
Last Updated
June 15, 2015
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Fundació La Marató de TV3
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1. Study Identification

Unique Protocol Identification Number
NCT01889940
Brief Title
Effectiveness of Psycho-emotional Support in Acute Spinal Cord Injury. ESPELMA Project
Acronym
ESPELMA
Official Title
Effectiveness of Psycho-emotional Support in Acute Spinal Cord Injury. ESPELMA Project.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Fundació La Marató de TV3

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-intervention group.
Arm Type
No Intervention
Arm Description
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.
Arm Title
Post-intervention group.
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Training for professionals (Spinal Cord Injury Unit staff).
Other Intervention Name(s)
- Focus groups., - Training., - Coaching.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Picker Patient Experience Questionnaire (PPE-33)
Description
Satisfaction with care received, the main outcome measure of the study, is evaluated with the Spanish version of the Picker Patient Experience Questionnaire (PPE).
Time Frame
At discharge (an expected average of 8 weeks after admission).
Secondary Outcome Measure Information:
Title
Resilience Scale (RS-25)
Description
Resilience is evaluated with the Spanish version of the Resilience Scale (RS-25).
Time Frame
At discharge (an expected average of 8 weeks after admission).
Title
WHOQoL-BREF (26 items)
Description
Quality of life is evaluated with the WHOQOL-BREF test developed by the World Health Organization.
Time Frame
At discharge (an expected average of 8 weeks after admission).
Title
Biomedical and demographics
Description
Medical and demographical data of patients is collected according to standard procedures.
Time Frame
Within the first week of admission and updated at discharge (an expected average of 8 weeks after admission).
Title
SCIM-III Questionnaire
Description
Patient functional status is measured with the third version of the Spinal Cord Independence Measure (SCIM-III) questionnaire.
Time Frame
Within the first week of admission.
Title
ASIA Classification
Description
International Standards for Neurological Classification of SCI, developed by the American Spinal Injury Association.
Time Frame
Within the first week of admission.
Title
HADS
Description
Psychological distress (anxiety and depression) is evaluated using the Hospital Anxiety and Depression Scale.
Time Frame
Within the first week of admission (plus 7-10 days).
Other Pre-specified Outcome Measures:
Title
VAS for family/caregivers' satisfaction with care.
Description
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.
Time Frame
At discharge (an expected average of 8 weeks after admission); (tool for family/caregivers).
Title
Resilience Scale (RS-25)
Description
Family/caregivers' resilience.
Time Frame
At discharge (an expected average of 8 weeks after admission); (tool for family/caregivers).
Title
Jefferson Scale for Professionals Empathy (JSPE)
Description
Rehabilitation professionals' empathy skills is rated with the 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).
Title
Maslach Burn-out Inventory (MBI-22)
Description
Burn-out is rated with the Maslach Burnout Inventory (MBI).
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).
Title
Resilience Scale (RS-25).
Description
Resilience is evaluated with the Spanish version of the 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).
Title
Job Content Questionnaire (JCQ).
Description
Job Content was assessed with the Spanish version of the Job Content Questionnaire.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pilar Lusilla-Palacios, MD, PhD
Organizational Affiliation
Hospital Universitari Vall d'Hebron de Barcelona, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Citations:
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).
Results Reference
background
PubMed Identifier
26770827
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.
Results Reference
derived
PubMed Identifier
26706812
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.
Results Reference
derived
PubMed Identifier
24311743
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.
Results Reference
derived

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

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