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

June 15, 2015 updated by: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Picker Patient Experience Questionnaire (PPE-33)
Time Frame: At discharge (an expected average of 8 weeks after admission).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resilience Scale (RS-25)
Time Frame: At discharge (an expected average of 8 weeks after admission).
Resilience is evaluated with the Spanish version of the Resilience Scale (RS-25).
At discharge (an expected average of 8 weeks after admission).
WHOQoL-BREF (26 items)
Time Frame: At discharge (an expected average of 8 weeks after admission).
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).
Biomedical and demographics
Time Frame: Within the first week of admission and updated at discharge (an expected average of 8 weeks after admission).
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).
SCIM-III Questionnaire
Time Frame: Within the first week of admission.
Patient functional status is measured with the third version of the Spinal Cord Independence Measure (SCIM-III) questionnaire.
Within the first week of admission.
ASIA Classification
Time Frame: Within the first week of admission.
International Standards for Neurological Classification of SCI, developed by the American Spinal Injury Association.
Within the first week of admission.
HADS
Time Frame: Within the first week of admission (plus 7-10 days).
Psychological distress (anxiety and depression) is evaluated using the Hospital Anxiety and Depression Scale.
Within the first week of admission (plus 7-10 days).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS for family/caregivers' satisfaction with care.
Time Frame: At discharge (an expected average of 8 weeks after admission); (tool for family/caregivers).
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).
Resilience Scale (RS-25)
Time Frame: At discharge (an expected average of 8 weeks after admission); (tool for family/caregivers).
Family/caregivers' resilience.
At discharge (an expected average of 8 weeks after admission); (tool for family/caregivers).
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).
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).
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).
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).
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).
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).
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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Fundació La Marató de TV3

Investigators

  • Principal Investigator: Pilar Lusilla-Palacios, MD, PhD, Hospital Universitari Vall d'Hebron de Barcelona, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

May 27, 2013

First Submitted That Met QC Criteria

June 28, 2013

First Posted (ESTIMATE)

July 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 15, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESPELMA (OTHER_GRANT: Fundació La Marató de TV3 (ref.112910))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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