Spinal Cord Injury, AcuteESPELMANCT01889940
Effectiveness of Psycho-emotional Support in Acute Spinal Cord Injury. ESPELMA Project
A study testing Training for professionals (Spinal Cord Injury Unit staff). in people with Spinal Cord Injury, Acute and Professional-Patient Relations, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Spinal Cord Injury, Acute, Professional-Patient Relations, Sensitivity Training Groups
- What is being tested?
- Training for professionals (Spinal Cord Injury Unit staff).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2012to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
Read the 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.
- Conditions
- Spinal Cord Injury, Acute, Professional-Patient Relations, Sensitivity Training Groups, Patient Non-Compliance, Satisfaction
- Being tested
- Training for professionals (Spinal Cord Injury Unit staff).
- Keywords
- Acute Spinal Cord Injury, Patient Satisfaction, Psychological Distress, Rehabilitation, Training Professionals, Burnout, Job Content
- Medical subject headings
- Spinal Cord Injuries, Patient Compliance, Personal Satisfaction, Patient Satisfaction, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training for professionals (Spinal Cord Injury Unit staff).Behavioural
Also called - Focus groups., - Training., - Coaching.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Training for professionals (Spinal Cord Injury Unit staff). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At discharge (an expected average of 8 weeks after admission).
Secondary outcomes (6)
Resilience Scale (RS-25)
Resilience is evaluated with the Spanish version of the Resilience Scale (RS-25).
Measured: At discharge (an expected average of 8 weeks after admission).
WHOQoL-BREF (26 items)
Quality of life is evaluated with the WHOQOL-BREF test developed by the World Health Organization.
Measured: At discharge (an expected average of 8 weeks after admission).
Biomedical and demographics
Medical and demographical data of patients is collected according to standard procedures.
Measured: Within the first week of admission and updated at discharge (an expected average of 8 weeks after admission).
SCIM-III Questionnaire
Patient functional status is measured with the third version of the Spinal Cord Independence Measure (SCIM-III) questionnaire.
Measured: Within the first week of admission.
ASIA Classification
International Standards for Neurological Classification of SCI, developed by the American Spinal Injury Association.
Measured: Within the first week of admission.
HADS
Psychological distress (anxiety and depression) is evaluated using the Hospital Anxiety and Depression Scale.
Measured: Within the first week of admission (plus 7-10 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startFeb 2012
- Primary completionSep 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injury, AcuteStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació La Marató de TV3
- Responsible party
- Sponsor
- Investigators
- Pilar Lusilla-Palacios, MD, PhD, Principal investigator, Hospital Universitari Vall d'Hebron de Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889940
- Sponsor's protocol ID
- ESPELMA
- Other IDs
- ESPELMA
- Acronym
- ESPELMA
- Status last verified
- Jun 2015
- First submitted
- 27 May 2013
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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).
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.
PubMed 26770827Lusilla-Palacios P, Castellano-Tejedor C. Spinal cord injury and substance use: a systematic review. Adicciones. 2015 Dec 15;27(4):294-310. English, Spanish.
PubMed 26706812Lusilla-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.
PubMed 24311743
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Psycho-emotional Support in Acute Spinal Cord Injury. ESPELMA Project.
- ClinicalTrials.gov ID
- NCT01889940
- Acronym / sponsor ID
- ESPELMA / ESPELMA
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Fundació La Marató de TV3
- Study start
- Feb 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 1 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Training for professionals (Spinal Cord Injury Unit staff).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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training for professionals (Spinal Cord Injury Unit staff).Also: - Focus groups., - Training., - Coaching.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. | Behavioural | Post-intervention group. |
Primary outcome
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).
6 secondary outcomes
Resilience Scale (RS-25)
Time frame: 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).
Biomedical and demographics
Time frame: 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.
ASIA Classification
Time frame: Within the first week of admission.
HADS
Time frame: Within the first week of admission (plus 7-10 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
- BackgroundConsultation-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).
- Derived from this study: PubMed 26770827Lusilla-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.
- Derived from this study: PubMed 26706812Lusilla-Palacios P, Castellano-Tejedor C. Spinal cord injury and substance use: a systematic review. Adicciones. 2015 Dec 15;27(4):294-310. English, Spanish.
- Derived from this study: PubMed 24311743Lusilla-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.
Related trials for Spinal Cord Injury, Acute
Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Recruiting
Functional Electrical Stimulation vs Transcutaneous Stimulation in Patients With Subacute Spinal Cord Injury
Non Traumatic Spinal Cord Injury, Sub-Acute Rehabilitation
RecruitingPhase 1
NG004 in Incomplete Spinal Cord Injury Patients
Acute Spinal Cord Injury (SCI), Spinal Cord Diseases
Recruiting
Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial
Spinal Cord Injuries, Spinal Cord Injury (SCI), Initial Encounter
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pilar Lusilla-Palacios, MD, PhD principal investigator
Hospital Universitari Vall d'Hebron de Barcelona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training for professionals (Spinal Cord Injury Unit staff). in people with Spinal Cord Injury, Acute and Professional-Patient Relations, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Picker Patient Experience Questionnaire (PPE-33) (time frame: At discharge (an expected average of 8 weeks after admission).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01889940, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.