Contact information
Type
Scientific
Primary contact
Dr Sylvie Cossette
ORCID ID
Contact details
R-1520
5000
Belanger Street
Montreal
Quebec
H1T 1C8
Canada
+1 514 376 3330 ext. 4012
sylvie.cossette.inf@umontreal.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FRSQ 10187
Study information
Scientific title
Acronym
TRANSIT-ER [TRANSIT-URGENCE]
Study hypothesis
We are studying the nursing discharge interventions modalities provided in the Emergency Room (ER) of a cardiology tertiary care centre where an important proportion of patients make repeated visits to the ER in the year following their discharge to home (24% of the patients).
It is hypothesised that the return rates to the ER in the month following discharge to home will be less important in the group receiving the intervention than in the control group.
Ethics approval
Ethics approval received from the research ethics committee of the Institut de Cardiologie de Montréal on the 7th September 2007 (ref: 07-963).
Study design
Randomised controlled trial - one ER (single centre)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Facilitation of hospital to home transition after a visit to the ER
Intervention
All eligible patients will meet with the research nurse after discharge care. Then, the study will be presented to the patient. After informed consent, the participants will be randomly assigned to the intervention or control group. The two groups will answer a questionnaire about the secondary outcomes and the baseline characteristics will be recorded.
Intervention group:
After randomisation, the nurse will proceed with an assessment of the patient's risks of repeated visits to the ER following discharge to home. The evaluation will include the following themes:
1. Patient's perception in regard to his discharge to home
2. Patient's self-management of his disease, symptoms and co-morbidities
3. Patient's self-management of his treatment
4. Patient's self-management of his daily living and domestic activities
5. Patient's self-management of his emotions and cognitions
6. Patient's external resources management
7. Patient's health-services utilisation management
Following the assessment, the nurse will propose tailored interventions to the patient aiming at managing the repeated emergency department visits risk factors identified. Those interventions include:
1. Teaching
2. Legitimisation and normalisation
3. Listening and empathy
4. Reassurance
5. Reframing
6. Confrontation
7. Recommendations
8. Warnings
9. Reinforcement
10. Referral to external resources
11. Support to external resources already in place
The research nurse will proceed with this assessment-intervention process thrice:
1. In person at the patient's discharge from the ER
2. By telephone 4 ± 3 days following discharge
3. By telephone 10 ± 3 days following discharge
Finally, the patient will be able to contact the nurse by telephone during working hours in the 30 days following discharge for any concerns he would like to address her.
Control group:
No specific intervention by the research nurse, the patient will return to home.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
'Return to ER: the occurrence of any visits to the cardiologic ER in the month following randomisation. This will be measured using the hospital patient's registry.
Secondary outcome measures
The secondary outcomes will be measured at baseline and one month following randomisation by a telephone interview and are as followed:
1. Health care continuity using the Heart Continuity of Care Questionnaire (HCCQ), a 41-item questionnaire using a 5 points Likert scale (score 1 to 5, 1 = strongly disagree, 5 = strongly agree) measuring the patients' perception of continuity of care in regard to eight different dimensions. A higher score indicate a better continuity of care process according to the patient.
2. Patient's self-care management using the Therapeutic Self-Care Tool (TSCT), a 12-item questionnaire using a 5 points Likert scale (score 0 to 5, 0 = not at all, 5 = very much so) measuring the patients' ability to initiate and perform activities aiming at maintaining health, managing health problems and restoring functioning. A higher score indicate better self-care capacities in the patient.
3. Medication adherence scale using the Self-Reported Medication-Taking Scale (SR-MTS), a 4-item questionnaire using a dichotomous (yes or no) scale measuring patients' adherence to prescribed medication. A higher score indicate a poorer adherence to medication.
4. Patients' perception of control over the disease and of its consequences using three subscales of the Illness Perception Questionnaire - Revised (IPQ-R), a 38-item questionnaire using a 5 points Likert scale (score 1 to 5, 1 = totally agree, 5 = totally disagree) measuring the patients' perception of his disease. The three subscales used are:
4.1. Consequences (6 items)
4.2. Personal control (6 items)
4.3. Treatment control (5 items)
Higher scores on the consequences subscale represent strongly held beliefs about the negative consequences of the disease. Higher scores on the control subscales represent positive beliefs about the controllability of the illness.
5. Anxiety and depressing feelings using the Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire using a 4 points ordinal rating scale and composed of two subscales (anxiety and depression - each score from 0 to 21). A higher score to each of the subscales indicate a higher degree of symptoms (anxiety or depression).
6. Health services utilisation using the medicare provincial registry (Régie de lassurance maladie du Québec). The occurence of ER visits, hospitalisation or medical consultations by the patient within the province of Québec will be collected at 1, 3, 6 and 12 months following discharge.
Overall trial start date
01/11/2007
Overall trial end date
01/03/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female aged 18 years old or more presenting both of the following repeated visits to the ER criterion:
1.1. Taking six medications or more a day
1.2. Having made one visit or more to the cardiologic ER in the last 12 months
2. Visiting the ER for an unplanned visit (i.e. not coming to the ER on a planned basis, e.g. to receive a laboratory or diagnosis procedure result)
3. Being discharged from the ER directly to their home
4. Having the physical and cognitive capacities to answer a written questionnaire and to communicate by telephone
5. Being able to communicate in French or in English
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
462
Participant exclusion criteria
1. Having already another nursing follow-up in the 10 days following discharge (e.g. from another research project or from a specialised clinic) to avoid duplication of the nursing interventions being provided to the patient
2. Having already been recruited in the study in a precedent visit to the cardiologic ER
Recruitment start date
01/11/2007
Recruitment end date
01/03/2010
Locations
Countries of recruitment
Canada
Trial participating centre
R-1520
Montreal, Quebec
H1T 1C8
Canada
Sponsor information
Organisation
Montreal Heart Institute (MHI) Research Centre (Canada)
Sponsor details
5000
Belanger Street
Montreal
Quebec
H1T 1C8
Canada
+1 514 376 3330
Richard.Maheu@icm-mhi.org
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Quebec Health Research Fund (Fonds de recherche en Santé du Québec [FRSQ]) (Canada) (ref: 10187)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary