Condition category
Not Applicable
Date applied
29/10/2007
Date assigned
06/02/2008
Last edited
08/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 l’assurance 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

http://www.icm-mhi.org/en/index.html

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

Publication citations

Additional files

Editorial Notes