Evaluation of the effectiveness of a nursing intervention aiming at facilitating the hospital to home transition for acute coronary syndrome admitted patients

ISRCTN ISRCTN95784143
DOI https://doi.org/10.1186/ISRCTN95784143
Secondary identifying numbers FRSQ 10187
Submission date
07/11/2007
Registration date
05/02/2008
Last edited
15/09/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sylvie Cossette
Scientific

R -1520
Montreal Heart Institute Research Center
5000 Belanger St
Montreal
H1T 1C8
Canada

sylvie.cossette.inf@umontreal.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific titleEvaluation of the effectiveness of a nursing intervention aiming at facilitating the hospital to home transition for acute coronary syndrome admitted patients
Study acronymTRANSIT-UC
Study objectivesIt is hypothesised that entering secondary prevention will be more important in the group receiving the intervention than in the control group.
Ethics approval(s)Ethics approval received from the Montreal Heart Institute Research Ethics Committee on the 11th April 2006 (ref: 06-854).
Health condition(s) or problem(s) studiedFacilitation of hospital to home transition after a hospitalisation for Acute Coronary Syndrome (ACS)
InterventionThe research nurse will meet all eligible patients and present the study to them before obtaining informed consent. At the discharge, 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:
The research nurse will give the discharge care using the study's intervention tool. The intervention will include the following theme:
1. Patient's medication
2. Patient's symptom and complication
3. Patient's care comprehension
4. Patient's adaptation's problem
5. Patient's change of lifestyle
6. Patient's projection in regard to his lifestyle change

Following the assessment, the nurse will propose tailored interventions to the patient for ameliorate the self management of his disease. 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
2. By telephone 1 - 3 days following discharge
3. By telephone or by a visit of the patient to research centre 8 - 10 days following discharge

Finally, the patient will be able to contact the nurse by telephone during working hours in the 6 weeks following discharge for any concerns he would like to address her.

Control group:
No specific intervention by the research nurse, the discharge care will do by the patient's nurse.
Intervention typeOther
Primary outcome measureParticipant who join in a secondary prevention programme from discharge to 6 weeks.
Secondary outcome measuresThe secondary outcomes will be measured at baseline and 6 weeks following randomisation by a telephone interview and are as followed:
1. Medication adherence scale
2. Anxiety
3. Patient's perception of control over the disease and of its consequences
4. Health services utilisation
5. Family support
6. Risk factors
Overall study start date03/10/2006
Completion date03/10/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants242
Key inclusion criteria1. Male and female aged 18 years old or more
2. Being discharged from the Coronary Intensive Care Unit (ICU) directly to their home
3. Having the physical and cognitive capacities to answer a written questionnaire and to communicate by telephone
4. Being able to communicate in French or in English
Key exclusion criteria1. Patient transferred in bypass surgery
2. Hospitalised for more than 7 days
3. Patient transferred in a convalescence centre or living in a prolonged care centre
4. Already having a follow up in specialised clinic
Date of first enrolment03/10/2006
Date of final enrolment03/10/2008

Locations

Countries of recruitment

  • Canada

Study participating centre

R -1520
Montreal
H1T 1C8
Canada

Sponsor information

Montreal Heart Institute Research Center (Canada)
Research organisation

5000 Bélanger Street
Montreal
H1T 1C8
Canada

Richard.Maheu@icm-mhi.org
http://www.icm-mhi.org/en/index.html
ROR logo https://ror.org/03vs03g62

Funders

Funder type

Industry

AstraZeneca (Canada) (ref: 10187)
Government organisation / For-profit companies (industry)
Alternative name(s)
AstraZeneca PLC, Pearl Therapeutics
Location
United Kingdom
Quebec Health Research Fund (Fonds de recherche en Santé du Québec [FRSQ]) (Canada) (ref: 10187)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2012 Yes No
Other publications secondary analysis 01/07/2019 15/09/2020 Yes No

Editorial Notes

15/09/2020: Publication reference added.

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