This study finally aims to provide hospitalized coronary heart disease patients who smoke with proven (cost)effective smoking cessation interventions. Point prevalence abstinence is estimated in the experimental groups at 60% at 6 months, against 43…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome will be point prevalence abstinence from smoking (PPA) after 6
and 12 months. PPA is considered to be the most sensitive and valid measure of
smoking cessation.
Secondary outcome
Secondary outcomes will be continued abstinence, quit attempts, lapses and
relapse into smoking. Health outcomes that will be measured are new coronary
events, hospital readmissions for coronary events, TC/HDL cholesterol ratio,
blood pressure, prescribed medication, number of visits to the cardiologist
since discharge.
In telephone interview after 6 and 12 months will assess: visits to general
practitioner in past months, cardiology outpatient visits in past months,
hospitalisations in past months and death related to cardiovascular disease,
contacts with caregivers, absence from work due to illness, and resource use
specifically for the interventions. Patients who die during the study will
directly be excluded from the study to avoid any further contact with family.
OTHER MEASUREMENTS
The baseline measurement (questionnaire) and the 6 and 12 months post-test
(telephone interview) will also include factors that are related to smoking
cessation and/ or relapse among this patient population. These include:
- demographics;
- smoking related factors (smoking history, addiction);
- disease related factors (severity of disease, diagnosis);
- BMI;
- psychological state (depression, anxiety, type D behaviour); smoking
cessation related cognitions (for example attitude, selfefficacy, smoking
behaviour of important others) only measured baseline
Background summary
Cardiovascular disease is the leading cause of death, and coronary heart
diseases have an important
share in this. Smoking cessation after development of coronary heart disease
improves prognosis
more than any other treatment and prevents future cardiovascular diseases. Yet,
57% of those who
smoked prior to a cardiac event persist in smoking or relapse. Usual smoking
cessation care in Dutch
cardiology wards is often very minimal and not structured. Moreover nurses
experience difficulties in
providing this care. Hence, there is need for improved intensive and feasible
smoking cessation interventions
for Dutch cardiac inpatients. Previous studies and reviews provide strong
indications that intensive
counselling interventions including relapse prevention strategies and
pharmacotherapy are effective, also among patients with coronary heart disease.
They are expected to be feasible in practice if carried out by smoking
cessation professionals instead of ward nurses and can be provided by telephone
of face-to-face. However, such interventions have not
yet been tested in cardiac inpatients nor cost-effectiveness is clear.
Study objective
This study finally aims to provide hospitalized coronary heart disease patients
who smoke with proven (cost)effective smoking cessation interventions. Point
prevalence abstinence is estimated in the experimental groups at 60% at 6
months, against 43% in the control group. After 12 months, 55% abstinence in
experimental groups and 35% in the control group are estimated.
The following studies are proposed:
STUDY 1:
- To assess effects of TC and FC on smoking cessation and health outcomes in
cardiac inpatients compared to usual care.
- To assess patients* appreciation of and experiences with the interventions.
STUDY 2:
- To assess incremental cost-effectiveness and budgetary impact of the
interventions comparing them to each other and to usual care.
- To compare health outcomes and smoking cessation outcomes with costs of the
interventions, including usual care.
STUDY 3:
- To assess feasibility of the interventions, experiences of counsellors,
nurses and
cardiologists in working with them, and detecting relevant conditions for
large-scale dissemination.
Study design
A crossover experiment with a baseline measurement and post-tests at 6 and 12
months after baseline
will be conducted. We have chosen to use a crossover experimental design with
seven comparable hospitals providing the interventions after each other.
Therefore the study has three phases: A) usual care; B) FC or TC; C) TC or FC.
Outline of the study design
Ward 1 O1 X FC TC O2 O3 Ward 4 O1 X FC FC O2 O3
Ward 2 O1 X FC TC O2 O3 Ward 5 O1 X TC FC O2 O3
Ward 3 O1 X FC TC O2 O3 Ward 6 O1 X TC FC O2 O3
Ward 7 O1 X TC FC O2 O3
O1: baseline measurements by means of questionnaire; X: usual care; FC:
face-to-face counselling; TC: telephone counselling; O2: 6 months after first
measurement by means of telephone interview; O3: 12 months after first
measurement by means of telephone interview + personal contact (for measuring
health outcomes).
Intervention
The interventions consist of intensive counselling by smoking cessation
professionals, either by telephone in one intervention and by face-to-face
counselling in the other. These comparable interventions differ in delivery
mode and
duration. In both interventions, ward nurses start assessing patients* smoking
behaviour followed by providing stop-smoking advice and referral to smoking
cessation counselling. In one intervention, we deliver counselling by telephone
(TC), in the other face-to-face (FC). During the TC, the patient is called
seven times x fifteen minutes. During the FC, the patient has six consultations
x 45 minutes with the personal coach and a telephone follow-up call five weeks
after the last consultation (fifteen minutes). Both interventions include
nicotine replacement therapy.
Study burden and risks
Patients who succesfully quit smoking reduce their risk of myocardial
reinfarction by 50%. Their mortality risk, hospitalisation rate and chance to
experience new revascularization procedures will also be lowered in case they
quit smoking.
Valkenburgerweg 177
6401 DL Heerlen
NL
Valkenburgerweg 177
6401 DL Heerlen
NL
Listed location countries
Age
Inclusion criteria
Patients who are admitted with coronary heart disease at cardiac wards and smoked at least five cigarettes a week prior to hospital admission will be recruted. Inclusion criteria are:
- stable cardiac situation
- one of the following diagnoses: angina pectoris, myocardial infarction, post-PCI, post-CABG or a combination
- 18 years or older
- sufficiently fluent in Dutch and able to read Dutch.
Exclusion criteria
Exlusion criteria are:
- unstable cardiac situation
- terminal stage of the disease
- smoking less than 5 cigarettes per week
- smoking cessation more than one month prior to hospital admission
- insufficiently fluent in Dutch.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27637.029.09 |