Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mary Byrne
ORCID ID
Contact details
Project Manager
Department of General Practice
Clinical Sciences Institute
National University of Ireland
Galway
-
Ireland
+353 (0)91 495205
mary.byrne@nuigalway.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PR054/2001
Study information
Scientific title
The SPHERE Study. Secondary prevention of heart disease in general practice: a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses
Acronym
SPHERE
Study hypothesis
The aim of the SPHERE study is to design, implement and evaluate a multi-faceted intervention to improve the process of care and objective clinical outcomes for patients with established coronary heart disease in general practice in Ireland. The intervention runs over eighteen months and involves 960 patients from 48 practices across three study centres (Belfast, Dublin and Galway). Complex interventions focusing on altering human behaviour at organisational, practitioner and patient levels represent a challenge to randomised controlled trial research. This study employs both qualitative and quantitative evidence, adopting a phased approach to the development and evaluation of the intervention as recommended in the MRC Framework for the Development and Evaluation of RCTs for Complex Interventions to Improve Health (Medical Research Council, 2000). The SPHERE study is a cluster randomised controlled trial, with practice-level randomisation to intervention and control groups. Economic, policy and qualitative analyses will be carried out on data collected at baseline and 18-month follow up.
Ethics approval
Ethical approval for the SPHERE study was granted by the Research Ethics Committees of the Irish College of General Practitioners and Queen's University Belfast in April 2002.
Study design
Practice level cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Condition
Coronary Heart Disease (CHD)
Intervention
INTERVENTION PRACTICES
Level 1: Tailored practice care plans.
1. Training for practice staff.
Training will be delivered independently in each of the three regional study centres. All trainers will adhere to a single training protocol to ensure standardised delivery of the training across centres. Training delivery will be planned and rehearsed jointly by all trainers using role-play and peer review techniques. In addition, the project manager will act as an observer during the first two training sessions in each centre and will provide feedback to trainers with a view to further standardizing the training.
1.1. First training session: Medication training.
GPs and practice nurses are invited to attend a ninety-minute training session on medication guidelines, delivered by the study GP in each region. This is an interactive session in which practice staff are invited to review and discuss the most recent medication prescribing guidelines for secondary prevention. The session uses case-based scenarios to enable the practitioners to reflect on their own practice. Practitioners are offered a summary sheet of prescribing guidelines and a summary prompt showing commonly used drugs and dosages within the various medication categories. If practices wish their practice nurse to make prescribing decisions the research nurse will help to prepare appropriate specific protocols.
The objectives of this session are:
1.1.1. To increase confidence and competence regarding prescribing and the secondary prevention of heart disease
1.1.2. To discuss the role of the Scottish Intercollegiate Guidelines Network (SIGN) guidelines and apply to real clinical situations
1.1.3. To explore practitioner attitudes to secondary prevention and to discuss points raised specifically by each practice
1.1.4. To address issues of patient adherence to medication
1.2. Second training session: Behaviour change training.
GPs and practice nurses are invited to attend a ninety-minute training session on facilitating patients with behaviour change, delivered by the research nurse in each region. This is an interactive session in which practice staff are invited to reflect on their views around lifestyle change and practice new techniques (through role play) to improve their ability to facilitate patients with behaviour change. Strategies to increase patient motivation are discussed, following guidelines from brief motivational interviewing literature. Additional techniques, based on principles of behaviour modification and social learning theory, include: setting small achievable goals, action planning, using prompts, self-monitoring, offering rewards, habit reinforcement, and relapse prevention.
The objectives of this session are:
1.2.1. To enable practitioners to develop skills based on leading behaviour change theories, which may help them with behaviour change consultations
1.2.2. To introduce the SPHERE patient-held booklet and the patient care plan (see Level 2 below)
2. Responding to individual practice needs.
Additional practice needs in relation to the delivery of preventive care for patients with established cardiovascular disease, as well as the day-to-day running of the study, are recorded on a tailored practice care plan and followed up by the SPHERE research nurse.
3. Ongoing support from the SPHERE research nurse.
The SPHERE research nurse maintains regular contact with the practices, and is easily contactable by phone if practice staff have any queries about SPHERE.
4. SPHERE newsletter.
Intervention practices receive a study newsletter which is published every four months. The newsletter contains the latest news and updates relating to the study.
Level 2: Tailored patient care plans.
1. Initial target setting consultations.
The first patient intervention consultation with the practice nurse takes place as soon as possible after baseline data collection, once training of practice staff has been completed. Blood pressure (BP) and body mass index (BMI) are measured, diet, smoking and exercise habits reviewed and the result of the baseline cholesterol assay discussed. The patient and nurse together identify areas of management which could be improved and the patient is invited to prioritise one particular aspect of their lifestyle for change. Possible ways of achieving targets reflecting optimal management (BP <140/90 mmHg, cholesterol <5 mmol/l, BMI <25, non-smoking, taking exercise for 30 minutes 5 days per week, eating fruit/vegetables daily and avoiding saturated fat intake, avoidance of stress) are identified. Plans for action are recorded on a personal care plan tailored for each patient and retained in the practice. The GP also sees the patient at this visit or at a further appointment within 2 weeks to determine if any change in medication is appropriate. A further follow up telephone call is made by the practice nurse to give support and address any questions 2 weeks later.
2. The patient-held booklet.
This booklet contains information on all the key risk factors for CHD. It is used by the practitioners in all initial target setting discussions with the patient and is given to the patient to be kept by them. The booklet can be referred to at subsequent consultations with the GP or practice nurse for consolidation of information relevant to secondary prevention and cardiovascular risk. There are 6 sections in the book:
2.1. Medications
2.2. Smoking
2.3. Exercise
2.4. Healthy eating
2.5. Stress
2.6. Community support
By providing a summary of lifestyle advice for secondary prevention of CHD, the booklet serves not only as an information resource for patients but also as a reference guide to help practitioners in their lifestyle-related consultations with patients.
3. Regular consultations with patients
Patients are invited to attend for an appointment with the GP/nurse every 4 months. At each visit a review of factors relating to targets and goals for optimal secondary prevention are made as appropriate. Routinely BP and BMI are checked and goals relating to diet, smoking and exercise habits are reviewed. Cholesterol is checked if it has been found to be raised at baseline, but if normal at baseline cholesterol is checked annually. Relevant measurements taken at each review visit are recorded and held in the practice and reviewed with the patient at subsequent review visits. Care which would be given according to current clinical guidelines will also be provided, as required.
CONTROL PRACTICES
Data are collected for patients in intervention and control practices in identical ways. In control practices, data are collected at baseline and 18-month follow-up. Otherwise, patients in control practices continue to receive health care as usual and the nature of this in each participating practice will be clearly described.
This research is being carried out jointly by:
Department of General Practice, National University of Ireland, Galway;
Department of General Practice, Queen's University Belfast;
Department of Public Health and Primary Care, Trinity College Dublin.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Blood pressure
2. Total cholesterol
3. Physical and mental health status: measured by the SF-12
4. Hospital readmissions
Secondary outcome measures
1. Process of care:
1.1. SPHERE visits
1.2. Total number of GP visits
1.3. Total number of hospital OPD visits
1.4 Recording of risk factors in GP records
2. Body Mass Index/Waist-Hip Ratio
3. Exercise: measured by Godin Leisure-Time Exercise Questionnaire
4. Smoking status
5. Diet: measured by Dietary Instrument for Nutrition Education (DINE), including question regarding portions of fresh fruit and vegetables
6. Adherence to medication: measured by MARS-5 (Medication Adherence Report Scale)
Overall trial start date
01/01/2003
Overall trial end date
30/06/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with existing cardiovascular disease (defined as: documented myocardial infarction [MI], coronary artery bypass graft [CABG] or angioplasty, or a diagnosis of angina confirmed by exercise stress test, isotope test or coronary angiogram) are eligible for inclusion in the study.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
960
Participant exclusion criteria
Patients with significant mental or physical illness (based on the recorded judgement of practice staff), which is likely to impair capacity to change lifestyle behaviour or assimilate new information, are excluded from the study.
Recruitment start date
01/01/2003
Recruitment end date
30/06/2008
Locations
Countries of recruitment
Ireland
Trial participating centre
Project Manager
Galway
-
Ireland
Sponsor information
Organisation
Health Research Board (Ireland)
Sponsor details
73 Lower Baggot Street
Dublin 2
-
Ireland
+353 (0)1 6761176
hrb@hrb.ie
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Research Board (Ireland) (ref: PR054/2001)
Alternative name(s)
HRB
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Ireland
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
1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16053525
2. 2005 results on the use of qualitative methods in http://www.ncbi.nlm.nih.gov/pubmed/16848896
3. Byrne M, Corrigan M, Cupples ME, Smith SM, Leathem C, Murphy AW. (2005) The SPHERE study: Using psychological theory to inform the development of behaviour change training for primary care staff to increase secondary prevention of coronary heart disease. Irish Journal of Psychology, June 2005.
4. Byrne MC, Houlihan A, Leathem C, OMalley M, Murphy AW, Cupples MC, Smith SS, Byrne M. Recruiting general practices to participate in research: experiences from the SPHERE study. Abstract. Family Practice 2005; Volume 22, Supplement 1.
5. 2007 results on monitoring treatment fidelity in http://www.ncbi.nlm.nih.gov/pubmed/17908130
6. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19875426
7. 2009 results on recruitment and retention in http://www.ncbi.nlm.nih.gov/pubmed/19545366
8. 2015 six year follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/26534729
Publication citations
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Results on the use of qualitative methods
Corrrigan M, Cupples ME, Smith SM, Byrne M, Leathem CS, Clerkin P, Murphy AW, The contribution of qualitative research in designing a complex intervention for secondary prevention of coronary heart disease in two different healthcare systems., BMC Health Serv Res, 2006, 6, 90, doi: 10.1186/1472-6963-6-90.
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Results on monitoring treatment fidelity
Spillane V, Byrne MC, Byrne M, Leathem CS, O'Malley M, Cupples ME, Monitoring treatment fidelity in a randomized controlled trial of a complex intervention., J Adv Nurs, 2007, 60, 3, 343-352, doi: 10.1111/j.1365-2648.2007.04386.x.
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Murphy AW, Cupples ME, Smith SM, Byrne M, Leathem C, Byrne MC, The SPHERE Study. Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411]., Curr Control Trials Cardiovasc Med, 2005, 6, 11, doi: 10.1186/1468-6708-6-11.
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Murphy AW, Cupples ME, Smith SM, Byrne M, Byrne MC, Newell J, , Effect of tailored practice and patient care plans on secondary prevention of heart disease in general practice: cluster randomised controlled trial., BMJ, 2009, 339, b4220.
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Leathem CS, Cupples ME, Byrne MC, O'Malley M, Houlihan A, Murphy AW, Smith SM, Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care., BMC Med Res Methodol, 2009, 9, 40, doi: 10.1186/1471-2288-9-40.