Coronary Artery Disease Clinical Trial
Official title:
Feasibility Study of Early Outpatient Review and Early Cardiac Rehabilitation After Coronary Artery Bypass Grafting: Mixed Methods Research Design
Current care after coronary artery bypass grafting (CABG) involves a check-up 6 weeks after
hospital discharge followed by an exercise programme called cardiac rehabilitation (CR) from
8 weeks. This practice is not evidence-based; it is therefore uncertain if earlier check-up
and CR would promote quicker recovery. The proposed research will examine the feasibility of
having check-up at 3 weeks and CR from 4 weeks after hospital discharge, and the associated
advantages.
The investigators plan to recruit 100 patients undergoing planned CABG through a median
sternotomy, at 2 NHS hospitals over 5 months. They will include 18 to 75 year olds, capable
of giving Informed consent and fit for CR exercises.
Patients will be approached before surgery and given study information to read. Four days
after surgery, patients who are willing to take part will have their routine clinical
examination, blood tests, chest x-rays and heart tracings reviewed to determine suitability
for the study. The investigators will obtain informed consent, do breathing tests and, ask
the patients to complete a general health questionnaire. A computer will allocate patients
equally to the proposed care (intervention group) or current care (control group). After
discharge, patients will attend check-up and semi-structured interview at 3 weeks
(intervention group) or 6 weeks (control group) before starting CR from 4 weeks (intervention
group) or 8 weeks (control group). CR will involve exercise classes once or twice a week for
8 weeks, and fitness tests. Patients will have a final assessment at 26 weeks, with clinical
examination, fitness and breathing tests, and completion of general health questionnaire.
The investigators will analyse patients' and staff experiences, patient fitness levels,
quality of life and costs, associated with each pathway. They will report potential benefits
of proposed care, if any. This study findings will be used to design a larger trial to
determine the best practice.
Rationale and Background
Currently following CABG, patients attend their first outpatient review six weeks after
hospital discharge, where recovery is assessed and fitness to commence CR is determined. CR
is then started from eight weeks. In a survey conducted in May/June 2017 by the
investigators, 35 of 42 UK cardiac centres responded, and confirmed this as current practice.
The long interval before postoperative review and CR extends the period of vulnerability and
inactivity for patients, with patients often seeking medical attention for surgery-related
complications during this period. In a prospective observational study (FORCAST6), the
investigators found that 44% of patients sought further medical help during this 6 week
period, and 41% would like an earlier review. This feasibility study will examine the
feasibility of bringing forward outpatient review and CR in order to facilitate recovery.
CABG is usually performed through a cut in the breastbone (median sternotomy) and patients
are required to refrain from upper body exercises, lifting of heavy objects and usual
strenuous activities for 12 weeks. These restrictions, called "sternal precautions" (SP), are
intended to aid healing of the cut breastbone. CR which has significant short- and long-term
benefits after CABG is therefore delayed. The delay can mitigate the benefits of CR,
contribute to physical deconditioning, and hinder the ability of CR to facilitate timely
recovery of fitness and physical activity status. According to the 2013 UK national audit of
CR, late CR commencement contributes to a substantial number of heart surgery patients
declining to participate in CR. Current time frames for postoperative review and CR are not
evidence-based and may prolong recovery after CABG, and be placing unnecessary limitations on
patient activity.
The standard access for heart operations is through a median sternotomy. In the UK, heart
operations have steadily increased since 2010. Of 36,134 operations performed in 2013, 17,630
were isolated CABG. Following CABG, the recovery pathway after hospital discharge has two
important elements, namely; outpatient review and CR.
First postoperative outpatient review: It is routine practice to undertake the first
postoperative review six weeks after hospital discharge. However, high rates of hospital
readmissions for surgery-related complications within this period have been reported. The
investigators conducted a prospective observational study (FORCAST6) to investigate
postoperative morbidity during, as well as patient opinion about, the six-week interval
between hospital discharge and first review. This study showed that 44% of patients reported
surgery-related complications; 17.5% required hospital readmission. Although majority of
patients who did not have complication were satisfied with the six weeks interval, 41% felt
it was too long. Early contact with patients has been associated with reduction in hospital
readmissions. Non-randomised studies have also shown lower 30-day adverse outcomes with early
review, for heart and other surgical patients.
Outpatient exercise-based cardiac rehabilitation: In current practice, CABG patients commence
CR from eight weeks after hospital discharge. Current guidelines for activity and exercise
after median sternotomy have been described as restrictive, conflicting, sometimes arbitrary,
frequently anecdotal and occasionally based on expert opinion [6]. There are variations in
types of exercises permitted, limits for weight of objects that can be lifted, guidelines for
activities, and timeline for resumption of driving. Parker et al demonstrated that the force
elicited on the breastbone by coughing far exceeded lifting above the recommended limit.
Adams and colleagues investigated forces associated with 32 activities of daily living and
reported that the majority not restricted by SP, such as opening and closing doors, generated
forces greater than the weight limit allowed. While SP may help to support bone healing, the
optimal nature and duration are unclear especially since sternal bone healing occurs by five
weeks. A prior observational study (FORCAST6) by the investigators showed that the incidence
of postoperative complications is highest in the first week after hospital discharge and
declines to lowest levels by 4 weeks. CR can therefore be safely commenced 5 weeks after
surgery (4 weeks after hospital discharge).
Early initiation and progressive physical exercise after heart surgery have well known
benefits and prolonged restrictions of physical activities appear detrimental to patient
health and wellbeing. LaPier et al reported functional limitation following sternotomy and
related this to surgeon-dictated SP. A small observational study noted that functional
recovery to pre-surgery levels was achievable at two months with physical therapy.
Improvement in post sternotomy symptoms is also associated with physical activity. The timing
of CR impacts functional recovery and level of physical fitness after heart surgery. The
National Audit of CR 2015, recommends early commencement of CR which has become standard
practice after coronary artery stents or heart attack.
A delay in starting CR can prolong the recovery process, increase dependence on family and/or
carers and can cause frustration. This may contribute to anxiety and depression that is
reported in patients recovering after CABG.
Published data is lacking about the appropriate timing of postoperative review and CR
following CABG. The dominant role of SP as a deterrent to early CR after heart surgery has
been questioned. Cahalin and associates identified major setbacks with current SP practice to
include; lack of supporting evidence, variation between institutions, lack of universally
accepted definition, and the functional limitations they engender. A similar experience was
reported in Europe and Australia. These inconsistencies create a dilemma for patients, their
families, and healthcare professionals alike. Nevertheless, SP continues to inform
conventional practice and recommendations of The British Heart Foundation.
Study goals and objectives
This study aims to establish the feasibility of delivering and evaluating a definitive RCT
of; current 8th week versus 4th week CR commencement pathways, reducing the period over which
patients are required to refrain from usual physical activities.
Objectives
1. To determine the feasibility of delivering outpatient review three weeks after discharge
post CABG, followed by CR from four weeks.
To achieve this, the study will:
- Collect qualitative data through interviews, diary entries and focus group meeting
with key research and clinical staff.
- Identify any organisational, operational and clinical barriers documented by
research staff.
- Identify additional costs or cost savings associated with the proposed pathway.
2. To test the feasibility of running a fully powered RCT comparing current with the
proposed pathway.
This will include:
- Assessing surgeons' willingness to conduct outpatient review three weeks after
discharge and refer patients to CR, from research staff records.
- Examining barriers to patient enrolment using contemporary record of the consent
process, by research staff.
- Identifying recruitment rates and drop-out to follow-up.
- Identifying the most appropriate outcome measures.
- Testing follow-up procedures and data collection tools and management.
- Planning the economic evaluation that would accompany the definitive RCT.
- Gathering outcome data for power and sample size calculations for the RCT.
3. To inform any necessary redesign of a new recovery pathway in light of information
gained from the above.
Research Questions
1. What are the barriers and facilitators to providing the proposed pathway, as these will
be multi-faceted and context specific?
2. Will the proposed pathway lead to better physical fitness and quality of life after
CABG, compared to current practice?
3. What would be the barriers to conducting a RCT to determine clinical and economic
benefits of the proposed pathway?
4. What would be the key outcomes for a definitive RCT, and how would they best be
measured?
Study design
This is a feasibility study designed as a Randomized Controlled Trial using mixed
quantitative and qualitative methods.
It is a feasibility study where, early review is conducted three weeks after hospital
discharge following coronary artery bypass grafting (CABG), and CR from 4 weeks. This will be
a multi-centre RCT of 100 patients comparing the proposed pathway with conventional practice.
Due to lack of literature in this area; unknown physician and patient acceptability of the
intervention and the intervention's influence on recruitment and retention, this trial has
been designed as a mixed methods study.
Study sites
Patients will be recruited at Castle Hill Hospital (Hull and East Yorkshire Hospitals NHS
Trust), the main study site, and James Cook University Hospital, Middlesbrough (South Tees
Hospitals NHS Foundation Trust).
The York Trials Unit (YTU) at University of York will be responsible for project and data
management for this study.
Study details
Enrolment: A Research Nurse will approach prospective patients who are admitted for CABG
through a median sternotomy, and provide them with an information sheet explaining the
research. The patients will be encouraged to read the information and make a decision about
participation prior to hospital discharge. Study patients will undergo surgery as normal and
receive standard in-hospital postoperative care.
From the 4th day after surgery, the medical staff will screen prospective participants for
eligibility by review of the results of routine clinical examination including sternal
stability, and postoperative day 4 tests, namely: electrocardiogram, chest x-ray, full blood
count, blood biochemistry, and transthoracic echocardiography when clinically indicated. The
Research Nurse will obtain informed consent from eligible and willing patients, administer
EuroQol five dimensions (EQ-5D-5L) questionnaire and request cardiopulmonary testing (CPEX)
for the first 50 patients that are recruited. Patients' baseline data including data from
these tests will be collected at enrolment.
Allocation: Enrolled patients will undergo 1:1 randomisation to either; current (control arm)
or the proposed pathway (intervention arm). Randomisation will be undertaken using a
centralised randomisation service provided by a York Trials Unit statistician not involved in
recruiting patients, and will be stratified by site using randomly permuted variable block
sizes.
Study intervention: Control (current pathway) - postoperative outpatient review 6 weeks after
hospital discharge, followed by commencement of CR from 8 weeks. Intervention (proposed
pathway) - postoperative outpatient review 3 weeks after hospital discharge, followed by
commencement of CR from 4 weeks. The structure of outpatient review and CR will be the same
for both arms of the trial, as in current practice, specifically:
1. First postoperative outpatient review: Specialist surgical team will perform
postoperative outpatient review, as is standard practice, for all study patients.
Postoperative history, clinical examination including sternal stability, chest x-ray,
electrocardiogram and medication review will be undertaken and, patients that are
certified fit for CR would be referred to start CR programme. This review will take
place at six weeks post hospital discharge in the control arm, and at three weeks in the
intervention arm. Patients considered unfit for CR will be given a further 3 week review
appointment and the reason(s) documented.
2. Outpatient exercise-based CR: Patients referred for CR will be offered a comprehensive
programme. A first appointment would be made with a cardiac specialist nurse who would
provide the patients with advice and leaflets on cardiac risk factor reduction. This
will typically include information on medication, diet, exercise and physical activity
as well as psychosocial wellbeing and smoking cessation. Patients will be invited to a
group education session on cardiac risk factor reduction. This will be delivered by
specialist cardiac rehabilitation staff. At this first appointment, referral to other
healthcare professionals such as specialist counsellors, pharmacists and dieticians may
also be considered when necessary. Unless contraindicated, referral to the exercise
component of the CR programme will be made. Before joining the CR exercise class,
patients will receive a holistic assessment from a specialist physiotherapist or
exercise professional. This will involve exercise testing using the incremental shuttle
walk test (ISWT). This baseline test will help to personalise exercise prescription for
each patent. Following this assessment, patients will be enrolled in exercise
programmes. CR exercise training will consist of supervised low-to-moderate intensity
exercise performed once or twice week for eight weeks (as is standard practice).
Exercise will be prescribed according to standards published by the British Association
for Cardiac Prevention and Rehabilitation and, the Association of Chartered
Physiotherapists in Cardiac Rehabilitation. Exercise training will be performed in a
gym-like environment with other patients. Interval circuit training is the most commonly
prescribed mode of exercise with each individual exercise programme tailored to
patients' specific needs and fitness level. The following equipment will be used; heart
rate monitors, treadmill, static bikes, and hand weights. At the end of CR, a
reassessment, including exercise testing using ISWT will be conducted. The pre and post
CR tests will be recorded. A discharge letter would be sent to patients' General
Practitioners summarising their treatment.
The control arm will commence CR at 8 weeks while the intervention arm will start at 4 weeks.
All study patients and CR staff will be encouraged to complete bespoke CR diaries for the
duration of CR. Patients will complete EQ-5D-5L questionnaires at the end of CR.
Sample size
The research is a feasibility study and therefore does not have a primary outcome measure to
inform a power calculation. One of this study's objectives is to establish a primary outcome
and its variability to inform sample size calculations for subsequent research. Sample sizes
of between 24 and 70 have been recommended for feasibility trials to allow for the reliable
estimation of a standard deviation for use in future sample size calculations. The
investigators hope to recruit 100 eligible patients. This will allow for a 30% attrition rate
to still have 70 patients in the final analysis. There will be a 5 month recruitment period
across two centres. The two clinical sites each perform over 300 isolated CABG operations
annually, and it is anticipated that about 200 of these per site will be eligible for the
study (100 per site over 5 months). The investigators therefore require a participation rate
of 33% to meet our target sample size. If 300 eligible participants are identified, the
investigators will be able to estimate a participation rate of 33% to within a 95% confidence
interval of ±6%.
Quantitative tests and data collection
In this study ISWT and CPEX would be used to assess physical fitness. The ISWT is a field
test and fairly crude measure of aerobic fitness. It is a popular aerobic fitness assessment
tool in UK CR programmes. For this reason it is important that we use an ecologically valid
tool to assess aerobic fitness if the findings from our study are to be extrapolated to
routine clinical practice.
CPEX is not just a tool to assess aerobic fitness; it is the gold-standard method of
assessing aerobic fitness and other prognostically important cardiopulmonary variables. CPEX
generates far more information on the cardiovascular and cardiorespiratory health of patients
meaning that we can characterise disease severity in a more meaningful way. CPEX produces a
lot of data that may help explain mechanisms for change which ISWT is not able to yield
unless we were to use telemetry base VO2 using something like COSMED. CPEX is the most
accurate method of assessing fitness change. This is potentially important if we are to
assess the beneficial/not harmful effects of early CR. Furthermore, the ISWT is not yet
validated for use in the early CR cohorts.
It is important and worthwhile to collect some data on CPEX in this trial, however, given the
cost of CPEX this will only be used in the first 25 participants randomised to each group,
i.e. half our intended sample size.
The investigators would use the field test (ISWT) for all participants and also assess half
the intended sample size with CPEX. This will reduce the costs but still give use useful
information to (1) understand any physiological change and (2) validate ISWT against CPEX at
baseline testing. This will also help to understand if they are measuring similar attributes
of fitness.
Quantitative data will be collected for all the study patients from enrolment to completion
of follow-up, using:
- Case report forms to collect general health and EQ-5D-5L questionnaires at baseline
(prior to randomisation), completion of CR and 26 weeks after hospital discharge,
- Medical records of outpatient clinical review and exit consultation, listing hospital
readmissions and, attendance at General Practitioners' surgeries and Accident and
Emergency departments for surgery-related complications.
- CR report of exercise testing results (ISWT) at start and end of CR, and at 26 weeks
post discharge,
- CPEX reports at baseline and 26 weeks post discharge The study design provides some
challenges for collection of comparable data because of the difference in the timings of
the components of the recovery pathway for the two study arms. For example, data
collected at outpatient review, beginning and end of CR will be at different times in
the recovery pathway for the 2 study arms. However changes in the parameters within each
study arm would yield useful information about the trend. Having considered these
challenges, the investigators intend to collect similar data for both study arms at
baseline prior to randomisation and at 26 weeks follow-up, for direct comparison, even
though late follow-up may carry a risk of high drop-out.
All data will be anonymised; patients will be identifiable only by a unique trial ID. Data
collection will be monitored and inconsistencies, validation errors or inaccuracies will be
followed up.
Qualitative data recording
Qualitative data will be collected from patients and, the research and clinical staff
through:
- Face-to-face semi-structured interviews with patients at both the outpatient review and
follow-up review at 26 weeks. Ten patients in each arm would be interviewed twice, ie 40
interviews. The topic guides for the interviews will use open ended questions to guide
respondents to consider their experiences and views of the timing of the outpatient
review, the offer of CR made to them, and, for the end of study interviews, their
experiences of attending CR. Interviews will be digitally recorded and transcribed
verbatim.
- Diary entries of patients, Research Nurse and CR staff. Patients would be given a
bespoke diary that will cover the 8-week period of CR, with tick boxes and free text
sections. They would be encouraged to make entries on a weekly basis during the 2 months
of CR. This will capture postoperative complications, their experiences of pain and any
health-related adverse occurrences during exercise-based CR. The Research Nurse shall
keep a diary with a record of patients' and surgeons' attitude to recruitment for the
study.
CR staff would also keep one diary at each of the 2 centres and will collect information
about patient drop-outs or opt-outs of CR sessions, level of participation and adverse events
during the sessions.
• A focus group meeting of the research and clinical staff involved in the trial would be
held after the 26 week follow-up period. The focus group topic guide will use open-ended
prompts to facilitate discussion on both individual and shared views of the CR offer made to
patients in each treatment arm, and the barriers and facilitators at individual, clinical and
organisational level associated with each treatment trajectory.
Safety consideration
Study patients will undergo clinical assessment after discharge following CABG, and be
certified fit for CR by the surgical team. Before commencing exercise-based CR they will
undergo exercise testing, and CR will be tailored to their fitness levels. At completion of
CR, they would have another assessment and exit consultation. This would enable early
detection of possible complications such as:
Sternal pain: Delayed sternal healing by forces or pressure not severe enough to disrupt
healing contributes to severe pain associated with tenderness along the sternotomy. This may
be confused with muscular or sternal wire pain, and paraesthesia which are more common.
Sternal instability: This is abnormal movement between the surgically divided sternum due to
delayed healing or non-union. This complication is rare.
Any study patient who complains of sternal wound pain or a feeling of "sternal click" will be
seen urgently by the surgical staff, examined and investigated appropriately. All adverse
events will be recorded. Patients who suffer adverse events with causality linked to sternal
instability will be given appropriate treatment, including surgery if required.
Follow-up
At 6 months (26 weeks) after surgery, all study patients will complete EQ-5D-5L quality of
life questionnaire, have CPEX, undergo ISWT, and have an end-of-study consultation with the
research staff, who will inquire about details of further medical treatment after hospital
discharge. Patients will be examined for sternal wound complications, including sternal
instability.
Statistical analysis
Statistical analysis will be undertaken in Stata version 13, or later, by a medical
statistician at York Trials Unit. The analysis and reporting of this feasibility trial will
follow CONSORT guidelines and a flow diagram will depict the progression of participants
through the trial. The number of patients screened, eligible, consenting and randomised will
be summarised, with reasons for non-participation given where possible. Baseline data will be
summarised by randomised group. No formal statistical comparisons will be undertaken.
Continuous variables will be summarised using descriptive statistics (n, mean, standard
deviation, median, minimum and maximum) while categorical data will be reported as counts and
percentages. Participant outcomes will be summarised descriptively by randomised group and
time point, including extent of missing data. As this is a feasibility trial, formal
hypothesis for effectiveness will not be carried out.
The number of participants attending their review appointment and entering CR, and the time
between surgery and these events, will be summarised by treatment group. Questionnaire return
rates will be presented. Adverse events will be summarised descriptively.
Qualitative data analysis
Data will be analysed separately per research grouping ie patients, research staff and
clinical staff. Data will be analysed using conventional content analysis, with the aim of
detailing individuals' views regarding the timing of outpatient review, commencement of CR,
and experiences of attending and undertaking CR.
Transcribed data from the interviews and focus groups will be downloaded into the qualitative
data analysis computer software package NVivo, coded and analysed inductively using thematic
content analysis.
Interviews: As interviews are to be conducted at two time points, the analysis will compare
themes both within and across time periods to determine if patients' views and experiences
differed over time. As patients will be purposively sampled by age, gender and ethnicity, the
analysis will also aim to identify intersections between these groupings. The findings from
the patient generated qualitative data will inform the feasibility and acceptability of the
offer and timing of CR.
Patient Dairies: The free text data detailing patient's experiences of receiving CR over the
eight week study period will be subject to thematic content analysis, where the richness of
the data allows. If data are quite 'thin', an analysis that counts recurring items within the
text will be used. These data will be triangulated with the themes arising from the patient
interviews as confirmation or refutation of the findings from those data.
Focus Groups: The focus group analysis will pay particular attention to the interactions
between group members and staff groupings in the development of themes, in order to determine
the barriers and facilitators perceived by staff groups at individual, clinical and
organisational level within each treatment trajectory.
Finally, the themes from the patient interviews staff focus groups will be compared to
determine the similarities and differences between the themes in order to reflect a complete
picture of the feasibility and acceptability of the offer of early versus late CR.
In combination these qualitative analyses will be used to inform the development of the
logistical processes involved in delivering a large-scale multi-centre RCT.
Economic analysis
Health economic analysis will be provided by a University of York (Centre for Health
Economics) health economist. Due to the feasibility nature of the proposed trial the analysis
will focus on the consideration of questions related to the feasibility of conducting a full
economic evaluation. Estimates of patient benefit, determined from the EQ-5D-5L will be
summarised for the two arms of the trial, including the rate of response of relevant
questionnaires. Exploration of the short and long term NHS resource use related to both
interventions will be conducted, and relevant sources of informative data required for a full
scale RCT identified.
Mortality and adverse event rates will also be monitored to determine the importance of long
term extrapolation of related outcomes for any future analysis of a full scale RCT. As this
is a feasibility trial, formal estimation of the cost-effectiveness of the respective
interventions will not be carried out.
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