Postoperative; Dysfunction Following Cardiac Surgery Clinical Trial
Official title:
The First Planned Outpatient Review After Cardiac Surgery: Is Six Weeks Too Long?
Although the first outpatient review following cardiac surgery is conventionally scheduled
for six weeks after hospital discharge, there is no evidence to support this practice.
Thirty-day mortality and morbidity rates, which are now widely used as indicators of the
quality of surgical care, reveal rates that are higher than corresponding in-hospital rates.
Secondly, the rates for mortality and morbidity occurring up to 6 weeks after surgery are not
known. The objectives of our study are to determine the postoperative mortality and morbidity
rates in the 6-week interval between hospital discharge and the first planned specialist
review after cardiac surgery, and to assess the level of patient satisfaction with current
practice.
The study will enrol eligible patients who are undergoing elective and urgent coronary artery
bypass and/or valve surgery at our institution over a 6-month period and provide them with
study information. Prior to discharge after surgery, prospective participants will be
consented and given a questionnaire to take home, complete and bring along to the outpatient
appointment.
The investigators will analyse the data to determine the rates and timing of the
complications, and the impact on postoperative recovery. The investigators will also assess
the level of patient satisfaction with the current practice.
Appropriate conclusions either in support of current practice or, a change in practice would
be drawn..
Rationale and Background In current practice, patients who have undergone cardiac surgery
return to the outpatient clinic for their first postoperative review by the specialist team,
six weeks after hospital discharge. However, there is no evidence to show that this is the
optimal interval before these patients with ongoing risks of postoperative complications are
reviewed. Not infrequently, after hospital discharge, cardiac surgery patients make unplanned
hospital visits and/or require readmission during the 6-week wait for outpatient review due
to surgery-related complications [1-3]. Whereas it is well established that 30-day mortality
and morbidity rates after surgery are in excess of the corresponding in-hospital rates [4],
the 42-day incidence of these postoperative complications before outpatient review, is not
known. In fact the 30-day readmission and mortality rates are widely used as indicators of
the quality of surgical care [5, 6], and 30-day hospital readmission rates after cardiac
surgery as high as 49% has been reported [7]. It can be argued the long interval between
hospital discharge and the first outpatient specialist review exposes patients to ongoing
risks which explain the higher rates of surgery-related complications over time.
Postoperative programmes that have incorporated cardiac surgery nurse home visits before
outpatient review report significant reduction in hospital readmissions [8].
Hospital readmissions contribute significantly to healthcare costs whilst compromising the
quality of care [9, 10]. As a result strategies directed at reducing 30-day adverse outcomes
and readmissions have focussed on the identification of predictors of readmission and their
management [11-16]. The risk factors identified older age and co-morbidities which are
prevalent among patients undergoing cardiac surgery in the current era; an even stronger
reason to re-examine the long-standing outpatient follow-up practice.
The purpose of this prospective observational study will be to assess the burden of
postoperative mortality and morbidity in the 6-week interval between hospital discharge and
the first planned outpatient review after cardiac surgery. This data will be helpful in
determining if the current timing of follow-up review should be revised.
The proposed study, will seek to answer these questions and provide scientific evidence to
support clinical practice.
Study goals and objectives After hospital discharge, patients who have undergone cardiac
surgery still develop complications which can impair their recovery and sometimes require
unplanned visits to accident and emergency departments, and hospital admissions.
The main study goal is to define the magnitude of ongoing postoperative complications
suffered by discharged cardiac surgery patients before their first planned review.
Study design The study is a prospective observational study that will involve administering a
questionnaire to consecutive adult patients who will undergone coronary artery bypass and/or
valve surgery at our institution over a 6-month period.
Methodology On admission for surgery, eligible participants will be approached and provided
with study information. Prior to discharge after surgery, prospective participants will be
consented and given the study questionnaire to take home to complete themselves or by their
spouse/carer.
Preoperative and peri-operative data will be collected using the standard cardiothoracic
surgery electronic database programme (Patient Analysis and Tracking System), as is routine
at the investigators' institution. In addition, post discharge data relating to planned and
unplanned hospital attendance and/or admission, and any intervention by General
Practitioner/Practice nurse during the 6 week interval before the first planned specialist
review, shall be prospectively collected using the study questionnaire.
Statistical analyses The data obtained from the study questionnaire will be linked with the
peri-operative data in the cardiothoracic database, managed by dedicated and specially
trained staff. The database is password-protected and access to the data is restricted.
The data will be anonymised and the variables coded for statistical analyses. The analyses
will include the determination of rates of different complications and the impact on the
postoperative recovery. The timing of the complications/intervention will be represented on a
frequency plot.
Results The study findings will be discussed at local and international scientific meetings
and published in specialty journals.
The result will be used to generate hypothesis to support the application for a randomised
clinical trial.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02931617 -
Comparison of Two Modes of Respiratory Physiotherapy in Cardio-thoracic Surgical Patients
|
N/A | |
Completed |
NCT02475694 -
Acute Lung Injury After Cardiac Surgery: Pathogenesis
|
N/A | |
Recruiting |
NCT02778165 -
My Cardiac Recovery (MyCaRe): A Pilot RCT.
|
N/A | |
Not yet recruiting |
NCT02729610 -
Bronchial Blocker for One-lung Ventilation in Cardiac Surgery
|
Phase 4 | |
Completed |
NCT02222532 -
Oral Triiodothyronine for Infants Less Than 5 Months & Malnourished Children Undergoing Cardiopulmonary Bypass in Indonesia
|
Phase 3 | |
Completed |
NCT02521168 -
Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia
|
Phase 3 | |
Completed |
NCT02756598 -
Stress, Anxiety and Type A Personality and Analgesics
|
Phase 4 | |
Completed |
NCT02312648 -
Impact of Mobilization on Cardiac Surgery
|
N/A | |
Terminated |
NCT01915654 -
Impact of RBC Transfusion Less Than 14 Days on Morbidity and Mortality in Cardiac Surgical Patients
|
N/A | |
Completed |
NCT01618006 -
Multiple Daily Doses Of Aspirin To Overcome Aspirin Hyporesponsiveness Post Cardiac Bypass Surgery
|
Phase 2 | |
Completed |
NCT02846818 -
Cerebral Energy State in Cardiac Surgery
|
N/A | |
Recruiting |
NCT02143544 -
Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery
|
N/A |