Clinical trial NCT02832427: Is Six Weeks Too Long for First Outpatient Review After Cardiac Surgery?
Official title: The First Planned Outpatient Review After Cardiac Surgery: Is Six Weeks Too Long?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative; Dysfunction Following Cardiac Surgery
Keywords: Coronary artery bypass grafting
Heart valve surgery
Postoperative morbidity
Operative mortality
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2016-07-14
Enrollment: 85
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing coronary artery bypass grafting and/or valve surgery

Brief summary: 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..

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing coronary artery bypass and/or valve surgery.
* Patients who can read and write in English

Exclusion Criteria:

* Postoperative stroke with neurologic deficit

Primary outcomes:
measure: The proportion of participants with postoperative mortality, or complications who require further interventions and hospital readmission .
timeFrame: 6 weeks
Secondary outcomes:
measure: The timing of postoperative mortality
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kingston-Upon-Hull
country: United Kingdom
facility: Castle Hill Hospital
state: East Yorkshire
Study officials:
affiliation: Castle Hill Hospital, Kingston-Upon-Hull, HU16 5JQ, UK
name: Dumbor Ngaage, MS, FRCS
role: PRINCIPAL_INVESTIGATOR
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