Developing and Implementing a Quality Assurance Strategy for Electroconvulsive Therapy

doi:10.21203/rs.3.rs-1304015/v1

Objectives

The objectives of this quality assurance project was to assess the practice of electroconvulsive therapy (ECT) in a psychiatric hospital by measuring the degree of compliance with Electroconvulsive Therapy Accreditation Service (ECTAS) standards.

Method

An audit tool was developed utilizing a quality criteria checklist by examining the ECTAS standards in relation to the requirements for ECT suites and reviewing the case notes of all patients who had ECT during the period between January 2017 and October 2017 (first audit) and January 2018 and October 2018 (re-audit). Data were quantitatively analysed and described.

Results

The psychiatric unit ECT practice generally was found to adhere to the ECTAS Standards. During the audit period, 29 patients received an ECT course. The mean age was 56 years with equal gender distribution. Bilateral ECT was used in all cases. Severe depressive illness was the most common indication for ECT treatment, followed by catatonia and severe suicidality. The ECT prescription was completed by the treating consultant psychiatrist in all patients’ records (100%) in both audits. However, the signature of the doctor administering ECT was not present in 40% in the first audit and 21% in the second audit.

Conclusion

High quality ECT is important not only for safe ECT, but is also an important step in removing the stigma that exists around this effective and occasionally lifesaving procedure. This complete audit cycle demonstrates the value of examining ECT care by highlighting areas of accomplishment as well as areas that require further development.

Electroconvulsive therapy

ECT

Quality assurance

Audit

Quality assurance is a fundamental and critical step in establishing and measuring evidence-based care standards in today's health-care environment. Clinical governance is based on quality assurance and clinical audit; to this end patient care is systematically analysed against specific criteria to inform improvements in service at individual, team or service levels [1]. The American Institute of Medicine (IOM) [2] asserted that quality healthcare should be: safe, effective, patient-centred, timely, efficient, and equitable and supports placing quality improvement efforts at the forefront of the healthcare organisation.

Electroconvulsive therapy (ECT) is an effective and reliable treatment for certain severe mental disorders [3,4]. In western countries, the use of ECT has decreased in recent years [5]. Media portrayal of unmodified ECT may have contributed to the negative perception of ECT and the stigma attached to it [6,7]. International guidelines have been developed to encourage good practice in the delivery of ECT. [3, 8]. In Ireland, ECT is governed by the Mental Health Act 2001 legislation [9].

The Royal College of Psychiatrists in the United Kingdom has developed Electroconvulsive Therapy Accreditation Service (ECTAS) standards [8], to improve the quality of ECT administration, and our local unit ECT protocol and policy have been derived from them. ECTAS standards and criteria have been categorised into the following ten sections: The ECT Clinic and Facilities, Staff and Training, Assessment and Preparation, Consent and Information Giving, Anaesthetic Practice, The administration of ECT, Recovery, Monitoring and Follow-up, Special Precautions Protocols, and Clinic Practice Nursing-checklist.

The ECTAS standards are categorised into three groups: Essential standards (type 1); failure to meet these would result in a significant threat to patient safety, rights or dignity and/or would breach the law. These standards also include the fundamentals of care, including the provision of evidence-based care and treatment. Expected standards (type 2) that all services should meet. Desirable standards (type 3) that high performing services should meet. To achieve accreditation, a team must meet 100% of type 1 standards, 80% of type 2 standards and 60% of type 3 standards [8].It is noteworthy that ECTAS standards relate to the process of administration of ECT and in this regard are consistent with National Institute for Health and Care Excellence (NICE) guidance [10]. They do not relate to clinical decisions about which patients should receive ECT.

Aims

The aim of this quality assurance project was to assess the practice of ECT in a psychiatric hospital in the mid-west of Ireland by measuring the degree of compliance with ECTAS standards and the local Unit ECT guidelines.

The project was carried out at a 40-bed acute psychiatric inpatient unit in the mid-west of Ireland. The Department of Psychiatry-University Hospital Limerick, provides ECT on an inpatient and outpatient basis for a population of 390,000 people, residing in three counties and representative of urban and rural areas [11]. An audit tool was developed utilizing a quality criteria checklist by examining the ECTAS standards in relation to the requirements of ECT suites and reviewing the case notes of all patients who had ECT during the period between January 2017 and October 2017 (first audit) and January 2018 and October 2018 (re-audit).

We divided the audit quality assurance checklist into two sections: the first section included standards related to the requirements of ECT suites in terms of number of rooms, equipment, anaesthesia, ECT processes and staff. The second section covered the standards related to the individual patient ECT treatment. This mainly investigated: individual patient demographic and clinical information, ECT treatment data, pre-ECT work up, documentation of consent, fulfilment of prescribing ECT standards, use of pre and post ECT depression and cognition scales and completion of ECT nursing checklist. Result was collated from these sources and summary statistics were performed.

Following the initial audit, the authors reviewed and redeveloped the local ECT booklet to make it more user-friendly for the clinician to complete. Educational sessions were held to present the new booklet and affirm the importance of complete documentation. The full audit policy is available from authors on request.

Summary of results regarding ECTAS requirements for ECT

The ECT suite is located in the acute psychiatric unit. ECT administration and recovery facilities met the ECTAS standards for safe ECT administration and recovery of patients following a general anaesthesia (table 1). The ECT machine provides brief pulse stimuli according to current guidelines and has two-channel EEG monitoring. There is a nominated psychiatrist responsible for the ECT department.

The ECT department has a designated specialised ECT nurse, responsible for the running of the department. There was at least one trained ECT nurse in both the treatment room and the recovery area. ECT was prescribed only by a consultant psychiatrist following consultation with the ECT consultant. ECT was administered by a consultant psychiatrist or a trained or supervised Non-Consultant Hospital Doctor (NCHD) in psychiatric training.

A nominated consultant anaesthetist had overall responsibility for ECT anaesthetic services. The anaesthesia was administered by a consultant anaesthetist or a trained supervised anaesthetic registrar. However in the first audit period, the named lead anaesthetist did not have dedicated sessional time for the provision of anaesthesia for ECT. This meant the consultant anaesthetist could not attend ECT clinic on a weekly basis. This was improved in the re-audit.

Demographic and clinical characteristics of patients who received ECT (n=29)

Fifteen patients received an ECT course during the first audit period and 14 during the re-audit. Of those patients: 87 % (n=13) received voluntary ECT in the first audit and 57 % (n= 8) in the re-audit, 47 % (n= 8) were female in the first audit and 57 % (n=8) in the re-audit (table 2). The mean age was 56 years in the first audit and 55 years in the re-audit. The most frequent indication for ECT was treatment resistant depression, which counted for 73 % (n=11) in the first audit and 71 % (n=10) in the re-audit, followed by catatonia 20 % (n= 3) in the first audit and 29 % (n=4) in the re-audit. Maintenance ECT was used in 13 % (n=2) in the first audit and 29 % (n=4) in the re-audit. The average number of ECT treatments per course in both audit was ten sessions. Half (50 %) were inpatient in the second audit, compared to 73 % in the first audit.

Completion of ECT booklet

Written consent was obtained and documented by the treating consultant psychiatrist in all patients (100%) in both audits. Anaesthetic consent was documented in in all patients (100%) in both audits. Bilateral ECT under general anaesthesia was used in all patients in both audits.

All patients (100%) received a physical health examination prior to ECT in both audits. All the patients (100%) received pre-ECT work up (chest x-ray, echocardiogram, blood tests, anaesthetic assessment, and medication review) in both audits. The ECT prescription was completed by the treating consultant psychiatrist in all patients’ records (100%) in both audits. However, the signature of the doctor administering ECT was not present in 40% in the first audit and 21% in the second audit.

There were notable problems with ECT response measure assessment tests. Pre-ECT depression rating scale completion was reduced from 100 % in the first audit to 93 % in the re-audit. Post-ECT it was completed in 53% of cases in the first audit and 64 % in the re-audit. Pre-ECT Cognitive test completion was reduced from 100 % in the first audit to 86 % in the re-audit. Post-ECT it was completed in 47% in the first audit and 71% in the re-audit. Pre-ECT Clinician Global Impression- Severity (CGI-S) completion was improved from 27% in the first audit to 93% in the re-audit. Post-ECT Clinical Global Impression-of Change (CGI-C) completion was significantly improved from 20% in the first audit to 100% in the re-audit.

Table 1. Compliance with ECT suite requirements modified from ECTAS

*Requirement*	*First audit*		*Re-audit*
*Requirement*	*Yes*	NO	*Yes*	NO
The ECT clinic: a waiting room, treatment room, recovery area and post-ECT waiting area.	✔		✔
Up to date protocols for the management of critical incidents are readily available and accessible to staff	✔		✔
The ECT machine can provide brief pulse stimuli according to current guidelines set out in the ECT Handbook, and has two-channel EEG monitoring.	✔		✔
The recovery area is large enough to accommodate the throughput of patients lying on trolleys with additional space to manoeuvre.	✔		✔
There is a fully equipped emergency trolley with adequate resuscitation equipment and a defibrillator.	✔		✔
There is an ECG monitor, which is always used during anaesthesia.	✔		✔
Anaesthetic drugs are used according to recommended standards. A nominated psychiatrist is responsible for the ECT department. There is an ECT nurse responsible for the ECT department. There is at least one trained nurse in the treatment room. There is at least one suitably trained psychiatrist present during treatment, as defined by the Mental Health Act 2001. There is a named ECT lead consultant psychiatrist. There is a named ECT lead consultant anaesthetist. The named lead consultant psychiatrist is covered during absence by a named psychiatrist who meets the competencies set out in the Royal College of Psychiatrists’ competency document.	✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔		✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

Table 2-Demographic and clinical characteristics of the sample

*Variable*	*First audit (n=15)*	*Re-audit (n=14)*
Age, Mean (range)	56 (27 – 84)	55 (23-82)
Male	53% (n=8)	43% (n=6)
Female	47% (n=7)	57% (n=8)
*Diagnosis / indication*
Treatment resistance depression Catatonia Acute suicidality	73% (n=11) 20% (n=3) 7% (n=1)	71% (n=10) 29% (n=4) 0
Maintenance	13% (n=2)	29% (n=4)
Voluntary	87 % (n=13)	57 % (n=8)
Inpatient	73.3% (n=11)	50% (n=7)
*PRE-ECT Work Up*
CXR ECG Blood tests Medical History Anaesthetic assessment Medications in Anaesthetic Record	100% 100% 100% 100% 100% 100%	100% 100% 100% 100% 100% 100%
*Consent documentation*
Capacity to consent documented by psychiatrist Anaesthetic Consent	100% 100%	100% 100%
*Administration of ECT documentation*
Laterality documentation	100%	100%
Responsible Treating Consultant Signature	100%	100%
Administering ECT Dr Signature documentation	60%	78.6%
Average number of sessions per course	10	10
*ECT response measure assessment tests*
Pre-ECT MADRS documentation	100%	93%
Post-ECT MADRS documentation	53%	64%
Pre-ECT Cognitive test documentation	100%	86%
Post-ECT Cognitive test documentation	47%	71%
Pre-ECT CGI-S documentation	27%	93%
Post-ECT CGI-C documentation	20%	100%

This was the first comprehensive review of local ECT practice in the mid-west of Ireland against clear and explicit standards. We collected data through two routes; direct check and observation and a review of patient case notes and the ECT register book. Our quality review results featured areas of good practice and areas that required improvement in the future.

It is encouraging that our unit ECT practice generally adheres to ECTAS [8] Standards. We identified issues that required improvement (Table 2). Although all anaesthesia was given by an experienced anaesthetist, in the first audit the named lead anaesthetist did not have dedicated sessional time devoted to direct clinical care in the provision of anaesthesia for ECT. A study of ten UK ECT services’ audits after introduction of ECTAS, revealed an improvement in dedicated consultant anaesthetist attendance from 22% in 1981 to 100% in 2011 [12].

Our data showed almost equal gender distribution in patients treated with ECT; this differs from findings in other European countries, where more female patients receive ECT [13, 14]. The majority of our patients were middle aged (mean age 56), slightly younger than mean of 60 years old found in similar studies in other Western countries [15] and older than patients who received ECT in Asia and in the Middle East [16, 17]. Chanpattana et al [16] proposed that this age difference in Asian ECT practice could be due to a demographic factor, and that the main indication for ECT in Asian studies is schizophrenia with more prevalence in young people.

More than two-thirds (71%) of the total sample were referred to ECT for treatment resistant or severe depressive illnesses within a context of a unipolar or bipolar depressive illness, consistent with previous international finding [3, 18]. Bilateral ECT was performed on all patients in our sample. Bilateral ECT is the common practice in most countries [15, 16]. Right unilateral ECT is used in some regions as first preference [18]. There is also variation in ECT use within Ireland [19].

Six patients (21%) received maintenance ECT (M-ECT). M-ECT is typically used in the most severe cases. Research in M-ECT is sparse. Van Schaik et.al [20] concluded that M-ECT after a successful course of ECT, is probably as effective and well tolerated as continuous antidepressants in older patients with severe depression.

There was good adherence to pre-ECT work up and consent documentation in both audit cycles. Documentation has improved with regards to administering ECT, doctor’s signature and post ECT response assessment measures. Completion of pre-ECT response measures documentation has slightly declined since the first audit.

This project lays the groundwork for a quality assurance strategy that can be used to track procedural safety and direct future improvements in delivering ECT treatment. High quality ECT is important not only for safe ECT, but is also an important step in removing the stigma that exists around this effective and occasionally lifesaving procedure. This complete audit cycle demonstrates the value of examining ECT care by highlighting areas of accomplishment as well as areas that require further development.

Author Contribution All authors have contributed to this article. MZ and KL designed the study. MZ, KL, and FH gathered the data. MZ and KL analyzed the data. MZ wrote the initial draft. S.OF and KL review initial draft. S.OF is the supervising author. All authors participated in critical review and have approved the final version to be submitted.

Data Availability Raw data available on request.

Code Availability Not applicable.

Declaration

Financial Support This research received no specific grant from any funding agency, commercial or not-for-profit sectors.

Conflicts of Interest The authors declare that they have no conflicts of interest.

Consent to Participate There is no patient identifiable in the data collection. So this section is not applicable.

Consent for Publication There is no patient identifiable data in the article. So this section is not applicable.

Ethical standards The authors of this audit assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and of the Helsinki Declaration of 1975, as revised in 2008. This audit was approved by the Limerick Mental Health Services audit committee.

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Developing and Implementing a Quality Assurance Strategy for Electroconvulsive Therapy

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Abstract

Objectives

Method

Results

Conclusion

Background

Methods

Results

Discussion

Conclusion

Declarations

References

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