Hey, M. (2008) Improving efficiency with delegated consent-taking. This is an extended version of the article published in Nursing Times; 104: 27, 30-31.
This article outlines an initiative allowing consultants to delegate the taking of patient consent to senior nurses and physiotherapists. It outlines the clinical context for its development and key issues including ethics, legal considerations, professional accountability, data protection, human rights issues, communication, record-keeping requirements, and training, along with its implementation and evaluation. The new system has improved efficiency and access to the clinic and increased professional responsibility and job satisfaction, while maintaining patient safety.
Martin Hey, MSc, Grad Dip Phys, non-medical prescriber, is clinical physiotherapy specialist in pain management, pain management service, Mid Yorkshire Hospitals NHS Trust.
This article demonstrates how the challenge to improve service efficiency can be an opportunity to improve patient-focused care. In this case, it involves the delegation of consent-taking in an acute trust’s pain management service from doctors to nurses and physiotherapists. The purpose of this was to use nurses’ and physiotherapists’ skills, knowledge and experience more effectively.
The importance of consent
As with all healthcare provision, patient care is the first concern. The initiative built on foundations for change outlined by Department of Health guidance (DH, 2000a), the blurring of professional boundaries (Lomas, 2008a) and on previous successful developments already achieved in the service.
Staff in extended roles may take on increased risk provided the level of knowledge and skills for safe practice is clear. A transparent line of accountability and a boundary of competence must be in place, in keeping with standards of good practice and the NMC Code of Conduct (2008).
The care of patients with long-term pain problems may involve using invasive procedures as an addition to other methods of treatment. To ensure informed patient choice it is vital they receive clear and accurate details regarding:
Aims and limitations of the intervention;
Potential benefits and risks, and the most common complications;
Pre-, peri- and post-operative care.
A verbal discussion of these issues should, where possible, be supplemented by appropriate, evidence-based, written information presented in an unbiased manner. The formal completion of a consent document ensures clinicians have discharged their professional duty of care and patients have had the opportunity to question and clarify this information. Patients have the right to change their mind about having the procedure; written consent is not legally binding but presents evidence of good practice (GMC, 1998).
The taking of consent is fundamental to nursing practice. It is defined as a legal condition where a person presented with the relevant facts and within his or her own reasoning faculties has granted consent based on an appreciation and understanding of these facts and the implications of an action (Lomas, 2008b).
Delegated consent-taking (the taking of consent by a professional other than the person who will perform the procedure) has traditionally followed a model of delegation from consultants to more junior medical staff within a clinical team’s hierarchical structure.
The Mid Yorkshire Pain Management Service has developed a method of safe practice that has allowed delegation of consent-taking from consultants to nurses and physiotherapists within a robust and supported training plan.
History of the service
In April 2002 the Pinderfields and Pontefract Hospitals NHS Trust amalgamated with neighbouring Dewsbury Health Care NHS Trust to form the Mid Yorkshire Hospitals NHS Trust. Like many acute trusts, the organisation had historical financial debt and services were facing an uncertain future as they started the process of clinical and administrative integration across hospital sites.
At the same time the NHS was undergoing rapid change, with a raft of policy documents outlining the vision of a UK health service fit for the 21st century (DH, 2005a; 2000a). With the competing pressures of service modernisation and financial prudence, it became clear that waiting for windfall payments to expand services would be a fruitless task.
The new Mid Yorkshire Hospitals NHS Trust Pain Clinic (as it was then known) found itself at a crossroads. It was composed of two geographically distant outpatient services with distinct identities, clinical traditions and staffing resources. It also catered for the perceived needs of very different local communities. From this, the pain management service has evolved and continues to grow, underpinned by a clear philosophy: ‘To work smarter, be proactive in embracing change and seize the opportunities change presents in order to improve both quality and efficiency of a patient-centred service.’ This is very much in keeping with the ethos of good medical practice where medical staff work ‘in ways that best serve patients’ interests’ (GMC, 2006).
Over the past six years the service has introduced a number of initiatives to streamline and improve practice, including the introduction of integrated nurse and physiotherapist-led review clinics. This evolved to incorporate joint assessment of carefully triaged and selected ‘new patient’ referrals (Elphee et al, 2006), which was the springboard for other initiatives.
Our integrated service now includes:
Stand-alone, nurse-led review clinics;
Physiotherapist-led review clinics;
Joint nurse/physiotherapist, new-patient, first-contact clinics.
All these clinics are on both sites, and there is a nurse-led, opiate review clinic on the larger site.
We have also increased clinical autonomy, through controlled and supported expansion of the scopes of professional practice among nurses and physiotherapists (Kersten et al, 2007; DH, 2004; 2002; 2000b). Such advances cover the ordering of radiological and laboratory investigations, the capacity to place patients onto waiting lists for invasive procedures without having to refer them first to the consultant, and the use of non-medical and supplementary prescribing for allied health professionals (DH, 2005b). All these postgraduate learning opportunities have a robust and equal-access training programme, accepted and ratified by the trust to ensure standards are upheld and workforce planning can be facilitated.
Developing delegated consent
The most recent development is the delegation of consent-taking for specific invasive procedures from medical staff to selected senior nursing and physiotherapy staff. In late 2004 it became apparent that the successful initiative of allowing direct listing of patients to waiting lists for invasive procedures had disadvantages. Once patients made an informed decision to go on the waiting list, they had to return to consultants to give written consent, which meant one of the following options: waiting in the clinic until consultants were free, which often caused delays for both consultants and other patients; returning to a future clinic (reducing service capacity by duplication); or waiting to have consent taken on the day of the procedure.
Service preference, supported by GMC good practice (1998), has always been to take consent in advance so patients have time to fully consider the procedure, ask questions and further consider the responses. If they decide to decline a treatment in advance, the appointment can be used for others, increasing efficiency. Taking consent on the day of a procedure during the theatre session is time-consuming for consultants and financially costly for a team of theatre staff in an empty operating environment.
We hypothesised that delegating consent-taking to experienced and appropriate senior nursing and physiotherapy staff would reduce this inefficiency and improve the one-stop care approach. We also thought consultants’ clinic throughput may increase without repeated interruptions to take consent and that clinics would keep to schedule better. Furthermore, we anticipated the service could achieve efficiencies in theatre throughput if more consent-taking was done in advance and on-the-day consent could be taken by appropriate staff other than consultants.
Consumers of healthcare have high expectations of standards of care and the method of delivery. Articles 8 and 9 of the Human Rights Act (1998) imply that patients should be informed about their medical care and that their privacy is respected (Coldicott et al, 2003). Since patient care is at the forefront of any development (NMC, 2008; GMC, 2006), it was essential that patients involved in the delegated consent-taking training were briefed about the nature of the training development and would have the right not to participate. In other words, they would consent to the process of delegated consent; the quality of patient care should not be sacrificed as the patient becomes a ‘teaching aid’, as Coldicott et al (2003) observed.
A non-patient learning environment was used for part of the role play of taking consent, where skills could be refined and formal examination of these skills evaluated.
The legal perspective
Innovation in role development between healthcare disciplines is occurring in an era of increasing medical litigation. A beginner in a certain role is always held to the standard of a competent performer. There is no evidence that nurses in these roles are more likely to make mistakes than doctors doing the same work (Horrocks et al, 2002).
It is vital that the trust supports the initiative and clearly understands the nature of the change in practice, the extent of the role, the training needs and process, and the professional and managerial support required. In addition, the trust needs to understand the potential legal difficulties in order to authorise this new role as part of the named nurse and physiotherapist’s normal ‘course of employment’. By this mechanism the trust assumes legal responsibility for the actions of all involved through the concept of vicarious liability (Dowling et al, 1996).
The GMC’s guidance allows doctors to delegate medical care to others if they are sure the professional concerned is competent to undertake the work. The doctor remains responsible for managing patients’ care, while other healthcare professionals remain individually accountable for their actions. Nurses and physiotherapists also remain accountable to the consultant on whose behalf they act. Unfortunately, none of the regulatory bodies deals specifically with the challenge presented by working under different codes of conduct in their advice on multi-professional working.
Good practice takes into account these various issues and recommends that innovative developments are jointly planned by those involved. All guidelines and policies are drawn up in compliance with the differing statutory bodies in mind (Dowling et al, 1996).
It is the professional’s obligation to ensure that data protection is carried out thoroughly, so that personal information is not lost. Manual records are often in a poor state of repair. Information should be strongly safeguarded and used only for the purpose with which it was granted consent by the patient (Smith, 1996). However, this needs to be set against the need to share information with colleagues when it is in the interests of patient safety (NMC, 2008). It is the responsibility of professionals to explain to patients how and why such information may be shared.
Patients must be given appropriate information in a way they can understand to enable them to make informed decisions about care (GMC, 2006). This may require specific arrangements to cater for individual language and communication needs, for example Braille, or the use of an advocate or medical interpreter. Also, patients have the right to decline care by a certain individual and their wishes should be respected where practicably possible.
It is widely agreed that successful relationships between healthcare staff and patients depend on trust and respect (GMC, 2006; Hickey, 2004; Coldicott et al, 2003). Effective communication is the key to enabling patients to make informed decisions. Receiving inaccurate, outdated information or having information withheld is problematic, whereas supportive, understanding communication is encouraging (Hickey, 2004).
Communication and interpersonal skills relate directly to patients’ views of staff competence. Mechanic and Meyer (2000) identified that competence included: listening, caring, concern and compassion (interpersonal aspects); experience, thoroughness and knowledge (technical components); and commitment to the patient and advocacy (trust). No single profession has the monopoly on good communication skills.
Patient case notes and/or a consent form should detail the key elements of the consent-taking discussion with the patient, including information provided, specific requests from patients and details of the scope of consent given. The trust’s consent form adheres to all these requirements. Furthermore, the NMC (2008) Code of Conduct has clear guidance on the keeping of clear, current and accurate records.
Plans and proposals
Having agreed on the potential benefits, the clinical team jointly proposed a development plan based on the most senior and experienced nurse and physiotherapist taking consent for a small number of regularly performed and lower-risk procedures. The plan was to pilot it initially in the smaller of the two outpatient sites under the delegation of the consultant (and lead clinician) and under the guidance of a written training protocol. The directorate manager granted support to formulate a comprehensive written proposal and a training document for formal consideration by the trust board.
The final proposal addressed issues related to the context of service delivery and the need for change (very much as highlighted above). It also identified the specific interventions that could require delegated consent to be taken (the remit of competence (NMC 2008)) and the specific members of staff by grade that could take consent. It also clearly stipulated the education and training required for these professionals, laid a transparent audit trail, predicted the resource implications and the benefits for service users. The default position for practitioners taking on the extended role would be that if they did not feel competent to address a particular consent-taking issue then they would involve consultants as per original practice (NMC, 2008).
The specific interventions named under this initiative were:
Lumbar facet joint injections;
Lumbar paravertebral injections;
Trigger point injections;
Intravenous regional anaesthetic block;
Intrathecal injection and piriformis injection.
The clinical nurse specialist and clinical physiotherapy specialist in pain management were at the time highly experienced, active members of the Pain Society (now the British Pain Society) and postgraduate lecturers for local higher education institutions on pain management.
Audit was to be conducted through two separate mechanisms. In line with the Clinical Negligence Scheme for Trusts (CNST, 2005), all consent documentation would be reviewed and assessed against appropriate medical record-keeping. A patient satisfaction survey tool already created and used by the service would be expanded to incorporate patient perceptions of their experience of delegated consent-taking.
The resource implications were negligible, as the new developments were part of scheduled on-the-job training within current service provision.
The anticipated benefits
Anticipated benefits for patients included: more seamless care; reduced duplication of tasks and appointments; shorter delays in delivery of complete care; reduced waiting times in clinic; and improved access times to clinic and to theatre for invasive procedures.
It is vital that quality of care is not compromised during the training process and, once completed, the standard of informed choice and patient safety must be upheld and, if possible, improved.
The training framework
Once it was agreed and written, the training framework included:
[bullets]Clear demonstration of understanding of the following:
- The trust policy on informed consent and the local protocol;
- The benefits, risks and limitations of generic invasive procedures;
- In detail, the range of procedures approved for delegated consent, the indications for their performance, and the specific risks and limitations inherent in the procedure;
Clear demonstration that there had been accurate explanation of: potential procedures including pre-, peri- and post-operative care;
Observation of performance of each clinical procedure and a consultant taking consent for each procedure;
Assessment of taking informed consent for each procedure and role play for difficult patients/complex cases/ethical dilemmas.
Yearly review of taking consent and viewing the procedures would be compulsory to maintain skills as recommended by the NMC (2008). This training programme generated a review of all written materials on invasive procedures used for patient information purposes as identified by the GMC (1998). As a result, all such information was re-written in an updated and evidence-based manner and cross-referenced. These would be reviewed every three years automatically as part of the trust’s clinical governance strategy.
Once satisfied that these elements of training had been completed, the consultant (and lead clinician) would formally sign off the training document as a written record and copies would also be registered with the directorate manager on behalf of the trust.
In March 2005 the proposal and training documents were accepted in final format and work began to achieve the learning outcomes. The first practitioner completed the process within three months.
In June 2006 the first delegated consent audit was performed in partnership with the audit department and demonstrated:
Compliance with quality standards for completion of consent documentation was 100% for patient identification, date, procedure identification, statement of benefits and risks, practitioner status, name, signature and contact details;
Provision of patient information status was achieved in 98% of cases and a second confirmatory health professional signature was present in 48%. It was unclear from the audit if patients had completed consent on the day and thus did not require a second signatory or if it had not been done by the duty staff. A change to future audits would make this explicit.
In June 2007 the second audit indicated:
Total (100%) compliance maintained on essential data collection;
The provision of patient information was documented in 96% of consents taken;
Second signatories were documented in 68% of all required consents.
Repeat patient satisfaction surveys have shown that respondents rate nurse and physiotherapy-led clinical contacts as very helpful, informative, efficient, effective and professional.
Already, high clinical standards and patient safety have been maintained. No adverse clinical incidents or near-misses have occurred related to this initiative.
Throughput in the clinic has become more patient-centred and efficient. One additional patient is seen per clinic per professional as routine, and two extra cases are seen per theatre session as routine, following the effective implementation of this programme.
Access times to clinic have continued to fall in keeping with the aspirations of the service and the government requirements. This initiative alone is not responsible but contributes to this progress.
After the trust medical director expressed concerns over clinical governance, the trust reviewed the whole issue of delegated consent-taking across all medical specialties over the last 12 months.
The pain management service’s robust training plan was praised and the evaluation information was invaluable in protecting the initiative.
Now in its third year, this framework is being implemented on the second site (phase 2 of the initiative) and work on expanded delegated consent (phase 3) has started for the most experienced clinicians involved with the initial phase.
The trust has accepted a written amendment to expand the procedures that can have delegated consent, to include:
Lumbar sympathetic blockade;
Cervical facet joint injections;
Stellate ganglion blockade;
Pulsed radiofrequency lesioning;
Radiofrequency lesioning (destructive treatment) by special agreement.
The training framework has been amended but the basis of achieving the learning objectives remains unchanged.
All staff involved are content with the improved clinical outcomes achieved so far but further work is required to advance the skills of all appropriate staff members. Additional re-audit is a continuing requirement and there is still room for improvement to achieve 100% compliance in all sections every time.
The initiative has maintained an excellent patient safety record and satisfaction ratings are extremely high. Throughput has increased, efficiency has improved, access targets have reduced and professional responsibility has increased, as has autonomy and role satisfaction.
The untapped potential of both experienced nurses and physiotherapists can be harnessed in many different ways through well-planned, supported and innovative ways of working to achieve improvements in efficiency and quality of patient care.
Indeed, given more and more challenging targets in an era of increasing financial prudence, it is vital that all fixed resources are used to their maximum capacity, including manpower and workforce skills. The blurring of professional boundaries is likely to continue and increase to achieve this aim. However, it should only do so within robustly planned developments that protect patients and practitioners. Quality and patient safety should be at the heart of all practice, whether innovative or traditional.
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