Digital consent business case template

Executive summary

The traditional paper-based consent process has been shown to lead to medicolegal risk due to errors and omissions, is not supporting the organisation to meet required standards with regards to shared decision making, and limits theatre efficiency with lost consent forms and on-the-day consent leading to delays and cancellations.

This business case outlines the case for the implementation of a digital consent process across the organisation, with the recommendation being to implement a specialist digital consent to treatment application. This is based on the alignment of this option with local and national priorities within the strategic context, evidence that mature options are available that can support the organisation successfully transition to digital consent, and that the change can be delivered in a financially sustainable way.

Strategic context

There is medicolegal, clinical care, and operational care context that is relevant to the case for change, alongside the organisation’s digital transformation agenda. The consent process within the organisation is a paper-based process, including carbon-copy ‘blank’ consent forms and patient information leaflets covering some treatments.

Medicolegal context

The Montgomery judgement at the Supreme Court in 2015 brought informed consent practices info focus for all within the healthcare system. The judgement updated medicolegal UK case law to require that the consent process aligns with the expectations of a reasonable patient, including the concept of ‘material risks’. In many ways the Supreme Court judgement brought UK case law into alignment with pre-existing best practice guidance from the General Medical Council, but has nevertheless increased the challenge for clinicians and organisations to demonstrate that an appropriate consent process has been followed.

The Royal College of Surgeons (RCSEng) in their 2016 guide to good practice, titled ‘Consent: Supported Decision-Making’ warned that, in the context of the Montgomery judgement, without significant changes to the consent process organisations would experience escalating medicolegal costs.

This has proven to be the case, with NHS Resolution reporting an increase of cases, within the NHS England, closed with a damages payment rising from 140 in the 2015/16 financial year to 320 in 2022/23. NHS Resolution report the cost of claims relating to ‘failure to warn/informed consent’ in 2022/23 to be £101m – 4% of the total amount spent on claims.

Subsequent medicolegal cases, such as Thefaut v Johnston (2017) and the Paterson Inquiry (2020) have highlighted the need for “adequate time and space” for the consent process, including a period of reflection wherever possible. Therefore, the organisation needs to transition from undertaking the consent process predominantly on the day of treatment.

As an organisation our Clinical Negligence Scheme for Trusts (CNST) payment is based on projected claim costs, with claims history taken into account.

The traditional paper-based consent process has been shown to lead to significant errors and inappropriate variation in practice. A paper published in the BJS demonstrated one or more significant clinical error in over 50% of paper consent forms, arising from manual entry and clinician recall of treatment risks.

Clinical care (shared decision making) context

Shared decision making (SDM) is a collaborative process which sees a clinician support a patient to make a decision about their treatment. This brings together the patient, who is the expert in their condition, and the clinician, who is the expert in the treatment options.

Embedding and improving SDM quality is a key priority locally and nationally due to the evidence that improving shared decision making (SDM) quality leads to better - often more conservative - decisions, more informed and engaged patients, and better outcomes.

Shared decision making has been a focus of a CQUIN target for 2022-24 (CQUIN11) as traditional shared decision making and consent processes have consistently shown that SDM best practice is being reported by fewer than 1 in 2 patients.

Operational (elective recovery) context

Paper-based consent processes are a major contributor to day-of-treatment delays – accounting for 5-10% of delays and cancellations. This is in part due to lost forms, and partly due to consent conversations occurring on the day of treatment, with both hampering elective recovery efforts.

With in excess of 7 million patients on a surgical waiting list, strategies to optimise surgical pathways to reduce elective long waits and cancer backlogs is a national priority within the NHS England business plan.

Options appraisal and preferred approach

The options available to the organisation are to:

• continue with the current paper-based consent process (Option A)
• procure a specialist digital consent to treatment application (Option B)
• develop digital consent functionality internally or within an existing system (Option C)

Continue with the current paper-based consent process

Option A describes an approach where the organisation continues with the current paper-based consent process. Given the strategic context, this option is not described as a ‘do nothing’ approach as there are a number of changes the organisation will need to consider if this approach is taken:

• The current medicolegal context means that the organisation needs to significantly reduce the practice of consent documentation on the day of treatment. This will mean introducing mechanisms to support 2-stage consent, either through time allocated in outpatient clinics, dedicated consent clinics, or through the introduction of a mechanism to share consent information with patients to review and sign remotely.

• Consent form error and omission rates represent an increasing medicolegal risk which is unacceptable to the organisation. Improvement work, supported by assurance processes, would be needed to reduce variation in consent process and documentation.

• As a national priority, improving shared decision making quality across the organisation requires widespread staff training, supported by educational resources and decision aids.

• No improvement in theatre delay and cancellation metrics are associated with this option, increasing the necessity for other improvement work to deliver targeted efficiency improvements and activity levels.

• As part of the organisation’s move away from the storage of paper records, processes would need to be introduced for consent forms to be scanned into the electronic record following treatment.

This option is not appealing due to the complicated process change required in the short-term to mitigate financial risk and improve clinical quality, in the context of a subsequent process change with the transition to a digital process, as per the organisation’s medium-term paper-free ambition.

Procure a specialist digital consent to treatment application

Option B involves market engagement and subsequent procurement of a digital consent application that is in current use, or is appropriate for use, in a UK healthcare organisation. Digital consent to treatment is a reasonably new product area with mature offerings available on the market, and available via public procurement frameworks used by the organisation, since around 2021.

A market analysis would be undertaken to assess any supplier’s ability to competently support the organisation to successfully transition to digital consent. This analysis would be supported by a digital consent tender specification covering technical, integration, and clinical requirements.

Evidence has been seen as part of developing this business case that there are specialist digital consent to treatment applications in current use that can deliver improvements in the domains described within the ‘strategic context’ section. Approximately 1 in 5 NHS Trusts in England have introduced a specialist digital consent to treatment application since 2020, with many successfully transitioning to digital consent by default with good patient, clinician, and organisational feedback.

This option would require project and integration resource from the IT/digital team to support deployment in year 1, broad clinical engagement prior to and during the deployment, and ongoing BAU support desk support, but has been shown to be cost-neutral from year 1 with medium-term cost-savings.

From discussions with organisations who have undertaken this option recently, the key risk is of limited or slow uptake, meaning either prolonged support prior to transition to BAU, or the risk of a longer-term mixed economy between paper and digital consent processes. This risk can be mitigated with appropriate resource and clinical engagement, but should be considered nevertheless.

This option is appropriate to consider given the evidence of effectiveness, cost-neutral or cost-saving financial impact, and well defined procurement route.

Develop digital consent functionality internally or within an existing system

Option C describes the development of equivalent functionality to that provided by Option B, but rather than utilising an existing specialist provider, to develop the functionality internally or as an extention to an existing system used within the organsiation.

Developing an application internally would provide organisation control over functionality and ongoing development priorities, but would require significant capital investment up-front for software development and clinical content creation, and would not be ready for clinical use for a significant period of time (approximately 2-3 years). Estimates place the development cost at between £500,000 and £1,000,000 prior to first clinical use, similar deployment costs as Option B, and ongoing maintenance and development costs of £100,000-£200,000 per year in the medium term.

There is a high level of uncertainty with the projected costs for developing an application internally. Presented costs and timeframes are modelled on previous projects of similar complexity and an analysis of publicly available data regarding costs of developing existing ‘Option B’ solutions. There is a risk that appropriate personnel both technically and clinically could not be sourced to deliver the project.

There are a small number of organisations who have embedded a homegrown digital consent solution into clinical practice, however, evidence has been seen as part of developing this business case of several organisations who have attempted to develop their own digital consent option internally but have subsequently introduced stopped development and procured a solution from a specialist provider.

Discussions have been held with providers who currently deliver digital systems within the organisation regarding digital consent functionality. There are currently no providers, including our Electronic Health Record, that can deliver equivant functionality as is described in the Option B tender specification. Whilst one or more can meet the integration requirements and provide form functionality and/or the ability to record an electronic signature, none are able to meet the clinical requirements of the process, including coverage of all consent form types, cross-specialty clinical content that can be modified to the individual, and remote access to information with remote consent. A like-for-like electronic replacement of the existing paper consent forms would not resolve the challenges described within the strategic context.

Option C does not provide a viable option as:

• the option of developing internally is associated with significant short-term and medium-term costs, would not deliver organisational benefits for several years, and introduces uncertainty regarding delivery timeframes and successful delivery, and
• there are no mature and market-ready options available from existing suppliers that could meet the required criteria of a tender specification.

Preferred option

The option analysis demonstrates that Option B – to procure a specialist digital consent to treatment application – should be the preferred option for the organisation, based on the alignment of this option with local and national priorities within the strategic context, evidence that mature options are available that can support the organisation successfully transition to digital consent, and that the change can be delivered in a financially sustainable way.

Benefits case

This benefits case outlines the key objectives of introducing a specialist digital consent to treatment application, the existing evidence base, and the proposed measurement strategy. The measurement strategies will require baseline measurement for each objective, and either ongoing or point-in-time measurement during the term covered by this business case.

Reduced medicolegal risk

Objectives:

• Reduce consent form errors and omissions through the use of evidence-based treatment templates.

• Reduce concerns, complaints, and legal cases relating to consent through improved documentation and transparency of the consent process.

• Increase the rate of two-stage consent, supported by patient access to information digitally, and remote consent functionality.

• Remove the risk of losing a completed consent form, through digital access and a copy automatically placed within the EHR.

• Reduce the rate of wrong-site surgery, due to improved legibility of the treatment name on consent forms.

Evidence base:

Whilst it is difficult to assess precisely the medium and long-term impact of moving to digital consent, legal teams at other similar organisations have predicted a 50% reduction in consent related medicolegal risk. This is supported by published evidence of a reduction in error and omission rates from >50% for the paper consent process to fewer than 2% following introduction of a digital consent process.

Measurement strategy:

The measurement strategy for the reduced medicolegal risk objectives will include:

• Measurement of consent form documentation quality, including pre/post comparison of errors and omissions, across several specialities/clinical teams.

• Annual review of number of concerns, complaints and legal cases relating to consent within the organisation, supported by the organisation’s legal team.

• Measure the rate of on-the-day consent within elective surgical cases, with a target of fewer than 10% of elective surgical cases having the consent documentation shared with patients for the first time on the day of surgery.

• Baseline and point-in-time audit of lost consent form rate at the day of surgery, and at 3 months following treatment.

• Annual review of wrong-site surgery cases, and analysis of whether the consent process was a factor.

• Clinician survey of confidence that their consent process, and the consent process of colleagues, is of appropriate quality as per GMC guidance.

Improved shared decision making

Objectives:

• Improve shared decision making quality across the organisation for treatments requiring a written consent process.

• Improve the proportion of patients that are provided access to evidence-based, accessible, understandable information that is tailored to their circumstances, to support decision-making.

Evidence base:

There are several peer-reviewed academic papers demonstrating a significant increase in patient-percieved shared decision making quality following the implementation of a specialist digital consent to treatment application. These works have demonstrated that introducing a digital consent process is one of the most effective mechanisms of driving shared decision making quality across an organisation. An example, in a study in The Surgeon, an increase from 28% to 72% of patients reporting gold-standard SDM was reported.

Measurement strategy:

• Continuous assessment of shared decision making quality across the organisation as part of post-consent survey, with manual process for baseline data collection.

• Quarterly review of submitted quantitative and qualitative patient feedback received as part of the consent process, with measurement of average experience star rating and thematic analysis of areas for improvement.

• Baseline and point-in-time analysis of post-treatment patient recall and decision certainty.

Improved surgical pathway efficiency

Objectives:

• Reduce day of surgery cancellations and delays, through removing the risk of lost consent forms, and a two-stage consent process.

• Reduce clinical time spent on administrative elements of the consent process.

• Incorporate 1st stage completion of consent process within waiting list readiness criteria, to ensure consent is not done on the day-of-surgery, and the associated delay and cancellation risk.

• Reduce carbon footprint of consent process by reducing the amount of paper used for consent forms and patient information leaflets (information must still be able to be printed for individuals that require a paper copy).

Evidence base:

Work by Imperial College Healthcare NHS Trust & Chelsea and Westminster Hospital NHS Foundation Trust, published as an NHS England digital playbook reported a 5-10% reduction in day-of-surgery cancellations and delays, and clinical time was released, once digital consent was embedded.

Measurement strategy:

• Baseline and point-in-time audit of admin time per consent episode, including both elective and emergency scenarios, across several specialties.

• Quarterly review of consent-related theatre delays and cancellations, with involvement of quality improvement team to optimise efficiency.

• Annual review of number of carbon-copy consent forms and paper patient information leaflets being printed/ordered within the organisation.

Financial analysis

Risks

The following are risks involved with the implementation of a specialist digital consent application which should be considered as part of the decision making process, and mitigations considered if a decision to proceed is made.

Long timeframe to, or unable to reach, digital consent by default

The business case is framed around transitioning the organisation from using a paper-based consent process by default, to a digital consent process by default. Whilst it is acknowleged that some paper consent provisions will need to continue, principally for business continuity purposes, the assumption made within the business case is that the process becomes digital consent by default, representing in excess of 95% of consent activity within the organisation.

As a cross-specialty, whole of organisation change, the deployment approach will need to be considered to minimise the risk of having a long period of deployment, and the risk of having significant areas within the organisation running paper and digital consent processes in parallel.

Paper process replacement without transformational change benefits

There is a risk that a digital consent solution could be introduced and directly replace the paper consent forms but without the associated benefits of reduced medicolegal risk, improved shared decision making and improved surgical pathway efficiency being realised. An inability to move away from completing the consent process on the day of treatment is seen as the key contributor to this risk.

To mitigate this risk the organisation will need to communicate clearly that a move to 2-stage consent for elective surgery is expected, and engage with clinical teams regarding how this change will be made operationally alongside the adoption of a digital consent approach.

Equality impact assessment

An Equality Impact Assessment (EQIA) has been completed which considers the impact in respect of; age, disability, gender-reassignment, pregnancy or maternity, marriage or civil partnership, race, religion or belief, sex and sexual orientation. The assessment concludes that whilst there are relevant considerations for the deployment, such as ensuring staff training regarding printing of consent information for those without digital access, and the appropriate use of a Consent Form 4 process for those who lack the mental capacity to consent to the treatment, that the impact on individuals covered by the EQIA is neutral or positive across each protected characteristic category.