Improving shared decision making and digital informed consent at Nottingham University Hospital NHS Trust

Clinicians at Nottingham University Hospitals NHS Trust (NUH) wanted to support patients to make informed decisions. They wanted to give them more time to consider the benefits, risks and alternatives to their proposed treatment.

Patients can access resources at home remotely to support shared decision making. This gives them the time they need without having a negative impact on clinic time.

It's possible to achieve a 'single meaningful consultation’ by:

• reducing the number of unnecessary hospital visits a patient has to make
• providing clinicians with information about the patient’s engagement during the consent process

Piloting this process with gallstone patients provides clinicians with data about how ready patients are for digital shared decision making and informed consent.

Situation

Informed consent to treatment relies on shared decision making. Patients need information about:

• the procedure and how the risks and benefits will impact their lives
• the alternatives they could consider
• what would happen if they did not go ahead with the procedure

Clinicians need information about the patient so they can consider the material risks and benefits in the context of the specific patient. This helps the patient understand what the proposed treatment involves. It also ensures that the patient realises the importance of sharing information with the healthcare team.

Patients often know very little about the surgery they’ve opted for due to:

• time pressures during consultation appointments
• a lack of available patient education resources

This is also the case with relatives or carers who are key people in the decision making process.

Technical language, out of date information and missing consent forms are common occurrences.

Handling complaints and litigation issues takes a significant amount of front line resources.

There has been little focus on digitising the processes around shared decision making and informed consent. This area has yet to receive the benefits of digitisation.

The COVID-19 pandemic, and the resulting elective surgery backlog, increased the need to digitally transform informed consent and shared decision making.

Aspiration

The clinical team wanted to:

• reduce variation in the consenting pathway
• embed the Benefits, Risks, Alternatives, do Nothing (BRAN) principles of informed consent and shared decision making for every elective surgery patient
• reduce the amount of poorly completed consent documentation to lessen the medico-legal risk to the Trust
• reduce the frequency and impact of litigation related to consent

The clinical team wanted to involve patients in their surgical journey. Communicating the risk and managing expectations of surgery outcomes helps to improve patient experience.

The team also wanted to record the patient’s engagement. They wanted the clinician to be able to access it before the patient’s consent consultation or the day of surgery. This means the clinician is better informed about how engaged in the consent process the patient is.

Solution and impact

The Trust used EIDO Healthcare’s Inform Consent Suite in general surgery.

EIDO’s Inform Patient Education module is an engaging and interactive environment for patients to learn about their upcoming procedure. 

After the patient and clinician have met to diagnose the problem and any recommended treatment, the patient will get a text or email inviting them to view an article about their procedure.

The initial meeting could be face-to-face, or supported by virtual consultation software. This part of the solution is important because it establishes the start date for the consent process.

The patient has time to consider the information about their procedure, known as the ‘cooling off period’. It’s a crucial part of ensuring that the consent process is medically and legally valid.

The suite is not a replacement for the patient’s consultation with their clinician. It reinforces the consultation.

The clinician will tell the patient that it’s important to read the procedure-specific information to make sure they get answers to their questions.

At this point, the team can identify patients who cannot or do not use digital services and give them the same information in paper format.

EIDO’s Inform library is available in accessible formats to support patients:

• with visual impairment
• with learning disabilities
• who speak English as a second language

The system dashboard keeps end-user clinicians up to date with the status of each patient in the consent journey.

If a patient does not engage with the system, staff can resend invitations. They can also contact the patient to see if they need the information in a different format.

After reading through the procedure-specific content at home, the clinician will invite patients to accept informed consent statements. They can then sign these digitally. This outputs a draft consent form that is both procedure and patient-specific, including any notes or questions from the patient.

All the relevant EIDO content is pre-populated on the draft consent form. This provides a number of benefits, for example:

• clinicians save 5 to 10 minutes for each content form by not hand writing information
• improves governance and risk management
• there’s no possibility of the information being out of date or missed off the consent form
• the content will be consistent with the information already provided to the patient as it comes from EIDO’s live publishing system
• the patient’s decision to go ahead with surgery is not based on a list of benefits, risks and alternatives
• the patient can rely on information about what the procedure involves, the aftercare requirements and recovery expectations

To provide final consent, patients can digitally access the draft consent form when they go to hospital for their procedure. The clinician reviews this form and the patient's engagement activity on a tablet device.

The clinician decides whether to convert the draft consent into final consent by adding any relevant notes, signing it and asking the patient to sign. 

Alternatively, they can choose to recap the procedure information in a guided discussion with the patient. This can be useful if the patient has not engaged with the digital content at home.

Functionality

The EIDO Inform Consent Suite can function as a completely standalone system, quickly installed and used by independent clinicians, pilots or small departments.

NUH’s pilot used EIDO’s application programming interface (API) to integrate with the Trust Integration Engine (TIE). It automates the triggers for sending information and receiving patient engagement reports.

The API will allow any Electronic Patient Record (EPR) or Patient Administration System (PAS) to send patient demographic information.

The EIDO API has 'create' and 'update' functions available via JSON, FHIR and HL7.

The JSON API has a fuller feature set, with endpoints to allow a deeper integration.

The HL7 translator will map requests made in HL7 through to the EIDO RESTful JSON API. The API is compatible with HL7 over https and over MLLP.

The EIDO Inform Consent Suite is a modular system. It consists of:

• a Patient Consent module which offers procedure and patient-specific digital consent forms
• a Home module which allows a patient to complete a draft consent form at home using their web browser
• a Hospital module which is a full digital consent solution for use in hospital
• a Patient Education module

The Patient Education module is based on a library of content that:

• is endorsed by the Royal College of Surgeons of England
• is endorsed by Association of Surgeons of Great Britain and Ireland
• has the Plain English Campaign ‘Crystal Mark’
• has the PIF TICK
• is kept up to date and maintained by EIDO’s in-house editorial team and expert clinician authors and reviewers
• can be sent directly to patients
• can be viewed on a web browser on the patient's computer, tablet or mobile device

Capabilities

The service:

• supports shared decision making principles by allowing the 2-way flow of information between the patient and clinician
• sends complete procedure-specific patient education documentation for patients to engage with at home
• is digitally inclusive but paper pathways are also supported
• works with Trust Integration Engines, PAS and EPR systems
• allows remote consent at home
• allows hospital consent
• supports consent form 1 to 4
• supports multiple and optional procedures
• has patient engagement reports for time spent reading the information, how often they visit it and which pages they have read
• records notes made by the patient at home
• allows clinicians to approve and address patient notes
• can provide third party or Trust-approved information to patients in addition to EIDO’s library of information
• does not allow clinicians to remove key information about material risks from the core consent form
• ensures all patients get standardised information

Scope

NUH has implemented the solution for general surgery patients in a hospital setting.

Patients who cannot or do not use digital services can complete the full digital consent process in the clinical setting.

NUH intends to extend the use case to more specialties and procedures. EIDO’s education content supports around 400 procedures in all key specialties.

The service can support patients having procedures where there is no EIDO content by hosting third-party or hospital-produced information.

Key learning points

There are many benefits of using digital content.

Content sent to the patient from EIDO’s core publishing system is always up to date. This is not possible with hard-copies as patients can sometimes get outdated copies. This is a significant medico-legal risk.

Many of EIDO’s articles include videos with animations in for patients to watch. These are usually around 1 minute long and give a helpful visual overview of what the patient can expect. They improve patient engagement, comprehension and experience with the content.

Patients have to authenticate their identity when they view the online content. The solution can then record how long patients have engaged with each section of the content. It records whether they viewed the content once or many times.

The solution addresses the organisation’s desire to support clinicians when assessing a patient’s understanding of the procedure and allows them to address any areas of weakness. 

In the event of consent-related litigation, it provides good evidence of a patient’s full engagement in the process.

As patients engage with the content, they can make notes of their concerns or questions to ask their consultant on the system. This is important to support the principle of shared decision making. Clinicians need to learn information about the patient as much as the patient needs to learn about the procedure.

The main challenges to adoption were the Information Governance and IT requirements. As an early adopter of this technology, there were challenges in allowing cloud-based systems and remote engagement by patients.

Ensuring the supplier met DSP Toolkit, Cyber Essentials Plus and DCB0129 requirements provided reassurance that due diligence had been observed.

The main challenges to clinician engagement were the perceived impact on clinic time to use a digital solution. These initial concerns eased when reports showed how much time patients saved by engaging with the process at home.

The main challenge to patient engagement was ensuring the digital readiness of the patient. This will vary by procedure as some procedures are more commonly performed on a population with lower digital capability.

Ensuring the supplier could still support a paper-based solution was important, but it's anticipated this requirement will decrease over time.

The COVID-19 pandemic was a digital accelerator for both NHS and patient experience.

Key figures and quotes

The system pilot ran for 18 months. During that time 898 patients were invited to take part.

The pilot procedure chosen was Laparoscopic Cholecystectomy. It was a good representative of a high volume, low complexity procedure.

The mean age of participants was 46.7 years between the age of 18 and 83. 81% of patients were female.

Patients spent on average 19 minutes reading the patient education material. They answered questions about the procedure to demonstrate their comprehension and engagement.

Patient experience feedback was generally excellent, but there were a few challenges. The team addressed some during the pilot, and others will feed into phase 2 of the pilot.

There was a significant improvement to patient engagement when the team added SMS communication, in addition to email.

Patient feedback showed that they felt:

• the language used is simple and easy to understand
• there was good use of diagrams and spot questions to keep the user engaged
• there was great use of videos and visuals
• the patient experience videos were really reassuring
• the process made them feel responsible for making a good decision about their own healthcare
• the PDF it produces at the end was very clever
• the concept and flow is excellent
• the leap to multimedia was very exciting
• the content was easy to read
• the content was easy to navigate

The team addressed a few areas for improvement during the pilot. They addressed feedback which said:

• there were too many security checks to log-in, with repeated lockouts
• there were some areas that had too much text and resulted in information overload
• it was difficult to use on mobile devices due to scrolling

Patients also felt there were also too many questions and repetition. The team plans to address this in phase 2.

“I am using the system regularly in this new world of virtual consultations. Patients are very happy that we can instantly email the EIDO leaflets so they can think about and reflect further on the information we discussed during the virtual consultation, in the comfort of their homes. The information leaflets also facilitate face-to-face discussions and enhance the consent process.”

Mr Simon Parsons, Clinical Director for General Surgery, NUH NHS Trust

Find out more

EIDO consent suite

EIDO inform procedure library

Key contact

Mr Simon Parsons, Consultant Surgeon, NUH NHS

simon.parsons@nuh.nhs.uk

Matthew Ravenscroft, UK Director of Sales and Customer Care, EIDO Healthcare

matthew.ravenscroft@eidohealthcare.com