A cost–consequence analysis of eLearning videos designed to supplement the consent process in lower limb arthroplasty

Abstract

Introduction

Since the Montgomery ruling in 2015 surgeons have been tasked with identifying material risk when taking informed consent. Despite this, there has been limited uptake of technological aids to supplement the consent process although such aids are shown to improve patient knowledge and satisfaction. ConsentPLUS is a free-to-access website with bite-sized educational videos designed to clearly explain lower limb arthroplasty procedures to patients and aid their consent.

Methods

The authors performed a prospective cost–consequence analysis, outlining any costs associated with the intervention and any quantitative or qualitative impacts the intervention may have on patients.

Results

A total of 3,143 consecutive patients were identified who were undergoing total knee or hip replacement in 25 elective NHS orthopaedic units. The total cost of development and projected 10-year running fees for ConsentPLUS total £75,000. Health Foundation support means the service is free-to-access for centres throughout the UK. Mean exposure time per patient was 10min 29s, equivalent to £185,437 of additional contact time according to the National Tariff. Mean clinic time was reduced by 17min owing to the earlier identification of material risk. Patient knowledge on pre- and post-video quizzes increased from 7.01 to 9.08 following eLearning (paired t-test = 0.998). The process had an overall satisfaction rate of 97%.

Conclusion

Educational eLearning videos are an accessible and digestible way to supplement the consent process. This enables earlier identification of material risk in clinics owing to improved patient knowledge, leading to increased patient satisfaction with arthroplasty consenting.

Introduction

On average, there are 7,926,360 surgical procedures a year in the UK.¹ In 2019, there were 109,629 total hip replacements (THR) and 115,514 total knee replacements (TKR).² Informed consent is a fundamental requirement for all surgical operations. Chong et al state that the mean consent time for doctors is 10min and this relatively short period has been identified as one of the main reasons for poor-quality discussion between patient and surgeon.^3,4 Based on the number of TKR and THR operations performed in 2019, this corresponds to almost 38,000h of consent time, and utilising the National Tariff payment structure this equates to over £12.4 million.

In 2016, the Montgomery ruling awarded £5.25m in hospital damages following a failure in explaining the material risk of shoulder dystocia to a diabetic mother during the consent process. British Orthopaedic Association guidance summarised the current view of the General Medical Council and highlighted the importance of eliciting a patient’s material risk.⁵

In England alone, between 2000 and 2006, litigation fees for orthopaedic surgery were estimated at £193,944,167. Some 25.9% of these claims are due non-technical errors and failures in the consent process.⁵ A further example of consent-related patient complaints is seen in spinal surgery, with inadequacies when explaining adverse effects/risks and alternative treatment options.⁶

Since the Montgomery judgement, only 35% of surgeons have reported a change in practice, citing a lack of protected time for discussion and minimal uptake of technological aids.⁷ Advancements in technological interventions have been placed at the forefront of the recently published National Health Service (NHS) 10-year plan.⁸ Multimedia videos are shown to have higher levels of patient satisfaction and comprehension compared with conventional patient information leaflets.⁹ These leaflets have been criticised for having overly dense material with a complex reading level.¹⁰

An example of multimedia videos making the consent process more patient-centred can be observed in arthroscopic surgery where online 20-min tutorials have improved patient knowledge and satisfaction scores.¹¹ Furthermore, video-assisted informed consent improved understanding of surgical steps and satisfaction for trauma patients in emergency departments.¹² Other surgical fields have also shown the advantages of multimedia input: a reduction in patient anxiety during emergency caesarean, improvements in legibility and greater completion rates for consent forms prior to the day of surgery in breast clinics, and improved understanding of appendicectomy surgery in the paediatric populations.^13-15

Current evidence is limited, with videos tending to focus on pathology and the technical aspects of surgery, and with limited information for patients regarding risks, complications and alternative procedures. There are a few studies published that outline the benefits of video-assisted informed consent. Pallett et al published one such study, demonstrating improved patient comprehension and reduced physician time.¹⁶ However, there is yet to be an economic analysis of the cost and impact of these types of intervention.

The aim of ConsentPLUS was to design a widely accessible, reproducible intervention that can be implemented nationally for hip and knee arthroplasty. The aim of this paper is to perform a cost–consequence analysis to summarise the multiple, varied outcomes of the developed intervention, and to outline the potential economic and patient-reported outcomes to facilitate further decisions by NHS financial reviewers.

Methods

Description of the intervention

ConsentPLUS is an innovative multimedia communication system that utilises the flip classroom principle to deliver information via illustrative videos. A flipped classroom encourages the learner to self-study at home to facilitate live problem-solving during contact time with their educator (ie, learning the complications of THR at home to facilitate discussion about material risks in the clinic). The process involves patients watching 13 educational videos, each around 1min in length; the bitesize design of the videos takes less time to consume and is more flexible for the learner. The videos take the patient on a journey through why they need an operation, what exactly the operation is, what to do on the day, what happens afterwards and what can go wrong. Each complication has its own bite-sized video (eg, fracture, thrombosis, pain, neurovascular injury). After being listed for an operation, patients can access the ConsentPLUS website, create a password-protected login and then choose their relevant consultant who will approve their choice of operation. The videos can be accessed at home and are delivered via a user-friendly web-based program. Patients are asked to complete an informal test/questionnaire to assess understanding and identify their ideas of material risk. There is a live prospective data capture of active users’ records, demographics, test results, video plays, platform choice (desktop, tablet), and feedback on patient knowledge and satisfaction. A recent update to the system since performing this study has integrated the site into the NHS secure Egress system to protect patient data and confidentiality. Further, Consent Form 1 has now been made available through the ConsentPLUS portal, so that patients can sign before clinic should they wish. ConsentPLUS is free to access and is being run not for profit. The online portal can be accessed at: www.consentplus.com.

Costs

ConsentPLUS was funded by the Health Foundation and, as a result, is a free and widely accessible web-based application that can be easily incorporated into NHS hospital infrastructure. The cost breakdown was divided into £30,000 for database and website development and £32,500 for video development. Website maintenance costs for the next 10 years are estimated to total £1,000, whereas administration costs for development and running are £3,000, for which the remaining funds are retained to cover.

Study design

The aim of this study was to perform a cost–consequence analysis in line with the CHEERS Checklist that presents the costs of developing and running the ConsentPLUS pathway, and to measure a variety of outcomes including patient satisfaction and knowledge.¹⁷

Results

Participants

A total of 3,143 patients and 200 orthopaedic surgeons in 25 hospitals across England and Wales registered online to use ConsentPLUS. Centres were recruited by consultants wishing to use ConsentPLUS for their arthroplasty patients; there were no specific exclusion criteria and uptake was voluntary and through advertisement. Data were collected from 2016 to 2019 via online data capture. Our primary outcome measures included calculation of tangible costs, additional time given to patient education through the video platform and any reduction in duration of consent clinic time. Our secondary outcome measures comprised intangible costs of patient knowledge and satisfaction, and any further benefits not measurable purely in financial terms. Outcomes would be offset against any costs of running the intervention.

Additional contact time, reduction in clinic time and overall attributable cost

Data capture collected a total of 3,143 users and 200 orthopaedic surgeons registered in 25 hospitals across England and Wales. The majority of users (54%) were aged 51–70 years. The preferred platforms were desktop computer (68% of users) and tablet (24%), with laptops and mobile phones also used. Fewer than 1% of patients did not complete the full video pathway, including the patient knowledge and satisfaction feedback questionnaires.

There were 45,010 video plays for 3,143 active users; a mean of 14.3 videos played per user. The mean time spent per video per user was 44s, which equates to a mean exposure time of 10min 29s per user. A local departmental audit of clinic data in the lead hospital (Princess of Wales Hospital, Bridgend) arthroplasty clinics showed an average reduction in overall clinic time of 17min per clinic. Audit data were not collated from the remaining centres.

The National Tariff cost of an orthopaedic follow-up consultation, lasting around 10min with a single professional, is £59 per patient. If additional contact time, through ConsentPLUS, of 10min per patient is equivalent or superior in quality to verbal consent received in an outpatient consent clinic, we assume a consultation cost, of ConsentPLUS, equal to £59. The potential attributable cost of the time added by ConsentPLUS equates to £185,437 thus far, if the information provided is assumed to be equal to that of a consultation. Table 1 summarises the additional patient contact time delivered.

Table 1 .

Summary of total contact time and cost added by ConsentPLUS

Summary of statistics	n
Number of active users	3,143
Total number of video plays	45,010
Mean number of videos played per user	14.3
Mean video time played (s)	44
Total time per user (s)	629.2
Total time per user (min)	10.29
Cost of orthopaedic follow-up consultation with a single professional (£)	59
Reduction in overall clinic time (min)	17
Additional ConsentPLUS contact time (min)	10.29
Attributable cost added by ConsentPLUS (£)	185,437

Patient knowledge and patient satisfaction

A feedback section was completed online by users, immediately after viewing all the videos and before attending clinic. This involved rating their level of knowledge, from 1 to 10, on the proposed operation based on the eLearning videos. Patients were asked to rate retrospectively how informed they felt before and after watching the videos. On average, patient knowledge increased from 7.01 to 9.08 following the eLearning, with a Student’s paired t-test result of 0.998, which is summarised in Figure 1.

Figure 1 .

How informed patients felt before and after ConsentPLUS

Results from the live data capture of 3,143 users between 1 January 2016 and 1 January 2019 found that overall, 95.8% of patients found the videos useful, with 97% getting the information they wanted and 91.3% willing to revisit the programme to seek help. This was rated on a scale of 1 to 5 (where 1 = not useful, 2 = somewhat useful, 3 = useful, 4 = very useful and 5 = extremely useful). A further 97.4% of patients were satisfied with the quality of service and 95.9% were willing to recommend the process to a friend. Around 84.3% of patients felt it was important for their family to watch the videos. These outcomes are summarised in Figure 2.

Figure 2 .

ConsentPLUS feedback

Patient self-rated scores on how informed they felt before and after the ConsentPLUS video eLearning.

Discussion

Through the Health Foundation grant, we have developed an online, free-to-access, consent-assistance tool for lower limb arthroplasty. This is available across the NHS and is in a direct trajectory to grow with its 10-year technological advancement plan. ConsentPLUS addresses gaps in our current consent process by creating a more patient-centred pathway, as identified by the Montgomery judgement.

The authors would like to make clear that ConsentPLUS is not designed to replace the current consenting pathway, but to facilitate higher level discussions surrounding material risk during face-to-face consultations.

Our data reflected the previous literature by showing that patients felt more informed following the eLearning modules.^9,11 In addition, the important benefits associated with patient education and satisfaction could have indirect positive effects increasing compliance, reducing complications and length of stay. Moreover, patient and family satisfaction could also reduce complaints and litigation costs.

Data capture suggests that the majority patients are utilising the service to its full potential. When compared with patient information leaflets or verbal consent, evidence suggests that multimedia videos are superior in terms of patient satisfaction and comprehension.⁹ We therefore assumed the quality of the information delivered via the videos is equivalent to that received in a follow-up orthopaedic consultation; as such, we have attributed an additional contact time cost of £185,437 to this. This value is equivalent to the cost required to run consent clinics under the current system. The overall cost of developing ConsentPLUS was £62,500 and the software will be maintained for a fraction of this while being free to access.

Clinic time was reduced because discussions were more concise and tailored, which have their own benefits. Anecdotally, this included firm establishment of material risk and helped ensure patients are correctly consented. Reducing consent clinic time by 17min on average would enable more patients to be listed for consent clinics and potentially free-up consultant time in other areas such as for waiting list initiatives, which reflects the study by Pallat et al.¹⁶

Over the 3-year period of ConsentPLUS we were not aware of any litigation costs to local health boards, whereas this cost has been quoted as £8,371,923 per annum for orthopaedics in England.⁵ Future research could look at this outcome in a longer-term study. However, the certificate of completion provides an additional checkpoint to the current consent process; although not a legal document, this is evidence of the provision of information on risks and complications.

Study strengths and limitations

The study was conducted in Major Trauma Centres and District General Hospitals across the UK with a representative cohort that reflects the arthroplasty population to which the results would be generalisable. It could be suggested that technological interventions may be limited in elderly populations owing to a lack of internet access in these populations. Importantly, a study by Zickuhr et al suggests that this is not the case, further our anecdotal experience suggests that families are eager to help, and that the intervention helps initiate this support network.¹⁸ The main disadvantage of this descriptive cost–consequence analysis is that it does not define or evaluate any specific cost-effectiveness thresholds and has a risk of outcome reporting bias. Further, because this is an opt-in adjunctive no data were available for comparison against patients that did not elect to complete the pathway.

Future study could focus on comparative analysis of both consenting pathways to determine superiority and long-term outcomes could consider the financial impacts of litigation. Furthermore, it may be appropriate to look at impacts on clinical outcomes such as pain, infection and other complications. The free-to-access format allows for realistic future expansion to further arthroplasty centres and larger, long-term analysis.

Conclusions

Health Foundation funding means this is a free-to-access, widely accessible service that is easy to implement in arthroplasty centres.

Bite-sized videos that supplement the consent process provided additional contact time equivalent to £185,437 at National Tariff. The process enables the identification of material risk and reduces the overall length of consent clinics by 17min. Patient knowledge, on average, increased from 7.01 to 9.08 following the eLearning, with a Student’s paired t-test result of 0.998. Further, this platform has the potential to reduce annual litigation costs. Overall satisfaction with the service was 97.4%.

ConsentPLUS eLearning videos are a free-to-access web service that supplements the consent process in arthroplasty, and consequentially provides additional contact time for patients, reduces overall clinic time and improves patient knowledge and satisfaction.