Trust creates a clinic for drug control and treatment implication for patients with polycystic kidney disease, resulting in pharmacy-led monitoring and reduced impact on kidney functions

Synopsis:

We report a service development delivering safe, patient centred access to treatment for polycystic kidney disease (PKD) patients. This has led to multiple care enhancements at local, regional and national levels. Context

• Providing easy, equitable access to new and complex treatments is challenging. Tolvaptan is the only licensed treatment for PKD and was NICE approved in November 2015. A patient focus group identified key desired service improvements. However, 300 patients in 16 different general renal clinics presented a challenge within logistic and resource constraints Patient Identified Needs

• Strong expression for dedicated PKD clinic

• Earlier patient education all aspects of PKD

• Access to specialist nurse/dietician/psychologist/pharmacist

• Greater opportunity research participation

• Focus on disease prevention to avoid dialysis

• Opportunity for disease modifying treatment (tolvaptan) Change Package

• Two monthly general clinics were recoded as dedicated PKD clinic

• Current PKD patients were invited over 2 years to transfer to new service

Challenges:

Goals: Equity, Opportunity and Safety

• All PKD patients should have accessed education on their disease and complications • All PKD patients should have been given opportunity to take part in research

• All PKD patients eligible for disease modification with treatment should be identified

• All eligible PKD patients should be offered drug education to make informed decision

• Patients initiated on treatment should be monitored in a risk management protocol to ensure patient safety

• Patient outcomes should be reported and results fed back to wider medical and patient communities Challenges and Solutions

• 300 PKD patients spread across 16 different clinics – EPR searched to identify

• Lack of uniformity in patient education – PKD patient information pack given at 1st visit

• Engagement/awareness of disease progression – patients invited to join PatientView to view records on home computer

• Patient eligibility for treatment by NICE criteria is complex – MDT reviews at each clinic

• Tolvaptan is a new therapy needing close monitoring – treatment pathway developed

• Patients motivation for treatment variable – pharmacy-led drug education ensures compliance and side-effect awareness

• New therapy needed monthly visits for 18 months – clinic capacity increased by all team members being skilled via risk management program to review, prescribe and monitor treatment

Outcomes:

Maximum 200 Words 182 All patient expressed goals have been achieved

• Strong expression for dedicated PKD clinic

• Earlier patient education all aspects of PKD

• Access to specialist nurse/dietician/psychologist/pharmacist

• Greater opportunity research participation

• Focus on preventing disease progression to avoid dialysis

• Opportunity for disease modifying treatment (tolvaptan) Treatment Uptake/Effectiveness

• Early collaboration with Otsuka Pharma indicated 80 eligible expected patients in our catchment.

• So far 86 have been identified (65 initiated, 12 declined and 9 more are considering treatment).

• Treatment safety and effectiveness is detailed in supporting documentation but in summary 90% of those on treatment have had a beneficial impact on kidney function. With major impact on long term outcomes. Excellent patient safety was supported by lower dropout rates in our cohort vs reported trail data Satisfaction

• High level satisfaction seen in feedback from independent service review is included in supporting documentation Research Participation

• No specific targets were made but patient numbers recruited via new service o RaDaR 153 o PASS 19 (9 in process)

o PatientView 227

o 100,000 genomes project 41

o eGFR study 17

o Nurture study 21

o Salford Kidney Study 168

o Oveture Study 16

o Reprise Study 3

Spread:

Clinical spread

• Salford was an early adopter of modifying therapy. The model was new and innovative. It is now recognised as an excellent model for patient experience and safe. The team made many presentations at Renal Association, British Renal Society, Symposia, advisory boards and individual units. (Please see detail in supporting documents). Many other units have adopted/modified the model within clinical services. We are collaborating to allow standardised monitoring to allow benchmarking outcomes nationally

• With the team contributing to Renal Association Treatment guidelines, patient identification/access to treatment was less challenging for others

• Collaboration with Otsuka pharmaceutical enabled accurate measurement of treatment uptake compared to expected population estimates. Success was noted and encouraged other teams to setup and provide similar services

• Close national working with PKD Charity has given patients awareness and confidence in many aspects of the disease. Contributing to the PKD disease and dietary advice is freely available 24/7 via the PKD charity website. We have spread good practice at PKD Patient and Carer Information Days

• PKD Charity launched their national befriending service at Salford. PKD Charity invited Salford to host a one hour webinar, viewable on their website. Excellent patient feedback is included in supporting information

Value:

Qualitative/Patient Experience

• All patients transferred to new service. All received latest uniform information on primary disease

• Appropriate patients invited to participate in observational/interventional research trials

• All invited to join PKD charity/PatientView access results/letters at home to encourage engagement

• Eligible patients for disease prevention identified, made aware and invited to drug education. High uptake of tolvaptan treatment/excellent outcomes

Service benefits

• Patient engagement/education enhances safety

• Increased referrals to service. Clinic viewed as excellent training environment

• Increased research activity and revenues

• High profile for department at national level/engaged with PKD charity/Patient groups/Pharma Quantitative PKD progresses slowly over decades. Prior to tolvaptan there was no modifying therapy. Impact on need for transplant/dialysis can only be inferred from rate of decline before and after treatment. Data is included in supporting documents. The group annual decline in kidney function has reduced from 6.6% previously to 1.2% on treatment. Importantly, 30% on treatment have had either improved/stabilised function, suggesting these patients will not need transplant or dialysis. For just one patient cost of dialysis for 15 years would be £450,000 vs therapy cost £105,000. Delaying the need for dialysis for 7yrs saves £161,000 per patient, however the value patient quality of life is clearly higher.

Involvement:

Local Stakeholders PKD patients and carers Engagement from initial focus group was consolidated by liaison with local KPA. Awareness via local and social media. Patients invited by personal letter to new service. Renal Team PKD team (medic/nurse practitioner/pharmacist/research/management/admin) identified.

Team developed patient pathways fitting workflows and resources. Progress/outcomes reported to business/CME meetings. Research Team Patients screened at MDTs and offered chance to participate in eligible research projects. External Stakeholders PKD Charity: close partnership with innovative national charity has delivered vital outcomes. See in supporting information. Ashford Medical Independent in-depth service review. Including user satisfaction by subjective/ objective patient feedback.

Engagement at all levels ensured service delivered information and benefits facilitating safe clinical care. Industry Otsuka Pharmaceutical Patient numbers for treatment and clinic capacity demand. Support to present service model and treatment outcomes detailed in supporting information. UK Renal Association: Team were invited to form national guidelines for use of Tolvaptan published 2016 Renal team presenting at 2 Patient and Carer support days (120 patients attended each day) Launch of national befriending service for peer support to newly diagnosed patients at Salford. Team invited to review and contribute to PKD information resource and develop dietary advice sheet for PKD patients.