Pursuing a cure for Alzheimer’s – but where are the patients?

There is no cure for Alzheimer’s disease and the Neuropsychiatry Service clinical trials team work tirelessly to discover an effective treatment. Patients with an Alzheimer’s disease diagnosis are not often referred through the service.

Aim

By February 2020, the Neuropsychiatry Service Alzheimer’s disease clinical trials will receive ten clinician referrals for patients who are 60 years or older with prodromal, mild to moderate Alzheimer’s disease each month.

Benefits

• Patients are empowered to play a more active role in their own health care.
• Patients can gain access to potentially disease modifying treatments before they are widely available.
• Patients can receive expert medical care by specialists, access to sophisticated imaging and genetic testing – free of cost.
• Patient’s health is monitored throughout the duration of the trial, with trial team access 24 hours/7 days a week.
• Patients report self-satisfaction in contributing to future generations through research.
• Investment in health and medical research also benefits the state’s economy, stimulating the biotechnology industry, building commercialisation capacity and helping to reduce the costs of health care delivery.

Background

Dementia is the leading cause of death in Australian females. Among men dementia is only second to heart disease as the most common cause of death. Alzheimer’s disease affects up to 70% of people with dementia.¹

The disease is not a normal part of aging, damaging the brain and resulting in impaired memory, thinking and behaviour. There is no cure or way to slow progression.

The Neuropsychiatry Service offers eligible patients with prodromal, mild to moderate Alzheimer’s disease the option to participate in clinical trials. It is led by Professor Peter Schofield, clinical director of the service with over 20 years of neurological experience.

• As few as 17 referrals were made to the trials between September 2018 to April 2019.
• It is estimated 85% of patients are unaware or unsure that participation in a clinical trial is an option at the time of diagnosis.²
• There is also evidence that patients taking part in clinical trials do better than others with the same disease or condition.³
• Based on limited referrals between a retiring local geriatrician and the existing neuropsychiatry outpatient service, a renewed approach to clinician referrals was required.

Implementation

The research project manager of the Neuropsychiatry Service proposed the improvement project to the clinical director, initially as a much broader scope across the district. The project proposal was modified to trial internally change ideas to impact the number of referrals.

Prior to the first working committee meeting a literature review was conducted by the Hunter New England (HNE) library service staff. Invitations to participate in a quality improvement initiative were sent to both internal team members as well as external partners and a consumer representative.

Three key work group meetings were held over the nine month trial period. An early investigation by the team outlined the Alzheimer’s disease clinical trials referrals through process mapping. This practice highlighted gaps and opportunities among external and internal team members and was the basis for identifying primary and secondary drivers to form change ideas.

Change ideas were identified and ranked by level of impact and implementation difficulty. Change ideas included:

• build relationships through regular attendance at geriatrician meeting
• educate Hunter area local general practitioners on current Alzheimer’s disease trials
• design internal system for tracking participant’s status
• use existing HNE systems for clinician referrals such as e-referrals or HealthPathways
• integrate into Dementia Australia & Research Foundation
• review educational performance by specialists for community and clinicians
• recruit volunteers for service
• team members were identified to lead these change ideas through an informal Plan Do Study approach.
• the Act module was used to monitor activities throughout the project period.

Project status

Implementation – The project is currently being implemented, piloted or tested.

Key dates

• Committee met initially March 8 – process mapping
• Change ideas agreed March 29 – topics distributed to members
• Informal progress meetings – as needed by topic area
• Final review November 15 –  member recognition, results, future direction

Implementation site

Hunter New England Local Health District Neuropsychiatry Service

Partnerships

• Geriatric Medicine Rankin Park Centre
• Community Health Pathways / E-referrals
• HNE Library Service
• HNE Research Innovation and Partnerships
• Lower Hunter Respite
• Dementia Australia Research Foundation
• UNSW – Step Up For Dementia
• HNE Strategic Relations & Communication
• Anglican Care – Booragul & Toronto
• Hunter New England and Central Coast Primary Health Network

Results

• Direct referrals to the Neuropsychiatry Service Alzheimer’s disease clinical trials was collected between 1 May to December 1, 2019. The number of new clinicians and type of clinician were also recorded.
• Referrals were also collected by community service groups and individuals within the Hunter region.
• The aim of the project was to receive a minimum of ten referrals monthly. This nine month project has shown over 100% increase in referrals, but at this early point has not met the aim each month.
• The number of clinicians referring has increase from two to six new clinicians. More importantly this improvement project has created new partnerships that will create referral linkages. Including:clinical trial staff meeting with geriatricians on an on-going six monthly basis, implementing cognitive screening tools in general practices and community aged care service providers to help assess cognition.
• Electronic referrals continues to be refined and supported through the Alzheimer’s disease clinical trials with secure data sharing being an essential system improvement.
• Partnering with the first national Alzheimer’s disease patient registry Step Up for Dementia requires a Human Research Ethics Committee or research governance officer ethics review for each trial, but also represents a system approach as opposed to relying on an individual to refer.

Lessons learnt

• Choose change ideas early in project development that will demonstrate success to keep committee members motivated.
• Be aware of change ideas that can be time consuming.
• Support team leaders with ongoing training such as CEC Clinical Leadership Program, Accelerating Implementation Methodology (AIM), Monash University Implementing Innovation in Healthcare.

References

1. Australian Bureau of Statistics (2018) Causes of Death, Australia, 2017 (cat. No. 3303.0)
2. Harris Interactive. 2001. Misconceptions and lack of awareness greatly reduce recruitment for cancer clinical trials. Health Care News 1(3).
3. Majumdar SR, Roe MT, Peterson ED, Chen AY, Gibler WB, Armstrong PW (2008). Better outcomes for patients treated at hospitals that participate in clinical trials. Archives of Internal Medicine 168(6):657–662.

Further reading

• Dementia Australia 
• Australian Clinical Trials
• About Clinical Trials
• Aisen P, et al. (2016) Registries and Cohorts to Accelerate Early Phase Alzheimer’s Trials: A Report from the EU/US Clinical Trials.  J Prev Alzheimers Dis 3(2):68-74.
• Carr S.A, et al. (2010). Comparison of recruitment efforts targeted at primary care physicians versus the community at large for participation in Alzheimer disease clinical trials. Alzheimer Dis Assoc Disord 24 (2):165-170

Contact

Laura Miles
Research Project Manager
HNE Neuropsychiatry Service – Alzheimer Disease Clinical Trials
Hunter New England Local Health District 
Laura.Miles@health.nsw.gov.au