How to design a community-based testing pilot to support a wide scale roll out of decentralized diagnostics
Tony Cambridge, Lead Biomedical ScientistPathology Management
How to design a community-based testing pilot to support a wide scale roll out of decentralized diagnostics25 August 2020
Healthcare needs urgent transformation
Early diagnosis of common conditions can improve patient outcomes and benefit the healthcare economy
Diagnostics must be accessible, meaningful, and improve the patient and clinician experience
Healthcare delivery in a post COVID-19 era will be closer to home
A new wave of support for decentralized diagnostics and point of care (POC) diagnostics has emerged following the first global SARS-CoV-2 infections. However, the focus of the deployment of these rapid diagnostic solutions is not within hospitals where the colossal fight against the microscopic adversary took place; moreover, the shift in accessibility of POC devices is now in community settings.
Healthcare systems worldwide deserve a huge debt of gratitude following the unwavering response to COVID-19 generated by health providers and commercial sectors, their staff and their policy makers. But now is the time to invest wisely in the future of healthcare provision across all global territories. The commercial sector must collaborate with healthcare administrations in transforming healthcare through the provision of diagnostics options.
If the general public were polled on where they expect to receive healthcare in the future, they would undoubtedly state that their care would be received at a general or acute hospital. The reason for this is multi-factorial consisting of a lack of awareness of advances in technology, the absence of choice, historical resistance of adoption in the community settings, lack of resource and expertise in the sector, and lethargy around what has always been will always remain. The list is lengthy. The contributing factors are worrying.
What is missing is the realization that if symptoms of ill health are identified early enough and assessed for potential interventions and treatments, a reduction in hospital based care would be expected and wholly achievable.
Decentralized diagnostics has the potential to improve patient outcomes and reduce healthcare spending
Supporting the rapid diagnosis and management of common medical conditions, the decentralization of key pathology tests could:1,2
- Lead to improved patient outcomes (prevention, reduced morbidity and mortality)
- Benefit the healthcare economy
- Relieve pressure on acute services
- Improve the relationship between the patient and the clinician
- Meet patient expectation and improve patient experience
Despite these significant advantages, the provision of such tests in community locations has previously been a challenge few have been willing to take on.
The diagnostics landscape is changing rapidly; patient expectations are growing; and healthcare funds in all settings demand effective and efficient use. What are the main drivers for change? Can the pressure on acute services be addressed; might emergency department visits be reduced; would admissions be lowered as a result of better management of patients in the community?
A well-designed POC pilot within community healthcare settings would provide the evidence to support the wide scale roll out of decentralized diagnostics.
It is widely believed that we will now live with SARS-CoV-2 for some time, rather than eradicate it quickly. If this is to be the picture across the healthcare landscape, the last place that infection free patients will want to be treated is in a hospital setting where large numbers of staff work and patients, some with COVID-19, will be receiving their care.
Indeed, the hospital administration will not want non-infected patients being treated in resource challenged secondary care settings such as major trauma centers, acute care hospitals, district general hospitals and medical centers. Many hospital-based services have already been moved off site to community areas including phlebotomy, cancer referrals and ante-natal clinics. The solution is to support diagnostics in multiple community settings where patients feel safe, well cared for, and crucially benefit from convenience.
Where can diagnostics be offered to improve accessibility?
The patient has a huge part to play in the future of healthcare. There is an educational gap to be addressed so that early symptoms can be identified by the patient, prompting them to seek advice where a healthcare professional can assess which tests and care plans are appropriate. This is where awareness and accessibility will be central to the success of any pilot of community testing. Practitioners need to know when and where to access diagnostic testing and how to record the event.
Point of care
The following sites have the potential to improve accessibility for patients, and provision of POC diagnostics in these settings will depend on the model of care health leaders choose to adopt:
- General Practitioners (GPs) and Health Centers
- Primary Care Network Hubs
- Minor Injury Units (MIUs)
- Local Care Centers
- Urgent Care Centers
- Ambulatory Units
- Community Clinics (sexual health/family planning)
- Community Team home visits
- Ambulance Service (including air)
- Mobile Units
- Gyms and Health Centers
This is by no means an exhaustive list, but illustrates the opportunities available to the healthcare sector to disrupt traditional care pathways. A bold approach is required and health sector leaders must review their regional strategy, and national bodies should influence a standardized approach within their territory.
Mobile testing units
Mobile testing units, where diagnostics can be made available to a large number of people at great convenience, cannot be underestimated in terms of the overall benefits to the healthcare economy. Improved accessibility, visibility, relaxed environments, and convenience are all benefits of a radically redesigned health service.
Such locations exist and can be exploited:
- Sporting events
- Care homes
- Other large gatherings
Resources necessary to conduct a community-based testing pilot
The following resources are required to conduct a successful community based pilot:
- Support from the Pathology point of care testing (POCT) teams to conduct validation work, monitor performance and establish governance processes
- Dedicated input from Pathology managerial and clinical leads
- Identify influential supporters within the community clinical teams
- Additional support staff for the duration of the pilot
- Training and equipment support from the manufacturers
- Connectivity of community based devices to secondary care middleware or a community data manager
- Adequate healthcare professional staff at each pilot site to conduct testing and ensure upkeep of equipment
Monitoring and data capture to demonstrate efficacy of decentralized diagnostics
The success of any trial is measured by the proven outcomes. This makes it imperative that pilots are well designed to capture the evidence required to transform healthcare. With executive support across the health landscape a must, investment and commitment from multiple organizations will need compelling data.
Test results from community-based decentralized diagnostic sites would be communicated back to the requesting clinician for interpretation, and advice offered to the patient. Thus, a formalized referral process is required in order to ensure clinical oversight of testing and should include:
- Assurance that requesting clinicians will record and follow up all cases
- A reporting mechanism and regular review of progress of the pilot by defined individuals
- The utility and interpretation of results is understood by the requesting clinician
- An established mechanism to review the impact of POC test provision on patient outcome
- Comparison of outcomes against patients who did not have access to POC diagnostics
- Record of other cost avoidance or health economic benefits observed during the study
In addition, captured data must be standardized in order to be comparable among community-based testing sites. The evidence generated must also answer the following questions in order to successfully introduce change:
- What action was taken in the absence of tests? – Outcomes are key to proving the model and must be recorded for all patients managed during the trial
- How does access to rapid diagnostics affect the clinician experience? – To ensure success, the model of care must benefit the clinician as well as the patient
- How has the patient experience been improved? – Transformation is not effective if there are no measurable benefits to patient care
- What are the perceived benefits? – Meeting the patient and clinician expectations is as valuable as the benefits indicated by data
- What are the quantifiable benefits? – These can be clinical, financial and efficiency based
- Which tools are available to quantify cost avoidance and potential savings? – Business intelligence software, informatics solutions and bespoke products can be used to assess financial outcomes
What is the potential impact of decentralized diagnostics within healthcare?
Initial discussions with community leads suggest support for the provision of a range of decentralized diagnostic tools in the community, accessed by GP referral or drop in. Such a model would support a move toward personalized healthcare whereby the patient receives investigations indicated by their symptoms, clinical and family history. A move away from the ‘one size fits all’ model of healthcare is long overdue.
A range of outcomes is possible: take no action based on normal results; watch and wait where mild abnormalities are detected; request further laboratory tests; or refer to the hospital if indicated.
Each of these options has a potential benefit to the healthcare economy and act to preserve essential secondary care resources.
- Where normal results are obtained, significant delays are removed, patient stress is reduced and unnecessary prescriptions avoided
- Further follow up appointments could be reduced or prioritized if indicated
- Only indicated pathology tests will be requested reducing unnecessary testing
- Treatment plans introduced earlier based on identifying conditions at earliest opportunity, which may influence the progression of medical conditions
- Hospital referrals avoided
- Emergency Department attendances reduced
- Minor Injury Unit and Local Care Center attendance increased appropriately and proportionately
- Hospital admissions and bed days reduced
Many of these outcomes can be quantified if they are recorded in a standardized way within a carefully designed pilot or service start up. As a result the evidence to prove the concept is within our grasp.
The impact does not stop there. Consider the wider implications for healthcare:
- Prescriptions avoided or appropriate treatments implemented early
- Personalized care for patients
- Increased patient choice
- Shared decision making (clinician and patient)
- A sense of control for patients over their treatment program
Essential elements to establish your pilot
Ownership and Leadership
Clinical and managerial leadership must be established to ensure an effective pilot is conducted with regular oversight at the right intervals. Ownership needs to be defined at all tiers within the pilot so that each element is delivered as designed by the project leads.
Multi-organizational collaboration will drive effective change across the healthcare landscape, efficiencies and effectiveness will be maximized, care plans will be modernized and this will lead to better options of standardization of care regardless of background, demographic, socio-economic or geographic circumstances.
Community decentralized diagnostics must ignore all perceived boundaries.
This must cover initial launch of any pilot or service commencement, with clear objectives through to regular reviews and sharing of progress. Ultimately there should be a publication or report from the national or regional administration detailing the successes and learning outcomes of the pilot/service. The following should be considered:
- What constitutes success? This must be defined at the outset of the pilot
- Was the pilot a success? If so, how? Is the evidence transparent and reproducible?
- If the pilot is not a success what are the learning points and is there scope to make adjustments for a future project?
- Are the benefits sustainable?
- Was the correct information collected and appropriate conclusions drawn?
- Was the engagement at the level required and how did this impact the outcome?
An effective pilot should generate as many questions as it answers in the pursuit of a true game changing redesign of healthcare delivery. The first attempt may not reflect the final complexion of the service.
The general public need to know what testing is available. Throughout the COVID-19 pandemic, central government has publicized SARS-CoV-2 testing availability and a campaign of similar weight would not be out of place for an approach that could revolutionize the way in which we all seek medical support.
All traditional providers of healthcare should engage in transforming the way in which patients view healthcare, from personalized care to increased choice.
Evidence-based disruption to improve the future of healthcare
Promoting more patient management in the community and improved access to decentralized diagnostics is key to disrupting traditional models of assessment and care.
We have the power to disrupt healthcare. Patients need to be assessed when symptoms first appear, preventing fully symptomatic patients presenting for interventions and subsequent care in the hospital setting.
The availability of more point of care testing (POCT) in the community could help reduce hospital attendances and subsequent admissions for a range of health conditions.
Significant financial improvements can be made if the potential wider impact is considered. This can be realized in a combination of ways:
- Cost avoidance
- Improving value for money
- Controlling patient flow
- Reducing activity in acute care settings
The provision of community-based decentralized diagnostics will require investment in technologies, pay and non-pay resources and facilities. This will include expansion of existing POC teams and an approach to developing diagnostics expertise in community healthcare professionals. Community based pilots will show the impact that such solutions can have on patient management, improved outcomes and the healthcare economy.
Tony Cambridge, Lead Biomedical Scientist is the Managing Director of Thornhill Healthcare Events and Consultancy, and Lead Biomedical Scientist in the Pathology Management team of a busy acute care hospital in England. He frequently speaks at national and international healthcare events and is a key opinion leader for point of care testing. He recently cowrote the British Society of Haematology’s point of care testing guideline for general hematology and remains active across healthcare platforms offering advice and guidance. He is also a member of a global diagnostics company’s scientific advisory committee.
- Turner et al. (2016). Family Practice 33, 388-394