Definition of the PICASO trials

Two trials will demonstrate and evaluate the PICASO platform: In Germany, the Policlinic of Rheumatology and Hiller Research Unit Rheumatology at the University Hospital of Düsseldorf and in Italy, the University Hospital of Tor Vergata in Rome.

The two trials represent different national settings and different patient groups: The University Hospital of Düsseldorf engages patients diagnosed with Rheumatoid Arthritis whereas Tor Vergata enrolls patients with Parkinson’s disease. However, both patient groups have Cardio Vascular Diseases as comorbidities, thus sharing the complexity of treating co-occurring diseases.

The overall purpose of the trials is to demonstrate the PICASO platform and its components as a platform, enabling collaborative sharing of patient information for a more holistic view of patients with comorbidities. The trials will also validate the PICASO impact on the effectiveness of the care systems and the degree of acceptance from the wider group of stakeholders, patients, and relatives. Apart from these common traits, there are noteworthy differences between the two settings.

Trial 1: Patients with Rheumatoid Arthritis 

The trial at the University Hospital of Düsseldorf (UDUS) will involve a total of 30 patients over 18 years of age with Rheumatoid Arthritis (RA) and Cardiovascular Disease as comorbidity. The trial is divided into two time periods of nine months with 15 patients participating in each period.

Treatment of RA is driven by a multidisciplinary approach and involves different experts, e.g. rheumatologists, ergo-/physiotherapists, orthopedics, general practitioners, and dermatologists. The patients are managed in terms of medication, physiotherapy, exercise and health status with the main aim of achieving/retaining a permanent good remission status of the inflammatory rheumatic disease. However, a strong focus is also on the comorbidities that the patients have;

In Rheumatology, despite a good control of the inflammatory rheumatic disease reflected by a permanent good remission status, the consequent management of comorbidities has come to the fore and is recommended by e.g. the European League against Rheumatism. However, rheumatologists and other specialists usually lack the necessary data which are not available at the point of care. PICASO aims at filling this gap, explains PD Dr. Jutta Richter from the Policlinic of Rheumatology and Hiller Research Unit at the University Hospital of Düsseldorf.

The aim of the trial is thus to support a collaborative sharing of care plans between the relevant actors for a more holistic view of the patient;

Sharing information about the patient provides the caring physicians with the opportunity to care not only for one disease but have a much more complete picture of the patient and all of his comorbidities and treatment plans. Having access to for example recent cardiology examinations, will also make it possible to avoid redundant examinations and associated costs, says Jutta Richter.

More information = new concerns?

The patients in the trial will be able to document and become more informed about their own health status by having home monitoring equipment installed, measuring blood pressure, weight and activity. They will also be asked to assess their physical well-being at the beginning of the trial and again at the end.

At first thought, the increase in information is beneficial for all stakeholders since it offers better insight into the health status and enables the patient to take proper action. However, at second thought, it also bears the risk of generating new concerns:

Although it is usually regarded as useful for the caring stakeholders to have a more complete picture of the patients and all their comorbidities and treatment plans, this opportunity might also lead to multi-faceted, varying resistances and concerns of the involved stakeholders. The trials will allow for an assessment of this issue and the results will be presented as part of the evaluation of the trials, concludes Jutta Richter.

Target outcomes for UDUS

The primary outcomes that the trial at the University Hospital in Düsseldorf target are:

  • User acceptance, adaptability and usability factors from the perspective of the patients and physicians;
  • Secure and accurate handling of data and data sharing in PICASO;
  • Improved outcome e.g. health and quality of life;
  • Active participation by patients and their informal carers in the care process and management;
  • Reduced number and length of admissions to hospital.

The secondary target outcomes are:

  • Increased medical knowledge on the provision and better management of integrated care for patients with multiple comorbidities;
  • More efficient, dynamic and personalised care;
  • More efficient sharing of relevant data and care plans between the involved physicians and other stakeholders as social carers.
  • At UDUS, recruitment is planned to start early 2017 after which the first nine-month trial will launch.

Trial 2: Patients with Parkinson’s disease

The trial at Tor Vergata (UTV) will involve patients over the age of 65 with Parkinson Disease (PD) and Cardiovascular Disease as comorbidity. 30 patients will be recruited of which ten patients will be selected to test PICASO and twenty will be part of a control group. The highest incidence of PD is detected in patients over 65 years of age and cardiovascular disease, diabetes and kidney failure are among the most frequent comorbidities.

A significant amount of data is usually generated for this patient group due the complexity of diseases, and data are difficult to manage since data are handled in paper and delivered in person by patients with the risk of irrelevant or missing test results;

The management of the complex patient generates a considerable amount of data that are difficult to manage and data are often are delivered in person by the patient during visits. This involves a burden of responsibility for both the patient and carers. On top of this, the specialist must use significant resources to handle the large amount of data, leaving less time for the patient. The trial will test the effect of using PICASO for better management of data, says Dr. Agostino Chiaravalloti from the University Hospital of Tor Vergata.

Analysing the effect of home monitoring

The patients involved in the trial will be able to measure blood pressure, heart rate, drug intake, medication reminders, sleep and activity at home so that they and their carers can view their health data.

The trial is unique as it is designed as a multi-site and multi-hospital case matched control trial (before-and- after PICASO system) of chronically ill patients affected by Parkinson’s Disease living in their own homes, which has never previously been attempted in Italy. The results will therefore be used to analyse the deployment of telehealth services across Italy;

The aim is to provide clinical and health economic evidence on how Telehealth services can be scaled up nationally to provide an alternative cost effective health service for the management of chronic disease in the community, explains Dr. Agostino Chiaravalloti.

Integrating formal and informal carers 

Since patient data are exchanged between two independent hospitals in the Italian trial, it will be possible to test the concept of integrating formal carers across institutions and discover potential issues affecting the scalability of the PICASO solution. Special attention will also be paid to the integration of informal carers e.g. family which take on a critical role in caring for the elderly patients in Italy and in more general in the Mediterranean;

There will be a strong focus on the involvement of informal carers to provide insight on how their close integration affects issues such as patient empowerment, autonomy and privacy. Also, we will specifically analyse the usability and impact of the PICASO solution on the older generation, since we deal exclusively with patients over the age of 65, says Dr. Agostino Chiaravalloti.

Target outcomes for UTV

Tor Vergata has identified the following primary target outcomes:

  • Inform unclear/equivocal treatment decisions;
  • Determine the efficacy of therapy and supporting appropriate adjustments;
  • Support the appropriate adjustments of drug therapy for patients who have previously misdiagnosed or over-treated;
  • Promote medication adherence (compliance) and lifestyle changes and to make patients more aware of their condition;
  • Evaluate control of clinical parameters in patients discharged home from hospital with newly commenced or altered therapy.

The secondary target outcomes are:

  • Usability both valued by patients and doctors;
  • Integration in the management of care;
  • Improved participation of patients and their informal carers.

UTV has started recruiting patients for PICASO and will start their trial in April 2017.