Clinical trial NCT03479034: Patients Empowered With Digital Scripts: ScalaMed
Official title: A Prospective Qualitative and Quantitative Controlled Study, Exploring the Impact of Patient Centred Digital Prescriptions on Health, in Patients With Chronic Health Conditions
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Technology
Keywords: digital
prescription
Application
Lead sponsor: Holdsworth House Medical Practice
Sponsor class: OTHER
Collaborators: name: ScalaMed
First posted: 2018-03-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of Holdsworth House Medical Practice

Brief summary: A prospective qualitative and quantitative controlled study, exploring the impact of patient centred digital prescriptions on health, in patients with chronic health conditions.

Detailed description: ScalaMed is an innovative new consumer centred solution for securing prescriptions through a blockchain solution - a cryptographic distributed database, that can give consumer access to their prescriptions at all times. It aims to solve interoperability challenges that exist in healthcare, by creating a ledger of prescriptions, and giving consumers access to this information to own and share as they need. The solution will be accessed through an application available on a smart phone, will be fully compliant with security and privacy laws, and will be made available to consumers, clinicians, and pharmacies enrolled in this study free of charge. The system also allows patients to monitor the usage of their prescriptions - eg when they need a new one, and allows them to choose how and where they want to use their prescriptions like with paper.

This study will explore whether empowering consumers with their digital prescriptions in a digital format through a blockchain based methodology of storing and accessing their data, will improve the flow of clinically important information, improve the frequency of data sharing, improve the self-management of the patient, improve adherence to treatments, reduce interactions and adverse events associated with medications, reduce the burden on clinical practice, improve efficiency, reduce the amount of paper, increase consumer engagement and improve patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Ages 18-85
* Cognitively able to understand instructions and care for themselves
* Lives in the community (not institutionalised)
* Owner of a smartphone and able to use Apps
* On 3 or more chronic prescription medications
* Informed consent as documented by signature (Appendix Informed Consent Form)
* Has had experience with prescriptions in Australia for at least 1 year
* For the clinicians - any clinician who is using the ScalaMed prescription system in the Holdsworth House
* For pharmacists - who are utilising the ScalaMed system in one of the four clinics

Exclusion Criteria:

* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study due to language problems, psychological disorders, dementia of the participant
* Previous enrolment into the current study

Primary outcomes:
measure: Patient preference
timeFrame: 6 months
Secondary outcomes:
measure: Clinician prefence
timeFrame: 3 months
measure: Prescriber satisfaction
timeFrame: 6 months
measure: Clinical Implications
timeFrame: 6 months
measure: Patient measures
timeFrame: 6 months
measure: Digital sharing
timeFrame: 6 months
measure: Care implications
timeFrame: 6 months
measure: Pharmacy engagement
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: ScalaMed
name: Tal Rapke, Dr
role: STUDY_DIRECTOR
References: