TechnologyPEDSNCT03479034
Patients Empowered With Digital Scripts: ScalaMed
An observational study of Technology, run by Holdsworth House Medical Practice.
Trial summary
A prospective qualitative and quantitative controlled study, exploring the impact of patient centred digital prescriptions on health, in patients with chronic health conditions. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Technology
- What is being tested?
- ScalaMed ePrescription application
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of Holdsworth House Medical Practice
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
About this study
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
A prospective qualitative and quantitative controlled study, exploring the impact of patient centred digital prescriptions on health, in patients with chronic health conditions.
Read the 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.
- Conditions
- Technology
- Being tested
- ScalaMed ePrescription application
- Keywords
- digital, prescription, Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScalaMed ePrescription applicationOther
Mobile phone application (Android and Apple) for storing electronic prescriptions
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | * 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
* Has had experience with prescriptions in Australia for at least 1 year
* Current patient attending Holdsworth House Medical Practice
Willing to use the ScalaMed ePrescription application Receives: Other: ScalaMed ePrescription application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient preference
Primary outcome is the change from baseline in patient preference for ScalaMed over previous prescription management tools after 3-months, determined through a questionnaire using a 4 point Likert scale.
- I prefer Scalamed to my previous system of managing prescriptions
- Strongly agree
- Somewhat agree
- somewhat disagree
- strongly disagree
Measured: 6 months
Secondary outcomes (7)
Clinician prefence
The change from baseline in clinician preference for ScalaMed over previous prescription management tools after 3-months, determined through a questionnaire using a 4 point Likert scale.
- I prefer ScalaMed over paper for helping patients manage their prescriptions
- Strongly agree
- Somewhat agree
- somewhat disagree
- strongly disagree
Measured: 3 months
Prescriber satisfaction
Outcome will be determined through a questionnaire and will describe prescriber satisfaction in managing patient's prescriptions at 6 months 19 questions in relation to the impact of electronic prescriptions on the patient's journey, from when a prescription is required to when their medicines are received with the options: Strongly Disagree, Slightly Disagree, Slightly Agree, Strongly Agree. For example:
- Easier for me to send patients prescriptions when they are not in the clinic
- Patients have increased control and understanding of their medicines
- Electronic prescriptions are more patient centric
Measured: 6 months
Clinical Implications
Determined through a questionnaire, a description of the clinical implications associated with consumers utilizing digital prescriptions at 6 months Please indicate the extent to which you agree with the following statements about the impact of ScalaMed electronic prescriptions on patient care: Strongly Disagree, Slightly Disagree, Slightly Agree, Strongly Agree
- Reduces the likelihood of prescription errors
- Makes it easier for patients to have their prescriptions dispensed
- Empowers patients with their data
- Reduces admin burden in the clinic
- Reduces fraud
- Helps patients adhere to their medicine
- Integrates data across providers
- Reduces workload
- Reduced lost of missing prescriptions
Measured: 6 months
Patient measures
Description of clinically relevant patient measures affected by proper utilization of medication information, measured through repeat questionnaires over 6 months
- Which of the following features of ScalaMed do you value? (Tick all that apply)
- No paper
- Value for patient - ease and convenience and source of truth data
- Ability to view patient's prescribing across doctors
- Ability to view patient's dispensing history
- Potential for interaction and allergy alerts
- Ability to send prescriptions to patients remotely (prescriber) / patients can send me prescriptions remotely (pharmacy)
Measured: 6 months
Digital sharing
To describe the relationship of digitally sharing data and communications between the consumer and their care team, measured through repeat questionnaires over 6 months
Measured: 6 months
Care implications
A description of the relationship between shared data and efficient and relevant care measured through a Combination of patient and clinical questionnaires over 6 months.
Patients questionnaires:
- Did you find a mistake, or issue with a prescription that you were sent BECAUSE of ScalaMed - that is, ScalaMed helped you see that you received an incorrect medicine or dosage? Yes/No
- Did you see another health care practitioner since you last completed a questionnaire? Yes /No Did you show them your prescription data on ScalaMed? Yes/No Clinician Questions
1.Which of the following features of ScalaMed do you value? (Tick all that apply) 2.Electronic prescriptions have the potential to reduce miscommunication between health professionals: Strongly Disagree, Slightly Disagree, Slightly Agree, Strongly Agree
Measured: 6 months
Pharmacy engagement
A description of consumer engagement and experience at the pharmacy over 6 months, as measured by repeat questionnaires.
Pharmacyexamples: 4 questions in relation to the impact of electronic prescriptions on the patient's journey, from when a prescription is required to when their medicines are received with the options: Strongly Disagree, Slightly Disagree, Slightly Agree, Strongly Agree. For example:
- Electronic prescriptions are more legible e. Has potential to reduce miscommunication between health professionals Patient examples:Since you last completed a questionnaire have you arrived in a pharmacy to find you had no more prescriptions/repeats available? Yes/no At the moment do you know where all your prescriptions are stored/kept? Yes/no
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study startJan 2019 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionOct 2019 (estimated)
Why it stopped: Investigator decided not to proceed in Australia at this stage.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TechnologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holdsworth House Medical Practice
- Sponsor type
- University, hospital or other
- Collaborators
- ScalaMed
- Responsible party
- Sponsor
- Investigators
- Tal Rapke, Dr, Study director, ScalaMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479034
- Sponsor's protocol ID
- SCALA001
- Acronym
- PEDS
- Status last verified
- Nov 2019
- First submitted
- 21 Jan 2018
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03479034
- Acronym / sponsor ID
- PEDS / SCALA001
- Conditions
- Technology
- Keywords
- digital, prescription, Application
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigator decided not to proceed in Australia at this stage.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Holdsworth House Medical PracticeUniversity, hospital or other
- Collaborators
- ScalaMed
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: ScalaMed ePrescription application* 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 * Has had experience with prescriptions in Australia for at least 1 year * Current patient attending Holdsworth House Medical Practice Willing to use the ScalaMed ePrescription application |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of Holdsworth House Medical Practice
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScalaMed ePrescription applicationMobile phone application (Android and Apple) for storing electronic prescriptions | Other | Group 1 |
Primary outcome
Patient preference
Time frame: 6 months
Primary outcome is the change from baseline in patient preference for ScalaMed over previous prescription management tools after 3-months, determined through a questionnaire using a 4 point Likert scale. 9) I prefer Scalamed to my previous system of managing prescriptions 1. Strongly agree 2. Somewhat agree 3. somewhat disagree 4. strongly disagree
7 secondary outcomes
Clinician prefence
Time frame: 3 months
Prescriber satisfaction
Time frame: 6 months
Clinical Implications
Time frame: 6 months
Patient measures
Time frame: 6 months
Digital sharing
Time frame: 6 months
Care implications
Time frame: 6 months
Pharmacy engagement
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tal Rapke, Dr study director
ScalaMed
Questions about this trial
What is this clinical trial studying?
An observational study of Technology, run by Holdsworth House Medical Practice.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient preference (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.