ClinicalTrials.gg
WithdrawnNCT03479034PEDSUpdated Nov 12, 2019

Patients Empowered With Digital Scripts: ScalaMed

An observational study in Technology, sponsored by Holdsworth House Medical Practice. Withdrawn. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-12.

Sponsored by Holdsworth House Medical Practice · Observational

Why this study was withdrawn
Investigator decided not to proceed in Australia at this stage.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Technology

Keywords

  • digital
  • prescription
  • Application
03

In context

Lead sponsor

Holdsworth House Medical Practice is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients of Holdsworth House Medical Practice

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Other: ScalaMed ePrescription application

Interventions

  • OtherScalaMed ePrescription application

    Mobile phone application (Android and Apple) for storing electronic prescriptions

06

What researchers measure

Primary outcomes

  1. 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. 9) I prefer Scalamed to my previous system of managing prescriptions 1. Strongly agree 2. Somewhat agree 3. somewhat disagree 4. strongly disagree

    Time frame: 6 months

Secondary outcomes

  1. 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. 1. I prefer ScalaMed over paper for helping patients manage their prescriptions 1. Strongly agree 2. Somewhat agree 3. somewhat disagree 4. strongly disagree

    Time frame: 3 months

  2. 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: 1. Easier for me to send patients prescriptions when they are not in the clinic 2. Patients have increased control and understanding of their medicines 3. Electronic prescriptions are more patient centric

    Time frame: 6 months

  3. 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 1. Reduces the likelihood of prescription errors 2. Makes it easier for patients to have their prescriptions dispensed 3. Empowers patients with their data 4. Reduces admin burden in the clinic 5. Reduces fraud 6. Helps patients adhere to their medicine 7. Integrates data across providers 8. Reduces workload 9. Reduced lost of missing prescriptions

    Time frame: 6 months

  4. Patient measures

    Description of clinically relevant patient measures affected by proper utilization of medication information, measured through repeat questionnaires over 6 months 1. Which of the following features of ScalaMed do you value? (Tick all that apply) 1. No paper 2. Value for patient - ease and convenience and source of truth data 3. Ability to view patient's prescribing across doctors 4. Ability to view patient's dispensing history 5. Potential for interaction and allergy alerts 6. Ability to send prescriptions to patients remotely (prescriber) / patients can send me prescriptions remotely (pharmacy)

    Time frame: 6 months

  5. 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

    Time frame: 6 months

  6. 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: 1. 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 2. 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

    Time frame: 6 months

  7. 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: d. 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

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2019; primary completion for Jul 2019, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 21, 2018
First posted
Mar 27, 2018
StartEst.
Jan 2019
Primary completionEst.
Jul 2019
CompletionEst.
Oct 2019
Last update
Nov 12, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03479034
Lead sponsor
Holdsworth House Medical Practice
Collaborators
ScalaMed
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Jan 2019 (estimated)
Primary completion
Jul 2019 (estimated)
Completion
Oct 2019 (estimated)
Last update
Nov 12, 2019

Study contacts

Tal Rapke, Dr
study director · ScalaMed

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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