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Patients Empowered With Digital Scripts: ScalaMed (PEDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03479034
Recruitment Status : Withdrawn (Investigator decided not to proceed in Australia at this stage.)
First Posted : March 27, 2018
Last Update Posted : November 12, 2019
Sponsor:
Collaborator:
ScalaMed
Information provided by (Responsible Party):
Holdsworth House Medical Practice

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Technology Other: ScalaMed ePrescription application

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
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : October 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Mobile phone application (Android and Apple) for storing electronic prescriptions


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Clinician prefence [ Time Frame: 3 months ]

    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

  2. Prescriber satisfaction [ Time Frame: 6 months ]

    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

  3. Clinical Implications [ Time Frame: 6 months ]

    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

  4. Patient measures [ Time Frame: 6 months ]

    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)

  5. Digital sharing [ Time Frame: 6 months ]
    To describe the relationship of digitally sharing data and communications between the consumer and their care team, measured through repeat questionnaires over 6 months

  6. Care implications [ Time Frame: 6 months ]

    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


  7. Pharmacy engagement [ Time Frame: 6 months ]

    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



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients of Holdsworth House Medical Practice
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479034


Sponsors and Collaborators
Holdsworth House Medical Practice
ScalaMed
Investigators
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Study Director: Tal Rapke, Dr ScalaMed
More Information
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Responsible Party: Holdsworth House Medical Practice
ClinicalTrials.gov Identifier: NCT03479034    
Other Study ID Numbers: SCALA001
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Holdsworth House Medical Practice:
digital
prescription
Application