Gamifying Patient's Personal Data Validation and Completion in a Personal Health Record

November 17, 2016 updated by: Hospital Italiano de Buenos Aires
A randomized controlled trial design is used to test the efficacy of gamification elements to drive user behavior in a personal health record.

Study Overview

Status

Unknown

Conditions

Detailed Description

Electronic personal health record systems (PHRs) support patient centered healthcare by making medical records and other relevant information accessible to patients, thus assisting patients in health self-management[1,2]. The Hospital Italiano de Buenos Aires (HIBA) is a private hospital in Buenos Aires, capital of Argentina. It has 500 beds and serves around 50,000 patients per month. Its main facilities cover a surface area of 78,000 m² (850,000 ft²). The hospital treats both private patients and those derived by social security. It also provides its own Health Maintenance Organization (HMO) being the most important pre-paid healthcare service in Argentina, with about 150,000 clients. HIBA has a Health Information System (HIS) and Electronic Health Records (EHR) since 1998 and implemented a PHR in 2007. The PHR gives patients access to aspects of the EHR related to their Health Care (laboratory, diagnosis, preventive information, medications lists), supports messaging with their physician, scheduling services and medication delivery for Self management, among other things. The majority of HIBA HMO affiliates are enrolled to this PHR. In 2015 HIBA underwent the process of accreditation by the United States Joint Commission[3]. As part of this process, HIBA redefined and refined the EHR/PHR data set, including new fields and regrouping pre-existent ones. EHR/PHR's personal data set is now composed of a series of fields grouped as depicted below. Personal data information is a difficult data set to capture, particularly those regarding social and cultural background information[4]. This data set is not only useful to help better healthcare system management, it is also relevant as it is used for epidemiological and preventive purposes[5-7].

Gamification is a term used to describe using game elements in non-game environments to enhance user experience[8,9]. It has been incorporated with commercial success into several platforms (Linkedin, Badgeville, Facebook). While over the past years gamification elements have been incorporated in healthcare scenarios there is still little evidence on how effective they are[10-12]. Game elements provide engagement consistent with various theories of motivation[13], positive psychology (e.g., flow)[14], and also provide instant feedback. Feedback is more effective when it provides sufficient and specific information for goal achievement and is presented relatively close in time to the event being evaluated. Feedback can reference individual progress, can make social comparisons, or can refer to task criteria.

In order to assess whether gamification is an effective tactic to drive PHR users' behavior, an intervention was designed. The investigators used gamification elements such as points, graphical representations and playful attitude to the design and interactions of the Bio page in the Hospital's PHR. These elements provide instant feedback to user actions. A control group with no game elements will be compared with a gamified group to see if these new game elements would increase patient's personal data rectification, validation and completion in the Hospital's PHR. A status variable was created and assigned to all fields according to the following scheme:

  • Completed: user has modified empty field.
  • Corrected: user has modified non-empty field.
  • Verified: user has updated Group but field data has experienced no change.
  • Validated: user has clicked on the "validate" button.

EHR/PHR Personal data set

  1. Contact Information

    • First Name
    • Last Name
    • Date of Birth
    • ID Number
  2. Nationality

    • Citizenship
    • Languages Spoken
  3. Place of Residence

    • Street
    • Number
    • Floor
    • Zip Code
    • Town
    • Province
    • Country
  4. E-Mail

    - E-mail address

  5. Phone Numbers

    • Home Number
    • Work Number
    • Fax
  6. Emergency Contact

    • First Name
    • Last Name
    • Relationship with patient
    • Address
    • Phone Number
  7. Billing Information

    • Street
    • Number
    • Floor
    • Zip Code
    • Town
    • Province
    • Country
  8. Social Aspects

    • Type of Residence
    • Living Situation
  9. Education

    - Highest Academic Degree Achieved

  10. Cultural Aspects

    - Religious Belief

  11. Special Needs

Study Type

Interventional

Enrollment (Anticipated)

40000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina
        • Hospital Italiano de Buenos Aires, Gascon 450

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients enrolled in the Hospital Italiano de Buenos Aires system who are over 18 years old
  • Patients who are registered in Hospital Italiano de Buenos Aires' Personal Health Record
  • Patients whose use of the Personal Health Record during the previous year exceeds the median of use

Exclusion Criteria:

  • Refusal to participate or to the informed consent process
  • Subjects with a record of Obsessive Compulsive Disorders or related condition as per DSM IV
  • Subjects with a record of Neurological conditions that could impair reading (aphasia, dementia, etc)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
Subjects will see in their Personal Health Record home page a simple text link pointing to their Bio page. Once in their Bio page, the site will display their personal information as usual with the only addition of a "validate data" button next to any non-validated field. The option to edit fields will also be present.
See Control Group in Arms description.
Experimental: Gamified Group
Subjects will see in their Personal Health Record home page a graphical representation of the percentage of completeness their Bio page has that when clicked acts as a link to their Bio page. Once in their Bio page, the site will display graphical elements such grayed out fields, graphical representations of the percentage of completeness for each data group and on mouse hover over any field a tooltip will inform of what percentage of completeness will be awarded if the data is validated. Also, an addition of a "validate data" button next to any non-validated field. The option to edit fields will also be present.
See Gamified Group in Arms description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Number of Completed Fields
Time Frame: Measured at baseline, 30 days after and 6 months after
See "Completed" and "EHR/PHR Personal data set" in Study Detailed Description for more information.
Measured at baseline, 30 days after and 6 months after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Number of Corrected Fields
Time Frame: Measured at baseline, 30 days after and 6 months after
See "Corrected" and "EHR/PHR Personal data set" in Study Detailed Description for more information.
Measured at baseline, 30 days after and 6 months after
Change in Number of Validated Fields
Time Frame: Measured at baseline, 30 days after and 6 months after
See "Validated" and "EHR/PHR Personal data set" in Study Detailed Description for more information.
Measured at baseline, 30 days after and 6 months after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Chair: Carlos Bonofiglio, MD, Hospital Italiano de Buenos Aires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

November 17, 2016

First Posted (Estimate)

November 22, 2016

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 17, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2258 (Bern University Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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