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

Primary Purpose

Chronic Disease

Status
Unknown status
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Gamified Group
Control Group
Sponsored by
Hospital Italiano de Buenos Aires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Disease focused on measuring personal health record, gamification, chronic patient care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Hospital Italiano de Buenos Aires, Gascon 450

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Gamified Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Number of Completed Fields
See "Completed" and "EHR/PHR Personal data set" in Study Detailed Description for more information.

Secondary Outcome Measures

Change in Number of Corrected Fields
See "Corrected" and "EHR/PHR Personal data set" in Study Detailed Description for more information.
Change in Number of Validated Fields
See "Validated" and "EHR/PHR Personal data set" in Study Detailed Description for more information.

Full Information

First Posted
November 15, 2016
Last Updated
November 17, 2016
Sponsor
Hospital Italiano de Buenos Aires
Collaborators
Salumedia Tecnologias
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1. Study Identification

Unique Protocol Identification Number
NCT02970461
Brief Title
Gamifying Patient's Personal Data Validation and Completion in a Personal Health Record
Official Title
Gamifying Patient's Personal Data Validation and Completion in a Personal Health Record
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Italiano de Buenos Aires
Collaborators
Salumedia Tecnologias

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized controlled trial design is used to test the efficacy of gamification elements to drive user behavior in a personal health record.
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 Contact Information First Name Last Name Date of Birth ID Number Nationality Citizenship Languages Spoken Place of Residence Street Number Floor Zip Code Town Province Country E-Mail - E-mail address Phone Numbers Home Number Work Number Fax Emergency Contact First Name Last Name Relationship with patient Address Phone Number Billing Information Street Number Floor Zip Code Town Province Country Social Aspects Type of Residence Living Situation Education - Highest Academic Degree Achieved Cultural Aspects - Religious Belief Special Needs

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
personal health record, gamification, chronic patient care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Gamified Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Gamified Group
Intervention Description
See Gamified Group in Arms description.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
See Control Group in Arms description.
Primary Outcome Measure Information:
Title
Change in Number of Completed Fields
Description
See "Completed" and "EHR/PHR Personal data set" in Study Detailed Description for more information.
Time Frame
Measured at baseline, 30 days after and 6 months after
Secondary Outcome Measure Information:
Title
Change in Number of Corrected Fields
Description
See "Corrected" and "EHR/PHR Personal data set" in Study Detailed Description for more information.
Time Frame
Measured at baseline, 30 days after and 6 months after
Title
Change in Number of Validated Fields
Description
See "Validated" and "EHR/PHR Personal data set" in Study Detailed Description for more information.
Time Frame
Measured at baseline, 30 days after and 6 months after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Bonofiglio, MD
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires, Gascon 450
City
Buenos Aires
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24477621
Citation
Cahill JE, Gilbert MR, Armstrong TS. Personal health records as portal to the electronic medical record. J Neurooncol. 2014 Mar;117(1):1-6. doi: 10.1007/s11060-013-1333-x. Epub 2014 Jan 30.
Results Reference
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PubMed Identifier
16357345
Citation
Tang PC, Ash JS, Bates DW, Overhage JM, Sands DZ. Personal health records: definitions, benefits, and strategies for overcoming barriers to adoption. J Am Med Inform Assoc. 2006 Mar-Apr;13(2):121-6. doi: 10.1197/jamia.M2025. Epub 2005 Dec 15.
Results Reference
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Citation
Jci. Joint Commission International Accreditation Standards for Hospitals. Jt Comm Resour Inc. 2013;5th Ed. doi:10.1017/CBO9781107415324.004.
Results Reference
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PubMed Identifier
17238444
Citation
Tang PC, Black W, Young CY. Proposed criteria for reimbursing eVisits: content analysis of secure patient messages in a personal health record system. AMIA Annu Symp Proc. 2006;2006:764-8.
Results Reference
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PubMed Identifier
21557106
Citation
Tenforde M, Jain A, Hickner J. The value of personal health records for chronic disease management: what do we know? Fam Med. 2011 May;43(5):351-4.
Results Reference
background
PubMed Identifier
18756002
Citation
Kaelber DC, Jha AK, Johnston D, Middleton B, Bates DW. A research agenda for personal health records (PHRs). J Am Med Inform Assoc. 2008 Nov-Dec;15(6):729-36. doi: 10.1197/jamia.M2547. Epub 2008 Aug 28.
Results Reference
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PubMed Identifier
25326601
Citation
Wells S, Rozenblum R, Park A, Dunn M, Bates DW. Organizational strategies for promoting patient and provider uptake of personal health records. J Am Med Inform Assoc. 2015 Jan;22(1):213-22. doi: 10.1136/amiajnl-2014-003055. Epub 2014 Oct 17.
Results Reference
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Citation
Deterding S, Dixon D, Khaled R, Nacke L, Sicart M, O'Hara K. Gamification: Using Game Design Elements in Non-Game Contexts. Proc 2011 Annu Conf Ext Abstr Hum Factors Comput Syst (CHI 2011). 2011:2425-2428. doi:10.1145/1979742.1979575.
Results Reference
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PubMed Identifier
25654660
Citation
Lister C, West JH, Cannon B, Sax T, Brodegard D. Just a fad? Gamification in health and fitness apps. JMIR Serious Games. 2014 Aug 4;2(2):e9. doi: 10.2196/games.3413.
Results Reference
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PubMed Identifier
23481424
Citation
King D, Greaves F, Exeter C, Darzi A. 'Gamification': influencing health behaviours with games. J R Soc Med. 2013 Mar;106(3):76-8. doi: 10.1177/0141076813480996. No abstract available.
Results Reference
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PubMed Identifier
26872801
Citation
McKeown S, Krause C, Shergill M, Siu A, Sweet D. Gamification as a strategy to engage and motivate clinicians to improve care. Healthc Manage Forum. 2016 Mar;29(2):67-73. doi: 10.1177/0840470415626528. Epub 2016 Feb 12.
Results Reference
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PubMed Identifier
11392867
Citation
Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000 Jan;55(1):68-78. doi: 10.1037//0003-066x.55.1.68.
Results Reference
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Citation
Mihaly Csikszentmihalyi. 1991. Flow: The psychology of optimal experience. HarperCollins Publishers, New York, New York, USA.
Results Reference
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Gamifying Patient's Personal Data Validation and Completion in a Personal Health Record

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