Supplementary Box 2 | Lessons learned from implementing the PFC in oncology care settings serving childhood cancer survivors*
Hardware and software
Clinical-decision-support project: the PFC clinical-decision-support system (software) proved feasible to provide recommendations for both evidence-based follow-up screening and surveillance, and survivor-specific educational resources to users with diverse needs and technological infrastructures
Clinical content
Content and technical development: because PFC software and guideline development began as independent initiatives, additional time was required for partners to integrate guidelines into electronic decision support tools; simultaneous engagement of guideline authors and the developers of the clinical-decision tools at project initiation would facilitate and accelerate tool development
Content management: experiences highlighted that clinical decision support requires an ongong commitment to and processes for evidence synthesis, review, and updating
Content updates: the public release of guideline revisons and PFC updates should be coordinated to avoid potential confusion among user communities
Human–computer interface
User-centred design: iterative feedback from stakeholders informed development and modifications of the PFC software, and enabled developers to accommodate a wide range of user needs
Web-based platform: a web-based platform proved feasible for addressing the diverse working and technical environments of users
People
Training and support: early and ongoing stakeholder engagement in software development was associated with positive feedback in the training sessions, limited requests for user support (1–2 per week), and the ability, ultimately, to substitute live training with archived training webcasts
Workflow and communication
Treatment summaries: developing and/or capturing treatment summaries for use in the PFC posed several challenges. For example, archival records could be electronic, paper-based, or in other storage formats; special requirements in determining exposures could require human decision making; and interoperability challenges across electronic health records remained unresolved. Out of concerns that additional data entry time, even among centres already creating summaries, could prove a substantial barrier to adoption of the PFC, two summary types were created: firstly, an abbreviated summary form (including only those data elements needed for recommendation generation) for use when time was limited in cases without relapse or second malignancies; and secondly, a comprehensive summary form (collecting additional detail as outlined by COG) for use for all survivors including those with relapses and second malignancies. Testing revealed that clinic personnel required 5–20mins to complete a summary, depending on the form used and treatment complexity. This approach proved acceptable and feasible and was often completed prior to the clinical encounter.
Workflow adjustments: in response to user input describing diverse workflow needs, the individualized survivor screening recommendations were made available with varying levels of detail and in differing formats to accommodate different levels of user familiarity with survivorship follow-up care and differing workflows; the various output options are used with similar frequencies confirming the validity of this approach
Communications: some guideline revisions affecting follow-up care necessitated the development of alerts to clinical users
Organizational policies and procedures
Enrollment: deployment to approximately 100 institutions proved feasible, but required addressing organizational policies and procedures at enrolling institutions; the organizational issues included, for example, ownership of data, use of data, intellectual property (see ‘External rules, regulations, and pressures’ below). Efficient management of the enrolment process required the development of standard documents, creation of a workflow/tracking system, and dedicating personnel by the PFC team to manage and track enrolment status.
External rules, regulations, and pressures
Security: a multidisciplinary team was required to manage the external rules and regulations, (those detailed under the HIPAA [1996]S1 and FISMA [2002],S2 for example). Standardizing documents and a formal review and agreement execution process proved necessary and addressed the security inquiries of enrolling institutions
Pressures: the continuing evolution of security requirements and monitoring of potential threats requires increases in the ongoing commitment of resources
System measurement and monitoring
Monitoring 24h per day, 7days per week: ongoing system assessment for security vulnerabilities and monitoring for 24h per day, 7days per week is required to ensure quality of service and availability for clinic users
Informing survivors: surveys of survivors and/or parents suggest that deployment of the PFC was associated with statistically significant increases in their receipt of treatment summaries, information on late effects of cancer or its treatment, and information on follow-up screening.S3
*On the basis of the eight-dimension Sittig–Singh sociotechnical model for evaluation of health information technology.S4 Abbreviations: COG, Children’s Oncology Group; FISMA, Federal Information Security Management Act; HIPAA, Health Insurance Portability and Accountability Act; PFC, Passport for Care.
S1. US Department of Health and Human Services. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security and Breach Notification Rules [online], http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/privacysummary.pdf (2014).
S2. US Government Printing Office. Federal Information Security Management Act of 2002 [online], http://csrc.nist.gov/drivers/documents/FISMA-final.pdf (2014).
S3. King, J. etal. Evaluating the clinical utility of the Passport for Care, an online decision-support system for managing survivors of childhood cancer [online], http://www.speakerready.com/abstracts/CPRIT/admin/detail_simple.php?height=520&width=600&abstract_id=380 (2012).
S4. Sittig, D.F. & Singh, H. A new sociotechnical model for studying health information technology in complex adaptive healthcare systems. Qual. Saf. Health Care 19 (Suppl. 3), i68–i74 (2010).
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