Clinical trial NCT02138448: Implementing Personal Health Records to Promote Evidence-Based Cancer Screening
Official title: Implementing Personal Health Records to Promote Evidence-Based Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Health Promotion
Keywords: Cancer Screenings
Health Information Technology
Patient Health Record
Preventive Services
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-05-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cancer screening can improve the length and quality of life, yet the average American receives only half of recommended services. Patient-centered personal health records with higher levels of functionality, combined with practice redesign to make use of these functions, can help patients obtain recommended cancer screening tests by linking them to their doctor's records, explaining information in lay language, displaying tailored recommendations and educational resources, providing logistical support and tools to stimulate action, and generating reminders. This project will measure whether making these resources available to primary care practices and patients promotes shared decision-making and increases the delivery of cancer screening compared to existing information systems.

Detailed description: We developed a theory-driven interactive Patient Health Record (PHR) that uses higher functionality to more deeply engage patients in health promotion. The model defines five levels of PHR functionality: (1) collecting patient information, (2) integrating with electronic health records (EHRs), (3) translating information into lay language, (4) providing individualized, guideline-based clinical recommendations, and (5) facilitating patient action. We hypothesize that implementing PHRs with these higher levels of functionality will inform and activate patients in ways that simpler PHRs cannot achieve and will increase uptake of preventive services. In Phase 1, we will randomize 46 practices from three practice-based research networks in eight states to implement a PHR with advanced versus simpler functionality. Control practices will use their existing PHR. Intervention practices will upgrade their PHR to feature an interactive preventive health record (IPHR) that we have previously developed and tested. Intervention practices will locally tailor the IPHR content and learn how to integrate new functions into practice. Phase 1 will feature an implementation assessment in intervention practices, based on the RE-AIM model, to measure Reach (creation of IPHR accounts by patients), Adoption (practice decision to use the IPHR), Implementation (consistency, fidelity, barriers, and facilitators of use), and Maintenance (sustained use). The randomized comparison of intervention and control practices will measure the incremental effect of the IPHR on shared decision-making and receipt of cancer screening tests compared to traditional PHRs (Effectiveness). Data sources will include the EHR/PHR/IPHR databases, patient and practice surveys, recruitment field notes, practice learning collaborative transcripts, practice diaries, and patient phone interviews. This study will inform future efforts to use patient-centered information technology to promote cancer prevention and the feasibility of national dissemination.

Eligibility criteria: Inclusion Criteria:

1. Practices in a practice based research network participating in our study that have an existing patient health record
2. Patients that attend our study practices

Exclusion Criteria:

Practices without a patient health record

Primary outcomes:
measure: Percent of patients who are up-to-date with recommended cancer screening tests in intervention versus control practices.
timeFrame: 1 year
Secondary outcomes:
measure: Shared decision-making outcomes (knowledge, communication, decisional conflict, and decision control) reported by patients in intervention versus control practices
timeFrame: 1 year
measure: To assess whether cancer screening rates differ for disadvantaged patients, defined as minorities and Medicaid beneficiaries.
timeFrame: 1 year
measure: To assess whether shared decision-making differ for disadvantaged patients, defined as minorities and Medicaid beneficiaries.
timeFrame: 1 year
measure: To assess whether perceptions of the technology differ for disadvantaged patients, defined as minorities and Medicaid beneficiaries.
timeFrame: 1 year
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico-RIOS Net
state: New Mexico
city: Portland
country: United States
facility: OCHIN
state: Oregon
city: Richmond
country: United States
facility: Virginia Commonwalth University
state: Virginia
Study officials:
affiliation: Virginia Commonwalth University
name: Alexander H Krist, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krist AH, Peele E, Woolf SH, Rothemich SF, Loomis JF, Longo DR, Kuzel AJ. Designing a patient-centered personal health record to promote preventive care. BMC Med Inform Decis Mak. 2011 Nov 24;11:73. doi: 10.1186/1472-6947-11-73.
citation: Krist AH, Woolf SH. A vision for patient-centered health information systems. JAMA. 2011 Jan 19;305(3):300-1. doi: 10.1001/jama.2010.2011. No abstract available.
citation: Kerns JW, Krist AH, Longo DR, Kuzel AJ, Woolf SH. How patients want to engage with their personal health record: a qualitative study. BMJ Open. 2013 Jul 30;3(7):e002931. doi: 10.1136/bmjopen-2013-002931.
citation: Krist AH, Woolf SH, Rothemich SF, Johnson RE, Peele JE, Cunningham TD, Longo DR, Bello GA, Matzke GR. Interactive preventive health record to enhance delivery of recommended care: a randomized trial. Ann Fam Med. 2012 Jul-Aug;10(4):312-9. doi: 10.1370/afm.1383.
citation: Krist AH, Aycock RA, Etz RS, Devoe JE, Sabo RT, Williams R, Stein KL, Iwamoto G, Puro J, Deshazo J, Kashiri PL, Arkind J, Romney C, Kano M, Nelson C, Longo DR, Wolver S, Woolf SH. MyPreventiveCare: implementation and dissemination of an interactive preventive health record in three practice-based research networks serving disadvantaged patients--a randomized cluster trial. Implement Sci. 2014 Dec 11;9:181. doi: 10.1186/s13012-014-0181-1.