Implementing Personal Health Records to Promote Evidence-Based Cancer Screening

Cancer Clinical Trial

Official title:

Implementing Personal Health Records to Promote Evidence-Based Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138448
• Other study ID #: HM15307
• Secondary ID: 1R01CA168795-01A
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: May 15, 2020

Study information

• Verified date: May 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Health Promotion

Intervention

Behavioral:
• Interactive Preventive Health Record
The interactive preventive healthcare record (IPHR) is a patient-centered application that links patients to their clinician's record, explains information in lay language, displays tailored recommendations and educational resources, and makes preventive care actionable.

Locations

Country	Name	City	State
United States	University of New Mexico-RIOS Net	Albuquerque	New Mexico
United States	OCHIN	Portland	Oregon
United States	Virginia Commonwalth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients who are up-to-date with recommended cancer screening tests in intervention versus control practices.	The percent of eligible patients who are up-to-date with all indicated cancer screenings (all-or-none measure).	1 year
Secondary	Shared decision-making outcomes (knowledge, communication, decisional conflict, and decision control) reported by patients in intervention versus control practices	To assess shared decision making a composite score based on the following measures will be calculated.; Knowledge gained will be measured by using the IPHR, we will use questions from NCI's Health Information National Trends Survey (HINTS).; To assess whether the IPHR helps patients weigh values regarding risks and benefits 2 measures will be used: (a) process (patient-clinician communication) and (b) patient perception (decisional conflict).; Communication will be measured by using questions from AHRQ's Consumer Assessment of HealthCare Providers and Systems (CAHPS) survey.; O'Connor's low literacy decisional conflict scale will be used to measure decisional conflict.; To assess whether the IPHR fosters decision-making engagement at the desired level, Degner's locus of control metric will be used.	1 year
Secondary	To assess whether cancer screening rates differ for disadvantaged patients, defined as minorities and Medicaid beneficiaries.	The difference in delivery of preventive services (Effectiveness) will be calculated for disadvantaged patients and the general population, using a two-level mixed-effects logistic regression for the all-or-none, composite, and individual screening tests.	1 year
Secondary	To assess whether shared decision-making differ for disadvantaged patients, defined as minorities and Medicaid beneficiaries.	To assess shared decision making a composite score based on the following measures will be calculated.; Knowledge gained will be measured by using the IPHR, we will use questions from NCI's Health Information National Trends Survey (HINTS).; To assess whether the IPHR helps patients weigh values regarding risks and benefits 2 measures will be used: (a) process (patient-clinician communication) and (b) patient perception (decisional conflict).; Communication will be measured by using questions from AHRQ's Consumer Assessment of HealthCare Providers and Systems (CAHPS) survey.; O'Connor's low literacy decisional conflict scale will be used to measure decisional conflict.; To assess whether the IPHR fosters decision-making engagement at the desired level, Degner's locus of control metric will be used.; These scores will be calculated for disadvantaged patients (minorities and Medicaid patients) and the general population that use the IPHR, then compared.	1 year
Secondary	To assess whether perceptions of the technology differ for disadvantaged patients, defined as minorities and Medicaid beneficiaries.	Post-implementation patient phone interviews will be conducted then analyzed using grounded-theory approach to understand disadvantaged patients' perceptions of and experience with the IPHR. These results will be compared to the phone interviews done with patients from the general population.	1 year

External Links

•   An Interactive Preventive Care Record: A handbook for implementing patient centered personal health records to promote prevention.