Implementing Personal Health Records to Promote Evidence-Based Cancer Screening

NCT ID: NCT02138448

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-05-15

Brief Summary

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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

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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.

Conditions

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Cancer Health Promotion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention practices

Intervention practices will implement an interactive preventive health record in addition to their standard personal health record functionality.

Group Type EXPERIMENTAL

Interactive Preventive Health Record

Intervention Type BEHAVIORAL

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.

Control practices

Control practices will continue to field their existing personal health record

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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MyPreventiveCare

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander H Krist, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwalth University

Locations

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University of New Mexico-RIOS Net

Albuquerque, New Mexico, United States

Site Status

OCHIN

Portland, Oregon, United States

Site Status

Virginia Commonwalth University

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22115059 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21245186 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23901027 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22778119 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25500097 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form: Focus group consent

View Document

Related Links

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http://healthit.ahrq.gov/sites/default/files/docs/page/PreventiveCareHandbook_062912comp.pdf

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

Other Identifiers

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1R01CA168795-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM15307

Identifier Type: -

Identifier Source: org_study_id

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