Implementing Personal Health Records to Promote Evidence-Based Cancer Screening

May 26, 2023 updated by: Virginia Commonwealth University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico-RIOS Net
    • Oregon
      • Portland, Oregon, United States, 97201
        • OCHIN
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwalth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention practices
Intervention practices will implement an interactive preventive health record in addition to their standard personal health record functionality.
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.
Other Names:
  • MyPreventiveCare
No Intervention: Control practices
Control practices will continue to field their existing personal health record

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of patients who are up-to-date with recommended cancer screening tests in intervention versus control practices.
Time Frame: 1 year
The percent of eligible patients who are up-to-date with all indicated cancer screenings (all-or-none measure).
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shared decision-making outcomes (knowledge, communication, decisional conflict, and decision control) reported by patients in intervention versus control practices
Time Frame: 1 year

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).

    1. Communication will be measured by using questions from AHRQ's Consumer Assessment of HealthCare Providers and Systems (CAHPS) survey.
    2. 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
To assess whether cancer screening rates differ for disadvantaged patients, defined as minorities and Medicaid beneficiaries.
Time Frame: 1 year
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
To assess whether shared decision-making differ for disadvantaged patients, defined as minorities and Medicaid beneficiaries.
Time Frame: 1 year

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).

    1. Communication will be measured by using questions from AHRQ's Consumer Assessment of HealthCare Providers and Systems (CAHPS) survey.
    2. 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
To assess whether perceptions of the technology differ for disadvantaged patients, defined as minorities and Medicaid beneficiaries.
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Alexander H Krist, MD, MPH, Virginia Commonwalth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

May 15, 2020

Study Completion (Actual)

May 15, 2020

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimated)

May 14, 2014

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HM15307
  • 1R01CA168795-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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