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Implementing Personal Health Records to Promote Evidence-Based Cancer Screening

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ClinicalTrials.gov Identifier: NCT02138448
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE May 12, 2014
First Posted Date  ICMJE May 14, 2014
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
Precent of patients who are up-to-date with recommended cancer screening tests in intervention versus control practices. [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2014)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
  • 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 whether cancer screening rates, shared decision-making, and perceptions of the technology differ for disadvantaged patients, defined as minorities and Medicaid beneficiaries. [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implementing Personal Health Records to Promote Evidence-Based Cancer Screening
Official Title  ICMJE Implementing Personal Health Records to Promote Evidence-Based Cancer Screening
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cancer
  • Health Promotion
Intervention  ICMJE 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 Name: MyPreventiveCare
Study Arms  ICMJE
  • Experimental: Intervention practices
    Intervention practices will implement an interactive preventive health record in addition to their standard personal health record functionality.
    Intervention: Behavioral: Interactive Preventive Health Record
  • No Intervention: Control practices
    Control practices will continue to field their existing personal health record
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2014)
46
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 15, 2020
Actual Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02138448
Other Study ID Numbers  ICMJE HM15307
1R01CA168795-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Alexander H Krist, MD, MPH Virginia Commonwalth University
PRS Account Virginia Commonwealth University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP