- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02138448
Implementing Personal Health Records to Promote Evidence-Based Cancer Screening
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Practices in a practice based research network participating in our study that have an existing patient health record
- Patients that attend our study practices
Exclusion Criteria:
Practices without a patient health record
Study Plan
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.
|
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:
|
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.
|
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.
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexander H Krist, MD, MPH, Virginia Commonwalth University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
Clinical Trials on Interactive Preventive Health Record
-
Virginia Commonwealth UniversityAgency for Healthcare Research and Quality (AHRQ)CompletedPreventionUnited States
-
University of Southern DenmarkUniversity of Copenhagen; University of Aarhus; Region North DenmarkCompletedQuality of Life | Life StyleDenmark
-
St George Hospital, AustraliaNational Health and Medical Research Council, Australia; The University of... and other collaboratorsUnknownPersonal Health Records | Chronic Medical Conditions | Electronic Medical RecordAustralia
-
China Medical University HospitalChina Medical University, China; Taipei Veterans General Hospital, Taiwan; National... and other collaboratorsCompletedHealth Promotion | Preventive MedicineTaiwan
-
St. Joseph's Healthcare HamiltonMcMaster UniversityUnknownChronic Kidney DiseaseCanada
-
Weill Medical College of Cornell UniversityCompleted
-
VA Office of Research and DevelopmentMiami VA Healthcare SystemCompletedPrediabetic StateUnited States
-
NYU Langone HealthNew York City Department of Health and Mental HygieneCompleted
-
Brigham and Women's HospitalAgency for Healthcare Research and Quality (AHRQ); CricoCompletedAdverse Event | Readmission | Patient Portals | Transitions of Care | General Medicine | Discharge Checklist | Patient-provider CommunicationUnited States
-
Taipei Medical UniversityActive, not recruiting