CancerNCT02138448
Implementing Personal Health Records to Promote Evidence-Based Cancer Screening
A study testing Interactive Preventive Health Record in people with Cancer and Health Promotion, run by Virginia Commonwealth University at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Health Promotion
- What is being tested?
- Interactive Preventive Health Record
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2017to 15 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Practices in a practice based research network participating in our study that have an existing patient health record
- Patients that attend our study practices
Who cannot join
- Practices without a patient health record
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of New Mexico-RIOS Net
Albuquerque, New Mexico, 87131
OCHIN
Portland, Oregon, 97201
Virginia Commonwalth University
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- Cancer, Health Promotion
- Being tested
- Interactive Preventive Health Record
- Keywords
- Cancer Screenings, Health Information Technology, Patient Health Record, Preventive Services
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Preventive Health RecordBehavioural
Also called MyPreventiveCare
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention practices | Experimental | Intervention practices will implement an interactive preventive health record in addition to their standard personal health record functionality. Receives: Behavioral: Interactive Preventive Health Record |
| Control practices | No intervention | Control practices will continue to field their existing personal health record |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startJan 2017
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alexander H Krist, MD, MPH, Principal investigator, Virginia Commonwalth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138448
- Sponsor's protocol ID
- HM15307
- Other IDs
- 1R01CA168795-01A1
- Status last verified
- May 2023
- First submitted
- 12 May 2014
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22115059Krist 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.
PubMed 21245186Kerns 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.
PubMed 23901027Krist 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.
PubMed 22778119Krist 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.
PubMed 25500097
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Personal Health Records to Promote Evidence-Based Cancer Screening
- ClinicalTrials.gov ID
- NCT02138448
- Acronym / sponsor ID
- HM15307
- Conditions
- Cancer, Health Promotion
- Keywords
- Cancer Screenings, Health Information Technology, Patient Health Record, Preventive Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2017 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention practices | Experimental | Behavioral: Interactive Preventive Health RecordIntervention practices will implement an interactive preventive health record in addition to their standard personal health record functionality. |
| Control practices | No intervention | –Control practices will continue to field their existing personal health record |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Practices in a practice based research network participating in our study that have an existing patient health record
- Patients that attend our study practices
Key exclusion criteria (1 listed)
- Practices without a patient health record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Preventive Health RecordAlso: MyPreventiveCareThe 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. | Behavioural | Intervention practices |
Primary outcome
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).
4 secondary outcomes
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 differ for disadvantaged patients, defined as minorities and Medicaid beneficiaries.
Time frame: 1 year
To assess whether shared decision-making differ for disadvantaged patients, defined as minorities and Medicaid beneficiaries.
Time frame: 1 year
To assess whether perceptions of the technology differ for disadvantaged patients, defined as minorities and Medicaid beneficiaries.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Background: PubMed 22115059Krist 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.
- Background: PubMed 21245186Krist 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.
- Background: PubMed 23901027Kerns 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.
- Background: PubMed 22778119Krist 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.
- Background: PubMed 25500097Krist 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.
- An Interactive Preventive Care Record: A handbook for implementing patient centered personal health records to promote prevention.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander H Krist, MD, MPH principal investigator
Virginia Commonwalth University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Preventive Health Record in people with Cancer and Health Promotion, run by Virginia Commonwealth University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients who are up-to-date with recommended cancer screening tests in intervention versus control practices. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02138448, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.