Breast CancerTopCareNCT01372527
Population-Based Patient-Centric Care: Comprehensive Preventive Cancer Screening Using Health IT
A study testing TopCare: Use of provider knowledge vs. automated system in people with Breast Cancer and Colorectal Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Although there is considerable evidence that current health IT can improve certain elements of care, the most effective and efficient implementation of health IT systems for primary care population management are not currently known. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Cervical Cancer
- What is being tested?
- TopCare: Use of provider knowledge vs. automated system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103,870 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jan 2013
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Breast cancer: Women 42-74 years old
- Cervical cancer: Women 21-65 years old
- Colorectal cancer: Women and men 52-75 years old
Who cannot join
- Breast cancer: History of bilateral mastectomy in their EHR
- Cervical cancer: History of total hysterectomy in their EHR
- Colorectal cancer: History of total colectomy in their EHR
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Technology for Optimizing Population Care in a Resource-limited Environment
Although there is considerable evidence that current health IT can improve certain elements of care, the most effective and efficient implementation of health IT systems for primary care population management are not currently known. Indeed, while many systems currently take a "case-management" approach to identify and address clinical care issues for high risk patients, no systems to our knowledge apply a risk-based approach that accounts both for adverse clinical outcome risk (e.g. breast cancer in a woman who has not had indicated screening for 4 years) and for clinical process risk (e.g. the likelihood that a specific patient will ignore a reminder letter and would therefore benefit from direct phone or in person contact). The investigators propose to directly test the hypothesis that implementing a health IT platform that 1) provides novel risk-based decision support using data derived from the electronic health record (EHR) and 2) leverages each clinician's unique knowledge of his or her patient panel will result in more effective and more efficient population-based primary care. The investigators will test this hypothesis in a practice-randomized clinical trial of preventive cancer screening within our primary care Practice-Based Research Network (PBRN).
Read the detailed description
In prior NIH-funded research, the investigators have demonstrated the efficacy of an IT-based population management system to improve breast cancer screening (NCI R21 CA121908). The investigators will expand our current IT platform from this single function (breast cancer screening) to a package of cancer prevention actions (breast, cervical, and colorectal cancer screening) and examine the added benefit of population-level preventive cancer care that is directed by specific clinician knowledge of individual patient needs. Moreover, rather than compare our system to currently sub-optimal "usual care" practice, our goal is to test whether the impact of our intervention exceeds the current state-of-the-art of IT-based population management. Therefore, control group practices will receive augmented standard care defined as a population-level reminder system with automated patient contacts.
In augmented standard care control practices, the investigators will implement a system that includes: 1) a population-based perspective to identify all eligible patients overdue for screening, 2) an automated, centralized process to contact selected patients by letter, 3) a result management system that automatically tracks test scheduling and completion, 4) a web-based, easily accessible tool allowing practice personnel to contact patients not completing testing, and 5) use of patient navigators for high risk patients not responding to initial outreach. In the control arm, the process of escalating the reminder intervention from a letter, to contact by phone call, to a patient navigator, will occur in a standard algorithmic fashion without provider input. While not yet the standard of care nationwide, prior studies have proven the efficacy of such an approach. In intervention practices, the investigators will enhance augmented standard care by implementing a novel system that will enable physicians and clinical population managers to individualize care for each patient in their panel using tools to classify and organize patients by their clinical attributes. The investigators hypothesize that this personalized identification of patients by both their clinical outcome and clinical process risk status will improve the efficacy and efficiency of resource allocation decisions. The key additions to the health IT system for intervention practices will be: 1) a clinical systems IT platform to organize and present clinical data for each clinician's patient panel, 2) an accessible Web-based tool allowing clinicians (physicians and clinical population managers) to view, organize, and investigate their patient panels, and 3) a simple process where the clinician can make a tailored screening decision and designate the method of clinical intervention based upon the patient's risk profile.
- Conditions
- Breast Cancer, Colorectal Cancer, Cervical Cancer
- Being tested
- TopCare: Use of provider knowledge vs. automated system
- Keywords
- medical informatics, health IT, primary care, screening, cervical cancer, colorectal cancer, breast cancer, mammography, colonoscopy, pap smear
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopCare: Use of provider knowledge vs. automated systemOther
We will be evaluating the system in practices where providers are involved in determining to contact a patient, including the most appropriate outreach method, compared with practices where the system is fully automated without provider input.
| Study group | Role | What they receive |
|---|---|---|
| TopCare Intervention | Experimental | The TOP-CARE intervention will be based on a medical informatics platform that:
1. Identifies all patients eligible for any of the three cancer screening programs
2. Links patients with a specific clinician
3. Offers a visit-independent method for clinicians to review panels of their eligible patients
4. For patients due for one or more cancer screenings, clinicians will access a web-based informatics tool to:
1. Screen their panel based upon risk
2. Defer patients, document exclusions, and update the EHR
3. Order a screening test with patient information material based upon the patient's risk profile and automatically initiate the process of:
1. Informing the patient by letter of the need to schedule a test, educating the patient with respect to the benefits of cancer screening, and properly documenting the transaction in the patient's EHR, or
2. Referral to a patient navigator for patients most likely to benefit from this more intensive approach Receives: Other: TopCare: Use of provider knowledge vs. automated system |
| Augmented Standard Care | Active comparator | In augmented standard care control practices, we will implement a system that includes: 1) a population-based perspective to identify all eligible patients overdue for screening, 2) an automated, centralized process to contact selected patients by letter, 3) a result management system that automatically tracks test scheduling and completion, 4) a web-based, easily accessible tool allowing practice personnel to contact patients not completing testing, and 5) use of patient navigators for high risk patients not responding to initial outreach. In the control arm, the process of escalating the reminder intervention from a letter, to contact by phone call, to a patient navigator, will occur in a standard algorithmic fashion without provider input. Receives: Other: TopCare: Use of provider knowledge vs. automated system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer completion for all eligible cancers
Average cancer screening test completion rate over the 1-year follow-up period for each eligible patient in all eligible cancers (breast, cervical, colorectal)
Measured: 1 year
Secondary outcomes (3)
% of patients completing all eligible cancer screenings
Percentage of patients completing all eligible cancer screening modalities at 1-year follow-up will be compared between study arms
Measured: 1 year
Primary outcome in specified patient subgroups
- Eligible population: prevalent (overdue at baseline) or incident (become overdue during study) cancer screening rates will be compared between study arms.
- Patient-physician linkage status: Analyses will be stratified to compare PCP-linked patients between study arms and practice-linked patients between study arms.
- Patient risk status: Patients at high risk for not completing screening will be compared between study arms.
Measured: 1 year
TopCare system measures (intervention practices)
- Percentage of providers (PCPs and clinical population managers) in intervention practices using TOP-CARE system and percentage of eligible patients in clinician panel screened
- Percentage of providers (practice personnel and patient navigators) in intervention and control practices using TOP-CARE system and percentage of eligible patients assigned to provider who were contacted
- Percentage of eligible patients in clinician (PCP and clinical population manager) panel deferred and reasons selected
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 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103,870 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Atlas, Massachusetts General Hospital
- Investigators
- Steven J Atlas, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372527
- Sponsor's protocol ID
- R18HS018161
- Acronym
- TopCare
- Status last verified
- Oct 2014
- First submitted
- 10 Jun 2011
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Atlas SJ, Zai AH, Ashburner JM, Chang Y, Percac-Lima S, Levy DE, Chueh HC, Grant RW. Non-visit-based cancer screening using a novel population management system. J Am Board Fam Med. 2014 Jul-Aug;27(4):474-85. doi: 10.3122/jabfm.2014.04.130319.
PubMed 25002002Zai AH, Kim S, Kamis A, Hung K, Ronquillo JG, Chueh HC, Atlas SJ. Applying operations research to optimize a novel population management system for cancer screening. J Am Med Inform Assoc. 2014 Feb;21(e1):e129-35. doi: 10.1136/amiajnl-2013-001681. Epub 2013 Sep 16.
PubMed 24043318
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology for Optimizing Population Care in a Resource-limited Environment
- ClinicalTrials.gov ID
- NCT01372527
- Acronym / sponsor ID
- TopCare / R18HS018161
- Conditions
- Breast Cancer, Colorectal Cancer, Cervical Cancer
- Keywords
- medical informatics, health IT, primary care, screening, cervical cancer, colorectal cancer, breast cancer, mammography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103,870 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 14 Jun 2011 (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.
Although there is considerable evidence that current health IT can improve certain elements of care, the most effective and efficient implementation of health IT systems for primary care population management are not currently known. Indeed, while many systems currently take a "case-management" approach to identify and address clinical care issues for high risk patients, no systems to our knowledge apply a risk-based approach that accounts both for adverse clinical outcome risk (e.g. breast cancer in a woman who has not had indicated screening for 4 years) and for clinical process risk (e.g. the likelihood that a specific patient will ignore a reminder letter and would therefore benefit from direct phone or in person contact). The investigators propose to directly test the hypothesis that implementing a health IT platform that 1) provides novel risk-based decision support using data derived from the electronic health record (EHR) and 2) leverages each clinician's unique knowledge of his or her patient panel will result in more effective and more efficient population-based primary care. The investigators will test this hypothesis in a practice-randomized clinical trial of preventive cancer screening within our primary care Practice-Based Research Network (PBRN).
Detailed description
In prior NIH-funded research, the investigators have demonstrated the efficacy of an IT-based population management system to improve breast cancer screening (NCI R21 CA121908). The investigators will expand our current IT platform from this single function (breast cancer screening) to a package of cancer prevention actions (breast, cervical, and colorectal cancer screening) and examine the added benefit of population-level preventive cancer care that is directed by specific clinician knowledge of individual patient needs. Moreover, rather than compare our system to currently sub-optimal "usual care" practice, our goal is to test whether the impact of our intervention exceeds the current state-of-the-art of IT-based population management. Therefore, control group practices will receive augmented standard care defined as a population-level reminder system with automated patient contacts.
In augmented standard care control practices, the investigators will implement a system that includes: 1) a population-based perspective to identify all eligible patients overdue for screening, 2) an automated, centralized process to contact selected patients by letter, 3) a result management system that automatically tracks test scheduling and completion, 4) a web-based, easily accessible tool allowing practice personnel to contact patients not completing testing, and 5) use of patient navigators for high risk patients not responding to initial outreach. In the control arm, the process of escalating the reminder intervention from a letter, to contact by phone call, to a patient navigator, will occur in a standard algorithmic fashion without provider input. While not yet the standard of care nationwide, prior studies have proven the efficacy of such an approach. In intervention practices, the investigators will enhance augmented standard care by implementing a novel system that will enable physicians and clinical population managers to individualize care for each patient in their panel using tools to classify and organize patients by their clinical attributes. The investigators hypothesize that this personalized identification of patients by both their clinical outcome and clinical process risk status will improve the efficacy and efficiency of resource allocation decisions. The key additions to the health IT system for intervention practices will be: 1) a clinical systems IT platform to organize and present clinical data for each clinician's patient panel, 2) an accessible Web-based tool allowing clinicians (physicians and clinical population managers) to view, organize, and investigate their patient panels, and 3) a simple process where the clinician can make a tailored screening decision and designate the method of clinical intervention based upon the patient's risk profile.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TopCare Intervention | Experimental | Other: TopCare: Use of provider knowledge vs. automated systemThe TOP-CARE intervention will be based on a medical informatics platform that: 1. Identifies all patients eligible for any of the three cancer screening programs 2. Links patients with a specific clinician 3. Offers a visit-independent method for clinicians to review panels of their eligible patients 4. For patients due for one or more cancer screenings, clinicians will access a web-based informatics tool to: 1. Screen their panel based upon risk 2. Defer patients, document exclusions, and update the EHR 3. Order a screening test with patient information material based upon the patient's risk profile and automatically initiate the process of: 1. Informing the patient by letter of the need to schedule a test, educating the patient with respect to the benefits of cancer screening, and properly documenting the transaction in the patient's EHR, or 2. Referral to a patient navigator for patients most likely to benefit from this more intensive approach |
| Augmented Standard Care | Active comparator | Other: TopCare: Use of provider knowledge vs. automated systemIn augmented standard care control practices, we will implement a system that includes: 1) a population-based perspective to identify all eligible patients overdue for screening, 2) an automated, centralized process to contact selected patients by letter, 3) a result management system that automatically tracks test scheduling and completion, 4) a web-based, easily accessible tool allowing practice personnel to contact patients not completing testing, and 5) use of patient navigators for high risk patients not responding to initial outreach. In the control arm, the process of escalating the reminder intervention from a letter, to contact by phone call, to a patient navigator, will occur in a standard algorithmic fashion without provider input. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Breast cancer: Women 42-74 years old
- Cervical cancer: Women 21-65 years old
- Colorectal cancer: Women and men 52-75 years old
Key exclusion criteria (3 listed)
- Breast cancer: History of bilateral mastectomy in their EHR
- Cervical cancer: History of total hysterectomy in their EHR
- Colorectal cancer: History of total colectomy in their EHR
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 |
|---|---|---|
| TopCare: Use of provider knowledge vs. automated systemWe will be evaluating the system in practices where providers are involved in determining to contact a patient, including the most appropriate outreach method, compared with practices where the system is fully automated without provider input. | Other | Augmented Standard Care, TopCare Intervention |
Primary outcome
Cancer completion for all eligible cancers
Time frame: 1 year
Average cancer screening test completion rate over the 1-year follow-up period for each eligible patient in all eligible cancers (breast, cervical, colorectal)
3 secondary outcomes
% of patients completing all eligible cancer screenings
Time frame: 1 year
Primary outcome in specified patient subgroups
Time frame: 1 year
TopCare system measures (intervention practices)
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 3 Oct 2014.
- Results publication: PubMed 25002002Atlas SJ, Zai AH, Ashburner JM, Chang Y, Percac-Lima S, Levy DE, Chueh HC, Grant RW. Non-visit-based cancer screening using a novel population management system. J Am Board Fam Med. 2014 Jul-Aug;27(4):474-85. doi: 10.3122/jabfm.2014.04.130319.
- Results publication: PubMed 24043318Zai AH, Kim S, Kamis A, Hung K, Ronquillo JG, Chueh HC, Atlas SJ. Applying operations research to optimize a novel population management system for cancer screening. J Am Med Inform Assoc. 2014 Feb;21(e1):e129-35. doi: 10.1136/amiajnl-2013-001681. Epub 2013 Sep 16.
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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.
Steven J Atlas, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TopCare: Use of provider knowledge vs. automated system in people with Breast Cancer and Colorectal Cancer, run by Massachusetts General Hospital at 1 site 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 3 inclusion and 3 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 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Cancer completion for all eligible cancers (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 NCT01372527, which also lists 2 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 3 Oct 2014.