Cardiovascular Disease (CVD) Risk FactorsFITNCT00517686
Feedback of Treatment Intensification Data to Reduce Cardiovascular Disease Risk (FIT)
A study testing Information feedback intervention in people with Cardiovascular Disease (CVD) Risk Factors, run by Kaiser Permanente at 1 site in United States.
Trial summary
The primary research question of this study is to determine whether measuring, reporting and feeding back information to primary care teams on the need for treatment intensification in patients at high risk for cardiovascular disease (CVD) can improve rates of treatment intensification and reduce levels of poorly… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Disease (CVD) Risk Factors
- What is being tested?
- Information feedback intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,584 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Sep 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Among the randomized medical facilities, we will study a population that is drawn from the PHASE registry and includes patients with at least one of the following:
- Diabetes, coronary artery disease; congestive heart failure; stroke/tia; peripheral artery disease; chronic kidney disease; hypertension; or hyperlipidemia
- PHASE patients must be in poor control for at least one CVD risk factor and meet study criteria for needing treatment intensification at some point during the 6-month period.
Who cannot join
- All patients eligible for the study will be included in the analyses
- There will be no exclusions based on clinical or other criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente - Division of Research
Oakland, California, 94612
About this study
The primary research question of this study is to determine whether measuring, reporting and feeding back information to primary care teams on the need for treatment intensification in patients at high risk for cardiovascular disease (CVD) can improve rates of treatment intensification and reduce levels of poorly controlled systolic blood pressure, LDL-c, and A1c.
Read the detailed description
Project Description: We propose a cluster randomized trial intervention involving eight or more medical facilities of Kaiser Permanente Northern California (KP) and more than 65,000 patients at high risk for CVD. At intervention facilities, patient-level information obtained from KP's electronic health record on the need for treatment intensification (for systolic blood pressure, LDL-c, and A1c) and on recent medication adherence are added to a population management database and fed back through software currently used by staff working with primary care providers. Staff at control facilities continue to use the same population management database and software but only receive information on risk factor levels and selected medications.
Specific Aims:
- Evaluate the effectiveness of measurement and feedback of treatment intensification information in patients at high risk of CVD for improving rates of treatment intensification and for reducing levels of poorly controlled systolic blood pressure, LDL-c, and A1c.
- Evaluate the impact of the intervention, compared with current practice, on total numbers of patient contacts, outpatient visits, and costs of care in relation to improvements in risk factor control.
- Evaluate the effect of this innovation on physician and staff perceptions of the value (effectiveness and efficiency) of the population management program for high-risk patients.
Relevance: If this translational study shows that feedback of information on treatment intensification leads to higher rates of intensification and improved risk factor control, this finding will have shown a population-level use of health information technology for improving clinical quality and will also have validated treatment intensification as a metric of clinical quality.
- Being tested
- Information feedback intervention
- Keywords
- Poor risk factor control, Treatment intensification, Medication adherence, Cardiovascular disease (CVD)
- Medical subject headings
- Cardiovascular Diseases, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information feedback interventionOther
This study will evaluate an information feedback intervention: measuring, reporting and feeding back information to primary care teams on the need for treatment intensification in patients at high risk for cardiovascular disease (CVD).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The study will use automated databases and PHASE information systems to identify patients and incorporate feedback on a monthly basis into the ongoing reports used by program staff at facilities randomized to this intervention arm (n=4). Receives: Other: Information feedback intervention |
| 2 | No intervention | Usual care facilities (n=4) will continue to use current PHASE reports that include information on recent risk factor levels and current use of selected medications but no treatment intensification information, and no information on medication adherence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tightly-linked processes (i.e., was treatment intensified more frequently) measured in the 3 months after initial reporting of need for intensification; and mean levels of intermediate outcomes (SBP, LDL-c, and A1c), measured for all study population.
Measured: 3 months; 1 year
Secondary outcomes (1)
Proportions in control for each risk factor; treatment intensification and risk factor improvements in subgroups; and efficiency in terms of patient contacts, visits and costs per unit improvement in risk factor control.
Measured: 3 months; 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startJul 2008
- Primary completionJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Disease (CVD) Risk FactorsStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16,584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Joe V Selby, MD, MPH, Principal investigator, Kaiser Permenante, Division of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517686
- Sponsor's protocol ID
- RFA-HS-07-002
- Acronym
- FIT
- Status last verified
- Aug 2012
- First submitted
- 15 Aug 2007
- Last updated
- 3 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Selby JV, Schmittdiel JA, Fireman B, Jaffe M, Ransom LJ, Dyer W, Uratsu CS, Reed ME, Kerr EA, Hsu J. Improving treatment intensification to reduce cardiovascular disease risk: a cluster randomized trial. BMC Health Serv Res. 2012 Jul 2;12:183. doi: 10.1186/1472-6963-12-183.
PubMed 22747998
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feedback of Treatment Intensification Data to Reduce Cardiovascular Disease Risk (FIT)
- ClinicalTrials.gov ID
- NCT00517686
- Acronym / sponsor ID
- FIT / RFA-HS-07-002
- Keywords
- Poor risk factor control, Treatment intensification, Medication adherence, Cardiovascular disease (CVD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16,584 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jul 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Aug 2007 (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.
The primary research question of this study is to determine whether measuring, reporting and feeding back information to primary care teams on the need for treatment intensification in patients at high risk for cardiovascular disease (CVD) can improve rates of treatment intensification and reduce levels of poorly controlled systolic blood pressure, LDL-c, and A1c.
Detailed description
Project Description: We propose a cluster randomized trial intervention involving eight or more medical facilities of Kaiser Permanente Northern California (KP) and more than 65,000 patients at high risk for CVD. At intervention facilities, patient-level information obtained from KP's electronic health record on the need for treatment intensification (for systolic blood pressure, LDL-c, and A1c) and on recent medication adherence are added to a population management database and fed back through software currently used by staff working with primary care providers. Staff at control facilities continue to use the same population management database and software but only receive information on risk factor levels and selected medications.
Specific Aims:
- Evaluate the effectiveness of measurement and feedback of treatment intensification information in patients at high risk of CVD for improving rates of treatment intensification and for reducing levels of poorly controlled systolic blood pressure, LDL-c, and A1c.
- Evaluate the impact of the intervention, compared with current practice, on total numbers of patient contacts, outpatient visits, and costs of care in relation to improvements in risk factor control.
- Evaluate the effect of this innovation on physician and staff perceptions of the value (effectiveness and efficiency) of the population management program for high-risk patients.
Relevance: If this translational study shows that feedback of information on treatment intensification leads to higher rates of intensification and improved risk factor control, this finding will have shown a population-level use of health information technology for improving clinical quality and will also have validated treatment intensification as a metric of clinical quality.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Information feedback interventionThe study will use automated databases and PHASE information systems to identify patients and incorporate feedback on a monthly basis into the ongoing reports used by program staff at facilities randomized to this intervention arm (n=4). |
| 2 | No intervention | –Usual care facilities (n=4) will continue to use current PHASE reports that include information on recent risk factor levels and current use of selected medications but no treatment intensification information, and no information on medication adherence. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Among the randomized medical facilities, we will study a population that is drawn from the PHASE registry and includes patients with at least one of the following:
- Diabetes, coronary artery disease; congestive heart failure; stroke/tia; peripheral artery disease; chronic kidney disease; hypertension; or hyperlipidemia
- PHASE patients must be in poor control for at least one CVD risk factor and meet study criteria for needing treatment intensification at some point during the 6-month period.
Key exclusion criteria (2 listed)
- All patients eligible for the study will be included in the analyses
- There will be no exclusions based on clinical or other criteria.
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 |
|---|---|---|
| Information feedback interventionThis study will evaluate an information feedback intervention: measuring, reporting and feeding back information to primary care teams on the need for treatment intensification in patients at high risk for cardiovascular disease (CVD). | Other | 1 |
Primary outcome
Tightly-linked processes (i.e., was treatment intensified more frequently) measured in the 3 months after initial reporting of need for intensification; and mean levels of intermediate outcomes (SBP, LDL-c, and A1c), measured for all study population.
Time frame: 3 months; 1 year
1 secondary outcome
Proportions in control for each risk factor; treatment intensification and risk factor improvements in subgroups; and efficiency in terms of patient contacts, visits and costs per unit improvement in risk factor control.
Time frame: 3 months; 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 Aug 2012.
- Derived from this study: PubMed 22747998Selby JV, Schmittdiel JA, Fireman B, Jaffe M, Ransom LJ, Dyer W, Uratsu CS, Reed ME, Kerr EA, Hsu J. Improving treatment intensification to reduce cardiovascular disease risk: a cluster randomized trial. BMC Health Serv Res. 2012 Jul 2;12:183. doi: 10.1186/1472-6963-12-183.
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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.
Joe V Selby, MD, MPH principal investigator
Kaiser Permenante, Division of Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information feedback intervention in people with Cardiovascular Disease (CVD) Risk Factors, run by Kaiser Permanente 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 2 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 Aug 2012. 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?
Tightly-linked processes (i.e., was treatment intensified more frequently) measured in the 3 months after initial reporting of need for intensification; and mean levels of intermediate outcomes (SBP, LDL-c, and A1c), measured for all study population. (time frame: 3 months; 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 NCT00517686, which also lists 1 linked publication.
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 Aug 2012.