HypertensionPhase 1IDOCCNCT00574808
Improved Delivery of Cardiovascular Care Through Outreach Facilitation
A Phase 1 study testing Outreach Facilitation implementing elements of the Chronic Care Model in people with Hypertension and Dyslipidemia, run by C. T. Lamont Primary Care Research Centre at 1 site in Canada.
Trial summary
The aim of the proposed study is to implement and evaluate Outreach Facilitation as a means to increase the uptake of evidence-based practice for secondary prevention and management of patients with established CVD and cardiovascular risk factors, in primary care practices throughout the Champlain LHIN. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension, Dyslipidemia, Diabetes
- What is being tested?
- Outreach Facilitation implementing elements of the Chronic Care Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2007to Feb 2013
- Phase
- Phase 1
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 40 years of age, who meet at least one of the following criteria:
- have established cardiovascular disease: Coronary Artery Disease, Cerebrovascular disease (documented stroke and/or TIA), and Peripheral Vascular Disease;
- have Diabetes Mellitus;
- have Chronic Kidney Disease ;
- are at high risk for CVD based on a presence of at least three of the following established cardiovascular risk factors: age (males ≥ 45, females ≥ 55), smoker status, hypertension, and dyslipidemia.
- No restrictions will be imposed on the recruitment process; all practices in the region will be eligible to participate.
Who cannot join
- see above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improved Delivery of Cardiovascular Preventive Care (IDOCC) Through Outreach Facilitation
The aim of the proposed study is to implement and evaluate Outreach Facilitation as a means to increase the uptake of evidence-based practice for secondary prevention and management of patients with established CVD and cardiovascular risk factors, in primary care practices throughout the Champlain LHIN. This initiative centers on the use of an Outreach Facilitation Model, in which skilled health professionals known as facilitators (Practice Change Consultants) serve as an expert resource to primary care practices in three areas: a) practice performance assessment, feedback, and consensus building towards goal setting and implementation; b) clinical, technical, organizational resources and practical advice; and c) encouragement to face and move through the challenges associated with implementing system change.
Read the detailed description
General practice visits can provide a unique opportunity to identify and treat individuals with or at risk for CVD. We plan to test implementation of system changes using nurse facilitation in the organization of primary care practices to enhance daily adoption by the practice staff of evidence-based guidelines and prevention strategies that can lead to better patient care.
Specifically, we will:
- Establish an Outreach Facilitation program in primary care practices throughout the Champlain District to improve the secondary prevention and management of cardiovascular disease in the primary care setting. The program will assist the practices (Champlain CVD Prevention Network) with implementation of evidence-based guidelines (Champlain Primary Care CVD Prevention Guidelines) by targeting the following risk factors:
- Hypertension
- Dyslipidemia
- Diabetes
- Chronic Kidney Disease
- Smoking
- Obesity
- Physical Inactivity ii) Rigorously evaluate this program's efficacy and cost effectiveness
Hypotheses
Implementation of the outreach facilitation program for CVD prevention and management will improve: i) the processes of cardiovascular health related care delivery by primary care practitioners in the Champlain LHIN, and ii) the clinical outcomes for patients with established CVD and those at high cardiovascular risk. The improvements will be evident on the comparisons of the pre- to post-implementation performance within the participating practices, and on the between practice comparisons of performance in those randomized to begin the program earlier with those randomized to begin it later.
Design
We will use a "stepped wedge" design where the outreach facilitation program will be rolled-out sequentially to the trial participants, in geographic regions chosen by random order, over a number of equally spaced time intervals during the 5 year program implementation period.
To allow for the sequential roll-out of the program, the Champlain LHIN has been divided into 9 smaller geographic regions, referred to from now on as "divisions", using GIS mapping technology. The order in which these divisions begin the program has been randomized, but stratified by the west/central/and east location within the LHIN, so that each division per stratum will have the same probability of beginning the program at any specific time.
There will be 4 data collection points throughout the 5-year implementation period. In the analysis, the data points before program implementation (the baseline section of the wedge) will be compared to the data points after the program begun (the implementation section of the wedge) both within and between the divisions. The multiple baseline data obtained for those divisions randomized to begin the program later than others will allow for underlying temporal changes to be considered as a variable in data analysis in order to determine, for example, whether any secular changes had an impact on effectiveness of the program.
Impact Evaluation
To measure the population-level impact of the program we will collaborate with the Institute for Clinical Evaluative Sciences (ICES). Specifically, we will evaluate the regional impact of the program on cardiovascular health by linking participating doctors with provincial administrative databases from ICES to determine the rates of CVD-related hospitalization and emergency department visits, mortality and morbidity, and drug prescription patterns for hypertension, lipid control, and other vascular protective agents.
In addition, we will measure the success of the program at the level of the primary care practice through a qualitative assessment of the following aspects of program implementation:
- the impact of the intervention on physicians, associated staff and patients
- the resources and activities required to implement the intervention and the extent to which it was implemented as intended
- the factors which contributed to success or which introduce barriers to success
Satisfaction with the program will be evaluated at the level of the physician, practice staff, and the facilitators.
- Conditions
- Hypertension, Dyslipidemia, Diabetes, Chronic Kidney Disease, Cardiovascular Disease, Stroke
- Being tested
- Outreach Facilitation implementing elements of the Chronic Care Model
- Keywords
- Primary care, Prevention of Cardiovascular Disease, Chronic Disease Management, Chronic Disease Prevention, Chronic Care Model, Outreach Facilitation
- Medical subject headings
- Hypertension, Dyslipidemias, Diabetes Mellitus, Renal Insufficiency, Chronic, Cardiovascular Diseases, Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outreach Facilitation implementing elements of the Chronic Care ModelOther
An outreach facilitator helps the practice identify areas for improvement, set goals and targets, and agree on the processes needed to reach them in order to improve the care delivery within the practices. Each facilitator will be assigned up to 12 practice sites. The first year of program implementation will involve frequent (once every 3-4 weeks) visits to the practices. Afterwards, the intervention will move into a sustainability mode, during which the frequency of visits will decrease to one every 6-8 weeks during the second year, and one every 12-15 weeks during the third year and thereafter. After the first year of program implementation, each facilitator will be able to take on 12 new practices during the second year, while still being able to sustain contact with the previous 12 practices. Similarly, in the third year, another set of 12 practices will begin the "intense" phase of program implementation.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Outreach Facilitation implementing elements of the Chronic Care Model. The facilitators will provide hands on support to practices and help to implement tools and processes designed to incorporate evidence-based practice into the routine delivery of cardiovascular care. Specifically, they will a) assist with practice performance assessment, feedback, and consensus building towards goal setting, b) offer clinical, technical, organizational resources and practical advice, and c) provide encouragement to face and overcome the challenges of implementing system change. Receives: Other: Outreach Facilitation implementing elements of the Chronic Care Model |
| control | No intervention | Baseline data before implementation of the program will serve as the control. Comparisons will be made between baseline and post-intervention within each divisions of primary care practices as well as between divisions (ie. baseline information from one division will serve as the control for another). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of care process index = ∑ of recommended services received by patient/ ∑ of the recommended services for which the patient was eligible
Measured: 5 years
Secondary outcomes (1)
Quality of care outcome index = ∑ of recommended targets reached / ∑ of the number of targets for which the patient is eligible based on the number of conditions suffered by the patient
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startApr 2007
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. T. Lamont Primary Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Dept of Family Medicine, Faculty of Medicine, Hebrew University, Jerusalem, Israel, Institute of Population Health, University of Ottawa, Ottawa Heart Institute Research Corporation, Ottawa Cardiovascular Centre, Ottawa Regional Stroke Program, Bruyère Health Research Institute., Champlain Primary Care Practices
- Responsible party
- Principal investigator, Dr. William Hogg, C. T. Lamont Primary Care Research Centre
- Investigators
- Clare E Liddy, MD, MSc, Principal investigator, University of OttawaWilliam Hogg, MD, MSc, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574808
- Sponsor's protocol ID
- IDOCC
- Other IDs
- 937200801
- Acronym
- IDOCC
- Status last verified
- Oct 2014
- First submitted
- 14 Dec 2007
- Last updated
- 6 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lemelin J, Hogg W, Baskerville N. Evidence to action: a tailored multifaceted approach to changing family physician practice patterns and improving preventive care. CMAJ. 2001 Mar 20;164(6):757-63.
PubMed 11276541Baskerville NB, Hogg W, Lemelin J. Process evaluation of a tailored multifaceted approach to changing family physician practice patterns improving preventive care. J Fam Pract. 2001 Mar;50(3):W242-9.
PubMed 11252222Hogg W, Baskerville N, Lemelin J. Cost savings associated with improving appropriate and reducing inappropriate preventive care: cost-consequences analysis. BMC Health Serv Res. 2005 Mar 9;5(1):20. doi: 10.1186/1472-6963-5-20.
PubMed 15755330Liddy C, Rowan M, Valiquette-Tessier SC, Drosinis P, Crowe L, Hogg W. Improved Delivery of Cardiovascular Care (IDOCC): Findings from Narrative Reports by Practice Facilitators. Prev Med Rep. 2016 Dec 23;5:214-219. doi: 10.1016/j.pmedr.2016.12.018. eCollection 2017 Mar.
PubMed 28271017Deri Armstrong C, Taljaard M, Hogg W, Mark AE, Liddy C. Practice facilitation for improving cardiovascular care: secondary evaluation of a stepped wedge cluster randomized controlled trial using population-based administrative data. Trials. 2016 Sep 5;17(1):434. doi: 10.1186/s13063-016-1547-2.
PubMed 27596224Liddy C, Hogg W, Singh J, Taljaard M, Russell G, Deri Armstrong C, Akbari A, Dahrouge S, Grimshaw JM. A real-world stepped wedge cluster randomized trial of practice facilitation to improve cardiovascular care. Implement Sci. 2015 Oct 28;10:150. doi: 10.1186/s13012-015-0341-y.
PubMed 26510577Liddy C, Singh J, Hogg W, Dahrouge S, Deri-Armstrong C, Russell G, Taljaard M, Akbari A, Wells G. Quality of cardiovascular disease care in Ontario, Canada: missed opportunities for prevention - a cross sectional study. BMC Cardiovasc Disord. 2012 Sep 12;12:74. doi: 10.1186/1471-2261-12-74.
PubMed 22970753Liddy C, Singh J, Hogg W, Dahrouge S, Taljaard M. Comparison of primary care models in the prevention of cardiovascular disease - a cross sectional study. BMC Fam Pract. 2011 Oct 18;12:114. doi: 10.1186/1471-2296-12-114.
PubMed 22008366Liddy C, Hogg W, Russell G, Wells G, Armstrong CD, Akbari A, Dahrouge S, Taljaard M, Mayo-Bruinsma L, Singh J, Cornett A. Improved delivery of cardiovascular care (IDOCC) through outreach facilitation: study protocol and implementation details of a cluster randomized controlled trial in primary care. Implement Sci. 2011 Sep 27;6:110. doi: 10.1186/1748-5908-6-110.
PubMed 21952084
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Delivery of Cardiovascular Preventive Care (IDOCC) Through Outreach Facilitation
- ClinicalTrials.gov ID
- NCT00574808
- Acronym / sponsor ID
- IDOCC / IDOCC
- Conditions
- Hypertension, Dyslipidemia, Diabetes, Chronic Kidney Disease, Cardiovascular Disease, Stroke
- Keywords
- Primary care, Prevention of Cardiovascular Disease, Chronic Disease Management, Chronic Disease Prevention, Chronic Care Model, Outreach Facilitation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- C. T. Lamont Primary Care Research CentreUniversity, hospital or other
- Collaborators
- Dept of Family Medicine, Faculty of Medicine, Hebrew University, Jerusalem, Israel, Institute of Population Health, University of Ottawa, Ottawa Heart Institute Research Corporation, Ottawa Cardiovascular Centre, Ottawa Regional Stroke Program, Bruyère Health Research Institute., Champlain Primary Care Practices
- Study start
- Apr 2007
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Dec 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 aim of the proposed study is to implement and evaluate Outreach Facilitation as a means to increase the uptake of evidence-based practice for secondary prevention and management of patients with established CVD and cardiovascular risk factors, in primary care practices throughout the Champlain LHIN. This initiative centers on the use of an Outreach Facilitation Model, in which skilled health professionals known as facilitators (Practice Change Consultants) serve as an expert resource to primary care practices in three areas: a) practice performance assessment, feedback, and consensus building towards goal setting and implementation; b) clinical, technical, organizational resources and practical advice; and c) encouragement to face and move through the challenges associated with implementing system change.
Detailed description
General practice visits can provide a unique opportunity to identify and treat individuals with or at risk for CVD. We plan to test implementation of system changes using nurse facilitation in the organization of primary care practices to enhance daily adoption by the practice staff of evidence-based guidelines and prevention strategies that can lead to better patient care.
Specifically, we will:
- Establish an Outreach Facilitation program in primary care practices throughout the Champlain District to improve the secondary prevention and management of cardiovascular disease in the primary care setting. The program will assist the practices (Champlain CVD Prevention Network) with implementation of evidence-based guidelines (Champlain Primary Care CVD Prevention Guidelines) by targeting the following risk factors:
- Hypertension
- Dyslipidemia
- Diabetes
- Chronic Kidney Disease
- Smoking
- Obesity
- Physical Inactivity ii) Rigorously evaluate this program's efficacy and cost effectiveness
Hypotheses
Implementation of the outreach facilitation program for CVD prevention and management will improve: i) the processes of cardiovascular health related care delivery by primary care practitioners in the Champlain LHIN, and ii) the clinical outcomes for patients with established CVD and those at high cardiovascular risk. The improvements will be evident on the comparisons of the pre- to post-implementation performance within the participating practices, and on the between practice comparisons of performance in those randomized to begin the program earlier with those randomized to begin it later.
Design
We will use a "stepped wedge" design where the outreach facilitation program will be rolled-out sequentially to the trial participants, in geographic regions chosen by random order, over a number of equally spaced time intervals during the 5 year program implementation period.
To allow for the sequential roll-out of the program, the Champlain LHIN has been divided into 9 smaller geographic regions, referred to from now on as "divisions", using GIS mapping technology. The order in which these divisions begin the program has been randomized, but stratified by the west/central/and east location within the LHIN, so that each division per stratum will have the same probability of beginning the program at any specific time.
There will be 4 data collection points throughout the 5-year implementation period. In the analysis, the data points before program implementation (the baseline section of the wedge) will be compared to the data points after the program begun (the implementation section of the wedge) both within and between the divisions. The multiple baseline data obtained for those divisions randomized to begin the program later than others will allow for underlying temporal changes to be considered as a variable in data analysis in order to determine, for example, whether any secular changes had an impact on effectiveness of the program.
Impact Evaluation
To measure the population-level impact of the program we will collaborate with the Institute for Clinical Evaluative Sciences (ICES). Specifically, we will evaluate the regional impact of the program on cardiovascular health by linking participating doctors with provincial administrative databases from ICES to determine the rates of CVD-related hospitalization and emergency department visits, mortality and morbidity, and drug prescription patterns for hypertension, lipid control, and other vascular protective agents.
In addition, we will measure the success of the program at the level of the primary care practice through a qualitative assessment of the following aspects of program implementation:
- the impact of the intervention on physicians, associated staff and patients
- the resources and activities required to implement the intervention and the extent to which it was implemented as intended
- the factors which contributed to success or which introduce barriers to success
Satisfaction with the program will be evaluated at the level of the physician, practice staff, and the facilitators.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: Outreach Facilitation implementing elements of the Chronic Care ModelOutreach Facilitation implementing elements of the Chronic Care Model. The facilitators will provide hands on support to practices and help to implement tools and processes designed to incorporate evidence-based practice into the routine delivery of cardiovascular care. Specifically, they will a) assist with practice performance assessment, feedback, and consensus building towards goal setting, b) offer clinical, technical, organizational resources and practical advice, and c) provide encouragement to face and overcome the challenges of implementing system change. |
| control | No intervention | –Baseline data before implementation of the program will serve as the control. Comparisons will be made between baseline and post-intervention within each divisions of primary care practices as well as between divisions (ie. baseline information from one division will serve as the control for another). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women over 40 years of age, who meet at least one of the following criteria:
- No restrictions will be imposed on the recruitment process; all practices in the region will be eligible to participate.
Key exclusion criteria (1 listed)
- see above
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 |
|---|---|---|
| Outreach Facilitation implementing elements of the Chronic Care ModelAn outreach facilitator helps the practice identify areas for improvement, set goals and targets, and agree on the processes needed to reach them in order to improve the care delivery within the practices. Each facilitator will be assigned up to 12 practice sites. The first year of program implementation will involve frequent (once every 3-4 weeks) visits to the practices. Afterwards, the intervention will move into a sustainability mode, during which the frequency of visits will decrease to one every 6-8 weeks during the second year, and one every 12-15 weeks during the third year and thereafter. After the first year of program implementation, each facilitator will be able to take on 12 new practices during the second year, while still being able to sustain contact with the previous 12 practices. Similarly, in the third year, another set of 12 practices will begin the "intense" phase of program implementation. | Other | intervention |
Primary outcome
Quality of care process index = ∑ of recommended services received by patient/ ∑ of the recommended services for which the patient was eligible
Time frame: 5 years
1 secondary outcome
Quality of care outcome index = ∑ of recommended targets reached / ∑ of the number of targets for which the patient is eligible based on the number of conditions suffered by the patient
Time frame: 5 years
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 6 Oct 2014.
- Background: PubMed 11276541Lemelin J, Hogg W, Baskerville N. Evidence to action: a tailored multifaceted approach to changing family physician practice patterns and improving preventive care. CMAJ. 2001 Mar 20;164(6):757-63.
- Background: PubMed 11252222Baskerville NB, Hogg W, Lemelin J. Process evaluation of a tailored multifaceted approach to changing family physician practice patterns improving preventive care. J Fam Pract. 2001 Mar;50(3):W242-9.
- Background: PubMed 15755330Hogg W, Baskerville N, Lemelin J. Cost savings associated with improving appropriate and reducing inappropriate preventive care: cost-consequences analysis. BMC Health Serv Res. 2005 Mar 9;5(1):20. doi: 10.1186/1472-6963-5-20.
- Derived from this study: PubMed 28271017Liddy C, Rowan M, Valiquette-Tessier SC, Drosinis P, Crowe L, Hogg W. Improved Delivery of Cardiovascular Care (IDOCC): Findings from Narrative Reports by Practice Facilitators. Prev Med Rep. 2016 Dec 23;5:214-219. doi: 10.1016/j.pmedr.2016.12.018. eCollection 2017 Mar.
- Derived from this study: PubMed 27596224Deri Armstrong C, Taljaard M, Hogg W, Mark AE, Liddy C. Practice facilitation for improving cardiovascular care: secondary evaluation of a stepped wedge cluster randomized controlled trial using population-based administrative data. Trials. 2016 Sep 5;17(1):434. doi: 10.1186/s13063-016-1547-2.
- Derived from this study: PubMed 26510577Liddy C, Hogg W, Singh J, Taljaard M, Russell G, Deri Armstrong C, Akbari A, Dahrouge S, Grimshaw JM. A real-world stepped wedge cluster randomized trial of practice facilitation to improve cardiovascular care. Implement Sci. 2015 Oct 28;10:150. doi: 10.1186/s13012-015-0341-y.
- Derived from this study: PubMed 22970753Liddy C, Singh J, Hogg W, Dahrouge S, Deri-Armstrong C, Russell G, Taljaard M, Akbari A, Wells G. Quality of cardiovascular disease care in Ontario, Canada: missed opportunities for prevention - a cross sectional study. BMC Cardiovasc Disord. 2012 Sep 12;12:74. doi: 10.1186/1471-2261-12-74.
- Derived from this study: PubMed 22008366Liddy C, Singh J, Hogg W, Dahrouge S, Taljaard M. Comparison of primary care models in the prevention of cardiovascular disease - a cross sectional study. BMC Fam Pract. 2011 Oct 18;12:114. doi: 10.1186/1471-2296-12-114.
- Derived from this study: PubMed 21952084Liddy C, Hogg W, Russell G, Wells G, Armstrong CD, Akbari A, Dahrouge S, Taljaard M, Mayo-Bruinsma L, Singh J, Cornett A. Improved delivery of cardiovascular care (IDOCC) through outreach facilitation: study protocol and implementation details of a cluster randomized controlled trial in primary care. Implement Sci. 2011 Sep 27;6:110. doi: 10.1186/1748-5908-6-110.
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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.
Clare E Liddy, MD, MSc principal investigator
University of Ottawa
William Hogg, MD, MSc principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Outreach Facilitation implementing elements of the Chronic Care Model in people with Hypertension and Dyslipidemia, run by C. T. Lamont Primary Care Research Centre at 1 site in Canada.
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 6 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 6 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of care process index = ∑ of recommended services received by patient/ ∑ of the recommended services for which the patient was eligible (time frame: 5 years). 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 NCT00574808, which also lists 9 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 6 Oct 2014.