Improved Delivery of Cardiovascular Care Through Outreach Facilitation
NCT ID: NCT00574808
Last Updated: 2014-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
194 participants
INTERVENTIONAL
2007-04-30
2013-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Integration of Chronic Disease Rehabilitation Services Into Primary Care
NCT01319656
Effectiveness New Health Care Organization Model in Primary Care for Chronic Cardiovascular Disease Patients Based
NCT01826929
A Community Health Worker Program to Support Rural Older Adults
NCT03843333
Relative Impacts on Preventative Primary Care--a Longitudinal Evaluation of COVID-19:Phase 1
NCT05813652
Reducing Cardiovascular Risk in Primary Care: a Randomized Clinical Trial
NCT05395806
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Specifically, we will:
i) 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
intervention
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.
Outreach Facilitation implementing elements of the Chronic Care Model
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.
control
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).
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Outreach Facilitation implementing elements of the Chronic Care Model
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. have established cardiovascular disease: Coronary Artery Disease, Cerebrovascular disease (documented stroke and/or TIA), and Peripheral Vascular Disease;
2. have Diabetes Mellitus;
3. have Chronic Kidney Disease ;
4. 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.
Exclusion Criteria
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dept of Family Medicine, Faculty of Medicine, Hebrew University, Jerusalem, Israel
OTHER
Institute of Population Health, University of Ottawa
OTHER
Ottawa Heart Institute Research Corporation
OTHER
Ottawa Cardiovascular Centre
UNKNOWN
Ottawa Regional Stroke Program
UNKNOWN
Bruyère Health Research Institute.
OTHER
Champlain Primary Care Practices
UNKNOWN
C. T. Lamont Primary Care Research Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. William Hogg
Dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clare E Liddy, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Ottawa
William Hogg, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Ottawa
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Elisabeth Bruyere Health Centre
Ottawa, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Baskerville 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.
Hogg 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.
Liddy 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.
Deri 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.
Liddy 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.
Liddy 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.
Liddy 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.
Liddy 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
937200801
Identifier Type: -
Identifier Source: secondary_id
IDOCC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.