search
Back to results

Improved Delivery of Cardiovascular Care Through Outreach Facilitation (IDOCC)

Primary Purpose

Hypertension, Dyslipidemia, Diabetes

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Outreach Facilitation implementing elements of the Chronic Care Model
Sponsored by
C. T. Lamont Primary Care Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Primary care, Prevention of Cardiovascular Disease, Chronic Disease Management, Chronic Disease Prevention, Chronic Care Model, Outreach Facilitation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women over 40 years of age, who meet at least one of the following 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:

  • see above

Sites / Locations

  • Elisabeth Bruyere Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention

control

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Quality of care process index = ∑ of recommended services received by patient/ ∑ of the recommended services for which the patient was eligible

Secondary Outcome Measures

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

Full Information

First Posted
December 14, 2007
Last Updated
October 3, 2014
Sponsor
C. T. Lamont Primary Care Research Centre
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, Bruyere Research Institute, Champlain Primary Care Practices
search

1. Study Identification

Unique Protocol Identification Number
NCT00574808
Brief Title
Improved Delivery of Cardiovascular Care Through Outreach Facilitation
Acronym
IDOCC
Official Title
Improved Delivery of Cardiovascular Preventive Care (IDOCC) Through Outreach Facilitation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
C. T. Lamont Primary Care Research Centre
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, Bruyere Research Institute, Champlain Primary Care Practices

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemia, Diabetes, Chronic Kidney Disease, Cardiovascular Disease, Stroke, Transient Ischemic Attacks
Keywords
Primary care, Prevention of Cardiovascular Disease, Chronic Disease Management, Chronic Disease Prevention, Chronic Care Model, Outreach Facilitation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Outreach Facilitation implementing elements of the Chronic Care Model
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: see above
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clare E Liddy, MD, MSc
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Hogg, MD, MSc
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elisabeth Bruyere Health Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 5C4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
11276541
Citation
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.
Results Reference
background
PubMed Identifier
11252222
Citation
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.
Results Reference
background
PubMed Identifier
15755330
Citation
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.
Results Reference
background
PubMed Identifier
28271017
Citation
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.
Results Reference
derived
PubMed Identifier
27596224
Citation
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.
Results Reference
derived
PubMed Identifier
26510577
Citation
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.
Results Reference
derived
PubMed Identifier
22970753
Citation
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.
Results Reference
derived
PubMed Identifier
22008366
Citation
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.
Results Reference
derived
PubMed Identifier
21952084
Citation
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.
Results Reference
derived

Learn more about this trial

Improved Delivery of Cardiovascular Care Through Outreach Facilitation

We'll reach out to this number within 24 hrs