Improved Delivery of Cardiovascular Care Through Outreach Facilitation

Stroke Clinical Trial

— IDOCC  

Official title:

Improved Delivery of Cardiovascular Preventive Care (IDOCC) Through Outreach Facilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574808
• Other study ID #: IDOCC
• Secondary ID: 937200801
• Status: Completed
• Phase: Phase 1
• First received: December 14, 2007
• Last updated: October 3, 2014
• Start date: April 2007
• Est. completion date: February 2013

Study information

• Verified date: October 2014
• Source: Bruyere Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Kidney Disease
• Diabetes
• Dyslipidemia
• Dyslipidemias
• Hypertension
• Ischemic Attack, Transient
• Kidney Diseases
• Renal Insufficiency, Chronic
• Stroke
• Transient Ischemic Attacks

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Elisabeth Bruyere Health Centre	Ottawa	Ontario

Sponsors (8)

Lead Sponsor	Collaborator
C. T. Lamont Primary Care Research Centre	Bruyere Research Institute, Champlain Primary Care Practices, Dept of Family Medicine, Faculty of Medicine, Hebrew University, Jerusalem, Israel, Institute of Population Health, University of Ottawa, Ottawa Cardiovascular Centre, Ottawa Heart Institute Research Corporation, Ottawa Regional Stroke Program

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of care process index = ? of recommended services received by patient/ ? of the recommended services for which the patient was eligible		5 years
Secondary	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		5 years