Improved Delivery of Cardiovascular Care Through Outreach Facilitation (IDOCC)

October 3, 2014 updated by: Dr. William Hogg, C. T. Lamont Primary Care Research Centre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1N 5C4
        • Elisabeth Bruyere Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C. T. Lamont Primary Care Research Centre

Collaborators

Ottawa Heart Institute Research Corporation
Dept of Family Medicine, Faculty of Medicine, Hebrew University, Jerusalem, Israel
Institute of Population Health, University of Ottawa
Ottawa Cardiovascular Centre
Ottawa Regional Stroke Program
Champlain Primary Care Practices
Bruyere Research Institute

Investigators

  • Principal Investigator: Clare E Liddy, MD, MSc, University of Ottawa
  • Principal Investigator: William Hogg, MD, MSc, University of Ottawa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

December 14, 2007

First Submitted That Met QC Criteria

December 14, 2007

First Posted (Estimate)

December 17, 2007

Study Record Updates

Last Update Posted (Estimate)

October 6, 2014

Last Update Submitted That Met QC Criteria

October 3, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDOCC
  • 937200801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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