Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT00574808
Study type Interventional
Source Bruyere Research Institute
Contact
Status Completed
Phase Phase 1
Start date April 2007
Completion date February 2013

See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Recruiting NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Active, not recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT05621980 - Finger Movement Training After Stroke N/A