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Clinical Trials/NCT03170752
NCT03170752CompletedNot Applicable

Implementing and Testing a Cardiovascular Assessment Screening Program to Promote Healthy Aging (CASP)

Memorial University of Newfoundland1 site in 1 country169 target enrollmentStarted: September 28, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
169
Locations
1
Primary Endpoint
Proportion of patients who are comprehensively screened to the number of eligible patients seen in the intervention group compared to the control group as assessed by the completeness of CV Screening Checklist data collection form.

Study Overview

Brief Summary

This study is a randomized controlled trial (RCT) and there will be two groups: an intervention group and a control group. Nurse practitioners (NPs) across Newfoundland and Labrador (NL) who agree to participate will be randomly assigned to one of the two groups. The NPs in the intervention group will be asked to screen about 30 individuals aged 40-74 years without established cardiovascular disease (CVD) that currently come to their clinics. The NPs will be asked to screen these patients for CVD using a set of specific data collection tools that will be in electronic format. The control group will carry on with usual practice. Their charts will be reviewed by the researchers at a later date. At the end of the study, the screening program, with tools and strategies for CVD screening, will be given to NPs in the control group.

Detailed Description

The RCT will be conducted to test the screening intervention, the Cardiovascular Assessment Screening Program, with nurse practitioners across NL.

Research Questions

  1. What is the effect of implementing the Cardiovascular Assessment Screening Program on comprehensiveness of screening by nurse practitioners in NL?
  2. What is the effect of implementation of the Cardiovascular Assessment Screening Program on the identification of individuals at high risk of CVD within the nurse practitioner practice?
  3. What is the effect of implementation of the Cardiovascular Assessment Screening Program on recommendations that are made by nurse practitioners in NL?
  4. What components of the Cardiovascular Assessment Screening Program are effective in promoting CVD screening and appropriate follow-up by nurse practitioners in NL?
  5. What are the patients' and nurse practitioners' factors that influence participation in the Cardiovascular Assessment Screening Program in NL? The main outcome is the comprehensiveness of CVD screening. The null hypothesis for the RCT is stated as follows: There will be no difference in comprehensiveness of screening between the intervention group and the control group.

Methodology The RCT study will involve implementation and evaluation of the Cardiovascular Assessment Screening Program across the province of NL. The RCT will use block randomization following NP recruitment to allocate participating NP practices to either the intervention group or the control group. The NPs in the intervention group will participate in scheduled face-to-face educational sessions as well as webinars from their workplaces to receive support on using specific tools to identify, screen, and follow-up with patients. The NPs will also receive instructions on data collection methods using the study's Access Database developed by Newfoundland and Labrador Centre for Health Information (NLCHI).

The NPs in the control group will participate in a webinar education session and will be instructed to follow usual practice to screen patients for CVD. The NPs in the control group will receive instructions on keeping a record of patients who were seen in their clinics and whether or not the patients will be eligible to participate in the study based on age and history. This information will be used by researchers to conduct a retrospective chart review on a specified date during the data collection period. The specific CVD screening tools provided to the NPs in the intervention group will be made available to NPs in the control group following conclusion of this study.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
20 Years to 74 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Employment as a full-time NP in community-based settings
  • •Access to healthy, asymptomatic patients between the ages of 40-74 years of age
  • •Ability of the practice to collect data.
  • •Inclusion Criteria for the Patients:
  • •Eligible based on age,
  • •No established CVD (such as coronary heart disease (CHD) or ischemic heart disease (IHD), myocardial infarctions (MIs), congestive heart failure (CHF), transient ischemic attacks (TIAs), cerebrovascular accidents (CVAs), peripheral vascular disease (PVD), and pulmonary emboli (PE).
  • •Willingness to participate in the study.

Exclusion Criteria

  • •Age less than 20 or over 75 years
  • •Established Cardiovascular Disease (such as coronary heart disease (CHD) or ischemic heart disease (IHD), myocardial infarctions (MIs), congestive heart failure (CHF), transient ischemic attacks (TIAs), cerebrovascular accidents (CVAs), peripheral vascular disease (PVD), and pulmonary emboli (PE)).
  • •Inability to attend NP clinic visit

Arms & Interventions

Intervention group

Experimental

The screening intervention Cardiovascular Assessment Screening Program (CASP) to be implemented by NPs in the intervention group has three steps:

  1. Identification of patients (using Eligibility for Heart Health Screening Form, Heart Health Assessment Pamphlet, Tracking Form for Heart Health Screening, Algorithm for NP to Screen);
  2. Screening utilizing appropriate tools (Cardiovascular Screening Checklist, Heart Health Screening Website/App);
  3. Actions to follow up on the screening results (Heart Health Screening Website/App, CV Decision Tree Algorithm).

Intervention: Cardiovascular Assessment Screening Program (CASP) (Behavioral)

Control group

No Intervention

The NPs in the control group will be instructed to follow usual practice to screen patients for cardiovascular disease.

Outcomes

Primary Outcomes

Proportion of patients who are comprehensively screened to the number of eligible patients seen in the intervention group compared to the control group as assessed by the completeness of CV Screening Checklist data collection form.

Time Frame: 6-8 weeks

If the CV screening Checklist is only partially completed or not completed at all then it will not be considered comprehensive. Logistic regression is used because the outcome is dichotomous (yes or no). The patients had comprehensive screening (Yes) or they did not have comprehensive screening (No).

Secondary Outcomes

  • The management recommendations that are made by the NPs as assessed by the responses collected on the CV Screening Checklist data collection form (intervention group) and the chart review (control group).(6-8 weeks)
  • Identification of individuals at high risk for cardiovascular disease as assessed by the calculated Framingham Risk Score.(6-8 weeks)
  • The patient and NP factors that influence participation in the CASP as assessed by content analysis of patient and NP feedback questionnaires.(6-8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jill Bruneau

Doctoral candidate

Memorial University of Newfoundland

Study Sites (1)

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