Implementing and Testing a Cardiovascular Assessment Screening Program (CASP)
Condition: Cardiovascular Risk Factor; Smoking; Diabetes Mellitus; Dyslipidemias; Hypertension; Physical Activity; Stress, Psychological
MeSH terms: Dyslipidemias; Stress, Psychological
Study type: Interventional

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.

      Setting & Sample The RCT will take place in community-based clinics with NP practices from
      both rural and urban areas in the various regional health authorities across NL. NPs may be
      working in solo practice or working with several other NPs in a group practice. There will be
      four types of NP practices: 1) rural solo, 2) rural group, 3) urban solo and, 4) urban group.
      NPs working in the same group practice will need to be allocated to the same group, so block
      randomization will be used once all of the NP practices have been recruited. Using a random
      number generator, NP practices will be allocated to either the intervention group or the
      control group within each block (type) of practice.

      The sample size estimation for this study was determined using the proportion of eligible
      patients who were comprehensively screened as the outcome measure of interest. A study that
      considered the effectiveness of a national risk assessment program for patients aged 40-74
      years found that approximately 40% had complete Health Checks and 60% had partial Health
      Checks among high risk patients in the United Kingdom (UK) National Health Service Health
      Check Program (Artec et al., 2013). The sample size for this proposed study was calculated
      based on the assumption that 40% of the screening will be comprehensive in the control group
      practices. The research team decided that comprehensive screening of 70% of patients seen by
      the NPs in the intervention group during this study would indicate an effective intervention.
      Using a two-sided alpha of 0.05 and 90% power, the sample size was calculated to be 250
      patients (125 patients per group). Considering that patients would need to provide consent to
      participate in this study the research team assumed that 20% of those approached would
      refuse. This means that 300 patients with 150 patients per group would be required. To be
      realistic about workload, each NP would need to include 25-30 patients. A minimum of 10 NPs
      therefore needs to be recruited. The duration of the data collection period will vary by NP
      according to the number of eligible patients seen. For example, if an NP sees one eligible
      patient per day for five days a week, then the data collection period would be six weeks for
      a total of 30 patients. If an NP sees two eligible patients per day, then the data collection
      period would be three weeks.
    

Intervention name(s): Cardiovascular Assessment Screening Program (CASP)
Intervention type(s): Behavioral
Intervention description(s): Step 1. Identification of patients; Step 2. Screening utilizing appropriate tools; and Step 3. Actions to follow up on the screening results.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: RCT, Cardiovascular Risk Factors, Screening