Pharmacist CVD Intervention for Patients With Inflammatory Arthritis

Rheumatoid Arthritis Clinical Trial

— RxIALTA  

Official title:

RxIALTA: Pharmacist CVD Intervention for Patients With Inflammatory Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03152396
• Other study ID #: Pro00072858
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2017
• Last updated: July 25, 2017
• Start date: July 17, 2017
• Est. completion date: September 2018

Study information

• Verified date: July 2017
• Source: Epidemiology Coordinating and Research Centre, Canada
• Contact: Andrea M Morgan, BScPharm
• Phone: (403) 589-2576
• Email: andrea.morgan[@]ahs.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cardiovascular disease (CVD) (disease of the heart and blood vessels) is one of the leading causes of death and disability in Canada today. The majority of CVD cases are caused by factors that can be controlled. These factors include tobacco use, obesity, high blood pressure, high cholesterol, diabetes, and physical inactivity. Such factors are common and not well controlled. Inflammatory arthritis (IA) (Inflammation of the joints and other tissues) is considered another risk factor or CVD. As such, people who have IA and any of the previously mentioned risk factors would be at high risk for developing CVD. Controlling these factors will bring down the risk of having cardiovascular disease and make the quality of the individuals' life better. Pharmacists work with patients and their family doctors to provide cardiovascular care. Having a pharmacist involved in the care process may help patients with IA reduce their CV risk. Pharmacists are easier to reach and may have more opportunities to educate people about medications. This might lead to better prevention and control of cardiovascular diseases.

Description:

Cardiovascular disease (CVD) is one of the leading causes of morbidity and mortality worldwide and in Canada accounting for nearly one third of the total deaths in both instances.1-2 The majority of CVD cases are caused by modifiable risk factors such as tobacco use, obesity, hypertension, hyperlipidemia, diabetes and physical inactivity.3 Inflammatory arthritis, inclusive of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS), is also recognized as an independent risk factor for CVD.4-7

It has been reported that the risk of myocardial infarction (MI), heart failure (HF) and CV death among patients with IA is 2-3-fold greater than in the general population.8-10 This increased CV risk reflects the combined impact of systemic inflammation, burden of traditional CVD risk factors and impact of certain medications (e.g. steroids, non-steroidal anti-inflammatories [NSAIDs]).5,6 An elevated risk of CVD can be identified early after IA diagnosis, emphasizing the need for early efforts in CV risk screening.11

Despite being recommended by international IA management guidelines,7 CV risk assessment has not been incorporated into clinicians' daily routine.7 Indeed, it has been reported that such assessments generally only exist in larger centers for non-rheumatology patients.12-14 Moreover, Keeling and colleagues reported that most rheumatologists, who are the main care givers for IA patients, conducted suboptimal CV risk assessments. 15 This gap in care for patients with IA is not consistently absorbed by family physicians due to lack of recognition of CV risk in these patients and competing demands of other healthcare needs (e.g. other chronic diseases, cancer, diabetes). 7

Special considerations need to be taken into account when calculating CV risk in patients with IA, as the 'classic' risk engines (such as Framingham16) might underestimate the overall risk,17 since they have not been adequately evaluated in this patient population.18,5 For example, IA patients who might benefit from lipid-lowering agents may be categorized "low risk" when using the Framingham risk engine.17 As such it has been recommended to use a modified Framingham risk engine (multiply the overall risk with 1.5) in patients with IA. 19

CV risk screening and management in patients with IA takes time and effort, but can be performed by other trained health professionals. As such, it has been recommended to utilize a multidisciplinary approach (integration of rheumatology, cardiology and primary care) to support the care of IA patients.6,20-23 Pharmacists are front line, accessible, primary healthcare professionals who see patients more frequently than any other healthcare provider.24 The efficacy of their interventions in managing chronic diseases including osteoarthritis,25, diabetes,7, 26 dyslipidemia,27 hypertension,28,29 heart failure,30 and CVD 31-34 has been well demonstrated in the literature. Pharmacists can systematically identify patients at high risk of CVD,35 improve their medication use,36 and help them achieve their treatment targets.27,28 In addition to clinical outcomes, pharmacist involvement in patient care is associated with improved patient satisfaction and adherence to therapy.28,35,36 This evidence, coupled with their advanced scope of practice, ideally position pharmacists to conduct CV risk screening and management. In addition, Canadian pharmacists have access to practice guidelines for management and prevention of cardiovascular disease in the general population.37 They also have access to the RxEACH CV risk calculator, an interactive CV screening and management tool, which will help them determine CV risk, simply communicate contributing risks to patients, and show patients the impact of modifying their risks. 34

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (=18 years of age) who have a physician-diagnosed IA including

• Rheumatoid arthritis

• Psoriatic arthritis

• Ankylosing spondylitis

• To be eligible for inclusion, all patients must have at least one uncontrolled risk factor (i.e., blood pressure, LDL-cholesterol, HbA1c, or current tobacco use)

Exclusion Criteria:

• Patients will be excluded if they

• Are unwilling to participate/sign consent form

• Are unwilling or unable to participate in regular follow-up visits

• Are pregnant

• Have uncontrolled IA (i.e., during a disease exacerbation)

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Cardiovascular Risk Factor
• Inflammatory Arthritis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• CV risk assessment and modification of global risk
Individualized CV risk assessment using the validated RxEACH CV risk calculator for baseline and subsequent risk assessment. Pharmacists will assist patient's to decrease CV risk over 6 months thru education, medication modification, and monthly follow-up.

Locations

Country	Name	City	State
Canada	Calgary Co-operative Association Limited	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Epidemiology Coordinating and Research Centre, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CV risk	CV risk re-assessment with validated RxEACH CV risk calculator	6 months
Secondary	change in blood pressure	CV risk re-assessment with validated RxEACH CV risk calculator	6 months
Secondary	change in LDL-cholesterol	CV risk re-assessment with validated RxEACH CV risk calculator	6 months
Secondary	change in total-cholesterol	CV risk re-assessment with validated RxEACH CV risk calculator	6 months
Secondary	change in HDL-cholesterol	CV risk re-assessment with validated RxEACH CV risk calculator	6 months
Secondary	change in hemoglobin A1C	CV risk re-assessment with validated RxEACH CV risk calculator	6 months
Secondary	tobacco cessation	CV risk re-assessment with validated RxEACH CV risk calculator	6 months