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Tailored intervention to improve cardiovascular risk management in primary care.

Effectiveness of a tailored intervention to improve cardiovascular risk management in primary care; a study protocol of a cluster randomized trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23209
Enrollment
30
Registered
2013-07-11
Start date
2013-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Een interventie programma op maat gericht op de praktijkondersteuner en patient met hart- en vaatziekten of een hoog risico hierop. tailored intervention program aimed at practide nurses and patient with cardiovascular diseases or at high risk

Interventions

Practice nurses will be guided by a professional trainer who is affiliated with MINTned (Dutch association of trainers in motivational interviewing). The trainer will provide feedback directly after

Sponsors

the study is conducted by the research team of UMC St Radboud, department IQ Healthcare
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Eligible patients will be extracted from the medical records by using International Classification of Primary Care (ICPC) codes, K74-K76, K85-K92, K99.1 and T93. Eligible patients are adults aged 18 or older, have a high risk of CVD (but no known CVD) or established CVD and are capable of providing informed consent. Patients at high risk have a risk score of 20% or higher of morbidity and mortality due to CVD based on age, gender, smoking status, systolic blood pressure and total cholesterol/ high density lipoprotein (HDL) cholesterol.

Exclusion criteria

Exclusion criteria: Exclusion criteria are: [1] diabetes mellitus, [2] pregnancy and lactation, [3] terminal illness, [4] cognitive impairments, access and [5] poor language skills. Patients with diabetes mellitus will be excluded because this illness has its own guideline/standard of care.

Design outcomes

Primary

MeasureTime frame
The primary outcome refers to the professional performance of practice nurses and reflects application of recommendations for personalized counselling and education of CVRM patients. As a primary outcome, a dichotomous score is created for measurement in each patient, reflecting adequate or inadequate performance. We considered practice nurses¡¦ professional performance to be adequate when at least one of the following conditions are met: 1)There is a record in the patients¡¦ medical file or other healthcare provider-based records that the patient has received advice on at least one lifestyle item as specified in prevailing guidelines of CVRM; diet, smoking or physical exercise, and which are relevant for the individual patient in the previous six months. Also at least one target for improving an aspect of lifestyle is recorded. This target is made up to maximal 15 months ago. When a patient has a perfect lifestyle then that will be recorded. 2)There is a notation in the patients¡¦ medical file that the patient has none, mild or major depressive symptoms and that the patient has been referred to E-health, a physical exercise group, or depression treatment respectively.

Secondary

MeasureTime frame
The secondary outcomes consist of the following: • Practice nurses Quality of effective referral: Using data from patients¡¦ medical files and the patient questionnaires, we will assess whether practice nurses referred patients to treatment options (E-health, a physical exercise group, or depression treatment) in accordance with our recommendations on depressive symptoms. This measurement of quality represents correct referral and is thus an extension of measurement of referral as defined in the primary outcome. Quality of motivational interviewing: For assessment of quality of motivational interviewing skills, audio taped interviews of practice nurses in the intervention group and control group will be transcribed verbatim and will be coded by trainers using the Motivational Interviewing Treatment Integrity (MITI) code. Results of these coding will be compared with baseline after six months. • Patients Cardiovascular risk predictors Using prevailing risk estimation tables (based on the Euro score data), the following parameters are used for calculation of the risk score for patients at high risk for CVD; age, gender, smoking status, systolic blood pressure and total cholesterol/ HDL- cholesterol ratio). For patients with established CVD smoking status, systolic blood pressure and total cholesterol/ HDL- cholesterol ratio will be used. Change of the parameters will be measured before and after implementation of the tailored intervention. Self-management: Using a composite questionnaire, we will assess whether patients applied lifestyle advices for improving their self-management. This questionnaire will be send at the start of the implementation program and after six months. The questionnaire will be sent to the patients home address.

Contacts

Public ContactElke Huntink

Geert Grooteplein Noord 21 postbus 9101

E.Huntink@iq.umcn.nl024-3619641

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)