Impact of Implementation Strategies on Lp(a) Testing in Secondary Care Settings

Официальное название

Lp(a)CCELERATE: Impact of Implementation Strategies on Lp(a) Testing in Secondary Care Settings

Обзор

Lipoprotein(a) \[Lp(a)\] is recognised as an independent, non-modifiable genetic risk factor for cardiovascular (CV) disease. Current guidelines from the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) recommend that Lp(a) be measured at least once in every adult's lifetime, however routine Lp(a) testing rates remains infrequent. The aim of this study is to assess the impact of implementation strategies (IStr) designed to increase the adoption of Lp(a) testing in routine practice, ultimately leading to more individuals being tested in secondary care. This, in turn, is expected to result in the identification and enhanced management of Cardiovascular Disease (CVD) risk patients with elevated Lp(a).

Первичные конечные точки

• Proportion of patients with at least one Lp(a) test prescribed at 12 months post-Implementation Strategy (IStr) vs 12 months pre-IStr [Срок оценки: 12 months pre-IStr, 12 months post IStr]

Вторичные конечные точки (4)

• Proportion of patients with at least one Lp(a) test prescribed at 6 and 12 months post-IStr compared to 12 months pre-IStr [Срок оценки: 12 months pre-IStr to 6 months post and 12 months pre-IStr to 24 months post]
• Change in proportion of patients with at least one Lp(a) test prescribed 12 months post IStr vs 12 months pre-IStr by pre-defined subgroups of interest [Срок оценки: 12 months pre-IStr, 12 months post IStr]
• Proportion of tested patients with elevated Lp(a) before and after the implementation of IStr [Срок оценки: 12 months pre-IStr, 12 months post-IStr]
• Proportion of HCPs indicating feasibility, appropriateness, and acceptability of interventions post-IStr vs pre-IStr [Срок оценки: 6 and 12 months post-IStr]

Критерии участия

Критерии включения

Each cluster within this study has a set of inclusion criteria. In addition, to be eligible for inclusion in this study, all the following criteria at the cluster-level must be met:

Inclusion criteria for centers:

• Lp(a) testing is available in this center and reimbursed.
• Capacity to increase Lp(a) testing in relevant patient groups (according to the defined patient eligibility criteria).
• Low and/or inconsistent Lp(a) testing rate(number of eligible patients tested for Lp(a)/number of eligible patients seen) <15%.
• Willingness to fulfill research requirements, e.g., repurposing existing clinic data for research etc.
• Seeing a defined number of eligible patients per year based on the sample size required for the study.
• Availability of local infrastructure and data interoperability.

Inclusion criteria for HCP survey participants:

1\. CV specialists or other HCPs managing and accessing CV risk at their respective centers (cardiology units or equivalent).

Electronic records are eligible for assessment in this study if they meet all the following criteria:

• ICF and/or ICF waiver will be sought prior to abstraction of electronic patient records.
• Patients attending at least one SOC visit during the pre-defined time intervals (12 months prior to index date and 0-6 months, 7-12 months and 13-24 months post-index).
• Previous Lp(a) testing:

• Patients with an Lp(a) test recorded before the index date will be included in the baseline assessment, which covers the 12 months prior to the index date.
• For post-index assessments at 6-, 12- and 24-months after the index date, patients with an Lp(a) test recorded before the index date will be excluded.
• Over 18 years of age and qualify for Lp(a) testing according to local practice.

Критерии исключения

Exclusion criteria at center cluster-level includes:

• Centers with no access to Lp(a) testing.
• Centers where Lp(a) testing is not reimbursed.

Electronic records will not be assessed for:

1\. Patients that have undergone Lp(a) testing prior to index date (for the post-index assessment)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• Novartis Investigative Site — Nuremberg

Идентификаторы

NCT: NCT07508007 · CTQJ230A12012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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