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Patient-Centered Adherence Intervention After Acute Coronary Syndrome (ACS) Hospitalization (MEDICATION)

6 avril 2015 mis à jour par: US Department of Veterans Affairs

Patient-Centered Adherence Intervention After ACS Hospitalization

We propose to test the effectiveness of a multi-faceted patient-centered adherence intervention among veterans following ACS hospitalization to improve adherence to cardioprotective medications (primary aim). Secondary aims will assess whether the intervention improves achievement of secondary prevention blood pressure (BP) and low density lipoprotein (LDL)-cholesterol goals, reduces cardiac endpoints (myocardial infarction ) MI hospitalization, coronary revascularization, all-cause mortality) and is cost-effective.

ANTICIPATED IMPACT(S) : If successful, the proposed intervention will increase adherence to cardioprotective medications (i.e., -blockers, statins, clopidogrel, and ACE inhibitors) by helping veterans take their medications routinely as prescribed, the quality of cardiovascular care for veterans by helping patients achieve BP and LDL goals which have been associated with improved outcomes, and the efficiency of care by using telephone calls and tele-monitoring for communication with patients rather than clinic visits. The findings of the study will address an important gap in knowledge (i.e., how to improve adherence to medications following ACS discharge) and will be generalizable to other VA Medical Centers and veterans.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

RATIONALE: Acute coronary syndrome, including acute myocardial infarction (MI) is one of the leading causes of hospitalization for veterans. Recent advances in the treatment of acute MI have led to declines in hospital mortality. Despite this, the risk of recurrent events and mortality after the index MI hospitalization remains substantial in the following year. Non-adherence to proven cardioprotective medications is a potentially modifiable risk factor that contributes to the persistently high risk of adverse outcomes following MI hospitalization. Prior interventions to improve medication adherence in cardiovascular populations have produced mixed results and have not specifically targeted patients after acute coronary syndrome (ACS) hospital discharge. It is currently unknown if interventions targeting medication non-adherence in the year after ACS discharge will improve medication adherence and intermediate outcomes or will be cost-effective

OBJECTIVE(S): We propose to test the effectiveness of a multi-faceted patient-centered adherence intervention among veterans following ACS hospitalization to improve adherence to cardioprotective medications (primary aim). Secondary aims will assess whether the intervention improves achievement of secondary prevention blood pressure (BP) and LDL-cholesterol goals, reduces cardiac endpoints (MI hospitalization, coronary revascularization, all-cause mortality) and is cost-effective.

METHODS: We propose a 3-year, multi-site patient-level randomized controlled trial to evaluate, relative to usual care, a multi-faceted patient-centered intervention to improve adherence to cardioprotective medication among veterans following ACS hospital discharge. The study will enroll 280 patients to intervention versus usual care for 12-months at 3 VA Medical Centers (Eastern Colorado, Pudget Sound, and Central Arkansas). The proposed intervention will be based on several conceptual frameworks (Chronic Care Model and Medication Adherence Model) and adapt elements of prior successfully adherence interventions, including: collaborative care, patient education, tailoring of medication regimens, and tele-monitoring. The primary analyses will be a comparison of adherence to cardioprotective medications using pharmacy refill records based on the ReCOMP adherence measure developed in the VA. Secondary analyses will compare achievement of secondary prevention BP and LDL goals and cardiac events. In addition, cost-effectiveness analysis will be performed. All analyses will be intention to treat

Type d'étude

Interventionnel

Inscription (Réel)

253

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Arkansas
      • Little Rock, Arkansas, États-Unis, 72205-5484
        • Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
    • Colorado
      • Denver, Colorado, États-Unis, 80220
        • VA Eastern Colorado Health Care System, Denver, CO
    • North Carolina
      • Durham, North Carolina, États-Unis, 27705
        • Durham VA Medical Center, Durham, NC
    • Washington
      • Seattle, Washington, États-Unis, 98108
        • VA Puget Sound Health Care System, Seattle

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 90 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

All patients admitted with acute coronary syndrome (ACS) as the primary reason for hospital admission and use the VA for their usual source of care, defined as having 1 primary care visit within the 12 months prior to hospital admission will be screened for eligibility to participate. ACS is defined as acute myocardial infarction (both ST-elevation MI and non-ST elevation MI) or unstable angina. The presence of acute myocardial infarction will be defined using standard definitions from an international consensus statement, based on the following: a rise and/or fall of cardiac biomarkers (preferably troponin) with at least one value above the 99th percentile of the upper reference limit and at least one of the following:

  • symptoms of ischemia;
  • ECG change indicative of new ischemia (new ST-T changes or new left bundle branch block);
  • development of pathological Q waves in the ECG; or
  • imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.42 Unstable angina will be defined by presence of ischemic symptoms and ECG changes indicative of new ischemia but without biomarker evidence of myonecrosis (i.e., biomarker elevation) and no evidence of new pathological Q waves, loss of viable myocardium or regional wall motion abnormality.

Exclusion Criteria:

  • Patient admitted for primary non-cardiac diagnosis and develop ACS as a secondary condition (e.g. perioperative MI);
  • planned discharge to nursing home or skilled nursing facility;
  • irreversible, non-cardiac medical condition (e.g. metastatic cancer) likely to affect 6-month survival or ability to execute study protocol;
  • lack of telephone/cell phone;
  • VA is not primary source of care;
  • regularly fill medications at non-VA pharmacy.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Arm 1
The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.
Comportemental: Intervention
The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.
Comparateur actif: Arm 2
Patients will receive usual care following ACS hospital discharge
Comportemental: Usual care
Usual care following ACS hospital discharge.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB)
Délai: 12-months
The primary outcome was the proportion of patients who were adherent to cardioprotective medications (beta-blockers, statins, clopidogrel, and ACE/ARB) in the year following ACS hospitalization.
12-months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

US Department of Veterans Affairs

Les enquêteurs

  • Chercheur principal: Michael Ho, MD PhD, VA Eastern Colorado Health Care System, Denver, CO

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juillet 2010

Achèvement primaire (Réel)

1 mars 2013

Achèvement de l'étude (Réel)

1 août 2013

Dates d'inscription aux études

Première soumission

13 mai 2009

Première soumission répondant aux critères de contrôle qualité

14 mai 2009

Première publication (Estimation)

15 mai 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

27 avril 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 avril 2015

Dernière vérification

1 septembre 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IIR 08-302

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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