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The Effectiveness of Improving Compliance With Diabetic Preventative Services and Modifying Vascular Risk

20 septembre 2013 mis à jour par: University of Chicago

The Effectiveness of Nurse Practitioner Led Group Visits in Improving Compliance With Diabetic Preventative Services and Modifying Vascular Risk

The purpose of the study is to evaluate the feasibility and efficacy of group visits led by nurse practitioners in improving diabetic preventive services and vascular risk. Diabetes is notable for its high burden on the health of urban populations, a rich literature supporting evidenced based care, and great opportunities to apply systemic primary care interventions to reduce its toll. Extensive literature demonstrates sub-optimal care in the community as well as in academic centers. Addressing the needs of patients with diabetes is challenging in the primary-care environment and nurse case management and disease-specific group visits which focus on education and self-management skills have been shown to be useful adjuncts to traditional outpatient care.

The study will attempt to demonstrate that nurse practitioner run group visits, during which the NP will provide didactic education, facilitate group interaction, and arrange referrals and laboratory testing as appropriate, will improve compliance with established American Diabetes Association guidelines for screening and preventive care and in doing so lower cardiovascular risk. Satisfaction with care, quality of life, and diabetic knowledge will be assessed before and after the patients complete the program. In addition, we will attempt to characterize barriers to care for patients who were formerly established with a primary care physician in the Primary Care Group, but who have not received diabetic care there for at least one year.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

Patients who are 40 to 79 years old, and who have had at least three visits with a primary care physician will be the focus of the study. Patients will be recruited by letter, co-signed by the PCP and the study P1 A second letter will be sent 2 weeks after the first. After an intake visit, random allocation will divide 150 patients into 2 arms, one a series of 3 NP-led group classes and the other, usual care. Baseline data, including blood pressure control, foot and retinal examination rates, serum lipids, Alc, microalbumin, pneumococcal vaccination, smoking status and counseling, and ASA and lipid medication use will be assessed at enrollment and again at completion of the study. In addition patients will complete a diabetic knowledge scale, quality of life assessment (SF- 12) and ADA patient satisfaction survey. Several measures will be gathered both by chart review and oral administration of the CDC's BRFSS 2002 diabetes module survey, permitting cross validation. Statistical analysis of the differences between proportions (2x2 for independent samples) will be performed using chi-square. Preliminary power analysis (Power Precision; Biostat, Englewood, NJ) suggests adequate power (using Fisher's exact test, alpha beta 0.1, assuming reasonably achievable effect sizes) for at least several intermediate outcomes.

Patients in the 'group visit' arm are expected to attend three 90-minute educational group visits over six months, with group visits directed by a nurse practitioner. Patients will be asked to attend three sessions (8-10 patients in each) within six months. All patients will continue to see their primary care physicians as scheduled. The focus of the visits will be on diabetic and vascular risk goals, dietary education, and self-management skills. A graphical 'Diabetic Health Tracker' modified from Chapin et al will be provided to group class attendees; such an intervention may improve vascular risk endpoints. The group visit provider team will have the ability to make referrals, administer recommended vaccines, and adjust medications in consultation with the primary care physician; NPs will also make phone contact with the class group members between visits to report results and help assure follow-up; such case management functions may also improve outcomes. Additional telephone outreach will be made to patients who both: 1) do respond to the 2 recruiting letters, and 2) who have not been seen in the past 12 months in order review barriers to care. A brief phone screen for depression will be considered given data linking depression to non-adherence.

As the burden of chronic illness rises along with healthcare costs, innovative approaches are required. Diabetes care has been repeatedly identified by government and private payers as area of focus and perhaps even a future subject for "pay for performance". We hope our study can contribute to better diabetic care and, in the longer term, to improved patient health.

Type d'étude

Interventionnel

Inscription

150

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

    • Illinois
      • Chicago, Illinois, États-Unis, 60637
        • The University of Chicago

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 79 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • All diabetic patients age 40-79 who are followed in the Primary Care Group for Type 2 diabetes and who have seen their PCP at least 3 times in order to establish regular care

Exclusion Criteria:

  • Patients younger than 40 years of age

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 ?

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Nurse practitioner run group visits will improve compliance with established American Diabetes Association guidelines for screening and preventive care

Mesures de résultats secondaires

Mesure des résultats
Compliance with established American Diabetes Association guidelines for screening and preventive care will lower cardiovascular risk

Collaborateurs et enquêteurs

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

Les enquêteurs

  • Chercheur principal: Andrew Davis, M.D., University of Chicago

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 août 2003

Achèvement de l'étude

1 décembre 2005

Dates d'inscription aux études

Première soumission

12 septembre 2005

Première soumission répondant aux critères de contrôle qualité

12 septembre 2005

Première publication (Estimation)

20 septembre 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

23 septembre 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 septembre 2013

Dernière vérification

1 septembre 2013

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 12567A

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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