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MedStar Diabetes Pathway Chart Reviews (MedstarBC2)

16 octobre 2020 mis à jour par: Michelle Magee, Medstar Health Research Institute

Expanded MedStar Diabetes Pathway Ongoing Chart Review Protocol

The MedStar Diabetes Pathway (MDP) is transitioning into a clinical program offered at various MedStar sites. The MDP clinical team is reviewing the data collected during the pilot to improve the program and adapt it to various clinical settings in order to better serve the target patient population. It is imperative to continue reviewing patient clinical outcomes as the program expands in order to insure continuous quality improvement of the program. This will be achieved through chart reviews of patients receiving diabetes care via the MDP and comparison with patients received diabetes standard of care through their primary care physician.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

The MedStar Diabetes Pathway (MDP) early pilot program has generated evidence that an innovative technology-enabled "Boot Camp" approach to the delivery of diabetes survival skills education and medication management has a significant impact on glycemic control and healthcare utilization measures. The MDP is a 12 week Diabetes "Boot Camp" technology-enabled intervention which will offer learner-centered survival skills self-management education (DSSE) and algorithm-driven diabetes medications (DM) titration by Endocrinologist-supervised Certified Diabetes Educators (CDE), NPs and PharmDs. The program has been offered at 5 MedStar Medical Group (MMG) Primary Care Practices from November 2014 to February 2016 to high risk adults with uncontrolled type 2 diabetes who have a hemoglobin A1C (A1C) level -a marker of average blood glucose (BG) levels in the 2-3 months prior to the time the test is done- which is at or above 9% - considered to be poor control, and 1 or more additional risk factors for poor health outcomes. The program has been well received by MedStar Primary Care Providers and their diabetes patients. Patients that participated in the MDP achieved significantly higher A1C reduction and decreased risk risk for acute care utilization then matched controls that received standard of care. The pilot evidence demonstrated a significant impact on glycemic control and healthcare utilization measures as the result of a concise, focused DM education and medication management intervention. Building on the success of the MDP Phase 1.0 pilot, the next steps in expanding the program will be as follows:

  • Transition of the Pathway from early feasibility pilot to the next phase as an expanded pilot program integrated within the MedStar Health System care delivery network and built upon a sustainable infrastructure across early adopter MMG practice sites.
  • Expand recruitment to include high risk patients with uncontrolled type 2 diabetes, including those with a new diagnosis and A1C >9%, who have MedStar Emergency Department and/or Inpatient encounters
  • Spread to additional targeted MedStar Primary Care Practices and/or to MedStar Managed Care Plan participants.

Chart reviews and data collection during the expansion phase will be essential to guide the process and allow rapid cycle adjustments to maximize the impact of the program and utilization of resources for the benefit of our patients.

Type d'étude

Observationnel

Inscription (Réel)

826

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

21 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adult patients with uncontrolled type 2 diabetes that meet inclusion and exclusion criteria.

La description

Inclusion Criteria:

  • Diagnosis of Type 2 Diabetes, A1C equal or higher than 9%, active patient of medstar health provider, english speaking, willing and able to participate in the program

Exclusion Criteria:

  • A1C less than 9%, severe illness that precludes participation such severe congestive heart failure or COPD, advanced kidney disease, recent acute illness such as heart attack or stroke in the past 30 days, active cancer, severe mental illness, high dose steroid, other types of diabetes, pregnant or lactating.

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

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Cases
patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway
Autre: Intensive diabetes education and medication management
Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.
Matched controls
patients with uncontrolled type 2 diabetes that match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percent Change in A1C
Délai: 12-16 weeks
Change in Hemoglobin A1C from baseline to 12-16 weeks for both cases and controls
12-16 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Risk for Emergency Room Visits at 30 Days From Baseline as Measured by Incidence Risk Ratio
Délai: 30 days
Comparison of risk of incurring an emergency room visits at 30 days from baseline for cases and controls. This was done by calculating and comparing the incidence risk ratio for an ER visit for each group and comparing them.
30 days
Risk for Hospitalizations at 30 Days From Baseline
Délai: 30 days
Comparison of risk for experiencing a hospital visit within 30 days from baseline in both group. This was done by calculating the incidence risk ratio for hospitalizations for cases and controls at 30 days from baseline and comparing them.
30 days
Risk for Composite of Emergency Room Visits and Hospitalizations at 30 Days From Baseline
Délai: 30 days
Comparison for risk of experiencing a visit to the emergency room and/or the hospital at 30 days from baseline. This was measured by calculating the Incidence risk ratio for acute care utilization at 30 days from baseline for both cases and controls and comparing them.
30 days
Risk for Emergency Room Visits at 90 Days From Baseline
Délai: 90 days
Comparison of the risk of experiencing an emergency room visit at 90 days from baseline in both groups. This was done by calculating the Incidence risk ratio for an emergency room visit at 90 days for both cases and controls and comparing them
90 days
Risk for Hospitalizations at 90 Days From Baseline
Délai: 90 days
Comparison of the risk for experiencing a hospitalization within 90 days from baseline in both groups. This was done by calculating the Incidence Risk Ratio for hospitalizations for cases and controls within 90 days of baseline and comparing them.
90 days
Composite of Risk for Hospitalizations and Emergency Room Visits Within 90 Days From Baseline
Délai: 90 days
Comparison of the risk for experiencing a hospitalization and/or emergency room visit within 90 days from baseline for both groups. This was done by calculating then comparing the incidence risk ratio for acute care utilization within 90 days from baseline for cases and controls.
90 days

Collaborateurs et enquêteurs

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

Parrainer

Medstar Health Research Institute

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 (Réel)

1 juillet 2016

Achèvement primaire (Réel)

31 décembre 2018

Achèvement de l'étude (Réel)

28 février 2019

Dates d'inscription aux études

Première soumission

16 février 2018

Première soumission répondant aux critères de contrôle qualité

16 février 2018

Première publication (Réel)

22 février 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 octobre 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 octobre 2020

Dernière vérification

1 octobre 2020

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2016-143

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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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