Program for Research on the Outcomes of VA Education (PROVE)
1 mai 2018 mis à jour par: Mark Schwartz, VA New York Harbor Healthcare System
Program for Research on the Outcomes of VA Education: Controlled Study of Panel Management and Microsystem Education Interventions to Improve Outcomes in Hypertension and Smoking Cessation
The PROVE aims to test the efficacy of panel management support and educational intervention in VA Primary Care Clinical Microsystems.
The study will test three increasingly intensive methods for implementing panel management strategies among health care providers in VA primary care clinics: providing only panel data, providing panel management support, and providing support plus clinical microsystem-enhancing education and training.It is hypothesized that the group receiving panel management and educational interventions will have better smoking cessation and hypertension outcomes than the group receiving only panel management assistance.
It is further supposed that the later will have better smoking cessation and hypertension patient outcomes than the data-only group.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Objective:
The specific aims for this study are: (1) to identify health professional educational and clinical microsystem determinants of outcomes for hypertension and smoking cessation in veterans. (2) to test the efficacy of three increasingly intensive methods for implementing panel management strategies among health care providers in VA primary care clinics: providing only panel data, providing panel management support, and providing support plus clinical microsystem-enhancing education and training.
Research design:
This project will consist of two phases. Phase I (one year) is the development of the necessary measurement and data infrastructure to assess health professional education, microsystem function, and clinical outcomes. In Phase 2 (two years) the study team will conduct a clinical demonstration project, comparing three interventions in a randomized controlled trial. Primary care teams will be randomly allocated to one of three arms: 1) panel management data, 2) panel management data and support, and 3) panel management data, support and education. The investigators will assess the impact of the implementation of panel management on primary patient outcomes in hypertension and smoking cessation (blood pressure and quit rates). The investigative team will also assess the impact of the implementation of panel management on secondary, intermediary, patient (patient activation, adherence, behavior change), provider (knowledge and attitudes, self-efficacy, job satisfaction) and microsystem outcomes (collective efficacy, teamwork, use of data, redesign of patient processes and provider roles/responsibilities, use of panel management strategies).
Methodology:
The study will utilize a multi-method, quasi-experimental design at VA NYHHS. Primary care is delivered through two teams at the Manhattan and five teams at the Brooklyn campuses. Patients, staff, nurses, and physicians are assigned to specific teams, thereby limiting contamination in this study.
Type d'étude
Interventionnel
Inscription (Réel)
5000
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
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New York
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Brooklyn, New York, États-Unis, 11209
- VA NYHHS Brooklyn Campus
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New York, New York, États-Unis, 10010
- VA NYHHS Manhattan Campus
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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
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- non-specialized primary care clinical microsystems
Exclusion Criteria:
- specialized clinical microsystems
- pilot clinical patient-aligned care teams
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 |
|---|---|
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Comparateur actif: PM-Data
Team will receive data only.
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The microsystem teams of providers, nurses, and clerks will receive monthly reports of their performance measures, which will include process and outcome data for smoking cessation and blood pressure control for veterans in their panel.
The reports will provide lists of individual patients in the panel with unmet goals on VA performance measures.
They will receive written informational material describing principles and practices of panel management and evidence-based guidelines for hypertension management and smoking cessation.
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Expérimental: PM-Support
Team will receive data and panel management support
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The microsystem teams of providers, nurses, and clerks will receive monthly reports of their performance measures, which will include process and outcome data for smoking cessation and blood pressure control for veterans in their panel.
The reports will provide lists of individual patients in the panel with unmet goals on VA performance measures.
They will receive written informational material describing principles and practices of panel management and evidence-based guidelines for hypertension management and smoking cessation.
PMAs will meet regularly with the members of the microsystem team for one hour/week.
The team will be asked to review progress on the health status of their patient panel and to plan strategies for improving their outcomes that the PMA will then implement.
A PMA toolkit of panel management strategies will be established that will include guidelines for using VA databases to identify care gaps and reaching out to panel patients via phone and mail to intervene (e.g.
reconnect patients to care with appointments, assess and enhance medication adherence, connect patients with VA services, motivational interviewing, and communication with the team about patient issues.
Autres noms:
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Expérimental: PM-Education
Team will receive data, panel management support, and educational interventions.
|
The microsystem teams of providers, nurses, and clerks will receive monthly reports of their performance measures, which will include process and outcome data for smoking cessation and blood pressure control for veterans in their panel.
The reports will provide lists of individual patients in the panel with unmet goals on VA performance measures.
They will receive written informational material describing principles and practices of panel management and evidence-based guidelines for hypertension management and smoking cessation.
PMAs will meet regularly with the members of the microsystem team for one hour/week.
The team will be asked to review progress on the health status of their patient panel and to plan strategies for improving their outcomes that the PMA will then implement.
A PMA toolkit of panel management strategies will be established that will include guidelines for using VA databases to identify care gaps and reaching out to panel patients via phone and mail to intervene (e.g.
reconnect patients to care with appointments, assess and enhance medication adherence, connect patients with VA services, motivational interviewing, and communication with the team about patient issues.
Autres noms:
The educational intervention will be administered throughout the duration of the study.
Our initial educational focus will be on content (concepts of population health and panel management) and process (practice change methodology).
Subsequent education will be process oriented, reviewing the changing system of care and discussing its functioning.
Education will cover panel management strategies, microsystem theory and skills, and specific strategies regarding the management of hypertension and smoking cessation.
It will include monthly seminars, reading materials, web-based modules, and skill building workshops, and PMA-conducted monthly academic detailing using panel data and feedback.
After the first three months, academic detailing will only be implemented on an as-needed basis.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Smoking Status
Délai: Baseline and 12 months
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clinical outcome
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Baseline and 12 months
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Change in Blood Pressure Reading
Délai: Baseline and 12 months
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clinical outcome
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Baseline and 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in weight
Délai: Baseline and most recent at 12 months
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Baseline and most recent at 12 months
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Change in Patient Activation
Délai: 6 months and 12 months
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The Patient Activation Measure (PAM) is used to assess patients' self-reported knowledge, skill, and confidence in self-managing of health and chronic conditions
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6 months and 12 months
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Change in Patient Perceptions of Quality of Care
Délai: 6 months and 12 months
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6 months and 12 months
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Change in Provider Behavior change expertise
Délai: 6 months and 12 months
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6 months and 12 months
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|
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Change in Provider Self-efficacy with Panel Management Tasks
Délai: Baseline and 12 months
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Baseline and 12 months
|
|
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Change in Provider Job Satisfaction
Délai: Baseline and 12 months
|
Baseline and 12 months
|
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Change in Microsystem function and collective efficacy
Délai: Baseline and 12 months
|
Baseline and 12 months
|
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Change in Provider's assessments of training that they received in panel management and working within a PACT team
Délai: Baseline and 12 months
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Baseline and 12 months
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Change in Proportion of panel smokers offered smoking cessation resources by study arm
Délai: Baseline and 12 months
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Baseline and 12 months
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Change in Proportion of smokers on the panel received any cessation medications
Délai: Baseline and 12 months
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This information will be culled from the Vista Smoking Database
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Baseline and 12 months
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Health care usage
Délai: Baseline and 12 months
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Number of primary care visits, mental health visits, emergency room/urgent care visits and the number of VA hospitalizations
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Baseline and 12 months
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Change in Patient-level costs
Délai: Baseline and 12 months
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Outpatient primary care visits, mental health visits, pharmacy and hospitalizations from the VA Decision Support System
|
Baseline and 12 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Mark D Schwartz, VA New York Harbor Healthcare System
- Chercheur principal: Scott Sherman, M.D., M.P.H., VA New York Harbor Healthcare System
- Directeur d'études: Colleen Gillespie, PhD, NYU Langone Health
- Directeur d'études: Anne Dembitzer, M.D., VA New York Harbor Healthcare System
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.
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 septembre 2009
Achèvement primaire (Réel)
31 août 2014
Achèvement de l'étude (Réel)
31 août 2015
Dates d'inscription aux études
Première soumission
28 août 2012
Première soumission répondant aux critères de contrôle qualité
29 août 2012
Première publication (Estimation)
3 septembre 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 mai 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 mai 2018
Dernière vérification
1 mai 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EDU 08-428-2
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