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Program for Research on the Outcomes of VA Education (PROVE)

1 maggio 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

5000

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • New York
      • Brooklyn, New York, Stati Uniti, 11209
        • VA NYHHS Brooklyn Campus
      • New York, New York, Stati Uniti, 10010
        • VA NYHHS Manhattan Campus

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • non-specialized primary care clinical microsystems

Exclusion Criteria:

  • specialized clinical microsystems
  • pilot clinical patient-aligned care teams

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: PM-Data
Team will receive data only.
Altro: Data
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.
Sperimentale: PM-Support
Team will receive data and panel management support
Altro: Data
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.
Altro: Panel Management Support
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.
Altri nomi:
  • Panel management assistant
Sperimentale: PM-Education
Team will receive data, panel management support, and educational interventions.
Altro: Data
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.
Altro: Panel Management Support
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.
Altri nomi:
  • Panel management assistant
Altro: Education
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.
Altri nomi:
  • Intervento Educativo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Smoking Status
Lasso di tempo: Baseline and 12 months
clinical outcome
Baseline and 12 months
Change in Blood Pressure Reading
Lasso di tempo: Baseline and 12 months
clinical outcome
Baseline and 12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in weight
Lasso di tempo: Baseline and most recent at 12 months
Baseline and most recent at 12 months
Change in Patient Activation
Lasso di tempo: 6 months and 12 months
The Patient Activation Measure (PAM) is used to assess patients' self-reported knowledge, skill, and confidence in self-managing of health and chronic conditions
6 months and 12 months
Change in Patient Perceptions of Quality of Care
Lasso di tempo: 6 months and 12 months
6 months and 12 months
Change in Provider Behavior change expertise
Lasso di tempo: 6 months and 12 months
6 months and 12 months
Change in Provider Self-efficacy with Panel Management Tasks
Lasso di tempo: Baseline and 12 months
Baseline and 12 months
Change in Provider Job Satisfaction
Lasso di tempo: Baseline and 12 months
Baseline and 12 months
Change in Microsystem function and collective efficacy
Lasso di tempo: Baseline and 12 months
Baseline and 12 months
Change in Provider's assessments of training that they received in panel management and working within a PACT team
Lasso di tempo: Baseline and 12 months
Baseline and 12 months
Change in Proportion of panel smokers offered smoking cessation resources by study arm
Lasso di tempo: Baseline and 12 months
Baseline and 12 months
Change in Proportion of smokers on the panel received any cessation medications
Lasso di tempo: Baseline and 12 months
This information will be culled from the Vista Smoking Database
Baseline and 12 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Health care usage
Lasso di tempo: Baseline and 12 months
Number of primary care visits, mental health visits, emergency room/urgent care visits and the number of VA hospitalizations
Baseline and 12 months
Change in Patient-level costs
Lasso di tempo: Baseline and 12 months
Outpatient primary care visits, mental health visits, pharmacy and hospitalizations from the VA Decision Support System
Baseline and 12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

VA New York Harbor Healthcare System

Investigatori

  • Investigatore principale: Mark D Schwartz, VA New York Harbor Healthcare System
  • Investigatore principale: Scott Sherman, M.D., M.P.H., VA New York Harbor Healthcare System
  • Direttore dello studio: Colleen Gillespie, PhD, NYU Langone Health
  • Direttore dello studio: Anne Dembitzer, M.D., VA New York Harbor Healthcare System

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 settembre 2009

Completamento primario (Effettivo)

31 agosto 2014

Completamento dello studio (Effettivo)

31 agosto 2015

Date di iscrizione allo studio

Primo inviato

28 agosto 2012

Primo inviato che soddisfa i criteri di controllo qualità

29 agosto 2012

Primo Inserito (Stima)

3 settembre 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 maggio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 maggio 2018

Ultimo verificato

1 maggio 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • EDU 08-428-2

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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