Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

1 maja 2018 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

5000

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • New York
      • Brooklyn, New York, Stany Zjednoczone, 11209
        • VA NYHHS Brooklyn Campus
      • New York, New York, Stany Zjednoczone, 10010
        • VA NYHHS Manhattan Campus

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • non-specialized primary care clinical microsystems

Exclusion Criteria:

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: PM-Data
Team will receive data only.
Inny: 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.
Eksperymentalny: PM-Support
Team will receive data and panel management support
Inny: 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.
Inny: 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.
Inne nazwy:
  • Panel management assistant
Eksperymentalny: PM-Education
Team will receive data, panel management support, and educational interventions.
Inny: 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.
Inny: 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.
Inne nazwy:
  • Panel management assistant
Inny: 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.
Inne nazwy:
  • Interwencja edukacyjna

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Smoking Status
Ramy czasowe: Baseline and 12 months
clinical outcome
Baseline and 12 months
Change in Blood Pressure Reading
Ramy czasowe: Baseline and 12 months
clinical outcome
Baseline and 12 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in weight
Ramy czasowe: Baseline and most recent at 12 months
Baseline and most recent at 12 months
Change in Patient Activation
Ramy czasowe: 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
Ramy czasowe: 6 months and 12 months
6 months and 12 months
Change in Provider Behavior change expertise
Ramy czasowe: 6 months and 12 months
6 months and 12 months
Change in Provider Self-efficacy with Panel Management Tasks
Ramy czasowe: Baseline and 12 months
Baseline and 12 months
Change in Provider Job Satisfaction
Ramy czasowe: Baseline and 12 months
Baseline and 12 months
Change in Microsystem function and collective efficacy
Ramy czasowe: 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
Ramy czasowe: Baseline and 12 months
Baseline and 12 months
Change in Proportion of panel smokers offered smoking cessation resources by study arm
Ramy czasowe: Baseline and 12 months
Baseline and 12 months
Change in Proportion of smokers on the panel received any cessation medications
Ramy czasowe: Baseline and 12 months
This information will be culled from the Vista Smoking Database
Baseline and 12 months

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change in Health care usage
Ramy czasowe: 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
Ramy czasowe: Baseline and 12 months
Outpatient primary care visits, mental health visits, pharmacy and hospitalizations from the VA Decision Support System
Baseline and 12 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

VA New York Harbor Healthcare System

Śledczy

  • Główny śledczy: Mark D Schwartz, VA New York Harbor Healthcare System
  • Główny śledczy: Scott Sherman, M.D., M.P.H., VA New York Harbor Healthcare System
  • Dyrektor Studium: Colleen Gillespie, PhD, NYU Langone Health
  • Dyrektor Studium: Anne Dembitzer, M.D., VA New York Harbor Healthcare System

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 września 2009

Zakończenie podstawowe (Rzeczywisty)

31 sierpnia 2014

Ukończenie studiów (Rzeczywisty)

31 sierpnia 2015

Daty rejestracji na studia

Pierwszy przesłany

28 sierpnia 2012

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 sierpnia 2012

Pierwszy wysłany (Oszacować)

3 września 2012

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 maja 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 maja 2018

Ostatnia weryfikacja

1 maja 2018

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • EDU 08-428-2

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Data

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Ghana

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

3
Subskrybuj