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

1. maj 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

5000

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • Brooklyn, New York, Forenede Stater, 11209
        • VA NYHHS Brooklyn Campus
      • New York, New York, Forenede Stater, 10010
        • VA NYHHS Manhattan Campus

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • non-specialized primary care clinical microsystems

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: PM-Data
Team will receive data only.
Andet: 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.
Eksperimentel: PM-Support
Team will receive data and panel management support
Andet: 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.
Andet: 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.
Andre navne:
  • Panel management assistant
Eksperimentel: PM-Education
Team will receive data, panel management support, and educational interventions.
Andet: 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.
Andet: 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.
Andre navne:
  • Panel management assistant
Andet: 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.
Andre navne:
  • Pædagogisk intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Smoking Status
Tidsramme: Baseline and 12 months
clinical outcome
Baseline and 12 months
Change in Blood Pressure Reading
Tidsramme: Baseline and 12 months
clinical outcome
Baseline and 12 months

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Health care usage
Tidsramme: 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
Tidsramme: Baseline and 12 months
Outpatient primary care visits, mental health visits, pharmacy and hospitalizations from the VA Decision Support System
Baseline and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

VA New York Harbor Healthcare System

Efterforskere

  • Ledende efterforsker: Mark D Schwartz, VA New York Harbor Healthcare System
  • Ledende efterforsker: Scott Sherman, M.D., M.P.H., VA New York Harbor Healthcare System
  • Studieleder: Colleen Gillespie, PhD, NYU Langone Health
  • Studieleder: Anne Dembitzer, M.D., VA New York Harbor Healthcare System

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2009

Primær færdiggørelse (Faktiske)

31. august 2014

Studieafslutning (Faktiske)

31. august 2015

Datoer for studieregistrering

Først indsendt

28. august 2012

Først indsendt, der opfyldte QC-kriterier

29. august 2012

Først opslået (Skøn)

3. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2018

Sidst verificeret

1. maj 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EDU 08-428-2

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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