Program for Research on the Outcomes of VA Education (PROVE)
1 mei 2018 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
5000
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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New York
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Brooklyn, New York, Verenigde Staten, 11209
- VA NYHHS Brooklyn Campus
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New York, New York, Verenigde Staten, 10010
- VA NYHHS Manhattan Campus
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- non-specialized primary care clinical microsystems
Exclusion Criteria:
- specialized clinical microsystems
- pilot clinical patient-aligned care teams
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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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Experimenteel: 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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Smoking Status
Tijdsspanne: 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
Tijdsspanne: Baseline and 12 months
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clinical outcome
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Baseline and 12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in weight
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 6 months and 12 months
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6 months and 12 months
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Change in Provider Behavior change expertise
Tijdsspanne: 6 months and 12 months
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6 months and 12 months
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Change in Provider Self-efficacy with Panel Management Tasks
Tijdsspanne: Baseline and 12 months
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Baseline and 12 months
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Change in Provider Job Satisfaction
Tijdsspanne: Baseline and 12 months
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Baseline and 12 months
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Change in Microsystem function and collective efficacy
Tijdsspanne: Baseline and 12 months
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Health care usage
Tijdsspanne: Baseline and 12 months
|
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
Tijdsspanne: Baseline and 12 months
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Outpatient primary care visits, mental health visits, pharmacy and hospitalizations from the VA Decision Support System
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Baseline and 12 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Mark D Schwartz, VA New York Harbor Healthcare System
- Hoofdonderzoeker: Scott Sherman, M.D., M.P.H., VA New York Harbor Healthcare System
- Studie directeur: Colleen Gillespie, PhD, NYU Langone Health
- Studie directeur: Anne Dembitzer, M.D., VA New York Harbor Healthcare System
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 september 2009
Primaire voltooiing (Werkelijk)
31 augustus 2014
Studie voltooiing (Werkelijk)
31 augustus 2015
Studieregistratiedata
Eerst ingediend
28 augustus 2012
Eerst ingediend dat voldeed aan de QC-criteria
29 augustus 2012
Eerst geplaatst (Schatting)
3 september 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
7 mei 2018
Laatste update ingediend die voldeed aan QC-criteria
1 mei 2018
Laatst geverifieerd
1 mei 2018
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EDU 08-428-2
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