Program for Research on the Outcomes of VA Education (PROVE)
1. mai 2018 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
5000
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
New York
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Brooklyn, New York, Forente stater, 11209
- VA NYHHS Brooklyn Campus
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New York, New York, Forente stater, 10010
- VA NYHHS Manhattan Campus
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- non-specialized primary care clinical microsystems
Exclusion Criteria:
- specialized clinical microsystems
- pilot clinical patient-aligned care teams
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: PM-Data
Team will receive data only.
|
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.
|
|
Eksperimentell: PM-Support
Team will receive data and panel management support
|
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.
Andre navn:
|
|
Eksperimentell: 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.
Andre navn:
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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
|
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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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Mark D Schwartz, VA New York Harbor Healthcare System
- Hovedetterforsker: 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
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. september 2009
Primær fullføring (Faktiske)
31. august 2014
Studiet fullført (Faktiske)
31. august 2015
Datoer for studieregistrering
Først innsendt
28. august 2012
Først innsendt som oppfylte QC-kriteriene
29. august 2012
Først lagt ut (Anslag)
3. september 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. mai 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. mai 2018
Sist bekreftet
1. mai 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EDU 08-428-2
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