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Program for Research on the Outcomes of VA Education

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01677533
Acronym
PROVE
Enrollment
5000
Registered
2012-09-03
Start date
2009-09-01
Completion date
2015-08-31
Last updated
2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Smoking Cessation

Keywords

Panel management, Clinical microsystems, Hypertension management, Smoking cessation, Continuing medical education, Quality improvement,, Population health

Brief summary

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.

Detailed description

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.

Interventions

OTHERData

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.

OTHERPanel 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.

OTHEREducation

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.

Sponsors

VA New York Harbor Healthcare System
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* non-specialized primary care clinical microsystems

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Blood Pressure ReadingBaseline and 12 monthsclinical outcome
Change in Smoking StatusBaseline and 12 monthsclinical outcome

Secondary

MeasureTime frameDescription
Change in Patient Activation6 months and 12 monthsThe Patient Activation Measure (PAM) is used to assess patients' self-reported knowledge, skill, and confidence in self-managing of health and chronic conditions
Change in Patient Perceptions of Quality of Care6 months and 12 months
Change in Provider Behavior change expertise6 months and 12 months
Change in Provider Self-efficacy with Panel Management TasksBaseline and 12 months
Change in Microsystem function and collective efficacyBaseline and 12 months
Change in Provider's assessments of training that they received in panel management and working within a PACT teamBaseline and 12 months
Change in Proportion of panel smokers offered smoking cessation resources by study armBaseline and 12 months
Change in Proportion of smokers on the panel received any cessation medicationsBaseline and 12 monthsThis information will be culled from the Vista Smoking Database
Change in Provider Job SatisfactionBaseline and 12 months
Change in weightBaseline and most recent at 12 months

Other

MeasureTime frameDescription
Change in Health care usageBaseline and 12 monthsNumber of primary care visits, mental health visits, emergency room/urgent care visits and the number of VA hospitalizations
Change in Patient-level costsBaseline and 12 monthsOutpatient primary care visits, mental health visits, pharmacy and hospitalizations from the VA Decision Support System

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026