Clinical trial NCT01677533: Program for Research on the Outcomes of VA Education
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Smoking Cessation
Keywords: Panel management
Clinical microsystems
Hypertension management
Smoking cessation
Continuing medical education
Quality improvement,
Population health
Lead sponsor: VA New York Harbor Healthcare System
Sponsor class: FED
First posted: 2012-09-03
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* non-specialized primary care clinical microsystems

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Smoking Status
timeFrame: Baseline and 12 months
measure: Change in Blood Pressure Reading
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in weight
timeFrame: Baseline and most recent at 12 months
measure: Change in Patient Activation
timeFrame: 6 months and 12 months
measure: Change in Patient Perceptions of Quality of Care
timeFrame: 6 months and 12 months
measure: Change in Provider Behavior change expertise
timeFrame: 6 months and 12 months
measure: Change in Provider Self-efficacy with Panel Management Tasks
timeFrame: Baseline and 12 months
measure: Change in Provider Job Satisfaction
timeFrame: Baseline and 12 months
measure: Change in Microsystem function and collective efficacy
timeFrame: Baseline and 12 months
measure: Change in Provider's assessments of training that they received in panel management and working within a PACT team
timeFrame: Baseline and 12 months
measure: Change in Proportion of panel smokers offered smoking cessation resources by study arm
timeFrame: Baseline and 12 months
measure: Change in Proportion of smokers on the panel received any cessation medications
timeFrame: Baseline and 12 months
Other outcomes:
measure: Change in Health care usage
timeFrame: Baseline and 12 months
measure: Change in Patient-level costs
timeFrame: Baseline and 12 months
Locations:
city: Brooklyn
country: United States
facility: VA NYHHS Brooklyn Campus
state: New York
city: New York
country: United States
facility: VA NYHHS Manhattan Campus
state: New York
Study officials:
affiliation: VA New York Harbor Healthcare System
name: Mark D Schwartz
role: PRINCIPAL_INVESTIGATOR
affiliation: VA New York Harbor Healthcare System
name: Scott Sherman, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Colleen Gillespie, PhD
role: STUDY_DIRECTOR
affiliation: VA New York Harbor Healthcare System
name: Anne Dembitzer, M.D.
role: STUDY_DIRECTOR
References:
citation: Savarimuthu SM, Jensen AE, Schoenthaler A, Dembitzer A, Tenner C, Gillespie C, Schwartz MD, Sherman SE. Developing a toolkit for panel management: improving hypertension and smoking cessation outcomes in primary care at the VA. BMC Fam Pract. 2013 Nov 21;14:176. doi: 10.1186/1471-2296-14-176.