Program for Research on the Outcomes of VA Education

Hypertension Clinical Trial

— PROVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677533
• Other study ID #: EDU 08-428-2
• Status: Completed
• Phase: N/A
• Start date: September 1, 2009
• Est. completion date: August 31, 2015

Study information

• Verified date: May 2018
• Source: VA New York Harbor Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: August 31, 2015
• Est. primary completion date: August 31, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• non-specialized primary care clinical microsystems

Exclusion Criteria:

• specialized clinical microsystems

• pilot clinical patient-aligned care teams

Related Conditions & MeSH terms

• Hypertension
• Smoking Cessation

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	VA NYHHS Brooklyn Campus	Brooklyn	New York
United States	VA NYHHS Manhattan Campus	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA New York Harbor Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Health care usage	Number of primary care visits, mental health visits, emergency room/urgent care visits and the number of VA hospitalizations	Baseline and 12 months
Other	Change in Patient-level costs	Outpatient primary care visits, mental health visits, pharmacy and hospitalizations from the VA Decision Support System	Baseline and 12 months
Primary	Change in Smoking Status	clinical outcome	Baseline and 12 months
Primary	Change in Blood Pressure Reading	clinical outcome	Baseline and 12 months
Secondary	Change in weight		Baseline and most recent at 12 months
Secondary	Change in Patient Activation	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
Secondary	Change in Patient Perceptions of Quality of Care		6 months and 12 months
Secondary	Change in Provider Behavior change expertise		6 months and 12 months
Secondary	Change in Provider Self-efficacy with Panel Management Tasks		Baseline and 12 months
Secondary	Change in Provider Job Satisfaction		Baseline and 12 months
Secondary	Change in Microsystem function and collective efficacy		Baseline and 12 months
Secondary	Change in Provider's assessments of training that they received in panel management and working within a PACT team		Baseline and 12 months
Secondary	Change in Proportion of panel smokers offered smoking cessation resources by study arm		Baseline and 12 months
Secondary	Change in Proportion of smokers on the panel received any cessation medications	This information will be culled from the Vista Smoking Database	Baseline and 12 months