Program for Research on the Outcomes of VA Education (PROVE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mark Schwartz, VA New York Harbor Healthcare System
ClinicalTrials.gov Identifier:
NCT01677533
First received: August 28, 2012
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Hypertension
Smoking Cessation
Other: Data
Other: Panel Management Support
Other: Education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by VA New York Harbor Healthcare System:

Primary Outcome Measures:
  • Change in Smoking Status [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    clinical outcome

  • Change in Blood Pressure Reading [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    clinical outcome


Secondary Outcome Measures:
  • Change in weight [ Time Frame: Baseline and most recent at 12 months ] [ Designated as safety issue: No ]
  • Change in Patient Activation [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    The 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 Care [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Change in Provider Behavior change expertise [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Change in Provider Self-efficacy with Panel Management Tasks [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Change in Provider Job Satisfaction [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Change in Microsystem function and collective efficacy [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Change in Provider's assessments of training that they received in panel management and working within a PACT team [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Change in Proportion of panel smokers offered smoking cessation resources by study arm [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Change in Proportion of smokers on the panel received any cessation medications [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    This information will be culled from the Vista Smoking Database


Other Outcome Measures:
  • Change in Health care usage [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Number of primary care visits, mental health visits, emergency room/urgent care visits and the number of VA hospitalizations

  • Change in Patient-level costs [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Outpatient primary care visits, mental health visits, pharmacy and hospitalizations from the VA Decision Support System


Estimated Enrollment: 38000
Study Start Date: September 2009
Estimated Study Completion Date: May 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PM-Data
Team will receive data only.
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.
Experimental: PM-Support
Team will receive data and panel management support
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.
Other: 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.
Other Name: Panel management assistant
Experimental: PM-Education
Team will receive data, panel management support, and educational interventions.
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.
Other: 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.
Other Name: Panel management assistant
Other: 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.
Other Name: Educational Intervention

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • non-specialized primary care clinical microsystems

Exclusion Criteria:

  • specialized clinical microsystems
  • pilot clinical patient-aligned care teams
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677533

Locations
United States, New York
VA NYHHS Brooklyn Campus
Brooklyn, New York, United States, 11209
VA NYHHS Manhattan Campus
New York, New York, United States, 10010
Sponsors and Collaborators
VA New York Harbor Healthcare System
Investigators
Principal Investigator: Mark D Schwartz VA New York Harbor Healthcare System
Principal Investigator: Scott Sherman, M.D., M.P.H. VA New York Harbor Healthcare System
Study Director: Colleen Gillespie, PhD New York University School of Medicine
Study Director: Anne Dembitzer, M.D. VA New York Harbor Healthcare System
  More Information

No publications provided by VA New York Harbor Healthcare System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark Schwartz, Primary Care Physician, VA New York Harbor Healthcare System
ClinicalTrials.gov Identifier: NCT01677533     History of Changes
Other Study ID Numbers: EDU 08-428-2
Study First Received: August 28, 2012
Last Updated: December 19, 2013
Health Authority: United States: Federal Government

Keywords provided by VA New York Harbor Healthcare System:
Panel management
Clinical microsystems
Hypertension management
Smoking cessation
Continuing medical education
Quality improvement,
Population health

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014