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

Primary Purpose

Hypertension, Smoking Cessation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Data
Panel Management Support
Education
Sponsored by
VA New York Harbor Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Panel management, Clinical microsystems, Hypertension management, Smoking cessation, Continuing medical education, Quality improvement,, Population health

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • non-specialized primary care clinical microsystems

Exclusion Criteria:

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

Sites / Locations

  • VA NYHHS Brooklyn Campus
  • VA NYHHS Manhattan Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

PM-Data

PM-Support

PM-Education

Arm Description

Team will receive data only.

Team will receive data and panel management support

Team will receive data, panel management support, and educational interventions.

Outcomes

Primary Outcome Measures

Change in Smoking Status
clinical outcome
Change in Blood Pressure Reading
clinical outcome

Secondary Outcome Measures

Change in weight
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
Change in Patient Perceptions of Quality of Care
Change in Provider Behavior change expertise
Change in Provider Self-efficacy with Panel Management Tasks
Change in Provider Job Satisfaction
Change in Microsystem function and collective efficacy
Change in Provider's assessments of training that they received in panel management and working within a PACT team
Change in Proportion of panel smokers offered smoking cessation resources by study arm
Change in Proportion of smokers on the panel received any cessation medications
This information will be culled from the Vista Smoking Database

Full Information

First Posted
August 28, 2012
Last Updated
May 1, 2018
Sponsor
VA New York Harbor Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT01677533
Brief Title
Program for Research on the Outcomes of VA Education
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2009 (Actual)
Primary Completion Date
August 31, 2014 (Actual)
Study Completion Date
August 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA New York Harbor Healthcare System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Smoking Cessation
Keywords
Panel management, Clinical microsystems, Hypertension management, Smoking cessation, Continuing medical education, Quality improvement,, Population health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PM-Data
Arm Type
Active Comparator
Arm Description
Team will receive data only.
Arm Title
PM-Support
Arm Type
Experimental
Arm Description
Team will receive data and panel management support
Arm Title
PM-Education
Arm Type
Experimental
Arm Description
Team will receive data, panel management support, and educational interventions.
Intervention Type
Other
Intervention Name(s)
Data
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Panel Management Support
Other Intervention Name(s)
Panel management assistant
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Education
Other Intervention Name(s)
Educational Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Smoking Status
Description
clinical outcome
Time Frame
Baseline and 12 months
Title
Change in Blood Pressure Reading
Description
clinical outcome
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Change in weight
Time Frame
Baseline and most recent at 12 months
Title
Change in Patient Activation
Description
The Patient Activation Measure (PAM) is used to assess patients' self-reported knowledge, skill, and confidence in self-managing of health and chronic conditions
Time Frame
6 months and 12 months
Title
Change in Patient Perceptions of Quality of Care
Time Frame
6 months and 12 months
Title
Change in Provider Behavior change expertise
Time Frame
6 months and 12 months
Title
Change in Provider Self-efficacy with Panel Management Tasks
Time Frame
Baseline and 12 months
Title
Change in Provider Job Satisfaction
Time Frame
Baseline and 12 months
Title
Change in Microsystem function and collective efficacy
Time Frame
Baseline and 12 months
Title
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
Title
Change in Proportion of panel smokers offered smoking cessation resources by study arm
Time Frame
Baseline and 12 months
Title
Change in Proportion of smokers on the panel received any cessation medications
Description
This information will be culled from the Vista Smoking Database
Time Frame
Baseline and 12 months
Other Pre-specified Outcome Measures:
Title
Change in Health care usage
Description
Number of primary care visits, mental health visits, emergency room/urgent care visits and the number of VA hospitalizations
Time Frame
Baseline and 12 months
Title
Change in Patient-level costs
Description
Outpatient primary care visits, mental health visits, pharmacy and hospitalizations from the VA Decision Support System
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: non-specialized primary care clinical microsystems Exclusion Criteria: specialized clinical microsystems pilot clinical patient-aligned care teams
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D Schwartz
Organizational Affiliation
VA New York Harbor Healthcare System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Sherman, M.D., M.P.H.
Organizational Affiliation
VA New York Harbor Healthcare System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Colleen Gillespie, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anne Dembitzer, M.D.
Organizational Affiliation
VA New York Harbor Healthcare System
Official's Role
Study Director
Facility Information:
Facility Name
VA NYHHS Brooklyn Campus
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11209
Country
United States
Facility Name
VA NYHHS Manhattan Campus
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24261337
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.
Results Reference
derived

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Program for Research on the Outcomes of VA Education

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