NCT01677533

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2015

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

5 years

First QC Date

August 28, 2012

Last Update Submit

May 1, 2018

Conditions

HypertensionSmoking Cessation

Keywords

Panel managementClinical microsystemsHypertension managementSmoking cessationContinuing medical educationQuality improvement,Population health

Outcome Measures

Primary Outcomes (2)

  • Change in Smoking Status

    clinical outcome

    Baseline and 12 months

  • Change in Blood Pressure Reading

    clinical outcome

    Baseline and 12 months

Secondary Outcomes (10)

  • Change in weight

    Baseline and most recent at 12 months

  • Change in Patient Activation

    6 months and 12 months

  • Change in Patient Perceptions of Quality of Care

    6 months and 12 months

  • Change in Provider Behavior change expertise

    6 months and 12 months

  • Change in Provider Self-efficacy with Panel Management Tasks

    Baseline and 12 months

  • +5 more secondary outcomes

Other Outcomes (2)

  • Change in Health care usage

    Baseline and 12 months

  • Change in Patient-level costs

    Baseline and 12 months

Study Arms (3)

PM-Data

ACTIVE COMPARATOR

Team will receive data only.

Other: Data

PM-Support

EXPERIMENTAL

Team will receive data and panel management support

Other: DataOther: Panel Management Support

PM-Education

EXPERIMENTAL

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

Other: DataOther: Panel Management SupportOther: Education

Interventions

DataOTHER

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.

PM-DataPM-EducationPM-Support
Panel Management SupportOTHER

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.

Also known as: Panel management assistant
PM-EducationPM-Support
EducationOTHER

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.

Also known as: Educational Intervention
PM-Education

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • non-specialized primary care clinical microsystems

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA NYHHS Brooklyn Campus

Brooklyn, New York, 11209, United States

Location

VA NYHHS Manhattan Campus

New York, New York, 10010, United States

Location

Related Publications (1)

  • 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.

    PMID: 24261337DERIVED

MeSH Terms

Conditions

HypertensionSmoking Cessation

Interventions

Educational StatusEarly Intervention, Educational

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsChild Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Mark D Schwartz

    VA New York Harbor Healthcare System

    PRINCIPAL INVESTIGATOR

  • Scott Sherman, M.D., M.P.H.

    VA New York Harbor Healthcare System

    PRINCIPAL INVESTIGATOR

  • Colleen Gillespie, PhD

    NYU Langone Health

    STUDY DIRECTOR

  • Anne Dembitzer, M.D.

    VA New York Harbor Healthcare System

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Care Physician

Study Record Dates

First Submitted

August 28, 2012

First Posted

September 3, 2012

Study Start

September 1, 2009

Primary Completion

August 31, 2014

Study Completion

August 31, 2015

Last Updated

May 7, 2018

Record last verified: 2018-05

Locations

US(2)