NCT01246050

Brief Summary

The aim of this study is to serve as a pilot showing the feasibility of a "Hub and Satellite" Heart Failure (HF) Provider's Network which will aim to provide improved, evidence-based care to Veterans with HF. Primary Care Providers in the VA Community Based Outpatient Clinics (CBOCs) will undergo a brief period of intensive training in HF management and then practice in a network of primary care providers supported by the Regional HF Center.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
8.4 years until next milestone

Results Posted

Study results publicly available

September 9, 2019

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

November 19, 2010

Results QC Date

February 22, 2016

Last Update Submit

October 29, 2019

Conditions

Keywords

Heart FailureOutcome AssessmentCongestive Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Number of Superior Heart Failure Performance Outcome Quality Measures

    This was a pilot, qualitative study to assess the feasibility and preliminary outcomes of a program to train primary care providers in specialty care. 9 Heart Failure Performance Outcome Quality Measures were studied: Patient weight measured at clinic visit; level of activity assessed; volume status assessed; Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker (ACEI/ARB) prescribed; ACEI/ARB at target dose; beta-blocker prescribed; beta-blocker at target dose; evidence-based beta-blocker used; coumadin prescribed in atrial fibrillation. Healthcare provider performance with each of the Performance Outcome Quality Measures was assessed at each study visit. Superior performance was defined as a higher score for each Measure on the follow-up visit compared to the baseline visit. The primary outcome of the study was considered to have been reached if 6 of the 9 outcome measures were superior to the baseline visit.

    12 months

Study Arms (2)

Arm 1: Received HF Training

EXPERIMENTAL

Providers will receive 3 days of HF training, receive access to clinical pharmacist medication titration serviced and receive performance feedback

Other: HF training

Arm 2: No HF Training

ACTIVE COMPARATOR

CBOC Providers in the same CBOC who did not received HF Training, access to clinical pharmacist services or performance feedback

Other: No HF training

Interventions

These are CBOC Providers who received HF Training as the active intervention. HF training includes didactic lectures, case discussions and interactive symposia, course materials including teaching material, textbooks, copies of HF clinical guidelines and patient education material for distribution, participation in HF Clinics and Inpatient Heart Failure Rounds. Providers were given access to clinical pharmacist services Including medication and disease teaching, adjustment and uptitration. There was quarterly analysis of patient compliance including individualized confidential, non-punitive feedback to providers from a set of prespecified core HF performance measures.

Arm 1: Received HF Training

These are control providers drawn from the same CBOCs who have not received HF training, access to clinical pharmacist medication titration services or performance feedback

Arm 2: No HF Training

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthcare providers (physicians, nurse practitioners, physician's assistants) who practice in a Community Based Outpatient Clinic (CBOC) in the Tennessee Valley Healthcare System, and are willing to undergo Heart Failure Training

You may not qualify if:

  • Community Based Outpatient Clinic (CBOC) Providers who are unable to attend the 3 day Heart Failure Training at the Regional Heart Failure Center.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Limitations and Caveats

High performance on baseline metrics and infrequent primary care visits limited improvement opportunity. Poor provider engagement and pharmacy service use may limit effect. High %Cardiology clinic co-management may limit study effectiveness.

Results Point of Contact

Title
Henry Ooi
Organization
VA Medical Center Nashville

Study Officials

  • Henry H Ooi, MD

    VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2010

First Posted

November 23, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

October 30, 2019

Results First Posted

September 9, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

Locations