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"Hub and Satellite" Heart Failure Provider's Network Study

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HF training
No HF training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Outcome Assessment, Congestive Heart Failure

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: Received HF Training

Arm 2: No HF Training

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 19, 2010
Last Updated
October 29, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01246050
Brief Title
"Hub and Satellite" Heart Failure Provider's Network Study
Official Title
Developing a Hub and Satellite Heart Failure Providers Network
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Background: Congestive heart failure (HF) is a major public health problem. There is a pressing need to improve treatment of HF, but lifesaving therapies remain underused in clinical practice. The investigators proposed a novel, potentially cost-effective model of community-based, multidisciplinary, collaborative HF care - the "Hub and Satellite" Heart Failure Providers Network. Primary care providers trained in HF management would provide improved care to their clinic patients with HF in "satellite" clinics, supported by the Regional HF Center "hub". Objectives: To establish and demonstrate the feasibility of the "Hub and Satellite" Heart Failure Providers Network To obtain data examining clinical effectiveness and barriers Methods: Volunteer community-based primary care providers underwent 3 days of HF management training at the regional HF center (Nashville), consisting of 21 hours of lectures, briefings, teaching sessions and case presentations. Multiple choice testing and a survey interview were completed at the beginning and end of training. Exclusive access was given to the services of a clinical pharmacist to titrate HF medications to clinical guideline-recommended doses. Providers received updates on advances in HF management. A confidential feedback report on their performance was given to HF providers. Formative evaluation was performed through pre-educational and 4 subsequent telephone interviews with HF providers. Decision Support System (DSS) data was used to identify patients with systolic HF (ejection fraction<40%) cared for by the HF providers; systolic HF patients in the same clinics cared for by non-HF trained providers were randomly selected as controls. Data on the care received over the one year period of follow-up was collected from DSS data and the computerized patient record system (CPRS). Status: One year of study follow-up has been completed. Primary data analysis is continuing. Work done to date has successfully demonstrated the feasibility of implementing a "Hub and Satellite" HF Providers network, including high provider satisfaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Outcome Assessment, Congestive Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Received HF Training
Arm Type
Experimental
Arm Description
Providers will receive 3 days of HF training, receive access to clinical pharmacist medication titration serviced and receive performance feedback
Arm Title
Arm 2: No HF Training
Arm Type
Active Comparator
Arm Description
CBOC Providers in the same CBOC who did not received HF Training, access to clinical pharmacist services or performance feedback
Intervention Type
Other
Intervention Name(s)
HF training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No HF training
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Superior Heart Failure Performance Outcome Quality Measures
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Community Based Outpatient Clinic (CBOC) Providers who are unable to attend the 3 day Heart Failure Training at the Regional Heart Failure Center.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry H Ooi, MD
Organizational Affiliation
VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

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"Hub and Satellite" Heart Failure Provider's Network Study

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