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

October 29, 2019 updated by: VA Office of Research and Development

Developing a Hub and Satellite Heart Failure Providers Network

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.

Study Overview

Status

Completed

Conditions

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:

  1. To establish and demonstrate the feasibility of the "Hub and Satellite" Heart Failure Providers Network
  2. 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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Nashville, Tennessee, United States, 37212-2637
        • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Received HF Training
Providers will receive 3 days of HF training, receive access to clinical pharmacist medication titration serviced and receive performance feedback
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.
Active Comparator: Arm 2: No HF Training
CBOC Providers in the same CBOC who did not received HF Training, access to clinical pharmacist services or performance feedback
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Superior Heart Failure Performance Outcome Quality Measures
Time Frame: 12 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Henry H Ooi, MD, VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

November 19, 2010

First Submitted That Met QC Criteria

November 22, 2010

First Posted (Estimate)

November 23, 2010

Study Record Updates

Last Update Posted (Actual)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 29, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRP 09-170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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