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

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ClinicalTrials.gov Identifier: NCT01246050
Recruitment Status : Completed
First Posted : November 23, 2010
Results First Posted : September 9, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: HF training Other: No HF training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Developing a Hub and Satellite Heart Failure Providers Network
Study Start Date : May 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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
Other: HF training
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
Other: No 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




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246050


Locations
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United States, Tennessee
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Henry H Ooi, MD VA Medical Center
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01246050    
Other Study ID Numbers: RRP 09-170
First Posted: November 23, 2010    Key Record Dates
Results First Posted: September 9, 2019
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by VA Office of Research and Development:
Heart Failure
Outcome Assessment
Congestive Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases