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Hub and Satellite Heart Failure Provider's Network Study

Developing a Hub and Satellite Heart Failure Providers Network

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01246050
Enrollment
6
Registered
2010-11-23
Start date
2010-05-31
Completion date
2011-05-31
Last updated
2019-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure, Outcome Assessment, Congestive Heart Failure

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: 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.

Interventions

OTHERHF 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.

OTHERNo 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

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Superior Heart Failure Performance Outcome Quality Measures12 monthsThis 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.

Countries

United States

Participant flow

Recruitment details

Primary care providers practicing were recruited from Primary Care Clinics in the local VA healthcare system. Providers volunteered to be trained as Heart Failure providers and underwent specialized training in May 2010.

Participants by arm

ArmCount
Arm 1: Received HF Training
CBOC Providers who have received HF Training 3 days of training in HF management: 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. Access to clinical pharmacist services: Including medication and disease teaching, adjustment and uptitration Quarterly analysis of physician compliance: Individualized confidential, non-punitive feedback to providers from a set of prespecified core HF performance measures.
129
Arm 2: No HF Training
CBOC Providers in the same CBOC who have not received HF Training
129
Total258

Baseline characteristics

CharacteristicArm 1: Received HF TrainingArm 2: No HF TrainingTotal
Age, Continuous65 years65 years65 years
Coronary Artery Disease
Coronary artery disease not present
28 participants32 participants60 participants
Coronary Artery Disease
Coronary Artery Disease present
101 participants97 participants198 participants
Diabetes
Diabetes not present
57 participants64 participants121 participants
Diabetes
Diabetes present
72 participants65 participants137 participants
Followed by Advanced Heart Failure Clinic
Followed by Heart failure Clinic
26 participants37 participants63 participants
Followed by Advanced Heart Failure Clinic
Not followed by Heart Failure Clinic
103 participants92 participants195 participants
Followed by Cardiology
Number followed by Cardiology
116 participants108 participants224 participants
Followed by Cardiology
Number not followed by Cardiology
13 participants21 participants34 participants
HF Hospitalization past year
No. with a HF hospitalization in the past year
26 participants15 participants41 participants
HF Hospitalization past year
No. without a HF hospitalization in the past year
103 participants114 participants217 participants
Hypertension
Hypertension not present
10 participants10 participants20 participants
Hypertension
Hypertension present
119 participants119 participants238 participants
Median ejection fraction30 % left ventricular end-diastolic volume30 % left ventricular end-diastolic volume30 % left ventricular end-diastolic volume
Sex: Female, Male
Female
4 Participants1 Participants5 Participants
Sex: Female, Male
Male
125 Participants128 Participants253 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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.

Time frame: 12 months

Population: 129 patients cared for by HF trained primary care providers in Intervention Arm. 129 patients in the Control group, cared for by non-HF trained primary care providers.

ArmMeasureValue (NUMBER)
Arm 1: Received HF TrainingNumber of Superior Heart Failure Performance Outcome Quality Measures5 number of outcome measures superior
Arm 2: No HF TrainingNumber of Superior Heart Failure Performance Outcome Quality Measures4 number of outcome measures superior

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026