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

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01246050
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: HF training; Other: No HF training	N/A

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 Design

• Study Type: Interventional
• 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 1, 2010
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Superior Heart Failure Performance Outcome Quality Measures [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tennessee Valley Healthcare System Nashville Campus, Nashville, TN	Nashville	Tennessee	United States	37212-2637

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01246050
• Other Study ID Numbers: RRP 09-170
• First Posted: Nov 23, 2010
• Last Update Posted: Oct 30, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• 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: Heart Failure

Study Results

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.

Arm/Group Title	Arm 1: Received HF Training	Arm 2: No HF Training
Arm/Group Description	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.	CBOC Providers in the same CBOC who have not received HF Training
Period Title: Overall Study
STARTED	6	6
COMPLETED	6	6
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Arm 1: Received HF Training	Arm 2: No HF Training	Total
Arm/Group Description	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.	CBOC Providers in the same CBOC who have not received HF Training	Total of all reporting groups
Overall Participants	129	129	258
Age (years) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [years]	65	65	65
Sex: Female, Male (Count of Participants)
Female	4 3.1%	1 0.8%	5 1.9%
Male	125 96.9%	128 99.2%	253 98.1%
Coronary Artery Disease (participants) [Number]
Coronary Artery Disease present	101 78.3%	97 75.2%	198 76.7%
Coronary artery disease not present	28 21.7%	32 24.8%	60 23.3%
Hypertension (participants) [Number]
Hypertension present	119 92.2%	119 92.2%	238 92.2%
Hypertension not present	10 7.8%	10 7.8%	20 7.8%
Diabetes (participants) [Number]
Diabetes present	72 55.8%	65 50.4%	137 53.1%
Diabetes not present	57 44.2%	64 49.6%	121 46.9%
Median ejection fraction (% left ventricular end-diastolic volume) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [% left ventricular end-diastolic volume]	30	30	30
Followed by Cardiology (participants) [Number]
Number followed by Cardiology	116 89.9%	108 83.7%	224 86.8%
Number not followed by Cardiology	13 10.1%	21 16.3%	34 13.2%
Followed by Advanced Heart Failure Clinic (participants) [Number]
Followed by Heart failure Clinic	26 20.2%	37 28.7%	63 24.4%
Not followed by Heart Failure Clinic	103 79.8%	92 71.3%	195 75.6%
HF Hospitalization past year (participants) [Number]
No. with a HF hospitalization in the past year	26 20.2%	15 11.6%	41 15.9%
No. without a HF hospitalization in the past year	103 79.8%	114 88.4%	217 84.1%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1: Received HF Training	Arm 2: No HF Training
Arm/Group Description	Patients followed by CBOC Providers who have received HF Training.	Patients followed by CBOC Providers in the same CBOC who have not received HF Training
Measure Participants	129	129
Number [number of outcome measures superior]	5	4

Adverse Events

Adverse Event Reporting Description	Neither providers or patients were monitored for adverse events
Arm/Group Title	Arm 1: Received HF Training		Arm 2: No HF Training
Arm/Group Description	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.		CBOC Providers in the same CBOC who have not received HF Training
All Cause Mortality
	Arm 1: Received HF Training		Arm 2: No HF Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1: Received HF Training		Arm 2: No HF Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Arm 1: Received HF Training		Arm 2: No HF Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.