Trial Outcomes & Findings for "Hub and Satellite" Heart Failure Provider's Network Study (NCT NCT01246050)

NCT ID: NCT01246050

Last Updated: 2019-10-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-10-30

Participant Flow

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.

Participant milestones

Measure	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.	Arm 2: No HF Training CBOC Providers in the same CBOC who have not received HF Training
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm 1: Received HF Training n=129 Participants 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.	Arm 2: No HF Training n=129 Participants CBOC Providers in the same CBOC who have not received HF Training	Total n=258 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	65 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	125 Participants n=5 Participants	128 Participants n=7 Participants	253 Participants n=5 Participants
Coronary Artery Disease Coronary Artery Disease present	101 participants n=5 Participants	97 participants n=7 Participants	198 participants n=5 Participants
Coronary Artery Disease Coronary artery disease not present	28 participants n=5 Participants	32 participants n=7 Participants	60 participants n=5 Participants
Hypertension Hypertension present	119 participants n=5 Participants	119 participants n=7 Participants	238 participants n=5 Participants
Hypertension Hypertension not present	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Diabetes Diabetes present	72 participants n=5 Participants	65 participants n=7 Participants	137 participants n=5 Participants
Diabetes Diabetes not present	57 participants n=5 Participants	64 participants n=7 Participants	121 participants n=5 Participants
Median ejection fraction	30 % left ventricular end-diastolic volume n=5 Participants	30 % left ventricular end-diastolic volume n=7 Participants	30 % left ventricular end-diastolic volume n=5 Participants
Followed by Cardiology Number followed by Cardiology	116 participants n=5 Participants	108 participants n=7 Participants	224 participants n=5 Participants
Followed by Cardiology Number not followed by Cardiology	13 participants n=5 Participants	21 participants n=7 Participants	34 participants n=5 Participants
Followed by Advanced Heart Failure Clinic Followed by Heart failure Clinic	26 participants n=5 Participants	37 participants n=7 Participants	63 participants n=5 Participants
Followed by Advanced Heart Failure Clinic Not followed by Heart Failure Clinic	103 participants n=5 Participants	92 participants n=7 Participants	195 participants n=5 Participants
HF Hospitalization past year No. with a HF hospitalization in the past year	26 participants n=5 Participants	15 participants n=7 Participants	41 participants n=5 Participants
HF Hospitalization past year No. without a HF hospitalization in the past year	103 participants n=5 Participants	114 participants n=7 Participants	217 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Arm 1: Received HF Training n=129 Participants Patients followed by CBOC Providers who have received HF Training.	Arm 2: No HF Training n=129 Participants Patients followed by CBOC Providers in the same CBOC who have not received HF Training
Number of Superior Heart Failure Performance Outcome Quality Measures	5 number of outcome measures superior	4 number of outcome measures superior

Adverse Events

Arm 1: Received HF Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2: No HF Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Henry Ooi

VA Medical Center Nashville

Phone: 615-8736373

Email: henry.ooi@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place