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Financial Incentives to Translate ALLHAT Into Practice: A Randomized Trial
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, July 2009
First Received: March 10, 2006   Last Updated: July 13, 2009   History of Changes
Sponsor: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00302718
  Purpose

The purpose of this study is to determine whether financial incentives for guideline-recommended treatment of hypertension are effective. We hypothesize that patients with hypertension cared for by physicians or physician groups receiving financial incentives will be more likely to be prescribed guideline-recommended anti-hypertensive medications and achieve JNC-7 guideline-recommended blood pressure goals compared to patients who are treated by providers that do not receive any financial incentives.


Condition Intervention
Hypertension
Behavioral: Physician-level financial incentive
Behavioral: Group-level financial incentive
Behavioral: Physician and group-level financial incentives

Study Type: Interventional
Study Design: Health Services Research, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: RCT of Financial Incentives to Translate ALLHAT Into Practice

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Use of guideline-recommended anti-hypertensive medications in ideal candidates for them, achievement of JNC-7 BP guidelines, and appropriate hypertension treatment responses [ Time Frame: Primary outcomes measured for baseline period (a 4-month period prior to start of the study intervention), during the 20-month intervention period, and for a 4-month period following a 7-month washout period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CRC screening, LDL cholesterol levels, HbA1c levels, and beta blocker use [ Time Frame: Secondary outcomes measured for baseline period, during the 20-month intervention period, and the post-washout period ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: February 2007
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Examines the effect of physician-level financial incentives on hypertension quality of care
Behavioral: Physician-level financial incentive
Enrolled physician subjects are eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes.
2: Experimental
Examines the effect of provider-group level financial incentives on hypertension quality of care
Behavioral: Group-level financial incentive
Enrolled provider groups (physician subjects and non-physician primary care personnel) are eligible to receive financial incentives based on the performance of the group during a 4-month interval on the hypertension care study outcomes.
3: Experimental
Examines the effect of provider-group and physician-level financial incentives on hypertension quality of care
Behavioral: Physician and group-level financial incentives
Enrolled subjects are eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tests the effect of combined financial incentives.
4: No Intervention
Control study arm

Detailed Description:

Background:

Despite compelling evidence of the benefits of treatment, hypertension is controlled in less than one-quarter of US citizens. While some of the reasons for poor blood pressure (BP) control are due to poor compliance on the part of patients, there is significant under-treatment of hypertension on the part of physicians. This is one example of what the Institute of Medicine calls the "chasm' between what we know, and how we practice. Translation of scientific knowledge from trials such as the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) into clinical practice is lagging. Using a cluster randomized controlled trial, we will test the effect of explicit physician-level and group-level financial incentives to promote the provision of guideline-recommended anti-hypertensive medications in ideal candidates for them and improved control of hypertension in the VA primary care setting. The VA is funding the group-level financial incentives arms of the study, and the National Institutes of Health (NIH) is funding the physician-level financial incentives arms of the study.

Objectives:

The goals of this study are to: (1) determine the effect of physician-level financial incentives on processes and outcomes of care for outpatients with hypertension; (2) assess the impact of group-level financial incentives; (3) ascertain whether there are additive or synergistic effects of physician- plus group-level financial incentives; (4) evaluate the persistence of the effect of financial incentives after the intervention ceases; and (5) identify any negative impacts of financial incentives on patients, providers, or health care organizations.

Methods:

A total of 84 primary care physician subjects from 12 VA hospitals will be asked to participate. The 12 hospitals will be randomized to one of the four study arms: (1) physician-level financial incentive + audit and feedback; (2) group-level financial incentive + audit and feedback; (3) physician- and group-level financial incentives + audit and feedback; and (4) audit and feedback only (control arm). Study sites in the group only and provider+group will include non-physician participants (e.g., nurses, pharmacists). Use of guideline-recommended anti-hypertension medications in ideal candidates for them and the proportion of patients with hypertension who achieve national (JNC 7) guideline-recommended blood pressure goals or receive appropriate treatment in response to an elevated blood pressure reading will be the primary dependent variables. Physicians and provider groups in the incentive arms will receive a bonus for each instance that they prescribe guideline-recommended anti-hypertensive medications and each instance the patient meets guideline-recommended blood pressure goals or receives appropriate treatment in response to an elevated blood pressure reading. Cross-sectional analyses at 3 time points will be used to compare the effect of the interventions, with audit and feedback to physicians and provider groups in both arms at 5 time points over the intervention period. Data on comorbid conditions, treatment, medications, and blood pressure will be collected from a sample of each physician's practice. We will use analytic methods appropriate for a cluster-randomized trial, as patients are nested within physicians, who are further nested in hospitals.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible for this randomized, clinical trial, study participants have to be full-time primary care physicians employed by the Veterans Health Administration (VA) at one of the 12 VA hospitals participating in the study.

A full-time primary care physician is defined as spending at least 0.60 full-time equivalent (FTE) delivering patient care services in the primary care setting. The primary care settings include internal medicine, prime care, and women's clinics. This randomized, controlled trial does not actively recruit patients into the study. This study retrospectively reviews a random sample of patients that had clinical encounters with the study physician during the intervention period.

Exclusion Criteria:

This study does not include VA physicians that are trainees.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302718

Contacts
Contact: Tracy H Urech, BA MPH (857) 364-2245 tracy.urech@va.gov
Contact: Kate Simpson, MPH (713) 794-8536 kate.simpson@va.gov

Locations
United States, Alabama
VA Medical Center, Birmingham Active, not recruiting
Birmingham, Alabama, United States, 35233
United States, Connecticut
VA Connecticut Health Care System (Newington) Recruiting
Newington, Connecticut, United States, 06111
Contact: Patricia Cioffi, MD     203-932-5711     patricia.cioffi@va.gov    
United States, Georgia
VA Medical Center, Augusta Recruiting
Augusta, Georgia, United States, 30904
Contact: Vidya C Sridharan, MD     706-733-0188     Vidya.Sridharan@va.gov    
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus Active, not recruiting
Boston, Massachusetts, United States, 02130
United States, Michigan
John D. Dingell VA Medical Center, Detroit Recruiting
Detroit, Michigan, United States, 48201
Contact: Saib S Gappy, MD     313-576-1000 ext 63733     saib.gappy@va.gov    
Aleda E. Lutz VA Medical Center Active, not recruiting
Saginaw, Michigan, United States, 48602
United States, Minnesota
VA Medical Center, Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Adam Powell, PhD     612-725-2000 ext 4364     adam.powell@va.gov    
United States, Mississippi
G.V. (Sonny) Montgomery VA Medical Center, Jackson Recruiting
Jackson, Mississippi, United States, 39216
Contact: Stephen Geraci, MD     601-364-1251     stephen.geraci@va.gov    
United States, Oklahoma
VA Medical Center, Oklahoma City Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Steven R Orwig, MD     405-270-5199     steve.orwig@va.gov    
United States, Rhode Island
VA Medical Center, Providence Active, not recruiting
Providence, Rhode Island, United States, 02908
United States, South Carolina
Ralph H Johnson VA Medical Center, Charleston Active, not recruiting
Charleston, South Carolina, United States, 29401-5799
United States, Texas
Houston VA Medical Center Active, not recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Laura A. Petersen, MD MPH Houston VA Medical Center
  More Information

Publications:
Responsible Party: Department of Veterans Affairs ( Petersen, Laura - Principal Investigator )
Study ID Numbers: IIR 04-349, HL079173-01
Study First Received: March 10, 2006
Last Updated: July 13, 2009
ClinicalTrials.gov Identifier: NCT00302718     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Physician Incentive Plan
Quality of Health Care
Reimbursement, Incentive
Randomized Controlled Trial
Physicians
Reward

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on November 30, 2009