Financial Incentives to Translate ALLHAT Into Practice: A Randomized Trial

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00302718
First received: March 10, 2006
Last updated: April 15, 2014
Last verified: April 2014
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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 the 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 ]

Enrollment: 83
Study Start Date: February 2007
Study Completion Date: September 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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.
Experimental: Arm 2
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.
Experimental: Arm 3
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.
No Intervention: Arm 4
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. 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 and improved control of hypertension in the VA primary care setting.

Objectives:

The goals 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 incentives; (3) ascertain whether there are additive or synergistic effects of physician+group-level incentives; (4) evaluate the persistence of the effect of incentives after the intervention ceases; and (5) identify any negative impacts of incentives on patients, providers, or health care organizations.

Methods:

Primary care physicians from 12 VA hospitals will be randomized to the following arms: (1) physician-level incentive; (2) group-level incentive; (3) physician+group incentives; and (4) audit and feedback only. Study sites in the group only and provider+group will include non-physician participants (e.g., nurses). Outcomes include the use of guideline-recommended anti-hypertension medications and the proportion of patients who achieve national (JNC 7) guideline-recommended blood pressure goals or receive 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 all study participants 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.

Status:

We are currently analyzing the post-washout data and preparing manuscripts describing the study's findings.

  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 or having a panel size of at least 500 patients at the time of study arm randomization. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Alabama
VA Medical Center, Birmingham
Birmingham, Alabama, United States, 35233
United States, Connecticut
VA Connecticut Health Care System (Newington)
Newington, Connecticut, United States, 06111
United States, Georgia
VA Medical Center, Augusta
Augusta, Georgia, United States, 30904
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
United States, Michigan
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, United States, 48201
Aleda E. Lutz VA Medical Center
Saginaw, Michigan, United States, 48602
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Mississippi
G.V. (Sonny) Montgomery VA Medical Center, Jackson
Jackson, Mississippi, United States, 39216
United States, Oklahoma
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, United States, 73104
United States, Rhode Island
VA Medical Center, Providence
Providence, Rhode Island, United States, 02908
United States, South Carolina
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, United States, 29401-5799
United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Laura A. Petersen, MD MPH Michael E. DeBakey VA Medical Center, Houston, TX
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00302718     History of Changes
Other Study ID Numbers: IIR 04-349, R01HL079173
Study First Received: March 10, 2006
Last Updated: April 15, 2014
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:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014