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| 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 |
| 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
|
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 |
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| Contact: Tracy H Urech, BA MPH | (857) 364-2245 | tracy.urech@va.gov |
| Contact: Kate Simpson, MPH | (713) 794-8536 | kate.simpson@va.gov |
| 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 | |
| Principal Investigator: | Laura A. Petersen, MD MPH | Houston VA Medical Center |
More Information
| 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 |
|
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