Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1 for:    NCT00302718
Previous Study | Return to List | Next Study

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: October 8, 2014
Last verified: October 2014

March 10, 2006
October 8, 2014
February 2007
October 2011   (final data collection date for primary outcome measure)
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 ]
Thiazide diuretic use and blood pressure control will be compiled over a three month interval. The primary outcomes will be assessed at baseline, at 5 periods during the 20-month intervention, and at the conclusion of the 7-month washout.
Complete list of historical versions of study NCT00302718 on ClinicalTrials.gov Archive Site
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 ]
CRC screening, LDL cholesterol levels, HbA1c levels, and beta blocker use will be compiled over a three month interval. Outcomes will be assessed at baseline, at 5 periods during the 20-month intervention, and at the end of the 7-month washout period.
Not Provided
Not Provided
 
Financial Incentives to Translate ALLHAT Into Practice: A Randomized Trial
RCT of Financial Incentives to Translate ALLHAT Into Practice

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

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 tested the effect of explicit physician-level and practice-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 were 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 practice-level incentives; (3) ascertain whether there were additive or synergistic effects of physician- and practice-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:

We randomized 12 VA hospital-based outpatient clinics to the following arms: (1) physician-level incentives; (2) practice-level incentives; (3) physician- and practice-level incentives; and (4) no incentives. We enrolled 83 primary care physicians and 42 practice group members (e.g., nurses). All participants received audit and feedback performance reports. Study measures included the use of guideline-recommended anti-hypertensive medications and the proportion of patients who achieved national (JNC 7) guideline-recommended blood pressure goals or received an appropriate response to uncontrolled blood pressure. The intervention period consisted of five four-month performance periods. For each period, trained reviewers collected medications, blood pressure readings, comorbid conditions, medication allergies, and lifestyle recommendations from the VA electronic health record system for a sample of eligible patients from the physicians' panels. After the final performance report, we implemented a 12-month washout period. To determine the impact of incentives for the intervention period, we performed a repeated-measures longitudinal analysis using the hospital as a random effect. We evaluated the rate of change in the proportion of patients who met the study measures over time for the intervention group physicians. We assessed post-washout performance using a linear analysis with clustering by hospital. To evaluate unintended consequences of the incentives, we examined the incidence of hypotension in the physicians' panels.

Status:

The study is completed. The primary findings were published in September 2013 in the Journal of the American Medical Association (JAMA). We are currently preparing manuscripts describing findings from the study's secondary aims.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Hypertension
  • 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.
  • 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.
  • 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.
  • Experimental: Arm 1
    Examines the effect of physician-level financial incentives on hypertension quality of care
    Intervention: Behavioral: Physician-level financial incentive
  • Experimental: Arm 2
    Examines the effect of provider-group level financial incentives on hypertension quality of care
    Intervention: Behavioral: Group-level financial incentive
  • Experimental: Arm 3
    Examines the effect of provider-group and physician-level financial incentives on hypertension quality of care
    Intervention: Behavioral: Physician and group-level financial incentives
  • No Intervention: Arm 4
    Control study arm

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
September 2012
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Study participants had to be full-time primary care physicians employed by the Veterans Health Administration (VA) at one of the 12 VA hospitals that participated in the study.

We defined a full-time primary care physician 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 included internal medicine, prime care, and women's clinics. The trial did not actively recruit patients into the study. This study retrospectively reviewed a random sample of health records of eligible patients that had clinical encounters with the physician participants.

Exclusion Criteria:

The study did not include VA physicians that were trainees.

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00302718
IIR 04-349, R01HL079173
No
Department of Veterans Affairs
Department of Veterans Affairs
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Laura A. Petersen, MD MPH Michael E. DeBakey VA Medical Center, Houston, TX
Department of Veterans Affairs
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP