Trial record 1 of 1 for:    NCT00302718
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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: December 4, 2014
Last verified: December 2014

March 10, 2006
December 4, 2014
February 2007
October 2011   (final data collection date for primary outcome measure)
  • Proportion of the Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure [ Time Frame: Baseline period (August-November 2007) ] [ Designated as safety issue: No ]
    This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the first performance period (baseline). Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the "Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)" to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension.
  • Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure [ Time Frame: Final intervention period (April-July 2009) ] [ Designated as safety issue: No ]
    This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the fifth and final intervention performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the "Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)" to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension.
  • Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure [ Time Frame: After the washout period (May-August 2011) ] [ Designated as safety issue: No ]
    This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the post-washout performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the "Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)" to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension.
  • Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications [ Time Frame: Baseline period (August-November 2007) ] [ Designated as safety issue: No ]
    This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the first performance period (baseline). Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the "Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)" to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications.
  • Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications [ Time Frame: Final intervention period (April-July 2009) ] [ Designated as safety issue: No ]
    This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the fifth and final intervention performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the "Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)" to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications.
  • Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications [ Time Frame: After the washout period (May-August 2011) ] [ Designated as safety issue: No ]
    This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the post-washout performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the "Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)" to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications.
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
Colorectal Cancer (CRC) Screening, Low-density Lipoprotein (LDL) Cholesterol Levels, Hemoglobin (Hb) A1c Levels, and Beta Blocker Use [ Time Frame: Secondary outcomes measured for baseline period, during the 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 Joint National Commission (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: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Hypertension
  • Behavioral: Physician-level financial incentives
    Enrolled physician participants are eligible to receive financial incentives and audit and feedback reports based on their performance during a 4-month interval on the hypertension care study outcomes.
  • Behavioral: Practice-level financial incentives
    Enrolled practices (physician physicians and non-physician primary care personnel) are eligible to receive financial incentives and audit and feedback reports based on the performance of the practice during a 4-month interval on the hypertension care study outcomes.
  • Behavioral: Physician- and practice-level financial incentives
    Enrolled participants are eligible to receive financial incentives and audit and feedback reports based on performance during a 4-month interval on the hypertension care study outcomes. This arm tests the effect of combined financial incentives (physician-level incentives and practice-level incentives).
  • Experimental: Physician-level incentives
    Examines the effect of physician-level financial incentives on hypertension quality of care
    Intervention: Behavioral: Physician-level financial incentives
  • Experimental: Practice-level incentives
    Examines the effect of practice-level financial incentives on hypertension quality of care
    Intervention: Behavioral: Practice-level financial incentives
  • Experimental: Physician- and practice-level incentives
    Examines the effect of physician- and practice-level financial incentives on hypertension quality of care
    Intervention: Behavioral: Physician- and practice-level financial incentives
  • No Intervention: No incentives (control)
    Physician participants in this arm received only audit and feedback performance reports as did the participants in the intervention arms.

*   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, primary care medical clinics, and women's health care 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
December 2014

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