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Completed

NCT Number: NCT00302718

Financial Incentives to Translate ALLHAT Into Practice: A Randomized Trial

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center, Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physician-level financial incentives

Behavioral

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.

Practice-level financial incentives

Behavioral

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.

Physician- and practice-level financial incentives

Behavioral

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).

Primary outcomes

  1. Proportion of the Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure

    Time frame: Baseline period (August-November 2007)

    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.

  2. Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure

    Time frame: Final intervention period (April-July 2009)

    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.

  3. Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure

    Time frame: After the washout period (May-August 2011)

    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.

  4. Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications

    Time frame: Baseline period (August-November 2007)

    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.

  5. Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications

    Time frame: Final intervention period (April-July 2009)

    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.

  6. Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications

    Time frame: After the washout period (May-August 2011)

    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.

Secondary outcomes

  1. Colorectal Cancer (CRC) Screening

    Time frame: Baseline period (August - November 2007)

    This measure reports the proportion of patients who had at least one of four CRC screens in the appropriate timeframe for the first performance period (baseline). Appropriate CRC screens consisted of at least one of the following: 1) fecal occult blood test every year; 2) barium enema every five years; 3) flexible sigmoidoscopy every five years; 4) colonoscopy every ten years. We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.

  2. Colorectal Cancer (CRC) Screening

    Time frame: Final intervention period (April-July 2009)

    This measure reports the proportion of patients who had at least one of four CRC screens in the appropriate timeframe for the fifth and final intervention performance period. Appropriate CRC screens consisted of at least one of the following: 1) fecal occult blood test every year; 2) barium enema every five years; 3) flexible sigmoidoscopy every five years; 4) colonoscopy every ten years. We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.

  3. Low-density Lipoprotein (LDL) Cholesterol Levels

    Time frame: Baseline period (August-November 2007)

    This measure reports the proportion of patients who had LDL control (LDL cholesterol < 100) for the first performance period (baseline). We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.

  4. Low-density Lipoprotein (LDL) Cholesterol Levels

    Time frame: Final intervention period (April-July 2009)

    This measure reports the proportion of patients who had LDL control (LDL cholesterol < 100) for the fifth and final intervention performance period. We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.

  5. Hemoglobin (Hb) A1c Levels

    Time frame: Baseline period (August-November 2007)

    This measure reports the proportion of patients with (Hb)A1c control ((Hb)A1c ≤ 9%) for the first performance period (baseline). We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.

  6. Hemoglobin (Hb) A1c Levels

    Time frame: Final intervention period (April-July 2009)

    This measure reports the proportion of patients with (Hb)A1c control ((Hb)A1c ≤ 9%) for the fifth and final intervention performance period. We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.

  7. Beta Blocker Use

    Time frame: Baseline period (August - November 2007)

    This measure reports the proportion of patients with beta blocker use at the time of the index visit for the first performance period (baseline). We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.

  8. Beta Blocker Use

    Time frame: Final intervention period (April-July 2009)

    This measure reports the proportion of patients with beta blocker use at the time of the index visit for the fifth and final intervention performance period. We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

RCT of Financial Incentives to Translate ALLHAT Into Practice

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Mar 14, 2006
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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