Clinical trial NCT00302718: Financial Incentives to Translate ALLHAT Into Practice: A Randomized Trial
Official title: RCT of Financial Incentives to Translate ALLHAT Into Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Physician Incentive Plan
Quality of Health Care
Reimbursement, Incentive
Randomized Controlled Trial
Physicians
Reward
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2006-03-14
Enrollment: 83
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of the Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure
timeFrame: Baseline period (August-November 2007)
measure: Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure
timeFrame: Final intervention period (April-July 2009)
measure: Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure
timeFrame: After the washout period (May-August 2011)
measure: Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications
timeFrame: Baseline period (August-November 2007)
measure: Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications
timeFrame: Final intervention period (April-July 2009)
measure: Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications
timeFrame: After the washout period (May-August 2011)
Secondary outcomes:
measure: Colorectal Cancer (CRC) Screening
timeFrame: Baseline period (August - November 2007)
measure: Colorectal Cancer (CRC) Screening
timeFrame: Final intervention period (April-July 2009)
measure: Low-density Lipoprotein (LDL) Cholesterol Levels
timeFrame: Baseline period (August-November 2007)
measure: Low-density Lipoprotein (LDL) Cholesterol Levels
timeFrame: Final intervention period (April-July 2009)
measure: Hemoglobin (Hb) A1c Levels
timeFrame: Baseline period (August-November 2007)
measure: Hemoglobin (Hb) A1c Levels
timeFrame: Final intervention period (April-July 2009)
measure: Beta Blocker Use
timeFrame: Baseline period (August - November 2007)
measure: Beta Blocker Use
timeFrame: Final intervention period (April-July 2009)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: VA Medical Center, Birmingham
state: Alabama
city: Newington
country: United States
facility: VA Connecticut Health Care System (Newington)
state: Connecticut
city: Augusta
country: United States
facility: VA Medical Center, Augusta
state: Georgia
city: Boston
country: United States
facility: VA Medical Center, Jamaica Plain Campus
state: Massachusetts
city: Detroit
country: United States
facility: John D. Dingell VA Medical Center, Detroit
state: Michigan
city: Saginaw
country: United States
facility: Aleda E. Lutz VA Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: VA Medical Center, Minneapolis
state: Minnesota
city: Jackson
country: United States
facility: G.V. (Sonny) Montgomery VA Medical Center, Jackson
state: Mississippi
city: Oklahoma City
country: United States
facility: VA Medical Center, Oklahoma City
state: Oklahoma
city: Providence
country: United States
facility: VA Medical Center, Providence
state: Rhode Island
city: Charleston
country: United States
facility: Ralph H Johnson VA Medical Center, Charleston
state: South Carolina
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Laura A. Petersen, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petersen LA, Simpson K, Pietz K, Urech TH, Hysong SJ, Profit J, Conrad DA, Dudley RA, Woodard LD. Effects of individual physician-level and practice-level financial incentives on hypertension care: a randomized trial. JAMA. 2013 Sep 11;310(10):1042-50. doi: 10.1001/jama.2013.276303.
citation: Hysong SJ, Simpson K, Pietz K, SoRelle R, Broussard Smitham K, Petersen LA. Financial incentives and physician commitment to guideline-recommended hypertension management. Am J Manag Care. 2012 Oct 1;18(10):e378-91.
citation: Petersen LA, Woodard LD, Urech TH. Financial incentives to control hypertension in patients--reply. JAMA. 2014 Jan 15;311(3):303-4. doi: 10.1001/jama.2013.284315. No abstract available.
citation: Woodard LD, Landrum CR, Urech TH, Wang D, Virani SS, Petersen LA. Impact of clinical complexity on the quality of diabetes care. Am J Manag Care. 2012 Sep;18(9):508-14.
citation: Petersen LA, Simpson K, Sorelle R, Urech T, Chitwood SS. How variability in the institutional review board review process affects minimal-risk multisite health services research. Ann Intern Med. 2012 May 15;156(10):728-35. doi: 10.7326/0003-4819-156-10-201205150-00011.
citation: Woodard LD, Urech T, Landrum CR, Wang D, Petersen LA. Impact of comorbidity type on measures of quality for diabetes care. Med Care. 2011 Jun;49(6):605-10. doi: 10.1097/MLR.0b013e31820f0ed0.
citation: Virani SS, Steinberg L, Murray T, Negi S, Nambi V, Woodard LD, Bozkurt B, Petersen LA, Ballantyne CM. Barriers to non-HDL cholesterol goal attainment by providers. Am J Med. 2011 Sep;124(9):876-80.e2. doi: 10.1016/j.amjmed.2011.02.012.
citation: Petersen LA, Urech T, Simpson K, Pietz K, Hysong SJ, Profit J, Conrad D, Dudley RA, Lutschg MZ, Petzel R, Woodard LD. Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol. Implement Sci. 2011 Oct 3;6:114. doi: 10.1186/1748-5908-6-114.
citation: Petersen LA. Pay for performance in myocardial infarction: are we reaping the rewards? Nat Clin Pract Cardiovasc Med. 2008 Mar;5(3):134-5. doi: 10.1038/ncpcardio1069. Epub 2007 Dec 4. No abstract available.
citation: Van Swol MA. Does pay-for-performance improve the quality of health care? Ann Intern Med. 2007 Apr 3;146(7):538; author reply 538-9. doi: 10.7326/0003-4819-146-7-200704030-00015. No abstract available.
citation: Petersen LA, Urech TH, Byrne MM, Pietz K. Do financial incentives in a globally budgeted healthcare payment system produce changes in the way patients are categorized? A five-year study. Am J Manag Care. 2007 Sep;13(9):513-22.
citation: Petersen LA, Simpson K, Urech T, Woodard L, Hysong S, Dudley RA. Do financial incentives to health care providers generate greater interest in adhering to performance measures than audit and feedback alone. Journal of general internal medicine. 2009 Apr 1; 24(S1):S58-S59.
citation: Petersen LA, Woodard LD, Henderson LM, Urech TH, Pietz K. Will hypertension performance measures used for pay-for-performance programs penalize those who care for medically complex patients? Circulation. 2009 Jun 16;119(23):2978-85. doi: 10.1161/CIRCULATIONAHA.108.836544. Epub 2009 Jun 1.
citation: Woodard LD, Petersen LA. Improving the performance of performance measurement. J Gen Intern Med. 2010 Feb;25(2):100-1. doi: 10.1007/s11606-009-1198-z. No abstract available.
citation: Petersen LA, Woodard LD, Urech T, Daw C, Sookanan S. Does pay-for-performance improve the quality of health care? Ann Intern Med. 2006 Aug 15;145(4):265-72. doi: 10.7326/0003-4819-145-4-200608150-00006.
citation: Hysong SJ, Kell HJ, Petersen LA, Campbell BA, Trautner BW. Theory-based and evidence-based design of audit and feedback programmes: examples from two clinical intervention studies. BMJ Qual Saf. 2017 Apr;26(4):323-334. doi: 10.1136/bmjqs-2015-004796. Epub 2016 Jun 10.
citation: Petersen LA, Ramos KS, Pietz K, Woodard LD. Impact of a Pay-for-Performance Program on Care for Black Patients with Hypertension: Important Answers in the Era of the Affordable Care Act. Health Serv Res. 2017 Jun;52(3):1138-1155. doi: 10.1111/1475-6773.12517. Epub 2016 Jun 22.
citation: Hysong SJ, SoRelle R, Broussard Smitham K, Petersen LA. Reports of unintended consequences of financial incentives to improve management of hypertension. PLoS One. 2017 Sep 21;12(9):e0184856. doi: 10.1371/journal.pone.0184856. eCollection 2017.