HypertensionNCT00302718
Financial Incentives to Translate ALLHAT Into Practice: A Randomized Trial
A study testing Physician-level financial incentives, Practice-level financial incentives and Physician- and practice-level financial incentives in people with Hypertension, run by VA Office of Research and Development at 12 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- Physician-level financial incentives, Practice-level financial incentives and Physician- and practice-level financial incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 12 sitesUnited States
- Study dates
- Feb 2007to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The study did not include VA physicians that were trainees.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
VA Medical Center, Augusta
Augusta, Georgia, 30904
VA Medical Center, Birmingham
Birmingham, Alabama, 35233
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, 02130
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, 29401-5799
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, 48201
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
G.V. (Sonny) Montgomery VA Medical Center, Jackson
Jackson, Mississippi, 39216
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417
VA Connecticut Health Care System (Newington)
Newington, Connecticut, 06111
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, 73104
VA Medical Center, Providence
Providence, Rhode Island, 02908
Aleda E. Lutz VA Medical Center
Saginaw, Michigan, 48602
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Physician-level financial incentives, Practice-level financial incentives, Physician- and practice-level financial incentives
- Keywords
- Physician Incentive Plan, Quality of Health Care, Reimbursement, Incentive, Randomized Controlled Trial, Physicians, Reward
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician-level financial incentivesBehavioural
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 incentivesBehavioural
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 incentivesBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Physician-level incentives | Experimental | Examines the effect of physician-level financial incentives on hypertension quality of care Receives: Behavioral: Physician-level financial incentives |
| Practice-level incentives | Experimental | Examines the effect of practice-level financial incentives on hypertension quality of care Receives: Behavioral: Practice-level financial incentives |
| Physician- and practice-level incentives | Experimental | Examines the effect of physician- and practice-level financial incentives on hypertension quality of care Receives: Behavioral: Physician- and practice-level financial incentives |
| No incentives (control) | No intervention | Physician participants in this arm received only audit and feedback performance reports as did the participants in the intervention arms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure
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.
Measured: Baseline period (August-November 2007)
Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure
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.
Measured: Final intervention period (April-July 2009)
Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure
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.
Measured: After the washout period (May-August 2011)
Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications
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.
Measured: Baseline period (August-November 2007)
Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications
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.
Measured: Final intervention period (April-July 2009)
Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications
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.
Measured: After the washout period (May-August 2011)
Secondary outcomes (8)
Colorectal Cancer (CRC) Screening
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.
Measured: Baseline period (August - November 2007)
Colorectal Cancer (CRC) Screening
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.
Measured: Final intervention period (April-July 2009)
Low-density Lipoprotein (LDL) Cholesterol Levels
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.
Measured: Baseline period (August-November 2007)
Low-density Lipoprotein (LDL) Cholesterol Levels
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.
Measured: Final intervention period (April-July 2009)
Hemoglobin (Hb) A1c Levels
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.
Measured: Baseline period (August-November 2007)
Hemoglobin (Hb) A1c Levels
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.
Measured: Final intervention period (April-July 2009)
Beta Blocker Use
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.
Measured: Baseline period (August - November 2007)
Beta Blocker Use
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
Measured: Final intervention period (April-July 2009)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startFeb 2007
- Primary completionOct 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Laura A. Petersen, MD MPH, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302718
- Sponsor's protocol ID
- IIR 04-349
- Other IDs
- R01HL079173
- Status last verified
- Jan 2019
- First submitted
- 10 Mar 2006
- Last updated
- 30 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24026599Hysong 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.
PubMed 23145846Petersen 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.
PubMed 24430324Woodard 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.
PubMed 23009301Petersen 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.
PubMed 22586010Woodard 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.
PubMed 21422952Virani 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.
PubMed 21854896Petersen 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.
PubMed 21967830Petersen 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.
PubMed 18059383Van 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.
PubMed 17404361Petersen 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.
PubMed 17803365Petersen 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.
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.
PubMed 19487595Woodard 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.
PubMed 19953336Petersen 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.
PubMed 16908917
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Financial Incentives to Translate ALLHAT Into Practice
- ClinicalTrials.gov ID
- NCT00302718
- Acronym / sponsor ID
- IIR 04-349
- Conditions
- Hypertension
- Keywords
- Physician Incentive Plan, Quality of Health Care, Reimbursement, Incentive, Randomized Controlled Trial, Physicians, Reward
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Mar 2006 (estimated)
- Results
- Posted 15 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physician-level incentives | Experimental | Behavioral: Physician-level financial incentivesExamines the effect of physician-level financial incentives on hypertension quality of care |
| Practice-level incentives | Experimental | Behavioral: Practice-level financial incentivesExamines the effect of practice-level financial incentives on hypertension quality of care |
| Physician- and practice-level incentives | Experimental | Behavioral: Physician- and practice-level financial incentivesExamines the effect of physician- and practice-level financial incentives on hypertension quality of care |
| No incentives (control) | No intervention | –Physician participants in this arm received only audit and feedback performance reports as did the participants in the intervention arms. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- The study did not include VA physicians that were trainees.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician-level financial incentivesEnrolled 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. | Behavioural | Physician-level incentives |
| Practice-level financial incentivesEnrolled 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. | Behavioural | Practice-level incentives |
| Physician- and practice-level financial incentivesEnrolled 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). | Behavioural | Physician- and practice-level incentives |
Primary outcome
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.
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.
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.
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.
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.
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.
8 secondary outcomes
Colorectal Cancer (CRC) Screening
Time frame: Baseline period (August - November 2007)
Colorectal Cancer (CRC) Screening
Time frame: Final intervention period (April-July 2009)
Low-density Lipoprotein (LDL) Cholesterol Levels
Time frame: Baseline period (August-November 2007)
Low-density Lipoprotein (LDL) Cholesterol Levels
Time frame: Final intervention period (April-July 2009)
Hemoglobin (Hb) A1c Levels
Time frame: Baseline period (August-November 2007)
Hemoglobin (Hb) A1c Levels
Time frame: Final intervention period (April-July 2009)
Beta Blocker Use
Time frame: Baseline period (August - November 2007)
Beta Blocker Use
Time frame: Final intervention period (April-July 2009)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24026599Petersen 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.
- Results publication: PubMed 23145846Hysong 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.
- Results publication: PubMed 24430324Petersen 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.
- Results publication: PubMed 23009301Woodard 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.
- Results publication: PubMed 22586010Petersen 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.
- Results publication: PubMed 21422952Woodard 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.
- Results publication: PubMed 21854896Virani 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.
- Results publication: PubMed 21967830Petersen 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.
- Results publication: PubMed 18059383Petersen 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.
- Results publication: PubMed 17404361Van 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.
- Results publication: PubMed 17803365Petersen 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.
- Results publicationPetersen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura A. Petersen, MD MPH principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician-level financial incentives, Practice-level financial incentives and Physician- and practice-level financial incentives in people with Hypertension, run by VA Office of Research and Development at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00302718, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.