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: April 6, 2015
Last verified: October 2014
Results First Received: November 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Hypertension
Interventions: Behavioral: Physician-level financial incentives
Behavioral: Practice-level financial incentives
Behavioral: Physician- and practice-level financial incentives

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We enrolled non-physician primary care personnel at the hospitals randomized to the two study arms that tested the effect of practice-level incentives. Only data from physicians were used to assess both physician-level and practice-level performances. This participant enrollment table does not include data on the non-physician participants.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Physician-level Incentives

Examines the effect of physician-level financial incentives on hypertension quality of care

Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes.

Practice-level Incentives

Examines the effect of practice-level financial incentives on hypertension quality of care

Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes.

Physician- and Practice-level Incentives

Examines the effect of physician and practice-level financial incentives on hypertension quality of care

Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives.

No Incentives (Control) Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.

Participant Flow:   Overall Study
    Physician-level Incentives     Practice-level Incentives     Physician- and Practice-level Incentives     No Incentives (Control)  
STARTED     20     21     21     21  
COMPLETED     19     20     19     19  
NOT COMPLETED     1     1     2     2  
Participant left the hospital                 1                 0                 0                 1  
Withdrawal by Subject                 0                 1                 0                 0  
Participant left primary care setting                 0                 0                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Distribution of Physician Characteristics Across Study Groups

Reporting Groups
  Description
Physician-level Incentives

Examines the effect of physician-level financial incentives on hypertension quality of care

Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes.

Practice-level Incentives

Examines the effect of practice-level financial incentives on hypertension quality of care

Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes.

Physician- and Practice-level Incentives

Examines the effect of physician and practice-level financial incentives on hypertension quality of care

Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives.

No Incentives (Control) Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
Total Total of all reporting groups

Baseline Measures
    Physician-level Incentives     Practice-level Incentives     Physician- and Practice-level Incentives     No Incentives (Control)     Total  
Number of Participants  
[units: participants]
  19     20     19     19     77  
Age [1]
[units: years]
Mean ± Standard Deviation
  45  ± 8     48  ± 8     44  ± 6     48  ± 7     46  ± 8  
Gender  
[units: participants]
         
Female     11     8     9     6     34  
Male     8     12     10     13     43  
Race/Ethnicity, Customized [2]
[units: participants]
         
White     7     7     9     8     31  
Black     3     2     1     0     6  
Asian Indian     5     5     6     5     21  
Other     4     6     3     6     19  
Region of Enrollment  
[units: participants]
         
United States     19     20     19     19     77  
[1] One physician participant in the physician-level incentive arm declined to provide age data.
[2] These data describe the race of the physician participants.



  Outcome Measures
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1.  Primary:   Proportion of the Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure   [ Time Frame: Baseline period (August-November 2007) ]

2.  Primary:   Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure   [ Time Frame: Final intervention period (April-July 2009) ]

3.  Primary:   Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure   [ Time Frame: After the washout period (May-August 2011) ]

4.  Primary:   Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications   [ Time Frame: Baseline period (August-November 2007) ]

5.  Primary:   Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications   [ Time Frame: Final intervention period (April-July 2009) ]

6.  Primary:   Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications   [ Time Frame: After the washout period (May-August 2011) ]

7.  Post-Hoc:   Incidence of Hypotension Among All Patients With Hypertension   [ Time Frame: February-May 2009 ]

8.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Laura A. Petersen
Organization: VA HSR&D Center for Innovations in Quality, Effectiveness & Safety (IQuESt)
phone: 713-794-8623
e-mail: Laura.Petersen@va.gov


Publications of Results:


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00302718     History of Changes
Other Study ID Numbers: IIR 04-349, R01HL079173
Study First Received: March 10, 2006
Results First Received: November 21, 2014
Last Updated: April 6, 2015
Health Authority: United States: Federal Government