Tailored Communication to Reduce Cardiovascular Risk

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephen Persell, Northwestern University
ClinicalTrials.gov Identifier:
NCT01286311
First received: January 27, 2011
Last updated: January 27, 2015
Last verified: January 2015
Results First Received: May 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Conditions: Hypercholesterolemia
Coronary Artery Disease
Dyslipidemia
Hypertension
Intervention: Behavioral: Direct-to-patient tailored cardiovascular risk message system

  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
Physicians were recruited at their clinic offices in January 2011. They provided written informed consent to be randomized and to have study staff mail risk messages directly to patients on their behalf if they were randomized to the intervention. Patients were included with a waiver of consent.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Direct-to-patient Tailored Cardiovascular Risk Message System Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
Control Eligible patients cared for by physicians randomized to the control group will receive usual care. After 9 months, control group physicians were provided with lists of their eligible patients and their risk scores.

Participant Flow:   Overall Study
    Direct-to-patient Tailored Cardiovascular Risk Message System     Control  
STARTED     232 [1]   232 [2]
COMPLETED     218 [3]   232 [4]
NOT COMPLETED     14     0  
Physician did not want outreach sent                 14                 0  
[1] 218 patients (of the 14 physician randomized to the intervention) started the study.
[2] 217 patients (of the 15 physician randomized to the intervention) started the study.
[3] 204 patients (of the 14 physician randomized to the intervention) completed the study.
[4] 217 patients (of the 15 physician randomized to the intervention) completed the study.



  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.
218 patients (of the 14 physician randomized to the intervention) and 217 patients (of the 15 physician randomized to the intervention) participated in the study.

Reporting Groups
  Description
Direct-to-patient Tailored Cardiovascular Risk Message System Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
Control No text entered.
Total Total of all reporting groups

Baseline Measures
    Direct-to-patient Tailored Cardiovascular Risk Message System     Control     Total  
Number of Participants  
[units: participants]
  232     232     464  
Age [1]
[units: patient┬áparticipants]
     
<=18 years     0     0     0  
Between 18 and 65 years     137     147     284  
>=65 years     81     70     151  
Age  
[units: years]
Mean ± Standard Deviation
  61.3  ± 9.4     60.1  ± 9.2     60.7  ± 9.4  
Gender [2]
[units: participants]
     
Female     49     50     99  
Male     169     167     336  
Region of Enrollment  
[units: participants]
     
United States     232     232     464  
[1] Physicians were not enrolled according to age criteria, and are therefore not included above.
[2] Physicians were not enrolled according to gender criteria, and are therefore not included above.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction   [ Time Frame: 9 months ]

2.  Secondary:   Frequency of Clinical Encounters   [ Time Frame: 9 months ]

3.  Secondary:   Medication Prescriptions for Dyslipidemia   [ Time Frame: 9 months ]

4.  Secondary:   Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed   [ Time Frame: 9 months ]

5.  Secondary:   Presence of an Aspirin Prescription   [ Time Frame: 9 months ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Stephen D. Persell, MD MPH
Organization: Northwestern University
phone: 312-503-6464
e-mail: spersell@nmff.org


No publications provided by Northwestern University

Publications automatically indexed to this study:

Responsible Party: Stephen Persell, Northwestern University
ClinicalTrials.gov Identifier: NCT01286311     History of Changes
Other Study ID Numbers: Reducing CV Risk, K08HS015647
Study First Received: January 27, 2011
Results First Received: May 13, 2013
Last Updated: January 27, 2015
Health Authority: United States: Federal Government