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Using Information Technology to Improve Asthma Adherence (AFFIRM)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00459368
First received: April 9, 2007
Last updated: August 10, 2010
Last verified: June 2010
History of Changes
Results First Received: June 17, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Asthma
Patient Compliance
Interventions: Behavioral: Feedback of patient adherence information
Behavioral: Active control group

  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
Health system primary care providers (i.e., in the areas of family practice, internal medicine, and pediatrics) were invited to participate. Physicians who consented to participate were grouped according to practice.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One hundred ninety-two (92%) of the 207 primary care staff clinicians, representing 34 pre-defined primary care practices within the health system, agreed to participate. One clinic was not included a priori since it functioned as the primary resident clinic for internal medicine trainees.

Reporting Groups
  Description
Patient Medication Adherence Feedback In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
Usual Care Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.

Participant Flow:   Overall Study
    Patient Medication Adherence Feedback     Usual Care  
STARTED     1335     1363  
COMPLETED     1040     1034  
NOT COMPLETED     295     329  



  Baseline Characteristics
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Reporting Groups
  Description
Patient Medication Adherence Feedback In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
Usual Care Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
Total Total of all reporting groups

Baseline Measures
    Patient Medication Adherence Feedback     Usual Care     Total  
Number of Participants  
[units: participants]
 		  1335     1363     2698  
Age  
[units: participants]
 		     
<=18 years     591     604     1195  
Between 18 and 65 years     744     759     1503  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  25.6  ± 37.3     27.7  ± 38.5     26.6  ± 37.9  
Gender  
[units: participants]
 		     
Female     737     753     1490  
Male     598     610     1208  
Region of Enrollment  
[units: participants]
 		     
United States     1335     1363     2698  



  Outcome Measures

1.  Primary:   Patient Adherence to Inhaled Corticosteroids (ICS)   [ Time Frame: 1 year ]
  Show Outcome Measure 1

2.  Secondary:   Asthma-related Emergency Room Visits   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Asthma-related Hospitalizations   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Oral Steroid Use   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Patient Self-efficacy to ICS Treatment   [ Time Frame: survey following intervention period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Readiness to Improve ICS Adherence (Transtheoretical Model)   [ Time Frame: survey following intervention period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Patient-physician Communication (Patient Reported Measure)   [ Time Frame: survey following intervention period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Patient Medical Care Costs   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: L. Keoki Williams, MD, MPH
Organization: Henry Ford Health System
phone: 313-874-5454


Publications:

Publications automatically indexed to this study:


Responsible Party: L. Keoki Williams, MD, MPH, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00459368     History of Changes
Other Study ID Numbers: R01HL079055
Study First Received: April 9, 2007
Results First Received: June 17, 2010
Last Updated: August 10, 2010
Health Authority: United States: Institutional Review Board