Using Information Technology to Improve Asthma Adherence

Asthma Clinical Trial

— AFFIRM  

Official title:

Adherence Feedback for Improving Respiratory Medication Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00459368
• Other study ID #: R01HL079055
• Status: Completed
• Phase: N/A
• First received: April 9, 2007
• Last updated: August 10, 2010
• Start date: May 2007
• Est. completion date: November 2009

Study information

• Verified date: June 2010
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether providing patient medication adherence information on inhaled corticosteroid use to clinicians will result in improved patient adherence and asthma control.

Description:

In 2001 an estimated 31.1 million people in the United States reported ever having had an asthma diagnosis. Asthma is a leading cause of preventable hospitalizations, and it accounts for an estimated 14 million days of missed school and 100 million days of restricted activity yearly.

The routine use of anti-inflammatory medications, particularly inhaled corticosteroids (ICS), in the treatment of asthma can markedly improve symptoms and reduce complications. Yet, evidence suggests that these medications are under-prescribed by physicians and poorly taken by patients. For example, in one study of asthma patients enrolled in a large, California HMO only 71.7% of patients with severe symptoms reported having a steroid inhaler, and only 53.6% of those reported using it daily in the preceding month. Using electronic monitoring devices to record inhaler use, researchers have estimated that patients use their ICS as directed 20 to 73% of the time. Using claims-based measures of adherence we have shown that adherence to inhaled steroids is inversely correlated with the frequency of oral steroid use and asthma-related emergency room visits. In addition, these measures suggest that non-adherence to ICS is an independent predictor of asthma-related hospitalizations. In our study population, we estimated that 60% of asthma-related hospitalizations were attributable to poor adherence to ICS. Together these findings suggest that increasing ICS use may improve asthma outcomes.

Studies employing health-behavioral models of adherence suggest that medication adherence is associated with treatment-related concerns regarding complications, efficacy, and benefits. Unfortunately, the results of behavioral and educational interventions to improve adherence have been disappointing. Despite, in some cases, considerable time spent with patients, these interventions have at best resulted in modest adherence improvements. Given the time, training, and resources required to implement these interventions, they are unlikely to be widely adopted in the clinical setting. Some recent studies, however, suggest that providing adherence data to clinicians may improve patient adherence. In one, clinicians gave repeated feedback to patients regarding ICS adherence; this resulted in sustained improvements over the study period. Unfortunately, this small study did not find differences in asthma outcomes.

In this proposal we seek to test an asthma adherence intervention specifically designed for use in the clinical setting. Adherence measures will be generated by linking currently available electronic data. In this cluster-randomized trial, primary care physician-practice groups will be randomized to receive asthma medication adherence information electronically for patients with asthma associated with these practices. In addition to ICS adherence information, clinicians in intervention practices will have data on patient beta-agonist use to better tailor ICS therapy to disease severity.

Eligible patients with asthma will be identified prior to randomizing practices and will be invited to participate. Patient surveys will be sent in the pre-intervention survey and in the post-intervention period. Patient-level outcomes will be assessed through the medical record, patient surveys, and claims data.

We will perform an intention-to-treat analysis with all eligible patients identified pre-randomization included in the analysis (the primary analysis). This study is powered to allow for only 60% of the eligible patient population being seen within the first 6-months (i.e., no effect in 40% of the patient population). As a secondary analysis, we will perform a modified intention-to-treat (or per protocol) analysis, whereby we will analyze the results of only those patients in both study arms seen within the first 6-months of the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2698
• Est. completion date: November 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 56 Years

Eligibility

Inclusion Criteria (patient-level):

• Age 5-56 years

• Physician diagnosis of asthma

• Continuous HMO enrollment with prescription drug rider

• Electronic prescription of an inhaled corticosteroid

Exclusion Criteria (patient-level):

• Diagnosis of chronic obstructive pulmonary disease

• Diagnosis of congestive heart failure

Inclusion Criteria (practice-level):

• Primary care practice (i.e., pediatrics, family practice, or internal medicine) within the health system. A practice is defined as a group of physicians who by virtue of speciality or geography care for a relatively contained population of patients and who cross-cover the care of these patients.

Exclusion Criteria (practice-level):

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Patient Compliance

Intervention

Behavioral:
• Feedback of patient adherence information
Patient inhaled corticosteroid adherence information is being provided to physicians at clinic sites randomized to the intervention arm. Adherence information is available via electronic prescribing software, and so is available to physicians when writing, renewing, or viewing medications. Physicians at intervention sites also receive standard training in how to interpret adherence metrics and how to intervene on poor adherence.
• Active control group
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.

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (13)

Apter AJ, Boston RC, George M, Norfleet AL, Tenhave T, Coyne JC, Birck K, Reisine ST, Cucchiara AJ, Feldman HI. Modifiable barriers to adherence to inhaled steroids among adults with asthma: it's not just black and white. J Allergy Clin Immunol. 2003 Jun;111(6):1219-26. — View Citation

Bender B, Milgrom H, Apter A. Adherence intervention research: what have we learned and what do we do next? J Allergy Clin Immunol. 2003 Sep;112(3):489-94. Review. — View Citation

Campbell MK, Elbourne DR, Altman DG; CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ. 2004 Mar 20;328(7441):702-8. — View Citation

Centers for Disease Control and Prevention (CDC). Self-reported asthma prevalence and control among adults--United States, 2001. MMWR Morb Mortal Wkly Rep. 2003 May 2;52(17):381-4. — View Citation

Cochrane MG, Bala MV, Downs KE, Mauskopf J, Ben-Joseph RH. Inhaled corticosteroids for asthma therapy: patient compliance, devices, and inhalation technique. Chest. 2000 Feb;117(2):542-50. Review. — View Citation

Donner A, Klar N. Pitfalls of and controversies in cluster randomization trials. Am J Public Health. 2004 Mar;94(3):416-22. — View Citation

Legorreta AP, Christian-Herman J, O'Connor RD, Hasan MM, Evans R, Leung KM. Compliance with national asthma management guidelines and specialty care: a health maintenance organization experience. Arch Intern Med. 1998 Mar 9;158(5):457-64. — View Citation

Leickly FE, Wade SL, Crain E, Kruszon-Moran D, Wright EC, Evans R 3rd. Self-reported adherence, management behavior, and barriers to care after an emergency department visit by inner city children with asthma. Pediatrics. 1998 May;101(5):E8. — View Citation

McDonald HP, Garg AX, Haynes RB. Interventions to enhance patient adherence to medication prescriptions: scientific review. JAMA. 2002 Dec 11;288(22):2868-79. Review. Erratum in: JAMA. 2003 Jun 25;289(24):3242. — View Citation

Onyirimba F, Apter A, Reisine S, Litt M, McCusker C, Connors M, ZuWallack R. Direct clinician-to-patient feedback discussion of inhaled steroid use: its effect on adherence. Ann Allergy Asthma Immunol. 2003 Apr;90(4):411-5. — View Citation

Schectman JM, Schorling JB, Nadkarni MM, Voss JD. Can prescription refill feedback to physicians improve patient adherence? Am J Med Sci. 2004 Jan;327(1):19-24. — View Citation

Schmaling KB, Afari N, Blume AW. Assessment of psychological factors associated with adherence to medication regimens among adult patients with asthma. J Asthma. 2000 Jun;37(4):335-43. — View Citation

Williams LK, Pladevall M, Xi H, Peterson EL, Joseph C, Lafata JE, Ownby DR, Johnson CC. Relationship between adherence to inhaled corticosteroids and poor outcomes among adults with asthma. J Allergy Clin Immunol. 2004 Dec;114(6):1288-93. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Adherence to Inhaled Corticosteroids (ICS)	Adherence to ICS medication was measured during the last 3 months of the intervention (i.e., for the time period of 9-12 months post-randomization). Adherence was measured using pharmacy claims data, and represents the percent of prescribed medication taken. The normal range for this value is 0-100%.	1 year	No
Secondary	Asthma-related Emergency Room Visits		1 year	No
Secondary	Asthma-related Hospitalizations		1 year	No
Secondary	Oral Steroid Use		1 year	No
Secondary	Patient Self-efficacy to ICS Treatment		survey following intervention period	No
Secondary	Readiness to Improve ICS Adherence (Transtheoretical Model)		survey following intervention period	No
Secondary	Patient-physician Communication (Patient Reported Measure)		survey following intervention period	No
Secondary	Patient Medical Care Costs		1 year	No