Clinical Trials Logo

Clinical Trial Summary

1. To determine if there are gender differences in asthma prevalence, severity, treatment, and health care utilization within patient populations in Kaiser Permanente Northwest and Colorado Regions.

2. To test the ability of an automated telephone outreach intervention to reduce health care utilization for acute asthma exacerbations and improve quality of life. The intervention used speech recognition technology to gather information about current asthma control, patterns of medication use, and recent acute health care utilization for asthma. This information allowed the intervention to provide tailored educational feedback and to flag patients deemed to be at high risk for future exacerbations so that they could be followed up by the health care system.


Clinical Trial Description

1. To determine gender differences, a questionnaire was mailed to a random sample of 800 members with asthma in Kaiser Permanente Northwest (KPNW) and 800 in KP Colorado (KPC) Regions, which are large, group-model health maintenance organizations. Results were combined with information from administrative databases on health care utilization..

2. The telephone intervention study was conducted within KPNW. 6,948 eligible HMO members were identified from the electronic medical record (EMR). Individuals 18 or older were eligible for the study if they were either (1) on the KPNW high risk asthma registry or (2) had at least 180 days of anti-asthma medication dispensings and at least one medical contact for asthma during a specified two-year period. Excluded were 850 individuals who had COPD listed in the electronic medical record.

Eligible individuals were randomly assigned to either usual care (n=3,367) or telephone outreach (n=3,581); 192 members of the telephone outreach group were randomly selected to receive calls from a real person, while the remaining 3,389 received automated calls.

The intervention consisted of three rounds of calling, spaced ~five months apart. Calls consisted of a brief series of questions to assess (1) recent emergency department or hospital care without a follow-up visit, (2) current level of asthma control, (3) current patterns of asthma medication use, and (4) whether the member could identify a primary provider for asthma care. (Sel-identified COPD patients received an abbreviated intervention but were kept on the call list unless a diagnosis of COPD was subsequently added in thier EMR.)

Based on the responses to these initial questions, members were offered tailored feedback regarding their overall level of asthma control and use of asthma medications. Feedback was designed to convey a positive message and not be prescriptive. The call concluded with an offer to receive information about additional Kaiser Permanente (KP) resources (a toll-free health line and KP’s online website for members), followed by an offer to call again in five months.

The calls were brief and lasted less than 10 minutes. Participants could refuse the tailored feedback. To maximize participation, calls were made using speech recognition (or speech enabled) technology, rather than requiring the respondent to respond by pushing buttons.

Automated and live person calls used identical scripts. Responses to the questions were computerized and used to generate different text messages that were entered into the electronic medical record and logged as telephone encounters. Members identified as being at high risk of a future acute exacerbation were brought to the attention of the system, ensuring that a clinician would have to physically review the encounter and initiate a follow-up contact with the patient.

Consistent with a standard intention to treat analysis, all randomized individuals were included in the analysis, even if they opted not to participate in the calls.

Primary outcomes of the study related to health care utilization, medication use, and quality of life. A secondary outcome was the extent to which the intervention could be successfully implemented, and the reaction to the intervention by patients and providers. Extensive process data was collected, including a survey of providers whose patients were enrolled in the intervention, mailed surveys to members, feedback from members obtained immediately following the third intervention call, and an audit of those charts where the encounter was left open to determine what, if any, follow-up occurred. Participation at each round of calling was also tracked.

Follow-up data was obtained from a survey of 1,583 randomly selected KPNW members one month following the final calling period and from an analysis of health care utilization data from the start of the initial calling until one month following the last round of calling. The response rate for the follow-up survey was 65% for both intervention participants and control participants. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00147810
Study type Interventional
Source Kaiser Permanente
Contact
Status Completed
Phase N/A
Start date November 2001
Completion date July 2004

See also
  Status Clinical Trial Phase
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device