Asthma Clinical Trial
Official title:
Adult Asthma Surveillance and Intervention in a Managed Care Setting
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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