Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147810
Status:
COMPLETED
Last Update Posted:
2006-03-24
First Post:
2005-09-02
Brief Title:
Adult Asthma Surveillance and Intervention in a Managed Care Setting
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Adult Asthma Surveillance and Intervention in a Managed Care Setting
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 6948 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 n3367 or telephone outreach n3581 192 members of the telephone outreach group were randomly selected to receive calls from a real person while the remaining 3389 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 KPs 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 1583 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
2 The telephone intervention study was conducted within KPNW 6948 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 n3367 or telephone outreach n3581 192 members of the telephone outreach group were randomly selected to receive calls from a real person while the remaining 3389 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 KPs 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 1583 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDCACHP 200-95-0953-48 | None | None | None |