AsthmaNCT00147810
Adult Asthma Surveillance and Intervention in a Managed Care Setting
A study testing Telephone outreach to enhance asthma care in people with Asthma, run by Kaiser Permanente at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Telephone outreach to enhance asthma care
- Type of treatment
- Surgery or procedure
- How many people
- 6,948 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Jul 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 18 years or older
- On KPNW high-risk asthma registry
- At least 180 days of asthma medications dispensings
- At least one visit for asthma in previous 2 years
Who cannot join
- Diagnosis of COPD on problem list in electronic medical record
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
About this study
- 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.
- 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.
Read the detailed description
- 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..
- 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.
- Conditions
- Asthma
- Being tested
- Telephone outreach to enhance asthma care
- Keywords
- telephone outreach, asthma care
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone outreach to enhance asthma careProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
health status
current asthma control
patterns of medication use
asthma quality of life
self-management practices
attitudes about asthma
satisfaction with care
health care utilization
dispensings of anti-asthma medications
routine and acute health care utilization
Secondary outcomes (2)
patient satisfaction
clinician satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startNov 2001
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 6,948 participants
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Investigators
- William M Vollmer, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147810
- Sponsor's protocol ID
- CASHEW 200-95-0953-48
- Other IDs
- CDC/ACHP 200-95-0953-48
- Status last verified
- Sep 2005
- First submitted
- 2 Sep 2005
- Last updated
- 24 Mar 2006
- Results posted
- No
Publications
Fuhlbrigge AL, Adams RJ, Guilbert TW, Grant E, Lozano P, Janson SL, Martinez F, Weiss KB, Weiss ST. The burden of asthma in the United States: level and distribution are dependent on interpretation of the national asthma education and prevention program guidelines. Am J Respir Crit Care Med. 2002 Oct 15;166(8):1044-9. doi: 10.1164/rccm.2107057.
PubMed 12379546Buchner DA, Butt LT, De Stefano A, Edgren B, Suarez A, Evans RM. Effects of an asthma management program on the asthmatic member: patient-centered results of a 2-year study in a managed care organization. Am J Manag Care. 1998 Sep;4(9):1288-97.
PubMed 10185979Lieu TA, Capra AM, Quesenberry CP, Mendoza GR, Mazar M. Computer-based models to identify high-risk adults with asthma: is the glass half empty of half full? J Asthma. 1999 Jun;36(4):359-70. doi: 10.3109/02770909909068229.
PubMed 10386500Vollmer WM, Markson LE, O'Connor E, Frazier EA, Berger M, Buist AS. Association of asthma control with health care utilization: a prospective evaluation. Am J Respir Crit Care Med. 2002 Jan 15;165(2):195-9. doi: 10.1164/ajrccm.165.2.2102127.
PubMed 11790654Corkrey R, Parkinson L. Interactive voice response: review of studies 1989-2000. Behav Res Methods Instrum Comput. 2002 Aug;34(3):342-53. doi: 10.3758/bf03195462.
PubMed 12395550Kaplan B, Farzanfar R, Friedman RH. Personal relationships with an intelligent interactive telephone health behavior advisor system: a multimethod study using surveys and ethnographic interviews. Int J Med Inform. 2003 Aug;71(1):33-41. doi: 10.1016/s1386-5056(03)00072-8.
PubMed 12909156Lavigne JV, Tapper K. Interactive voice response in disease management: Providing patient outreach and improving outcomes. Rochester:2000, pp 40-57.
Krishna S, Balas EA, Boren SA, Maglaveras N. Patient acceptance of educational voice messages: a review of controlled clinical studies. Methods Inf Med. 2002;41(5):360-9.
PubMed 12501806
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adult Asthma Surveillance and Intervention in a Managed Care Setting
- ClinicalTrials.gov ID
- NCT00147810
- Acronym / sponsor ID
- CASHEW 200-95-0953-48
- Conditions
- Asthma
- Keywords
- telephone outreach, asthma care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,948 participants
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Nov 2001
- Study completion
- Jul 2004
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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
- 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..
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- On KPNW high-risk asthma registry
- At least 180 days of asthma medications dispensings
- At least one visit for asthma in previous 2 years
Key exclusion criteria (1 listed)
- Diagnosis of COPD on problem list in electronic medical record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone outreach to enhance asthma care | Procedure or surgery | – |
Primary outcome
health status
current asthma control
patterns of medication use
asthma quality of life
self-management practices
attitudes about asthma
satisfaction with care
health care utilization
dispensings of anti-asthma medications
routine and acute health care utilization
2 secondary outcomes
patient satisfaction
clinician satisfaction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2006.
- Background: PubMed 12379546Fuhlbrigge AL, Adams RJ, Guilbert TW, Grant E, Lozano P, Janson SL, Martinez F, Weiss KB, Weiss ST. The burden of asthma in the United States: level and distribution are dependent on interpretation of the national asthma education and prevention program guidelines. Am J Respir Crit Care Med. 2002 Oct 15;166(8):1044-9. doi: 10.1164/rccm.2107057.
- Background: PubMed 10185979Buchner DA, Butt LT, De Stefano A, Edgren B, Suarez A, Evans RM. Effects of an asthma management program on the asthmatic member: patient-centered results of a 2-year study in a managed care organization. Am J Manag Care. 1998 Sep;4(9):1288-97.
- Background: PubMed 10386500Lieu TA, Capra AM, Quesenberry CP, Mendoza GR, Mazar M. Computer-based models to identify high-risk adults with asthma: is the glass half empty of half full? J Asthma. 1999 Jun;36(4):359-70. doi: 10.3109/02770909909068229.
- Background: PubMed 11790654Vollmer WM, Markson LE, O'Connor E, Frazier EA, Berger M, Buist AS. Association of asthma control with health care utilization: a prospective evaluation. Am J Respir Crit Care Med. 2002 Jan 15;165(2):195-9. doi: 10.1164/ajrccm.165.2.2102127.
- Background: PubMed 12395550Corkrey R, Parkinson L. Interactive voice response: review of studies 1989-2000. Behav Res Methods Instrum Comput. 2002 Aug;34(3):342-53. doi: 10.3758/bf03195462.
- Background: PubMed 12909156Kaplan B, Farzanfar R, Friedman RH. Personal relationships with an intelligent interactive telephone health behavior advisor system: a multimethod study using surveys and ethnographic interviews. Int J Med Inform. 2003 Aug;71(1):33-41. doi: 10.1016/s1386-5056(03)00072-8.
- BackgroundLavigne JV, Tapper K. Interactive voice response in disease management: Providing patient outreach and improving outcomes. Rochester:2000, pp 40-57.
- Background: PubMed 12501806Krishna S, Balas EA, Boren SA, Maglaveras N. Patient acceptance of educational voice messages: a review of controlled clinical studies. Methods Inf Med. 2002;41(5):360-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William M Vollmer, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone outreach to enhance asthma care in people with Asthma, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health status. The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00147810, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2006.