Telephone-Based Program to Promote Inhaled Corticosteroid Adherence Among Individuals With Asthma
Phone Calls to Promote Adherence With Inhaled Corticosteroids
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Asthma is a serious, chronic disease that affects lung function and impairs an individual's ability to breathe normally. ICS reduce airway inflammation and are often prescribed to treat these conditions. However, poor medication adherence is a common problem that can lead to treatment failure, hospitalization, or death. A telephone-based system that uses interactive voice recognition technology to remind individuals to follow their medication regimen may prove beneficial in promoting adherence. The purpose of this study is to evaluate the effectiveness of such a telephone-based intervention at improving adherence to inhaled corticosteroid regimens among individuals with asthma. If this study proves successful, telephone-based interventions may be developed to promote treatment adherence for other chronic medical conditions.
This 19-month study will enroll approximately 14,000 members of the Kaiser Permanente Northwest or Hawaii health system. Participants will be randomly assigned to either take part in the telephone intervention or receive usual medical care. Over the 19-month period, participants in the intervention group will receive between one and eight phone calls that will remind them to refill their prescriptions and offer education about ICS. If needed, the call may also offer a transfer to a pharmacy refill line or to speak with a pharmacist. Approximately 2,000 participants will complete questionnaires at study entry and at the end of the 19-month intervention period. The questionnaires will assess quality of life, respiratory health, asthma control, depression, inhaler use beliefs, and satisfaction with the intervention. Electronic medical record data and questionnaires will be used to determine adherence rates.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Hawaii
-
Honolulu, Hawaii, Forenede Stater, 96817
- Center for Health Research/KPH
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97227
- Center for Health Research-KPNW
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Received treatment for asthma in the year prior to study entry
- Received at least one respiratory medication at a Kaiser Permanente Northwest (KPNW) or Kaiser Permanente Hawaii (KPH) outpatient pharmacy in the year prior to study entry
- Continuous Kaiser Permanente membership from the year prior to study entry through study entry
- Willing to participate in the study
Exclusion Criteria:
- Excluded from primary analyses if fewer than three months of follow-up
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Automated Phone-Based Refill Reminders
Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.
|
The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions.
Andre navne:
|
|
Ingen indgriben: Usual Care
Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the "usual care" study arm, and therefore, receive no intervention.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Modified Medication Possession Ratio
Tidsramme: Measured over 19 months
|
We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure.
The MPR is computed as the number of days' supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window.
Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days' supply that would extend beyond the end of the window.
The MPR, and by extension the mMPR, assumes that medications were used as directed and that a new inhaled corticosteroid canister was not started until any medication on hand was exhausted.
|
Measured over 19 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Juniper Asthma Quality of Life Questionnaire (Global Score)
Tidsramme: Measured at 19 months
|
Asthma specific quality of life measurement developed by Dr. Elizabeth Juniper.
This is the overall summary score and ranges from 1=poorest quality of life to 7=best quality of life.
|
Measured at 19 months
|
|
Rate of Acute Health Care Visits for Asthma
Tidsramme: Measured over 19 months of follow-up
|
annualized rate of acute asthma health care utilization events (urgent care, emergency department use, hospitalization) based on data derived from the electronic medical record.
Each type of event was given equal weight for this analysis.
|
Measured over 19 months of follow-up
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: William M. Vollmer, PhD, Center for Health Research/KPNW
- Ledende efterforsker: Cynthia Rand, PhD, Johns Hopkins University
- Ledende efterforsker: Joan Dubanoski, PhD, Center for Health Research/KPH
- Ledende efterforsker: Adrianne Feldstein, MD, Center for Health Research/KPNW
- Ledende efterforsker: David Smith, PhD, Center for Health Research/KPNW
Publikationer og nyttige links
Generelle publikationer
- Vollmer WM, Xu M, Feldstein A, Smith D, Waterbury A, Rand C. Comparison of pharmacy-based measures of medication adherence. BMC Health Serv Res. 2012 Jun 12;12:155. doi: 10.1186/1472-6963-12-155.
- Vollmer WM, Feldstein A, Smith DH, Dubanoski JP, Waterbury A, Schneider JL, Clark SA, Rand C. Use of health information technology to improve medication adherence. Am J Manag Care. 2011 Dec;17(12 Spec No.):SP79-87.
- Schneider J, Waterbury A, Feldstein A, Donovan J, Vollmer WM, Dubanoski J, Clark S, Rand C. Maximizing acceptability and usefulness of an automated telephone intervention: Lessons from a developmental mixed-methods approach. Health Informatics J. 2011 Mar;17(1):72-88. doi: 10.1177/1460458210391220.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 443
- R01HL083433 (U.S. NIH-bevilling/kontrakt)
- R01HL083433-01A1 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .