jurnal anak lia asthma

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Improving Asthma Outcomes in Minority Children: ARandomized, Controlled Trial of Parent Mentors

WHATS KNOWN ON THIS SUBJECT: Asthma disproportionatelyaffects minorities, but few studies have evaluated interventions that target minority children with asthma, and none has

evaluated the effects of PMs on asthma outcomes for minority children.

WHAT THIS STUDY ADDS: For minority children with asthma and their families, PMs can reduce wheezing, asthma exacerbations,ED visits, and missed parental work days while improving

parental self-efcacy. These outcomes can be achieved at a reasonablecost, with net cost savings for high participants.

abstractOBJECTIVE: Because asthma disproportionately affects minorities, weevaluated the effects of parent mentors (PMs) on asthma outcomes inminority children.

METHODS: This randomized, controlled trial allocated minority asth-matic children to the PM intervention or traditional asthma care. Inter-vention familieswereassigned PMs(experienced parents of asthmaticchildren who received specialized training). PMs met monthly withchildrenandfamilies at community sites, phoned parentsmonthly,and

made home visits. Tenasthma outcomes andcosts were monitored for1 year. Outcomes were examined by using both intention-to-treat anal-yses and stratied analyses for high participants (attending 25% of community meetingsandcompleting 50%of PM phoneinteractions).

RESULTS: Patients were randomly assigned to PMs ( n 112) or thecontrol group( n 108). In intention-to-treat analyses, interventionbutnot control childrenexperienced signicantlyreduced rapid-breathingepisodes, asthma exacerbations, and emergency department (ED) vis-its. High participants (but not controls or low participants) experi-enced signicantly reduced wheezing, asthma exacerbations, and EDvisits and improved parental efcacy in knowing when breathing prob-

lems are controllable at home. Mean reductions in missed parentalwork days were greater for high participants than controls. The aver-age monthly cost per patient for the PM program was $60.42, and netsavings of $46.16 for high participants.

CONCLUSIONS: For asthmatic minority children, PMs can reducewheezing, asthma exacerbations, ED visits, and missed parental workdays while improving parental self-efcacy. These outcomes areachieved at a reasonable cost and with net cost savings for high participants. PMs may be a promising, cost-effective means for reducingchildhood asthma disparities. Pediatrics 2009;124:15221532

AUTHORS: Glenn Flores, MD,a,b

Christina Bridon, BA,a,b

Sylvia Torres, BA,c Ruth Perez, BA,d Tim Walter, BA,e JaneBrotanek, MD, MPH,a,b Hua Lin, PhD, MS,a and SandyTomany-Korman, MSf

a Division of General Pediatrics, Department of Pediatrics, UT Southwestern Medical Center, Dallas, Texas; b Division of General Pediatrics, Childrens Medical Center, Dallas, Texas; c Medical College of Wisconsin, Milwaukee, Wisconsin; d Center for Urban Population Health, Aurora-Sinai Hospital, Milwaukee, Wisconsin; e Shorewood, Wisconsin; and f Signature Science, LLC, Austin, Texas

KEY WORDSasthma, minority groups, children, African-American, Hispanic,randomized, controlled trials

ABBREVIATIONSEDemergency departmentRCTrandomized, controlled trialPMparent mentorPedsQLPediatric Quality of Life Inventory 4.0 Generic CoreScalesQoLquality of lifePACQLQPaediatric Asthma Caregivers Quality of LifeQuestionnairePAMSESParent Asthma Management Self-efcacy ScaleICERincremental cost-effectiveness ratioITTintention-to-treatORodds ratioCIcondence interval

This study was presented in part as a platform presentation in the American Academy of Pediatrics Presidential Plenary of the2008 annual meeting of the Pediatric Academic Societies (May 4,2008; Honolulu, HI); as platform presentations at the 2008 annualmeetings of AcademyHealth (June 9, 2008; Washington, DC) and the American Public Health Association (October 27, 2008; SanDiego, CA); and as a late-breaking poster at the 2008 annualmeeting of the American Academy of Allergy Asthma &Immunology (March 18, 2008; Philadelphia, PA).

This trial has been registered at www.clinicaltrials.gov(identier NCT00800020).

www.pediatrics.org/cgi/doi/10.1542/peds.2009-0230

doi:10.1542/peds.2009-0230

Accepted for publication Jun 24, 2009

Address correspondence to Glenn Flores, MD, UT SouthwesternMedical Center, Division of General Pediatrics, Department of Pediatrics, 5323 Harry Hines Blvd, Dallas, TX 75390. E-mail:[email protected]

PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).

Copyright 2009 by the American Academy of Pediatrics

FINANCIAL DISCLOSURE: The authors have indicated they have no nancial relationships relevant to this article to disclose.

(Continued on last page)

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Childhood asthma disproportionatelyaffects minority children. The preva-lence of asthma in USchildren is 18.7%in Puerto Rican children, 12.5% inAfrican-American children, and 7.7% inwhite children. 1 African-American chil-

dren have an annual asthma hospital-ization rate of 57 per 10 000 children,more than triple that of white children,at 16 per 10 000.2 African-Americanchildren are 3 times more likely thanwhite children to seek asthma carein the emergency department (ED). 2

Asthma mortality among African-American children, at 10.1 per million,is almost 5 times higher than for whitechildren, at 2.2 per million. 2 Multiple

studies have documented that minor-ity children with asthma frequently re-ceive an inferior quality of medicalcare. 39 In addition, the prevalence,morbidity, and mortality of childhoodasthma are greatest in the inner city. 10

These disparities are particularlystriking in light of declines in hospital-izations and deaths for most otherchildhood conditions and recent ad-vances in asthma treatment.

Although asthma disproportionately af-fects urban minority children, little isknown about effective interventions forimprovingasthmaoutcomes in this pop-ulation. We therefore conducted a ran-domized, controlled trial (RCT) to deter-mine whether parentmentors (PMs)aremore effective than traditional asthmacare in improving asthma outcomes forminority children.

METHODS

Participants

This RCT enrolled participants between February 2004 and May 2007from a consecutive series of African-American and Latino children 2 to 18years oldwhohad a primary diagnosisof asthma and were seen in EDs andinpatient wards of the 4 hospitals thatprovide care to almost all childrenwith asthma in Milwaukee, Wisconsin.

Eligibility criteria included that the child(1) be 2 to 18 years old, (2) be African-American or Latino by parent identica- tion, (3) reside in a Milwaukee zip code,and (4) have asthma as the primary EDor admitting diagnosis. Exclusion crite-

ria were (1) signicant comorbidities(other pulmonary conditions, cardio-pathologies, renal abnormalities, diabe- tes, or epilepsy) that might lead to EDvisitsorhospitalizations, and(2)currentenrollment in another asthma study/program.

Baseline Assessment

The childs primary caregiver (hereaf- ter referred to as parent) completed

2 previously piloted enrollment ques- tionnaires, both orally administeredby bilingual research assistants. Therst questionnaire consisted of 12multiple-choice questions regardingparent and household sociodemo-graphics. The second questionnaire,addressing childrens characteristics,included 30 open-ended, multiple-choice, and yes/no questions regard-ing sociodemographics, health care,and asthma. English prociency wasdetermined by asking parents to ratehow well they and their child spoke En-glish by using the following choices:very well, well, not very well, and not atall. Responses other than very wellwere classied as limited English pro-ciency. The question and responsechoices were taken verbatim from theEnglish prociency item used by theUSCensus. 11

RandomizationParticipants were randomly assigned to the PM interventionor controlgroupby using SAS 9.1.3 (SAS Institute, Cary,NC). The control group received nointervention other than traditionalasthma care. Participantsand familieswho were assigned to the interventionwere assigned to PMs, in addition tocontinuing traditional asthma care.PMs were recruited from the Chil-

drens Hospital of Wisconsin Asthma/Allergy Clinic and were experiencedAfrican-American or Latino parents of childrenwhohave asthmaandresidedin the same communities as partici-pants. PMs were matched with inter-

vention families by race/ethnicity, pri-mary language spoken at home, and(whenever possible) zip code, to maxi-mize matching by socioeconomic status, educational attainment, and otherfactors. The Spanish prociency of bi-lingualPMswasconrmedby bilingualresearch assistants by (1) asking the parents whether they considered themselves uent in Spanish, and 2)assessing conversational Spanish u-

ency by asking PM candidates toprovide detailed answers to severalquestions about childhood asthma inSpanish. Six of 9 PMs were African-American and 3 were Latina.

Intervention

PMs received an intensive 2 1 2-day trainingsession led by a nurse asthmaspecialist and program coordinator.Training sessions and the 73-page training manual (available in Englishand Spanish) focused on (1) whyasthma is such an important issue forAmerican children, (2) sharing experi-ences on caring for an child withasthma, (3) keeping children withasthma out of hospitals, (4) details (inlay terms) regarding the PM intervention and study, (5) asthma basics, (6)asthma medications and triggers, (7)regular and follow-up appointments,(8) cultural issues that affect asthmacare, and (9) being a successful PM. Inaddition, PMs received training and re-sources on insurance programs foruninsured children, locations of freeclinics, medication and equipment teaching sheets, and creating re-minder calendars for health careprovider appointments. PMs also re-ceived training and resource manu-als on assisting families with unmetneeds for health insurance, housing,

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food, and other social concerns. En-glish and Spanish versions of the PM training manual are available onlineat http://www4.utsouthwestern.edu/ParentMentor/. A 34-item test to as-sess PM knowledge revealed a mean

SD pretraining score of 77.7% 5.0% and mean posttraining score of 89.9% 5.0%, a signicant increase(P .0001).

PMs were instructed that they wouldaugment childrens asthmacare bybe-ing peer counselors, family advocates,and parent resources collaboratingwith the clinical team to enhance chil-drens asthma management. PMs metmonthly with the study nurse to dis-cuss issues that arose with partici-pants and families. For interventionfamilies, the initial PM contact was ahome visit within 3 days of the childsED visit or hospitalization, includingcompletion of baseline surveys and acontact information form. Thereafter,PMs met monthly with assigned chil-dren and families at a communitylearning center, Boys and Girls Club,church, or family resource center.

Meetings included asthma education,meals, opportunities for children andfamilies to interact socially, and thepotential for social networking andpeer support; a total of 57 meetingwere held during the course of thestudy, with separate meetings at sepa-rate venues for the African-Americanand Latino participants. The pediatricasthma educator gave various infor-mative presentations on 15 topics and

answered questions from PMs andparticipants. PMs telephoned parentsmonthly until 1 year after the initial EDvisit or hospitalization and made sec-ond home visits 6 months after the initial ED visit or hospitalization. For fam-ilies without telephone access, PMsconducted home visits to collect data.PMs were available by telephone to intervention families 24 hours/day (with telephone backup by the asthma

nurse) to answer questions, clarify is-sues, or refer families to appropriatehealthcare providers. In therst homevisit and subsequent parent contacts,PMs reviewed each area of emphasisfrom the initial training session.

Control Group

Control children continued receiving their usual pediatric asthma care. Aswith intervention families, they werecontacted monthly by a blinded re-search assistant to evaluate out-comes. All families received an initial$50 participation incentive and $10 foreach subsequent participation month.

Outcome Measures

A research assistant who was blinded to group allocation assessed 10 out-comes for 12 months by using stan-dardized telephone interview methodswith parents. Frequency of the childssymptoms and asthma exacerbationsin the previous month were assessedmonthly through parent self-reportand have been shown to correlate withhealth care use and health status. 12

Missed school and work days in the previous month were assessedmonthly by parental report. Scores on the Pediatric Quality of Life Inventory4.0 Generic Core Scales (PedsQL) wereassessed monthly. This 23-item in-strument measures parent-reportedhealth-related quality of life (QoL), byusing a 5-point scale (from 0 never aproblem to 4 almost always a prob-lem). 13 Items are reverse-scored andlinearly transformed on a scale from 0 to 100, with higher scores indicatingbetter QoL.13 PedsQL is valid and reli-able and correlates with morbidityandillness burden. 13 Scores on the Pediat-ric Asthma Caregivers Quality of LifeQuestionnaire (PACQLQ) were as-sessed monthly.The PACQLQ measuresproblems that parents experience as aresult of their childs asthma. It consistsof13questionswith7-point responseop- tions (1 severe impairment and 7

no impairment); has excellent reliability,responsiveness, and validity 14,15; and isavailable in 9 different Spanish versions that are customized to specic sub-groups. 16 Higher PACQLQ scores indicatebetter QoL.

ED visits for asthma were assessedmonthly by parent self-report and con-rmedbymedical recordreviewanduseof a computerized surveillance system that tracks 1500 children with asthmain Milwaukee. Asthma hospitalizationswere assessed monthly by parental re-port and periodic monitoring of medicalrecords and inpatient admission logs.Scores on the Parent Asthma Manage-ment Self-efcacy Scale (PAMSES) were

assessedatbaselineandstudyend point(month 12 of follow-up). PAMSES con-sists of13 Likert scale items ona 5-pointscale (1 not at all sure and 5 com-pletely sure) that were designed tomea-sure parent self-efcacy in preventingand managing childrens asthma attacks, and it is reliable and valid. 17 Over-all PAMSES scores can range from 13 to65, with higher scores indicating higherparental self-efcacy. 17 Scores on the

Asthma Satisfaction Survey were as-sessed at baseline and study end point.This 10-item questionnaire addressesparental satisfaction with childrensasthma care; satisfaction for each itemis rated on a 5-point Likert scale (1poorand5 excellent), andtotal scorescan range from 10 to 50, with higherscores indicating higher satisfaction. 18

Cost outcomes included costs of per-sonnel, PM stipend payments, sup-

plies, PM training sessions, andmonthly meetings with PMs and inter-vention participants. Costs of carewere calculated by using differencesbetween the intervention and controlgroups in asthma-related charges,including ED and physician visits,hospitalizations, home care, medicalequipment, and other asthma-relatedclaims. The cost-effectiveness evaluation used asthma-related medical



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costs from the Pediatric Health Infor-mationSystem, a databaseof inpatientand selected outpatient data fromNorth American pediatric hospitals that are afliated with the Child HealthCorporation of America (Shawnee Mis-

sion, Kansas). The incremental cost-effectiveness ratio (ICER) was com-putedby subtracting total costs for thecontrol group from those for the inter-vention group, then dividing by themean difference between the controland intervention groups in reductionof asthma exacerbation days from therstmonth to the nal month of follow-up. Total costs for the interventiongroup included program costs, direct

medical costs, and indirect incomecosts from missed work days. Pro-gram costs were estimated by sum-ming costs forpersonnel, PM stipends, training, and monthly meetings. Directmedical costs included charges for EDvisits and hospitalizations. ICU staycharges were not included because of multiple missing values. Person-levelindirect costs of missed work dayswere obtained by multiplying em-

ployed caregivers missed workeddays by the midpoint of the familys in-come. Total costs for the control groupincluded only direct and indirect med-ical costs.

Analyses

SAS 9.1.3 for Windows was used for allanalyses. 2 and Wilcoxon tests wereperformed to examine baseline inter-group differences.

In addition to intention-to-treat (ITT)analyses, all outcomes were examinedby using stratied per-protocol analy-ses,giventheanticipated highattritionrates (because this was a community-based study of impoverished, under-served, urban populations that movefrequently) and the focus on countingevents appropriate to actually receiv-ing the intervention. 19 Interventionpar- ticipants were stratied into high-

participation and low-participationgroups, depending on the extent towhich they received PM interventioncomponents. High participants weredened as those who attended 25%of scheduled monthly communitymeetings and completed 50% of monthly PM telephone calls; the re-maining participants were classiedas low participants.

Changes in asthma outcomes from

baseline to the study end point (the -nal 12-month follow-up assessment)were analyzed by using the Wilcoxon,Wilcoxons paired signed rank, andFishers exact tests. For asthma exac-erbations, time trends were examinedby plotting the mean number of exac-erbations over time, followed by loga-rithmic regression line tting.

For cost analyses, the percentage ef-fort that project personnel devoted to

program implementation was esti-mated to be 30% for the asthma nurseeducator, 60% for the program coordi-nator, and 15% for each research as-sistant. Multivariable analyses wereperformed by using general linearmodels with nonlinear link functions to examine time trends. Generalizedestimating equations adjustedfor multiple measurements and family clus- tering (ie, 1 child per family). Covari-

ates in multivariable models includedgroup assignment, time since studyentry, and a time-by-group interaction term.

Using a power 80%, .05, 20%, and an anticipated attrition rateof 40%, we calculated that a total sam-ple size of 220 would detect differ-ences between the intervention andcontrol groups in the co-primary out-comes of at least 2 asthma exacerba-

220 participants randomly assigned

648 children screened for eligibility

428 excluded307 didnt meet inclusion criteria

64 declined participation57 could not be contacted

112 included in primary analysis

112 assigned to intervention group 108 assigned to control group

45 (40%) dropped out/withdrew 44 (41%) dropped out/withdrew

67 (60%) completed 12-mo follow-up 64 (59%) completed 12-mo follow-up

108 included in primary analysis

85 (76%) low participation(attended


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tions per year, 4 wheezing episodesper year, 0.4 missed school days peryear, 0.7 ED visits per year, a 17% dif-ference in the asthma hospitalizationrate, $318 in asthma care charges,0.16 points on the PedsQL, and 0.3

points on the PACQLQ and PAMSES.

Institutional Review BoardApproval

The study protocol was approved by the institutional review boards of Chil-drens Hospital of Wisconsin, AuroraHealth Care, and Wheaton FranciscanHealth Care. Written informed consentand child assent (when indicated)were obtained for all participants.

RESULTS

Study Population

Of 648 families who were screenedfor eligibility, 428 were excluded be-cause of ineligibility, parents declin-ing participation, or no response tosubsequent contacts (Fig 1). A totalof 220 participants were randomlyassigned to the intervention ( n 112) or control group ( n 108), withsimilar dropout/withdrawal rates inboth groups; dropouts and with-drawals occurred at a fairly constantrate for both groups across the 12-month follow-up period. Because of institutional review board con-straints, the reasons for dropout andwithdrawal could not be determined.The families who dropped out orwithdrew were more likely than those who completed the study to beAfrican-American (91% vs 76%, re-spectively; P .01) and born in theUnited States (96% vs 85%; P .01),and less likely to pursue educationbeyond high school (17% vs 31%; P .02) or be married and living with thespouse (7% vs 23%; P .01), but didnot differ in age, gender, English pro-ciency, employment status, or fam-ily income. There were no signicantdifferences between completers and

TABLE 1 Baseline Sociodemographic Characteristics of Study Parents ( N 220)

Characteristic Control ( N 108) Intervention ( N 112) P

Age, mean SD, y 32.5 9.1 31.3 7.6 .33Female, % 90.7 91.7 .93Education beyond high school, % 27.8 23.2 .18Married, living with spouse, % 18.5 15.2 .75Race/ethnicity, % .46

African-American 83.3 79.5Latino 16.7 20.5Limited English prociency, % 12.0 13.4 .76Employed full-time, % 37.0 42.9 .66Born in United States, % 90.6 89.4 .60Annual combined family income, % .23

$0$2500 17.6 23.4$2501$5000 14.8 12.6$5001$7500 12.0 8.1$7501$17 500 19.4 26.1$17 501$25 000 14.8 11.7$25 001$35 000 11.1 12.6$35 001$45 000 3.7 4.5$45 001$60 000 0.0 0.9$60 001$75 000 1.9 0.0

More than $75 000 4.6 0.0

TABLE 2 Baseline Characteristics of Study Children ( N 220)

Characteristic Control(N 108)

Intervention(N 112)

P

Age, mean SD, y 7.3 4.4 7.1 4.3 .72Female, % 47.2 40.2 .29Limited English prociency, % 24.1 31.3 .23Family member in household smokes, % 36.7 46.6 .31Has primary care provider, % 95.4 89.3 .08Health status, % .80

Excellent 12.0 9.8

Very good 24.1 18.8Good 34.3 39.3Fair 25.9 26.8Poor 3.7 5.4

Asthma severity, % .40Mild intermittent 25.0 28.6Mild persistent 17.6 24.1Moderate persistent 13.0 13.4Severe persistent 44.4 33.9

Health insurance coverage, %Public 79.6 86.6 .52Private 16.7 9.8None 2.8 2.7Other a 0.9 0.9

Has asthma specialist, % 15.2 17.9 .73Has asthma care plan, % 48.1 39.6 .45Takes prescribed medications, % 94.4 95.5 .70ED most likely place to be taken for asthma care, % 61.9 64.3 .31Asthma attacks in previous year, mean SD 13.9 42.7 10.4 36.0 .53Doctor visit for asthma in previous year, mean SD 6.7 10.8 4.9 5.8 .13ED visit for asthma in previous year, mean SD 3.4 3.7 3.1 3.4 .49Hospitalizations for asthma in previous year, mean SD 0.6 1.1 1.0 1.9 .11ICU for asthma in previous year, mean SD 0.10 0.48 0.10 0.44 .74Asthma attacks in previous month, mean SD 2.2 4.1 1.8 4.0 .41Daytime asthma symptoms in previous month, mean SD 10.7 13.8 14.1 19.4 .13Nighttime asthma symptoms in previous month, mean SD 12.7 14.4 11.4 17.5 .56Missed school days in previous year, mean SD 8.1 15.5 6.8 10.9 .47Parental missed work days in previous year, mean SD 7.3 14.4 4.8 9.9 .17a Includes combination of public and private insurance.



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drop-outs in any of the 22 childhoodso-ciodemographicorasthmacharacteris- tics examined.

A total of 67 intervention-group and 64control-group participants completed the nal 12-month follow-up interview.In the intervention group, 85 PM groupparticipants had low participation and27 had high participation.

No signicant baseline intergroup dif-ferences existed for any parent (Table1) or child (Table 2) characteristic. Of note, the annual combined family in-come was $5000 or less for approxi-mately one third of households and$17 500 or less for approximately two

thirds of households. Study children atbaseline collectively experienced sub-stantial asthma morbidity, includingaveraging approximately 1 asthmasymptom daily; 1 exacerbation monthly;and 7 missed school days, 6 missedparental work days, 3 ED visits, and 1hospitalization yearly (these collectivedata are not shown in Table 2).

There were no signicant differencesamong high participants, low partici-

pants, and control subjects in asthmaseverity categories ( P .48 for the3-way comparison and P .47 for thecomparison between high and lowparticipants). In addition, there wereno signicant baseline differencesamong the 3 groups for 13 of the 14asthma outcome measures. The onlysignicant difference noted was forwheezing episodes in the previousmonth, experienced by 92.0% of highparticipants, 62.9% of low partici-pants, and 73.3% of control subjects(P .02).

Outcomes

ITT Analyses

In ITT analyses, intervention but notcontrol children experienced signi-cant reductions in rapid-breathing ep-isodes, asthma exacerbations, and ED

visits (Table 3). Per-protocol analyses(Tables 4 and 5) revealed additionalsignicant differences.

Asthma Symptoms

Those with high participation experi-enced signicant reductions frombaseline to study end point in wheez-ing, coughing, and difculty-breathing

episodes (Table 4). For all 3 outcomes, there was a difference of 30 percent-age points between baseline and endpoint means for high participants. Nosignicant reductions in rapid breath-ing or chest tightness were noted forhigh participants. Control subjects ex-perienced reduced coughing and dif-culty breathing, and low participants

TABLE 3 ITT Analysis of Differences Between Baseline and End Point (12-Month Follow-up) forStudy Outcomes Among Control Subjects ( N 108) and Intervention-Group Children(N 112)

Outcome Baseline, Mean (95% CI) End Point, Mean (95% CI) P

Wheezing episode a

Control group 73.30 (63.70 to 82.80) 61.20 (51.40 to 71.00) .08Intervention group 70.70 (60.70 to 80.80) 61.70 (51.70 to 71.70) .21

Coughing episode a

Control group 100 71.30 (62.60 to 80.00) .01Intervention group 100 64.30 (55.30 to 73.30) .01

Difculty-breathing episode a


Rapid-breathing episode a


Chest-tightness episode a


Asthma exacerbationsControl group 2.30 (1.40 to 3.20) 1.60 (1.10 to 2.10) .05Intervention group 2.90 (1.70 to 4.00) 1.80 (1.00 to 2.60) .01

Missed school days bControl group 1.90 (1.20 to 2.50) 0.80 (0.40 to 1.20) .01Intervention group 2.20 (1.50 to 3.00) 1.00 (0.60 to 1.40) .01

Missed parental work days b


PedsQL scoreControl group 74.00 (69.40 to 78.50) 83.00 (74.10 to 91.90) .02Intervention group 72.30 (66.80 to 77.80) 82.30 (74.10 to 90.50) .02

PACQLQ scoreControl group 5.10 (4.80 to 5.40) 5.70 (5.50 to 6.00) .02Intervention group 5.10 (4.70 to 5.50) 5.80 (5.30 to 6.20) .04

ED visits for asthmaControl group 0.30 (0.10 to 0.40) 0.10 (0.06 to 0.21) .09Intervention group 0.50 (0.20 to 0.70) 0.10 (0.06 to 0.22) .03

Hospitalizations for asthmaControl group 0.07 (0.01 to 0.13) 0.01 ( 0.01 to 0.03) .07Intervention group 0.20 (0.00 to 0.40) 0.05 (0.01 to 0.10) .37

Doctor visits for asthmaControl group 1.00 (0.70 to 1.30) 0.70 (0.50 to 0.90) .01Intervention group 1.30 (1.00 to 1.60) 0.50 (0.30 to 0.70) .01

PAMSES scoreControl group 55.30 (54.00 to 56.60) 57.50 (55.00 to 60.00) .07Intervention group 55.20 (53.40 to 57.00) 58.30 (55.30 to 61.20) .05

Asthma satisfaction survey scoreControl group 37.90 (36.30 to 39.50) 40.20 (37.50 to 42.90) .19Intervention group 39.10 (37.50 to 40.70) 41.00 (38.20 to 43.90) .27

a Unit of evaluation is symptom episode in past month.b In past month.

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had signicant reductions only incoughing.

Other Outcomes

High participants experienced signi-cant reductions in asthma exacerbations (decrease from baseline mean toend-point mean: 3.0), missed schooldays (decrease from baseline mean toend-point mean: 2.9), missed parentalwork days (decrease from baselinemean to end-point mean: 2.6), and EDvisits (decrease from baseline mean toend-point mean: 0.6), and signicantimprovements in PedsQL scores (in-crease from base-line mean to end-point mean: 15.9) (Table5).Forasthmaexacerbations, a time-trend analysis(Fig 2) revealed that the decrease of 3exacerbations from the baseline meanfor high participants was signicantlygreater than exacerbation reductionsamong control subjects and lowparticipants. Generalized estimatingequation models showed both controlsubjects (odds ratio [OR]: 1.16; P .001) and low participants (OR: 1.20;P .001) had greater odds over timeof asthma exacerbations than high

participants. The mean reduction inmissed parental work days also wassignicantly greater for high partici-pants (OR: 3.3 [95% condence inter-val (CI): 6.7 to 0.1]) than control subjects (OR: 0.4 [95% CI: 0.70 to

0.02]), but the reduction for low participants (OR: 0.4 [95% CI: 0.9 to0.2]) did not differ signicantly from that of control subjects.

Control subjects had reduced missedschool and parental work days and im-proved PedsQL and PACQLQ scores, butlowparticipantshad no changes in anynonsymptom outcome (Table 5). Nosignicant changes were observed forhigh participants in asthma hospital-izations or in PACQLQ, PAMSES, orasthma satisfaction scores. A signi-cant improvement, however, wasnoted in the PACQLQ activity-relatedsubscore, although control subjectsand low participants also experiencedimprovements (Fig 3). In addition, 2signicant PAMSES subscale scorechanges were observed (Fig 4). Highparticipants experienced signicantimprovements in parental self-efcacyin controlling serious breathing prob-

lems at home (although control subjects also did) and in the parentsknowing when a serious breathingproblem is controllable at home.

Control children had 3 ICU admissions,and intervention-group children had 2ICU admissions. Although the asthmanurse for the study regularly wasasked questions at community meet-ings by PMs about assisting familieswith childhood asthma management, the asthma nurse never received any telephone calls from PMs regardingasthma management.

Costs and Cost-Effectiveness

The PM intervention was relatively in-expensive (Table 6), with an averagemonthly cost per patient of $60.42.Most monthly costs were for person-nel; the next most expensive itemswere PM stipend payments andmeeting costs. The intervention cost$120.84 per child for the rst monthand the nal month of follow-up. Theintervention group experienced sav-ings of $361.48 forhospitalizations and$50.33 for ED visits. Income loss as a

result of parental missed work dayswas similar for both groups ($4.36difference). The mean reduction inasthma exacerbation days was 1.26days for the intervention group and0.78 for control subjects. The ICER for the intervention was $597.10 perasthma exacerbationfree day gained,indicating a total cost savings for intervention participants.

The high-participation group experi-

enced savings of $51.06 for asthmahospitalizations, $120.01 for ED visits,and $28.15 for missed parental workdays. The ICER for the high participation group was $46.16, indicating anoverall cost savings.

DISCUSSION

This RCT revealed that a PM intervention for minority children with asthmacan signicantly reduce wheezing,

TABLE 4 Per-Protocol, Stratied Analysis of Differences Between Baseline and End Point (12-MonthFollow-up) for Asthma Symptom Outcomes Among Control Subjects ( N 108) andIntervention-Group Children With Low ( N 85) and High (N 27) Participation

Outcome a Baseline, % (95% CI) End Point, % (95% CI) P

Wheezing episodeControl subjects 73.3 (63.782.8) 61.2 (51.471.0) .08Low participation 62.9 (50.575.3) 62.3 (50.674.0) .94High participation 92.0 (84.5105.5) 60.0 (39.480.6) .01

Coughing episodeControl subjects 100 71.3 (62.680.0) .01Low participation 100 62.4 (51.872.9) .01High participation 100 70.4 (52.088.8) .01

Difculty-breathing episodeControl subjects 76.7 (67.685.9) 55.1 (45.165.1) .01Low participation 74.2 (63.085.4) 58.0 (46.070.0) .05High participation 90.0 (75.6104.4) 60.0 (39.480.6) .03

Rapid-breathing episodeControl subjects 54.7 (43.965.4) 45.9 (35.956.0) .24Low participation 54.8 (42.167.6) 40.6 (28.752.5) .10High participation 65.0 (42.187.9) 44.0 (23.164.9) .17

Chest-tightness episodeControl subjects 40.7 (30.151.3) 37.8 (28.047.5) .68

Low participation 41.9 (29.354.6) 43.5 (31.555.5) .86High participation 50.0 (26.074.0) 48.0 (27.069.0) .90

a Unit of evaluation is symptom episode in past month.



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asthma exacerbations, ED visits, andmissed parental work days, and im-prove parental self-efcacy in identify-ing serious breathing problems thatare controllable at home, all at a netcost savings. This is the rst RCT (to

our knowledge) to examine the effectsof PMs on asthma outcomes in minor-itychildren. Recent systematic reviewsof RCTs of culture-specic asthma pro-grams and self-management education programs by lay leaders forchronically ill patients revealed nopublished studies on PMs. 20,21

Although no previous RCTs have evalu-ated PMsin childhoodasthmaor otherchronic illnesses, 2 studies examined

lay-worker interventions for asthma. Asmall pilot observational study of layworkers who made home visits and attended patients clinic appointmentsindicated pre-to-post reductions inasthma ED and follow-up clinic visits. 22

An RCT of adults that compared clinic-based lay educators with nurses indi-cated comparable outcomes in healthcare visits, oral steroid courses, andpatient satisfaction. 23 The only otherpublishedRCT of a PM-like program (toour knowledge) examined monthlyhome visits to rst-time mothers of in-fants by trained volunteer communitymothers. 24 Compared with standardsupport, the community mothers pro-

gram resulted in increased infant im-munization rates and reading to chil-dren and decreased inappropriatedietary practices.

Intervention children but not controlsubjects experienced signicant re-ductions in rapid-breathing episodes,asthma exacerbations, and ED visits.Stratied, per-protocol analyses addi- tionallyrevealed that high-interventionchildren but not control subjects orlow-intervention children had reducedwheezing, asthma exacerbations, andED visits; improved parental self-efcacy in recognizing serious breath-ing problems that are controllable athome; and greater reduction than con-

trol subjects in missed parental workdays. For 4 additional outcomes, highparticipants and either control subjects or low participants experiencedsignicant changes from baseline.Both high participants and controlsubjects had reduced missed schooldays and coughing and improvedPedsQL scores, and both high and lowparticipants had decreased difcultybreathing. For these 4 outcomes,

larger sample sizes and multicenterstudies may be required to determinedenitively whether PMs can improveoutcomes. No changes from baselinewere observed for high participantsin hospitalizations; rapid breathing;chest tightness; or PAMSES, PACQLQ, orphysician satisfaction scores. Addi- tional research is needed to examinedwhether changes in these outcomesmight occur in larger studies or might

be achieved only through quality im-provement or nurse case manage-ment interventions.

For high participants, a motivating fac- tor for more active participation in theintervention may have been the en-hanced opportunity for improvementin the childs wheezing frequency.High-participant children were signi-cantlymore likely at baseline than low-participant and control children to have

TABLE 5 Per-Protocol, Stratied Analysis of Differences Between Baseline and End Point (12-MonthFollow-up) for Study Outcomes Among Control Subjects ( N 108) and Intervention-GroupChildren With Low (N 85) and High (N 27) Participation

Outcome Basel ine, Mean (95% CI) End Point, Mean (95% CI) P

Asthma exacerbationsControl subjects 2.30 (1.40 to 3.20) 1.60 (1.10 to 2.10) .05Low participation 2.10 (1.30 to 2.90) 1.70 (0.70 to 2.60) .10High participation 5.20 (1.00 to 9.30) 2.20 (0.80 to 3.60) .03

Missed school days a

Control subjects 1.90 (1.20 to 2.50) 0.80 (0.40 to 1.20) .01Low participation 1.70 (1.00 to 2.40) 1.00 (0.50 to 1.50) .06High participation 3.70 (1.50 to 5.90) 0.80 (0.30 to 1.40) .03

Missed parental work days a

Control subjects 0.80 (0.30 to 1.30) 0.30 (0.02 to 0.50) .01Low participation 1.00 (0.40 to 1.60) 0.80 (0.30 to 1.20) .41High participation 2.90 (0.50 to 5.30) 0.30 ( 0.10 to 0.60) .01

PedsQL scoreControl subjects 74.00 (69.40 to 78.50) 83.00 (74.10 to 91.90) .02Low participation 72.80 (66.30 to 79.30) 77.10 (66.60 to 87.70) .64High participation 70.60 (59.20 to 82.00) 86.5 (73.30 to 99.80) .04

PACQLQ scoreControl subjects 5.10 (4.80 to 5.40) 5.70 (5.50 to 6.00) .01

Low participation 5.10 (4.60 to 5.50) 5.70 (5.50 to 6.00) .07High participation 5.20 (4.50 to 5.80) 5.90 (5.50 to 6.40) .08

ED visits for asthmaControl subjects 0.30 (0.10 to 0.40) 0.20 (0.06 to 0.21) .09Low participation 0.40 (0.11 to 0.63) 0.20 (0.04 to 0.24) .20High participation 0.70 (0.15 to 1.20) 0.10 ( 0.02 to 0.26) .05

Hospitalizations for asthmaControl subjects 0.20 (0.00 to 0.40) 0.02 ( 0.01 to 0.03) .07Low participation 0.20 (0.00 to 0.40) 0.10 (0.00 to 0.10) .38High participation 0.10 ( 0.10 to 0.30) 0.00 ( 0.04 to 0.10) .85

PAMSES scoreControl subjects 55.30 (54.00 to 56.60) 57.50 (55.00 to 60.00) .05Low participation 55.40 (53.30 to 57.60) 58.50 (52.60 to 64.30) .05High participation 54.50 (51.20 to 57.80) 58.10 (54.90 to 61.30) .13

Asthma satisfaction survey scoreControl subjects 37.90 (36.30 to 39.50) 40.20 (37.50 to 42.90) .19Low participation 39.70 (37.80 to 41.60) 42.70 (37.40 to 48.00) .18High participation 37.20 (34.40 to 40.00) 39.60 (36.10 to 43.10) .15

a In past month.

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had a wheezing episode in the previousmonth (Table 4). This greater likelihoodof wheezing might have provided extramotivation for parents to seek assis-

tance, support, and education through the PM program. In future work, we in- tend to examine parents reasons forhigh and low participation to gain agreater understanding of participationcharacteristics and risk factors, as wellas possible mechanisms for enhancingintervention participation.

Certain study limitations should benoted. The study was single- rather than double-blinded, but double-

blinding was not possible because of immediate participant awareness of PM assignment. This study was per-formed in 1 Midwestern city, so nd-ings may not necessarily generalize toother urban, suburban, or rural popu-lations. Only African-American andLatino children were enrolled, so theresults maynot pertain to other races/ethnicities. Data were not collected on the number of calls to PMs by intervention parents or the call pattern over time. It was not possible to determineand disaggregate whether improve-ments in parental knowledge and

asthma management behavior for the intervention group resulted fromasthma educator presentations at thecommunity meetings versus the peermentor and family advocate inuenceof PMs (or some combination). The

attrition rate was 40%, but this iscomparable to attrition in othercommunity-based studies of impover-ished minority populations. 25,26 Compari-son of dropouts/withdrawals with studycompleters indicates that future PMRCTs should focus special attention onretentionstrategies forparents whoareAfrican-American and US-born, headsingle-parent households, and havelower educational attainment.

Certain study strengths also should benoted. This is the rst RCT to examineeffects of PMs on asthma outcomes inminority children. Multiple clinical out-comes were examined, and severalrecommendations from recent systematic reviews were addressed. 20,21

The intervention had numerous char-acteristics of interventions that aresuccessful in eliminating pediatric dis-parities, including the RCT design,

blinding, appropriate comparisongroups, and a community-based andculturally and linguistically sensitiveapproach. 26

Although additional studies and larger trials are needed to evaluate the im-pact of PMs on disparities in asthmaand other pediatric conditions, we be-lieve that the ndings of this RCT haveseveral potential implications for re-search, practice, and policy. A PM in-

tervention for minority children withasthma can be an effective means of reducing wheezing, asthma exacerbations, ED visits, and missed parentalwork days while improving parentalself-efcacy in recognizing seriousbreathing problems thatare controlla-ble at home, all at a fairly reasonablecost and with net cost savings. Addi- tional benets include providing PMemployment in urban, impoverished,

0

1

2

3

4

5

6

7

8

1 2 3 4 5 6 7 8 9 10 11 12

Follow-up month

M e a n

N o .

o f e x a c e r b a

t i o n s

ControlsLow participationHigh participation

High participation(P < .01 vs controlsand vs low participation)

Low participation

Controls

FIGURE 2Time-trend lines for asthma exacerbations from baseline to study end point (12-month follow-up).

0.0

0.2

0.4

0.6

0.8

1.0

1.2

Overall QoL Activity-related QoL

S

c o r e c

h a n g e : m o n

t h 1 t o m o n

t h 1 2


P = .01 P = . 07

P = . 08

P = . 02

P = . 02

P = . 04

FIGURE 3Changes in pediatric asthma caregivers QoL scores (PACQLQ) from baseline to study end point(12-month follow-up).



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minority communities, which fre-quently experience high unemploy-ment, and empowering underservedcommunities to address their chil-drens health and health care. The re-sults also suggest that a PM program

is a cost-effective approach to improv-ingasthmaoutcomes forminority chil-dren who are covered by Medicaid. PMinterventionsand analogous peer

mentor interventions for adultsmight potentially be effective, low-costapproaches to eliminating racial/ethnic disparities for other chronicconditions.

ACKNOWLEDGMENTSThis study was funded by grants to DrFlores from the Commonwealth Fundand the Improving Chronic Illness Care

program of the Robert Wood JohnsonFoundation.

We thank the following individuals andorganizations for assistance with thisstudy: Laurie Smrz, Rhonda Durst, Re-becca Schultz de Parra, JacquelineGonzales, Kristin Costello, MarthaStevens, Duke Wagner, AmandaSchultz, John Meurer, Jennifer Cohen,Kevin Kelly, Marc Gorelick, Joseph Lee,John Whitcomb, the Mary Ryan Club, LaCausa, Blessed Trinity Parish, and theUnited Community Center. We aregrateful to Anne Beal at the Common-wealthFundand Brian Austin in the Im-proving Chronic Illness Care Programof the Robert Wood Johnson Founda- tion for continuous support and assistance. We also thank the anonymousreviewers for comments.

REFERENCES

1. Moorman JE, Rudd RA, Johnson CA, et al.National surveillance for asthma: UnitedStates, 19802004. MMWR Surveill Summ.2007;56(8):154

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childhood asthma: prevalence, health careutilization, and mortality. Pediatrics. 2002;110(2 pt 1):315322

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guidelines in enhancing quality and re-ducing racial/ethnic disparities in pediat-ric care. Paediatr Respir Rev. 2002;3(1):5258

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0.5

0.0

1.5

1.0

2.5

2.0

3.5

3.0

4.0

S c o r e c

h a n g e : m o n

t h 1 t o m o n

t h 1 2


P = . 05

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P = . 13

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P = . 39

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Can control seriousbreathing problem at home

rather than go to ED

Know when seriousbreathing problem iscontrollable at home

FIGURE 4Changes in parental self-efcacy score (PAMSES) from baseline to study end point (12-month follow-up).

TABLE 6 Program-Related Costs

Item Quantity Unit Cost, $ Average MonthlyCost Per Patient, $

Personnel 1.2 FTE 4555.00/mo 40.67Payments to PMs 9 mentors 88.00 per mentored family per mentor 16.811-time supplies 78.94/mo 0.703-d training sessions 8 sessions 102.00 per training session 0.18

Monthly meetings 55 meetings 120.05 per meeting 1.49Bus tickets 63.00/mo 0.56Total 60.42

FTE indicates full-time equivalent.

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9. Lieu TA, Lozano P, Finkelstein JA, et al.Racial/ethnic variation in asthma statusand management practices among chil-dren in managed Medicaid. Pediatrics.2002;109(5):857865

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the United States: urban issues. Pediatr Pul- monol. 2002;33(1):4755

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rics. 2002;110(4):79780413. Varni JW, Seid M, Kurtin PS. PedsQL 4.0: re-

liability and validity of the Pediatric Qualityof Life Inventory version 4.0 generic corescales in healthy and patient populations.Med Care. 2001;39(8):800 812

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22. Stout JW, White LC, Rogers LT, et al. TheAsthma Outreach Project: a promising ap-proach to comprehensive asthma manage-ment. J Asthma. 1998;35(1):119127

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77878324. Johnson Z, Howell F, Molloy B. Community

mothers programme: randomised controlled trial of non-professional intervention in parenting. BMJ. 1993;306(6890):14491452

25. Flores G, Abreu M, Chaisson CE, et al. A ran-domized controlledtrial of the effectivenessof community-based case management ininsuring uninsured Latino children. Pediat- rics. 2005;116(6):14331441

26. Flores G. Devising, implementing, and eval-uating successfulinterventions to eliminate

racial/ethnic disparities in childrenshealth and health care: tips, pitfalls, and aresearch agenda. Pediatrics. 2009;124(3 suppl):S214S223

(Continued from rst page)

Dr Flores had full access to all study data and takes responsibility for the data integrity and accuracy of the data analysis and was solely responsibly for study concept and design, critical revision of the manuscript for important intellectual content, and obtaining funding. Dr Flores, Ms Bridon, Ms Torres, Ms Perez, and Mr Walter were responsible for acquisition of data; Drs Flores and Lin and Ms Tomany-Korman were responsible for analysis and interpretation of data; Dr Flores, Ms Bridon, and Dr Lin were responsible for drafting of the manuscript; Dr Lin and Ms Tomany-Korman were responsible for statistical analysis; Drs Flores and Brotanek were responsible for administrative, technical, or material support; and Dr Flores and Ms Bridon were responsible for study supervision. The funding agencies had no involvement in the design or conduct of the study; analysis or interpretation of the data; or preparation, review, or approval of the manuscript.



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Trial of Parent MentorsImproving Asthma Outcomes in Minority Children: A Randomized, Controlled

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