Trial of enhanced interconception care for high-risk, low-income postpartum women Allison S. Bryant,...
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Transcript of Trial of enhanced interconception care for high-risk, low-income postpartum women Allison S. Bryant,...
Trial of enhanced Trial of enhanced interconception care for interconception care for
high-risk, low-income high-risk, low-income postpartum womenpostpartum women
Allison S. Bryant, MD, MPHAllison S. Bryant, MD, MPH
T2 Class Final Project ProtocolT2 Class Final Project Protocol
June 3, 2008June 3, 2008
Specific AimSpecific Aim
To reduce the risk of adverse birth To reduce the risk of adverse birth outcomes and short birth intervals outcomes and short birth intervals among high-risk women by among high-risk women by introducing a program of introducing a program of interconceptioninterconception care care– Participants will be randomized to Participants will be randomized to
enhanced vs. usual careenhanced vs. usual care
SignificanceSignificance
Wide racial/ethnic and socioeconomic Wide racial/ethnic and socioeconomic disparities in infant mortality ratesdisparities in infant mortality rates– Leading cause of infant mortality among Leading cause of infant mortality among
racial/ethnic minorities and low income racial/ethnic minorities and low income women is women is prematurity/ low birth weightprematurity/ low birth weight
– Infant mortality rateInfant mortality rate among Black infants in among Black infants in Bay area = Bay area = 16/1000 LB16/1000 LB
Infant Mortality for African Americans and Infant Mortality for African Americans and Whites, Whites,
United States, 1980-2000United States, 1980-2000
0
2
4
6
8
10
12
14
16
18
1980
1982
1984
1986
1988
1990
1992
1994
1996
1998
2000
Mor
talit
y R
ate
Per
1,0
00 L
ive
Bir
ths
0
1
2
3
4
Afr
ican
Am
eric
an:W
hit
e R
atio
African American White Ratio
Lu, UCLA/ NCHS
Prenatal CarePrenatal Care
Fiscella, Obstet Gynecol 1995
Prenatal Care: Too Little Too Prenatal Care: Too Little Too Late?Late?
50% of pregnancies in the U.S. are 50% of pregnancies in the U.S. are unintendedunintended– Unintended pregnancies associated with Unintended pregnancies associated with
later entry into prenatal care, worse later entry into prenatal care, worse outcomesoutcomes
Nationally, only 83% of women Nationally, only 83% of women receive prenatal care in first trimester receive prenatal care in first trimester (state range 67-91%, NHQR)(state range 67-91%, NHQR)– Developmental vulnerability in first few Developmental vulnerability in first few
post-conception weekspost-conception weeks
Prenatal Care: Too Little Too Prenatal Care: Too Little Too Late?Late?
Pathways leading to adverse birth Pathways leading to adverse birth outcomes likely have onset at start outcomes likely have onset at start of pregnancy, or beforeof pregnancy, or before
Little hope of reversing medical or Little hope of reversing medical or social risks in limited period of social risks in limited period of gestationgestation
Short birth interval Short birth interval associated with associated with adverse outcomesadverse outcomes
Pre-/Interconception CarePre-/Interconception Care
DefinitionDefinition– A prevention-based strategy to improve A prevention-based strategy to improve
pregnancy outcomes by identifying and pregnancy outcomes by identifying and modifying a woman’s biomedical, modifying a woman’s biomedical, behavioral and social risks behavioral and social risks priorprior to to pregnancypregnancy
PrevalencePrevalence– Only 30-50% of eligible women report Only 30-50% of eligible women report
receiving any pre-pregnancy counseling receiving any pre-pregnancy counseling (D’Angelo; Hillemeier)(D’Angelo; Hillemeier)
– Limited access to services for low-income Limited access to services for low-income womenwomen
Pregnancy1
Interpregnancy Interval
Pregnancy2
Preconception Period
Use of Interconception Health Services
Patient Characteristics Age, Parity Education, Income Race/Ethnicity Place of birth Primary language Chronic health problem Current health status Pregnancy outcomes Experience with health care system Knowledge, attitudes & beliefs Socio-cultural influences
Interconception Outcomes Unintended pregnancy Interpregnancy interval
Pregnancy Outcomes Preeclampsia Gestational diabetes Antepartum hemorrhage Hospital admissions Stillbirth Preterm birth Low birth weight Postpartum hemorrhage
Health Care Policy Financial access to services Social marketing of services Provider/health system incentives
Health Care System Provider attitudes Bias Barriers/enabling features
Provider CharacteristicsKnowledge/attitudes/ beliefsClinical specialtyExperience with adverse OB outcomesTraining in interconception counseling
Conceptual FrameworkConceptual Framework
Preliminary StudiesPreliminary Studies
Compliance with traditional Compliance with traditional postpartum visit dependent upon postpartum visit dependent upon perceived need, socioeconomic perceived need, socioeconomic factors, enabling factors (Bryant et factors, enabling factors (Bryant et al, al, Mat Child Health J Mat Child Health J 2006)2006)
What Do Patients Think?What Do Patients Think?
“…“…I didn’t get the [IUD]… I was I didn’t get the [IUD]… I was supposed to get it, but the lady was supposed to get it, but the lady was busy with the next visit… They said busy with the next visit… They said to call [to make another to call [to make another appointment] but now I don’t have appointment] but now I don’t have Medi-Cal, so what’s the point to call if Medi-Cal, so what’s the point to call if I don’t have Medi-Cal? So I’m not I don’t have Medi-Cal? So I’m not happy.”happy.”
Focus group participant
What Do Patients Think?What Do Patients Think?
“ …“ …the doctors were likethe doctors were like ‘ ‘Who’s your Who’s your regular doctor?’ … And it was like, I regular doctor?’ … And it was like, I haven’t had time to go get one yet. haven’t had time to go get one yet. But they kept pushing… You’re so But they kept pushing… You’re so busy afterwards, you don’t even busy afterwards, you don’t even think about it. And you probably think about it. And you probably won’t think about it until something won’t think about it until something feels like it’s wrong. And then you’re feels like it’s wrong. And then you’re like, ‘Maybe I should see a doctor’”like, ‘Maybe I should see a doctor’”
Focus group participant
InterventionIntervention
Target population: Target population: Low-income womenLow-income women with a with a recent preterm birthrecent preterm birth at UCSF, at UCSF, San Francisco General or Highland San Francisco General or Highland HospitalHospital
Intervention components: Intervention components: – Counseling Counseling via health educator and via health educator and
computer-based educational tool at six computer-based educational tool at six week postpartum visit week postpartum visit
– Six month follow-up visitSix month follow-up visit with health with health educator and obstetrical providereducator and obstetrical provider
Patient StrategiesPatient StrategiesHealth Belief Model ConceptHealth Belief Model Concept Strategies for InterventionStrategies for Intervention
Perceived susceptibilityPerceived susceptibility• May not correctly estimate risk of adverse May not correctly estimate risk of adverse
birth outcome in next pregnancy birth outcome in next pregnancy • May not be aware of longer-term maternal May not be aware of longer-term maternal
risks associated with minimal health risks associated with minimal health promotion/disease prevention efforts promotion/disease prevention efforts
Review personal risks of prematurityReview personal risks of prematurity Explain risks of obesity, hypertension, Explain risks of obesity, hypertension,
diabetes, cardiovascular disease associated diabetes, cardiovascular disease associated with not addressing pregnancy conditions with not addressing pregnancy conditions
Perceived severityPerceived severity • May not feel consequences of adverse birth May not feel consequences of adverse birth
outcomes are great outcomes are great • May not be concerned about implications of May not be concerned about implications of
maternal health conditions postpartummaternal health conditions postpartum
Review long-term health consequences, Review long-term health consequences, costs (economic, societal, familial)costs (economic, societal, familial)
Review costs and consequences of Review costs and consequences of maternal obesity, substance abuse, maternal obesity, substance abuse, smoking, chronic illnesssmoking, chronic illness
Perceived benefits Perceived benefits • May see no link between going to see health May see no link between going to see health
care provider and health benefitscare provider and health benefits Explain implications of birth spacing, Explain implications of birth spacing,
benefits of smoking cessation, diabetes benefits of smoking cessation, diabetes screening, stress reduction, breast feedingscreening, stress reduction, breast feeding
Perceived barriersPerceived barriers • May worry about lost time away from work or May worry about lost time away from work or
child care, ability to pay for visit, additional child care, ability to pay for visit, additional medical proceduresmedical procedures
Reassurance regarding coverage of visit, Reassurance regarding coverage of visit, explain anticipated procedures; conditional explain anticipated procedures; conditional cash transfercash transfer
Cue to actionCue to action• New visit may be easily forgottenNew visit may be easily forgotten Send reminders by mail, email or phoneSend reminders by mail, email or phone
Provider StrategiesProvider Strategies
Evidence-based guidelines for providing careEvidence-based guidelines for providing care Available literature regarding impactAvailable literature regarding impact Clinical examples of effectsClinical examples of effects Collect patient satisfaction and feedbackCollect patient satisfaction and feedback Referral list of available specialty providersReferral list of available specialty providers [Suggest scheduling templates, use of mid-[Suggest scheduling templates, use of mid-
level practitioners, billing strategies]level practitioners, billing strategies]
Tools: PatientTools: Patient Interactive computer-based Interactive computer-based
educational tool and visit with health educational tool and visit with health educatoreducator– At 6 week postpartum visitAt 6 week postpartum visit– Messaging related to interconception Messaging related to interconception
care, birth spacingcare, birth spacing– Tailored to needs, culturally & Tailored to needs, culturally &
linguistically appropriatelinguistically appropriate– Cue to 6 month visitCue to 6 month visit
Visit reminderVisit reminder $50 payment for compliance with 6 $50 payment for compliance with 6
month visitmonth visit
Tools: ProviderTools: Provider
Visible reminders on patient charts at Visible reminders on patient charts at 6 week visit to cue clinical follow-up 6 week visit to cue clinical follow-up discussion and work-updiscussion and work-up
Monthly updates regarding patient Monthly updates regarding patient compliancecompliance
Endorsement from senior Endorsement from senior organizational leadersorganizational leaders
Program EvaluationProgram Evaluation
Quantitative measuresQuantitative measures– Compliance with 6 month visitCompliance with 6 month visit– Post-intervention knowledge scoresPost-intervention knowledge scores– Patient satisfaction scoresPatient satisfaction scores– Incidence of short interpregnancy Incidence of short interpregnancy
intervalinterval Qualitative measuresQualitative measures
– Patient experience with educational tool Patient experience with educational tool and 6 month visitand 6 month visit
– Provider experiencesProvider experiences
Study Design/Sample SizeStudy Design/Sample Size
Eligible women randomized to Eligible women randomized to intervention vs. usual careintervention vs. usual care– Minimal contamination anticipated – Minimal contamination anticipated –
health educator and computer tool as health educator and computer tool as variable componentsvariable components
Sample size to detect 30% vs. 10% risk Sample size to detect 30% vs. 10% risk of pregnancy interval < 18 monthsof pregnancy interval < 18 months– At At αα = 0.05, = 0.05, ΒΒ = 0.80, will need ~65 = 0.80, will need ~65
women in each armwomen in each arm