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

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ate

Per

1,0

00 L

ive

Bir

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0

1

2

3

4

Afr

ican

Am

eric

an:W

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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