Addressing Barriers to Treating Pregnant
Women’s Tobacco use and Dependence
Richard Windsor, MS PhD MPH
Professor of Public Health &
NIH SCRIPT Trials Principal Investigator: 1982-2012
Department of Prevention & Community Health
School of Public Health & Health Services
George Washington University Medical Center
2175 K Street, NW #701 Washington, DC 20037
Phone: 202-994-3572, rwindsor@gwu.edu
Presidential Professor of Public Health (2007-12)
University of Alaska, Anchorage
Disclosure
• I have no real or perceived vested interests that
relate to this presentation nor do I have any
relationships with pharmaceutical companies,
and/or other corporations whose products or
services are related to pertinent therapeutic
areas.
2
Objectives
1. To summarize the relationship of maternal
smoking and secondhand smoke exposure to
maternal & infant health
2. To describe current best practice treatment for
tobacco use, dependence and exposure
3. To discuss successes and challenges in
treating tobacco use in pregnancy
3
Health effects of smoking during
pregnancy
• Tobacco use is the most important modifiable
cause of adverse pregnancy outcomes in the
U.S. (Fang, 2004)
• Smoking accounts for 20% of low birth weight
deliveries (<2500 grams), 8% of preterm births
and 5% of all perinatal deaths (Orleans, 2001)
4
Health effects of smoking during
pregnancy
• Fetus is exposed to harmful chemicals such
as tar, nicotine and CO
• CO lowers the amount of oxygen received
• Nicotine is a vasoconstrictor: less oxygen
and nutrients reach the fetus (ACOG, 2011)
5
Health effects of smoking during
pregnancy
• Greater risk of ectopic pregnancy, pre-term
delivery, stillbirth, and low birth weight (Dietz,
2010)
• Continued risk from secondhand smoke after
birth: sudden infant death syndrome (SIDS),
asthma, infantile colic and childhood obesity
(Li, 2005, Sondergaard, 2001, von Kries, 2002);
cognitive, emotional and behavioral problems
in children (HHS, 2006, ACOG, 2005)
6
Health effects of smoking during
pregnancy
• Low birth weight is associated with increased
risk for neonatal, perinatal and infant morbidity
and mortality (CDC, Surgeon General’s Report,
2010)
7
Average Doses of Selected Chemicals Per
Pregnancy
Chemicals
1. CO
2. Nicotine (PATCH)
3. Hydrogen cyanide
4. Nitrogen oxide
5. Methanol
6.. Ammonia
7. Hydrogen sulfide
8. Arsenic
9. Hex. Chromium
10. Cadmium
11. Nickel
12. Lead
5 CPD
10 CPD
20 CPD
NRT (10 wks)
44,550
2,700
607,500
472,500
236,250
94,500
67,500
108,000
49,950
49,950
405,000
80,325
89,100
5,400
1,215,000
945,000
472,500
189,000
135,000
216,000
99,900
99,900
810,000
160,650
178,200 mg
10,800 mg
2,430,000 mg
1,890,000 mg
945,000 mg
378,000 mg
270,000 mg
432,000 mg
199,800 ng
199,800 ng
1,620,000 ng
413,100 ng
0
< 50%
0
0
0
0
0
0
0
0
0
0
8
Ave. Dose of Carcinogens by Selected Chemicals
During Pregnancy
Chemicals
10 CPD
20 CPD
168,750
337,500
675,000
ng
0
11,475
22, 550
140,400
ng
0
3,442,500
6,885,000
13,770,000
ng
0
4. Aromatic-amines
472,500
945,000
1,890,000
ng
0
5. N-heterocyclic amines
229,500
459,000
918,000
ng
0
6. Aldehydes
1,401,300
2,794,500
5,589,000
ng
0
7.Volatile Hydrocarbons
1,113,750
2,227,500
4,455,000
ng
0
1. PAH
2. Heterocyclic comp.
3. N-nitrosamines
5 CPD
NRT(10 wks)
9
Smoking Rate During Pregnancy and % Change: 1990-2006
Years Total
Black
White
Hispanic
Other
1990 18.4%
--------1993 15.8% 15.9%
21.0%
6.7%
8.6%
1995 13.9%
--------1997 13.2%
10.6%
17.1%
4.3%
7.5%
1999 12.3%
-------2002 11.4%
9.0%
13.0%
3.2%
6.8%
2004 10.2%
--------2006 10.0% No National Survey with a Valid Biomarker of Self-Reports
---------------------------------------------------------------------------------------------------------% Change
< 45%
< 43%
< 25.%
< 45%
< 46%
Source: NCHS-NVSS-CDC
10
Smoking Rates of Women 15-44:1990- 2006 *
Survey
1990-92
1994-96
1999-01
2003-06
Pregnant
Average
Average
Average
Average
20.0% (N=800K)
20.6%
19.4%
18.0% (N=768K)
Non-Pregnant
30.0%
31.8%
30.2%
30.7%
No National Survey with a Valid Biomarker of Self-Reports
National Epidemiologic Survey, 2001-02, Goodwin, et al, Obstetrics & Gynecology, 2007,
21.7% Pregnant Smokers
* Tobacco Use--Last Month, National Home Survey on Drug Use & Health,
SAMHSA, Office of Applied Studies, Annual Reports
11
Effective Interventions- Pregnant Patients
Ershoff, et al (1989)
Brief health educator discussion of risks (3-5 min)
+ advised of cessation class+ pregnancy-specific
self-help materials mailed weekly for 7 wks .
Walsh, et al (1997)
Brief MD risk advice (2-3 min.); Video about risks,
barriers, and quitting tips + one 10-minute session
by CNM + self-help manual; and follow up letters.
Windsor, et al (1985)
PHASE I - AJPH
Pregnancy–specific self-help materials (Pregnant
Woman’s Guide To Quit Smoking) + one 10minute counseling session with a health educator.
Windsor, et al (1993)
PHASE II - AJPH
Cessation counseling:15-minute session-how to
use pregnancy- specific self-help materials
(Guide—Windsor et al., 1985); follow up MD letter +
social support + buddy letter + contract + tip sheet.
Windsor, et al (2000)
PHASE III - AJOb/Gyn
SCRIPT Methods: Guide & Commit to Quit Video
10 min.) & Patient Counseling (5 min.). NOTE:
Published >>> AHRQ, 2000 Review
Agency for Health Care Research & Quality (AHRQ, 2000, 94)
12
U.S.P.H.S. Clinical Practice Guidelines,
2008 Update
• 1. Pregnant smokers should be offered faceto-face psychosocial interventions that
exceed minimal advice to quit (Strength of
evidence = A) (HHS, 2008)
• 2. Clinicians should offer effective tobacco
dependence interventions to pregnant
smokers at the first prenatal visit as well as
throughout the course of pregnancy
(Strength of evidence = B)
13
U.S.P.H.S. Clinical Practice Guidelines,
2008 Update
• 1. Evidence for Psychosocial interventions
n = 8 studies: usual care (<3 minutes, selfhelp material, referral) vs. psychosocial
intervention with intensive counseling
Pregnant
smokers
Number of arms
Estimated OR
(95% CI)
Estimated
abstinence rate
(95% CI)
Usual care
8
1.0
7.6
Psychosocial
intervention
9
1.8 (1.4-2.3)
13.3 (9.0-19.4)
14
U.S.P.H.S. Clinical Practice Guidelines,
2008 Update
1. Components of Psychosocial interventions
– MD advice (2-3 minutes); video on risks, barriers to
and tips for quitting; midwife counseling (10
minutes); self-help manual; follow-up letters (Walsh,
1997)
– Pregnant Woman’s Self-Help Guide to Quit Smoking;
counseling (10 minutes) (Windsor, 1985, 1993)
– 90-minute counseling; bimonthly follow-up phone
calls; monthly calls after delivery (Dornelas, 2006)
15
U.S.P.H.S. Clinical Practice Guidelines,
2008 Update
2. Clinical practice suggestions for assisting pregnant
smokers in quitting
ASK: assess tobacco use status using a multiplechoice question to improve disclosure
(e.g. smoke same #, smoke less #, quit before
finding out I was pregnant)
ADVISE: Motivate quit attempts by providing
educational messages about health impact
ASSESS: Assess the patient’s willingness to quit
16
U.S.P.H.S. Clinical Practice Guidelines,
2008 Update
2. Clinical practice suggestions for assisting pregnant
smokers in quitting
ASSIST: Provide self-help materials (book, video)
ARRANGE: Arrange for follow-up assessments
throughout pregnancy
17
U.S. P.H.S. Clinical Practice Guidelines,
2008 Update
• Rationale for assisting pregnant smokers during
prenatal visits
– Many women are motivated to quit during pregnancy;
46% of smokers quit directly before or during
pregnancy (Colman, 2003)
– *Up to 60% of those who quit during pregnancy will
relapse within 6 months postpartum, and 80-90% by
12 months postpartum (Floyd, 1993, Fingerhut, 1990)
– Health benefits result from quitting at any time
(Husten, 2008, England, 2001, Lieberman, 1994,
DiClemente, 2000)
18
U.S. P.H.S. Clinical Practice Guidelines,
2008 Update
• NRT for pregnant smokers?
– U.S. P.H.S. Clinical Practice Guidelines
• Evidence on both safety and effectiveness of NRT
is inconclusive
• Nicotine may contribute to adverse effects of
smoking during pregnancy and result in injury to
the fetus (Jacobsen, 2007, Ginzel, 2007, Slotkin,
2007)
• Cases should be considered in context – nicotine
from NRT vs. nicotine from cigarettes (plus 4,000
chemicals and toxins)
19
“Behavioral and Pharmacotherapy Treatment Strategies
for Pregnant Smokers: Issues for Clinical Practice”
R. Windsor, PhD, MPH, C. Oncken, MD, J. Henningfield, PhD, K. Hartmann, MD, PhD,
and N. Edwards, PhD, RN., J. of the American Medical Women’s Association, Vol. 55(5), 304309, 2000.
Conclusion: The judicious use of NRT medications may significantly reduce harm
to the infants of heavy smokers. More evidence derived from large populationbased research, however, is needed to provide guidance to the physician about
NRT eligibility, dose, scheduling, and effectiveness in clinical practice.
---------------------------------------------------------------------------------------“Pharmacotherapy for Smoking Cessation during Pregnancy”
Benowitz, Neal., Dempsey, Delia. Nicotine & Tobacco Research, Vol.6, Supp. 2, April, 2004,
S189-S202.
Conclusion: Clinicians should consider the use of nicotine replacement therapies
as an adjunct to smoking cessation in pregnant women
who cannot quit smoking with behavioral treatments alone. Available clinical trial
data suggest that nicotine replacement therapy is safe during pregnancy,
although its efficacy in aiding cessation has not been demonstrated.
--------------------------------------------------------------------------------------------------------------------Coleman, et al, “A RCT of NRT-Patches in Pregnancy”, NEJM, March 1, 2012
E NRT Group = 521- 9.4% vs C Group = 529 – 7.6% (NS)
20
“Nicotine Replacement and Behavioral Therapy for smoking
cessation in pregnancy”
K.Pollak, et al., Vol.33, No.4, 2007, American Journal of Preventive
Medicine
Methods and Results
Eligibility: ≥ 5 CPD, 13-25 weeks gestational age, ≥ 18 years old
Intervention Group: 6 counseling sessions + NRT (patch, gum or lozenge)
Control Group: 6 counseling sessions
Measurement: saliva cotinine and self-report
-------------------------------------------------------------------------------------------------------Behavioral Impact: At 7 weeks, the intervention group had a 24% quit rate,
compared to 8% in the control group. At 3 months postpartum, the
intervention group had a 20% quit rate, compared to 14% in the control
group.
21
“Nicotine Gum for Pregnant Smokers: a RCT”
C. Oncken , et al. Vol. 112, No. 4, 2008, Obstetrics &
Gynecology
Methods and Results
--------------------------------------------------------------------------------------Eligibility: > 1 cigs per day, < 26 weeks gestational age, > 16 years old
Intervention Group: Two, 35-min counseling sessions, 2mg nicotine gum
Control Group: Two, 35-min counseling sessions, placebo gum
Measurement: 1st , 2nd, 3rd, 4th, 5th visit, based on CO & Self Report
Process: 71% of the intervention group attended visits. 60% of the
control group attended visits. Gum use did not differ significantly
between the groups.
Behavioral Impact: Quit rate for intervention group was 18.0%, compared
to 14.9% for the control group.
Birth weight for the intervention group was 3287g, compared to 2950g for
the control group.
22
Successes and challenges in the
treatment of smoking during pregnancy:
feasibility, and barriers to
implementation and sustainability
23
What is the Smoking Cessation and
Reduction In Pregnancy Treatment
(SCRIPT) Program?
24
Evaluation PHASES: Producing the SCRIPT Process-Impact
Evidence for Prenatal Care – Practice - Patients
PHASE I
PHASE II
EVALUATION RESEARCH
(Theory Based)
FORMATIVE
EVALUATION
EFFICACY
EVALUATION
INTERNAL VALIDITY
PHASE III
PHASE IV
PROGRAM EVALUATION
(Practice Based)
EFFECTIVENESS
EVALUATION
DISSEMINATION
- ADOPTION
EVALUATION
INTERNAL + EXTERNAL VALIDITY
META + QUALITATIVE + PROCESS + COST EVALUATIONS & ANALYSES
(Systematic Reviews of Primary Results of Treatment Program)
25
SCRIPT Evaluations: E vs C Group Quit Rates
Evaluation Study
P.I. Location
Measure
Intervention
Group (E)
N
%
Windsor,WV, 2011, Trial IV *
Windsor, AL, 2000, Trial III
CO
S-COT
259
126
13.9%
17.3%
259
139
4.6%
8.8%
+ 9.3%
+ 8.5%
Gebauer, Ohio,1998 *
S-COT
84
15.5%
94
0.0%
+ 15.5%
Hartmann, NC,1996
CO
107
20.0%
100
10.0%
+ 10.0%
Valbo (Norway),1994-1996 *
CO
107
27.0%
105
11.4%
+ 15.7%
Windsor, AL,1993, Trial II
S-COT
400
14.2%
414
8.4%
+ 5.8%
O’Connor, (Canada),1992
U-COT
90
13.3%
84
6.0%
+ 7.3%
Hjalmarson, (Sweden),1991
SCN
444
12.6%
209
8.6%
+ 4.0%
Windsor, AL,1985, Trial I
SCN
102
14.2%
104
2.0%
+ 11.8%
US Studies
Difference
(E vs. C)
Total= 15.0%
6.5%
+ 8.5%
Non-US Studies (N = 1039)
Total = 15.0%
8.8%
+ 6.2%
* Q-Exp
Total = 15.2%
7.5%
+7.7%
(Total N = 2697)
(N = 2176)
Control
Group (C)
N
%
26
SCRIPT Procedures for Clinical Practice
Procedures
Completed
ASK < 1 minute
1.Document smoking status + cigarettes per day (cpd) + CO Sample
A. Never smoker or quit before pregnant 
B. Quit since pregnant
C. Smoker: reduced cpd

D. Smoker: same cpd



Response A and B: Congratulate her on success and stop home & social ETS
Response C and D: ASSESS--ADVISE--ASSIST--ARRANGE
ASSESS <1 minute

2.Document readiness to quit
ADVISE <1 minute
3.Provide clear, strong messages about risks of smoking to mother/fetus
4.Provide clear, strong and personal advice to quit and stay quit
ASSIST >10 minutes
5.Review cessation skills in Video-Guide & sign an agreement to use Guide
6.Express confidence that use of the Guide and methods will help them to quit
7.Encourage patient to seek family & social support to quit
8.Advise patient to stop ETS exposure at home, car and social
9.Remind patient of next visit and put "smoker" label in notes





ARRANGE < 1 minute
10.Schedule next visit for patient & Call Patient on Quit Date (Optional)

27
The Core SCRIPT Procedures
--------------------------------------------------------------Component #1: Commit to Quit Smoking During &
After Pregnancy Video (10 Min.) *
Component #2: A Pregnant Women’s Guide to Quit
Smoking (5th-6th grade literacy) *
Component #3: Patient-centered counseling session
(10-15 Minutes) *
----------------------------------------------------------------
* Society for Public Health Education (SOPHE)
28
29
30
SCRIPT Patient-Practice Flow Analysis (PFA)
Prenatal Clinic #1
Patient #1
Total Time By Personnel
=
2 hours, 25 minutes
Sign In → Clerk → Lab → Nurse → Social → Nutritionist → Appointment Clerk
Interview Worker
Sign Out
8:05 am
8:50 to
8:55
8:55 to
9:11
Patient #2
9:20 to
9:35
9:42 to
9:55
Total Time By Personnel
10:00 to
10:25
=
10:25 to
10:30
2 hours_______________
Sign In → Clerk → Lab → Nurse → Social → Nutritionist → Appointment Clerk
Interview Worker
Sign Out
10:30 am
10:30 to
10:35
10:35 to 10:50 to
10:45
11:15
11:17 to
11:55
12:00 pm to
12:25
12:25 to
12:30
Education/Counseling Content Summary
Nurse Interview: History, appointment with midwife, SCRIPT, drug/alcohol prevention counseling
Social Worker: Education, home environment, feeling about pregnancy, Medicaid, birth control options
Nutritionist: Nutrition assessment/recommendations, WIC, voter registration, no vouchers available today
Remarks
 Only 4 of 10 scheduled patients her appointment
 Patients stay with same RN throughout pregnancy
31
Smoking Cessation and Reduction In Pregnancy
Treatment (SCRIPT) Procedures:
Provider Counseling Manual & Guidelines
----------------------------------------------------------------------Richard Windsor, MS PhD MPH
SCRIPT Principal Investigator
32
1st Steps:
Prepare a Valid Epidemiologic-Behavioral
Profile >>> SAR of the adverse Perinatal
Rates and Trends
--------------------------------------------------------------How many pregnant smokers do you
Have at each/all of your care sites and
how large a problem to you have ?
33
What is the evidence-base for
measurement of active tobacco use during
prenatal care in the U.S and at your Prenatal
Care Program?
34
SCRIPT Trial III Smoking History Study: Baseline Smoking
Status + Cotinine Levels of 416/446 = 93% (A.J.Ob/Gyn,2000)
Group Cot. < 20ng
A
B
C
D
E
Total
2
7
31
24
171 *
235 *
Cot. > 21ng
18
58
24
20
28 *
148 *
No Sample
0
6
2
1
120
128
A = Current Smoker
B = Reduced but Current Smoker
C = Quit > Pregnant
Total
20
73
57
45
205 *
416
Deception RATE
35%
40%
13%
24%
D = Quit < Pregnancy
E = Never Smoker
Cotinine Confirmed Deception Rate = 24.2%
White = 36% & African-American = 12%
35
Time after cessation to cut-off concentration:
Distinguishing Smokers from Non-Smokers
Type
Cotinine (Saliva)
General population
African-American
Pregnant Women
Cut-off
15 ng/ml
15 ng/ml
15 ng/ml
10 ng/ml
Cotinine (Urine)
50 ng/ml
CO (expired air)
Active
Sleep
8-10 ppm
8-10 ppm
Benowitz, N. SRNT Subcommittee on Biochemical Verification (Chair),
NTR (2002)149-159.
36
“Accuracy of Self-Reported Smoking Status Assessed by CotinineTest
Strips”
D. Parker, T. Lasater, R. Windsor, et al. (2002). Nicotine & Tobacco
Research, Vol. 4, pp.
305-09. (New England SCRIPT Trial)
-------------------------------------------------------------------------------------We evaluated a new urine cotinine test (CT) strip gas
chromatography (GC) and self-reports to assess smoking
status in pregnancy (n = 95) from 22 sites in MA, CT, and RI.




The 1st study to evaluate the accuracy of CT strip--(NicAlertTM).
CT strips confirmed smokers with a very high level of agreement
(97% = 100 ng/ml and 97% = 250 ng/ml cutoff) and nonsmokers with a moderate level of agreement (79% = 100 ng/ml
and 86% = 250 ng/ml cutoff).
CT strips + self-reports were almost 100% accurate.
A larger trial is needed to evaluate the validity of the CT strip,
compared to GC and self report.
37
LITERATURE SYNTHESIS
------------------------------------------------------------------------------------Recommended VALID Assessment of smoking status in Prenatal Care
includes: Patient Self Reports + Biomarker
-------------------------------------------------------------------------------------------------------
A. Carbon Monoxide (CO): >8 PPM is considered smoker
B. Urine Cotinine Dipstick: >100 ng/ml is considered
smoker
C. Saliva Cotinine Strips-Dipstick (NicAlert): > 50 ng/ml is
considered smoker
D. Saliva or Urine Cotinine Test : 7-10 days in Lab;
Saliva: > 20 ng/ml is considered smoker, & Urine: > 80100ng/ml is considered smoker
-----------------------------------------------------------------------------------38
Discussion of Measurement
--------------------------------------------------------------What evidence is available that regular
prenatal care staff (RN/SW) can deliver the
SCRIPT Program with fidelity for > 1 year:
A Process Evaluation Model (PEM)?
39
Steps to plan a SCRIPT Dissemination
Program for a Prenatal Care
System, Regular Providers and
Population of Pregnant Smokers?
----------------------------------------------------------------What are we doing now and what/why do we
want to introduce new, “Best Practice” methodsprocedures into our Prenatal Care Program
and Ob Practices:
A Multi-Level Challenge?
40
1st Steps >>> Primary Partners to Plan Disseminate - Adopt - Evaluate a SCRIPT Program
Planning Problem Solving
Partners at the Table
Trans-Disciplinary Science
41
What is the SCRIPT evidence-base that defines the
assessment (O’s) and treatment (X’s) methods that
a trained professional should routinely provide to
their patients at prenatal care visit 1-2-3?
----------------------------------------------------------------Cochrane + AHRQ + NIH +
ACOG Systematic Reviews:
Treatment-Practice Guidelines
for Specific Problems > MD/CNM/RN/SW
----------------------------------------------------------------The SCRIPT Committees Reviews the Evidence:
How do we fit the evidence to its program?
42
Planning a Performance-Process Evaluation
-------------------------------------------------------------------------Major problem documented by all MetaEvaluations: Did ALL staff deliver all Program
Assessment (O) + Treatment (X) Procedures (P)
to all patients?
------------------------------------------------------------------------What is the Process and Behavioral Impact?
43
__________________________________________________
Objectives
Factors: Issues-Barriers to SCRIPT
____________________________________________________________
>>> Feasibility
Policy-Structure-Process-Time-FrequencyComplexity-Content-Materials/Staff Cost/Patient
>>> Acceptability
Staff Skill-KAP-Self Efficacy
Patient Skill-KAP-Self Efficacy
>>> EfficacyEffectiveness
Behavioral Impact-Clinical Outcomes
<<< Cost
>>> Efficiency
Economic Savings or Cost Neutral
Health-Financial Benefits (CEA-CBA)
____________________________________________________
Other Factors? Rogers: “Diffusion of an Innovation in an Organization”
44
National Committee for Quality Assurance
1100 13th St., NW, Suite 1000
Washington, DC 20005
(www.ncqa.org or 1-888-275-7585)
-------------------------------------------------------------------------Healthcare Effectiveness Data Information System
(HEDIS)
Consumer Assessment of Healthcare Providers and Systems
(CAHPS)
4.0H Survey by Managed Care Plans (90%)
45
“A Process Evaluation Model (PEM) * for Patient
Education Programs for Pregnant Smokers”
Windsor, R. Whiteside, P. Jr., Solomon, L. et al.
Tobacco Control, 2000, 9 (Supp. III): iii 28-35
-----------------------------------------------------------------------Process Evaluation Model:
1. Definition of the eligible patient sample
2. Documentation of patient exposure to each
procedure
3. Computation of procedure exposure rate
4. Specification of a practice performance standard
or benchmark
5. Computation of an implementation index or rate
--------------------------------------------------------------------------------* Developed for the RWJF-SFF-NPO: 1994-02
46
SCRIPT Program Evaluation III
Performance Measurement-Process Evaluation Results *
----------------------------------------------------------------------------------------------------Twenty-eight staff (RN/SW/WIC) at the 10 randomly selected clinics in
eight counties implemented Trial III CORE patient assessment (O) and
intervention (X1 + X2 + X3) Procedures (P) for patients as part of
routine practice without additional compensation.
A Process Evaluation confirmed that 6514 patients were screened over
a 36 (42 months) period: 77% of eligible smokers (1340/1736) agreed to
participate (P1).
Regular Staff performed 100% of baseline (P2) and 82% of follow-up
assessments (P7), and collected 99% of baseline (P3) and 72% of the
follow-up (P8) saliva samples. Based on patient follow-up reports, staff
provided the Video to 95% (P4), the Guide to 99% (P5), and counseling
methods (P6) to 97% of the Experimental (E) Group.
------------------------------------------------------------------------------------------------------
* R. Windsor, L. Woodby, T. Miller, & M. Hardin, “Effectiveness of SCRIPT
Methods in Medicaid Supported Prenatal Care: Trial III,
Health Education and Behavior, No 4, August, 2011
47
SCRIPT Process Evaluation Model (544 Patients)
Eligible
Exposed Exposure Performance Implementation
Clinical Procedures
Patients
Patients
Rate
Standard
(P)
(A)
(B)
(C)
(D)
(E)
P#1. Smokers (S) recruited
100
77
77%
80%
0.96
P#2. S Baseline Form: O1A
100
100
100%
100%
1.00
P#3. Smoker Cotinine: O1B
100
99
100%
100%
0.99
P#4. E group-Video: X1
100
95
95%
100%
0.95
P#5. E group-Guide: X2
100
99
99%
100%
0.99
P#6. E group-Counseling: X3
100
97
97%
100%
0.97
P#7. Follow-up Form: O2A
100
85
85%
90%
0.94
P#8. Follow-up Cot. :O2B
100
72
72%
90%
0.80
Patient
Rate-Index
Program Implementation Index (PII) :
Measures Program Fidelity of Delivery by 1 or ALL
Professional Staff (28 RN/SW/RD) in 10 Clinics
48
(I)
49
50
General Dissemination Guidelines:
Integrating the Evidenced-Based SCRIPT
into a Ob-Prenatal Care Program & Practices
---------------------------------------------------------------------------------------#1: SCRIPT (O’s + X’s) Science-Evidence Base: AHRQ + ACOG
#2: Organizational Policy-Program-Practice: Consensus Development
#3: Communication-Transparency: Dissemination Plan + Budget
#4: Systemic Assessment: Smoking History Study of Patients + Staff
#5: Training: Assessment (New O’s) + Counseling Skills (New X’s)
#6: Site + Practice + Patient Flow Analysis (PFA)
#7: Site + Practice + Pilot Tests >>> Finalize SCRIPT Program
#8: Policy + Practice Guidance: Process-Impact-Cost Evaluations
---------------------------------------------------------51
Evaluability Assessment of Readiness
and Reality to modify-change your Program?
---------------------------------------------------------Have we identified the salient policy provider-practice-patient (+/-) factors, to adapt –
disseminate – adopt - evaluate a SCRIPT Program
(O’s + X’s) for our Prenatal Care Program?
----------------------------------------------------------------DISCUSSION
52