4P's Plus

For the past several years, NTI Upstream has been involved in developing and field-testing a screening methodology that will identify pregnant women at risk for alcohol, tobacco, and illicit drug use. The 4P’s Plus^© is a five-question screen specifically designed to quickly identify obstetrical patients in need of in-depth assessment or follow up monitoring. Taking less than one minute, it can easily be integrated into the initial prenatal visit and used for follow-up screening through the pregnancy. The questions are broad-based and highly sensitive. 

Development of the 4P’s Plus^©

The first step in the development of the 4P’s Plus^© was a three-year study, the goal of which was to identify risk factors for substance use during pregnancy. The results of this study were published in 2001.¹ Participants were 2,002 Medicaid-eligible pregnant women with two or less visits to prenatal care clinics in South Carolina and Washington State. Structured interviews were used to collect data. Logistic regressions and recursive partitioning classification and regression trees (CART analysis) identified predictors for pregnant women at high risk for substance use. Approximately 9% of the sample reported current use of either drugs or alcohol or both. Significant correlates of alcohol or drug use in pregnancy are documented in the following table.

Factors Correlated with Alcohol or Drug Use in Pregnancy (N=1949)

*Significantly different from 1 at P = .01 level, 2-tailed test
^#Significantly different from 1 at P = .05 level, 2-tailed test

The regression results confirmed that past cigarette or alcohol use was significantly correlated with current drug or alcohol use. Furthermore, the effects of the various factors were cumulative; that is, women who had smoked and had ever used alcohol were 8 times more likely to use alcohol or drugs during pregnancy than women who had done neither. To refine the analysis and identify a small set of risk factors that could serve as the basis for a screening protocol for risk of alcohol or other drug use during pregnancy, a CART analysis was performed. Within the sample, the CART analysis generated three groups with increasing levels of risk for alcohol or illicit drug use during pregnancy:

1. Low risk – those women who had never used alcohol: 1.4 % of women in the low-risk group reported using either drugs or alcohol or both during the time they had been pregnant
2. Average risk – those women who had used alcohol in the past but not in the month before pregnancy: 8.7% of women in the average risk group reported using either drugs or alcohol or both during the time they had been pregnant
3. High risk – those women who used alcohol in the month before pregnancy: 36% of women in the high risk group reported using either drugs or alcohol or both during the time they had been pregnant .

Entering cigarettes into the CART analysis, we found that the number of cigarettes smoked in the month before pregnancy helped to further distinguish the average risk and high risk groups. Of those women who had used alcohol in the past but did not smoke three or more cigarettes in the month before pregnancy, 3.4% reported using drugs during the time they had been pregnant. For those women who had used alcohol in the past and smoked three or more cigarettes in the month before pregnancy, 14.5% reported using drugs during pregnancy. 

On the basis of these three levels of risk, we suggested that primary prenatal care providers could ask three questions in the context of the health evaluation:

• Have you ever drunk alcohol?
• How much alcohol did you drink in the month before pregnancy?
• How many cigarettes did you smoke in the month before pregnancy?

We integrated these three questions into the 4P’s screening instrument developed by Ewing² and field-tested our new instrument, the 4P’s Plus^©, in a variety of settings and communities with over 100 physicians from around the country. Through this field-testing, we learned:

1. Physicians and other providers feel most comfortable if substance use screening can be incorporated into routine prenatal care and flows naturally within the context of the prenatal interview. Thus, we made the P for Parents the first question and advised physicians to ask the question within the context of the family history. A positive response does not predict the woman’s substance use, but it normalizes the following questions about substance use by making it clear that these are questions that are part of routine medical care.
2. The second P, for Partner, is similar to the first P, in that a positive response does not predict the woman’s use of substances in pregnancy. However, a partner’s alcohol or drug use was found to correlate with risk for domestic violence in the home. 
3. A positive response to the third P, for Past, placed the woman at low risk for alcohol use during pregnancy (9.5%), an indication for prevention services to be instituted as part of primary prenatal care. 
4.  The two questions related to the fourth P, for Present Pregnancy, were converted to open-ended questions in an attempt to obtain an answer that most truthfully reflected the woman’s substance use patterns prior to pregnancy. In addition, the questions were changed to “In the month before you knew you were pregnant….” This phrasing of the questions was found to be less threatening for the woman. As documented in the initial research,¹ the woman’s admission or denial of alcohol or tobacco use during pregnancy was not as an effective predictor of substance use during pregnancy as her acknowledgement of any alcohol or tobacco use prior to pregnancy.
5. In administering the 4P’s Plus^©, it is important not to use the term alcohol since many men and women do not recognize beer or wine to be alcohol. Thus, when administering the 4P’s Plus^©, the terms beer, wine or liquor are used rather than alcohol. In addition, any forms of alcohol popular in the local community – such as daiquiris in Louisiana – should specifically be included in the questions.
6. Physicians and other providers, with training, gave strong support to the use of the 4P’s Plus^© as a screening instrument. The reasons the instrument gained this high level of approval were:
   •  Physicians appreciated the fact that they were not being asked to question the woman about illicit drug use, only alcohol and tobacco use prior to pregnancy. As shown in our previous research, the level of denial of illicit drug use was so high, questions about illicit drugs did not provide usable information for the primary care physician.
   • The 4P’s Plus^© is efficient, requires little training, and is easily interpreted.
   • Providers more readily accepted screening responsibility if the procedures could be integrated into routine prenatal care and had a logical flow within the clinical interview of the pregnant woman. The screening easily flows from the family history, and, since the latter inquiries about past and present substance use are the more potentially threatening questions, they are less likely to elicit defensiveness or denial on the part of the patient if less personal questions are asked first.

The 4P’s Plus^© has been validated across a variety of populations. The latest validity data were collected in a population of 1,884 pregnant women enrolled in community health centers and maternal and child health programs in Alameda County, California. The instrument demonstrated moderately high sensitivity (83%) and specificity (80%). In addition, the goal of the 4P’s Plus^© is to identify women with risky drinking patterns prior to learning of pregnancy, not just those women drinking once they learned of pregnancy. This was accomplished, as demonstrated by excellent levels of positive and negative predictive validity (50% and 95%, respectively). These levels of predictive validity demonstrate that we are able to identify not only those pregnant women who are drinking heavily or whose alcohol use is at a high enough level to impair daily functioning, but also identifies those women whose pregnancies are at risk from relatively small amounts of alcohol use. Importantly, by identifying women with a positive screen for alcohol use but whose assessment is negative (meaning the woman stopped drinking once she found out she was pregnant), the pregnant woman can receive prevention materials and education regarding the impact of even low levels of alcohol use during pregnancy and be given a strong prevention message. 

In 2004, the effectiveness of the 4P’s Plus^© in identifying pregnant women at risk for alcohol or illicit drug use was compared to universal urine toxicology testing. In this study of close to 1,500 pregnant women enrolled in a managed care system in Southern Illinois, urine toxicologies were positive in 2% of the women; however, the 4P’s Plus^© identified 20% of the population as using alcohol or illicit drugs during pregnancy.   In a similar study in Baton Rouge, Louisiana, the 4P’s Plus^© was compared to the T-ACE. Among 1,133 pregnant women, 42% of the women with a positive 4P’s Plus^© were negative on the T-ACE. The 4P’s Plus^© was able to identify women who were drinking 2 to 3 days and less, while the T-ACE identified only the heavier drinkers.

Work to expand the application of the 4P’s Plus^© to include screening for depression and domestic violence was begun in 2000. Preliminary data among a population of approximately 10,000 women in Fresno, California, had demonstrated a 65% correlation between substance abuse and domestic violence. High rates of depression also were found in the clinical populations. It was thus decided to add straightforward, nonjudgmental questions regarding risk for domestic violence and depression to more fully explore these areas and to give the woman an opportunity to talk with her provider about her experiences with abuse or depression. Such an approach through routine and multiple screenings by skilled health care providers, when conducted face to face, markedly increases the identification of domestic violence and depression.

In developing questions for depression screening, there were several depression screening instruments available, most of which were easy to use and could be administered in less than five minutes. However, a study on a hospitalized population of armed services veterans demonstrated that simply asking two questions about depressed mood and anhedonia detected a majority of depressed patients, and, in some cases, performed better than the original instrument from which they were derived. However, these two areas of questioning had never been validated in pregnant women. Through a series of three generations of questions, tested against the Edinburgh Postnatal Depression Scale and a comprehensive psychosocial clinical interview, we were able to validate two questions regarding depression and two questions regarding risk for domestic violence.

Depression

Sensitivity = 1.00
Specificity =   .798
Positive Predictive Value =    .417
Negative Predictive Value = 1.00

Domestic Violence

Sensitivity = .833
Specificity = .981
Positive Predictive Value =   .833
Negative Predictive Value = .981

By incorporating the questions for domestic violence and depression into the original substance abuse screen, The 4P’s PlusScreen for Behavioral Health Risk in Pregnancy^© (still called the 4P’s Plus^©)is the first validated instrument that has been developed to screen for substance abuse, depression, and domestic violence in pregnant women.

Evaluation of clinical usefulness of the 4P’s Plus^© has shown successful outcomes. Access Family Health Network in Chicago, Illinois, initiated universal screening of pregnant women with the 4P’s Plus^© in 1998. Access Community Health Network is a PHS 330 community health center network with 20 sites in medically underserved Chicago neighborhoods. Its prenatal care clinics operate in eight federally qualified health centers, a residential substance abuse treatment program, a hospital, and a community based health advocacy group. The target population for the universal screening was comprised of 80% African American and 20% Hispanic pregnant women. Within the target area, 40% of target area residents were under 185% of the poverty level at the time of the 1990 census. Medicaid or a Medicaid managed care plan covered nearly all the patients living in these community areas. Within one year, screening rates in the Access system went from 5% of women to 50% of women. By year two, and since that time, screening rates with the 4P’s Plus^© have consistently remained at 95%. 

In 1999, Fresno County, California, instituted universal screening with the 4P’s Plus^© for pregnant women in its health care system. Supported by an intensive training program conducted by NTI Upstream, after one year, 25% of private and Medicaid prenatal care providers screen all their pregnant patients with the 4P’s Plus^©.   Currently, 75% of providers participate in the screening program. As a result of the growing demand for treatment for pregnant women identified through screening with the 4P’s Plus^©, Fresno County developed and funded a 240-slot intensive outpatient program for substance abusing pregnant and parenting women, followed two years later by the opening of 50 residential beds in gender-specific treatment programs for pregnant women.

The state of Kentucky initiated a state-wide approach to addressing substance use in pregnancy through universal screening with the 4P’s Plus^©. After NTI Upstream’s facilitating a training of trainers program for key state personnel, these trainers then conducted programs for providers across Kentucky. Prior to initiation of this project, in FY 2001, 431 pregnant women in the entire state entered substance abuse treatment. In the first six months of FY 2002, with only one-third of the state having initiated the 4P’s Plus^©, this number grew to 520 pregnant women having entered treatment.

Screening with the 4P’s Plus^© has now been instituted in over 50 communities around the nation, and three states have developed state-wide initiatives for universal screening with the instrument. The 4P’s Plus^© has been used in a wide range of populations and has been translated into five languages. The research, development and clinical experience with the 4P’s Plus^© has shown it to be a viable procedure for instituting universal substance use screening in pregnant women. An outside review of the 4P’s Plus^© published in the Journal of Perinatology supported the clinical usefulness of the instrument and the successful integration of providing an opportunity for integrating screening into primary prenatal care.