Predictors of intentions to stop smoking early in prenatal care.

OBJECTIVE: To determine baseline variables associated with low intentions of stopping smoking early in pregnancy. DESIGN: Cross sectional survey. PARTICIPANTS: Pregnant smokers pooled across seven Smoke-Free Families trials (n = 1314). RESULTS: 36% of pregnant smokers had low intentions of stopping smoking within the next 30 days. In contrast to pregnant smokers with higher intentions of quitting, pregnant smokers with low intentions were less confident in their ability to quit, less likely to have private health insurance, and less likely to agree that smoking harms the unborn child. They were more likely to smoke heavily, more likely to have fewer years of education, and more likely to have friends and family members who smoke. CONCLUSIONS: Three options to smoking cessation assistance are proposed for pregnant smokers with low intentions of quitting: targeting, triage, and tailoring. Further research is needed to determine which approach is most appropriate.

The Kaiser Permanente prenatal smoking-cessation trial: when more isn't better, what is enough?

INTRODUCTION: The effectiveness of low-cost smoking interventions targeted to pregnant women has been demonstrated, although few gains in absolute cessation rates have been reported in the past decade. Under conditions of typical clinical practice, this study examined whether outcomes achieved with brief counseling from prenatal care providers and a self-help booklet could be improved by adding more resource-intensive cognitive-behavioral programs. DESIGN: Randomized Clinical Trial. SETTING: A large-group-model managed care organization. PARTICIPANTS: 390 English-speaking women 18 years of age or older who self-reported to be active smokers at their initial prenatal appointment. INTERVENTION: Participants were randomized to one of three groups: (1) a self-help booklet tailored to smoking patterns, stage of change, and lifestyle of pregnant smokers; (2) the booklet plus access to a computerized telephone cessation program based on interactive voice response technology; or (3) the booklet plus proactive telephone counseling from nurse educators using motivational interviewing techniques and strategies. No attempt was made to change smoking-related usual care advice from prenatal providers. MAIN OUTCOME MEASURE: Biochemically confirmed abstinence measured by level of cotinine in urine samples obtained during a routine prenatal visit at approximately the 34th week of pregnancy. RESULTS: Twenty percent of participants were confirmed as abstinent with no significant differences found between intervention groups. Multivariate baseline predictors of cessation included number of cigarettes smoked per day, confidence in ability to quit, exposure to passive smoke, and educational level. No differential intervention effects were found within strata of these predictors or by baseline stage of readiness to change. Cessation rates among heavier smokers were strikingly low in all intervention groups. CONCLUSION: Neither a computerized telephone cessation program nor systematic provision of motivational counseling improved cessation rates over a tailored self-help booklet delivered within the context of brief advice from prenatal providers. Innovative strategies need to be developed to increase the effectiveness of existing prenatal smoking interventions. Special attention should be paid to the needs of heavier smokers.

Postpartum return to smoking: who is at risk and when.

PURPOSE: Despite high rates of spontaneous and assisted smoking cessation during pregnancy, postpartum maintenance is disappointingly low. Predictors of return to smoking remain unclear, thus limiting the development of interventions that could protect the health of women and their children. This study followed women who had participated in a prenatal smoking cessation intervention trial and successfully stopped smoking to address two aims: (1) describe the probability of relapse in confirmed quitters during the first 6 months after the birth, and (2) identify factors that increase relapse. DESIGN: Prospective design during pregnancy and retrospective report at 6 months postpartum used survival analysis with return to smoking as the dependent variable and the Cox proportional hazards regression technique. MEASURES: Questionnaires were used at the first prenatal visit and telephone interviews at the 26th week of pregnancy and 6 months postpartum. Nonsmoking after the 20th week was measured by urine cotinine tests (m = 3); nonsmoking postpartum was measured by retrospective self-report. SETTING: The setting was an HMO-based group practice in Los Angeles. SUBJECTS: Subjects were white, black, and Hispanic women (n = 127) available for follow-up. RESULTS: The proportion of the sample classified as relapsers at 6 months postpartum was 62.9%. The final model identified the following risk factors for smoking: taking puffs in late pregnancy and having friends who smoke at the first prenatal visit, less confidence in mid-pregnancy that they could maintain nonsmoking postpartum, and a partner who smokes postpartum. CONCLUSIONS: Intervention should begin in late pregnancy, and smoking networks, including partner smoking, should be addressed.

A randomized trial of comprehensive geriatric assessment in the care of hospitalized patients.

BACKGROUND: Although many studies describe benefits from the comprehensive assessment of elderly patients by an interdisciplinary team (comprehensive geriatric assessment), the most supportive evidence for the process has come from programs that rely on specialized inpatient units and long hospital stays. We examined whether an inpatient geriatric consultation service might also be beneficial in a trial involving four medical centers of a group-practice health maintenance organization (HMO). METHODS: We conducted a randomized clinical trial with 2353 hospitalized patients 65 years of age or older in whom at least 1 of 13 screening criteria were present: stroke, immobility, impairment in any basic activity of daily living, malnutrition, incontinence, confusion or dementia, prolonged bed rest, recent falls, depression, social or family problems, an unplanned readmission to the hospital within three months of a previous hospital stay, a new fracture, and age of 80 years or older. Of the 1337 patients assigned to the experimental group, 1261 (94 percent) received a comprehensive geriatric assessment in the form of a consultation, with limited follow-up; the 1016 patients assigned to the control group received usual care. The functional and health status of the patients was measured at base line and 3 and 12 months later; survival was assessed at 12 months. Subgroups of patients who might be presumed to benefit from comprehensive assessment were also studied. RESULTS: The survival rate at 12 months was 74 percent in the experimental group and 75 percent in the control group. At base line, 3 months, and 12 months the scores of the two groups on measures of functional and health status were similar. The analysis of 16 subgroups did not identify any with either clearly improved functional status or improved survival. CONCLUSIONS: In this HMO, comprehensive geriatric assessment by a consultation team, with limited follow-up, did not improve the health or survival of hospitalized patients selected on the basis of screening criteria.

Relapse prevention among women who stop smoking early in pregnancy: a randomized clinical trial of a self-help intervention.

Studies have demonstrated the effectiveness of smoking cessation interventions targeted at women who are smoking during pregnancy. In contrast, there is limited information about the experience of smokers who have stopped before entering prenatal care--"spontaneous quitters." These women constitute the majority of women who stop smoking sometime during pregnancy, although evidence suggests that as many as one third relapse prior to delivery. We report the results of a population-based randomized clinical trial that tested the effectiveness of a relapse prevention program for spontaneous quitters. The intervention consisted predominantly of printed materials received through the mail. The population (n = 171) of spontaneous quitters was an ethnically diverse group of women enrolled in a large health maintenance organization. Biochemical confirmation of continuous abstinence through delivery revealed that 16% of the women in the experimental self-help program relapsed compared with 20% of usual care controls (NS). Analysis confirmed that the program was equally ineffective among all subgroups including women at highest risk for relapse. Given the negative outcomes associated with self-help materials and clinic-based counseling reported in this and other trials, alternative intervention strategies need to be developed and tested for this significant group of prepregnancy smokers.

Rationale and design of a multi-center randomized trial of comprehensive geriatric assessment consultation for hospitalized patients in an HMO.

OBJECTIVE: To describe the evaluation of an interdisciplinary comprehensive geriatric assessment (CGA) consultation program for targeted hospitalized patients. DESIGN: Multi-center randomized clinical trial (RCT) at four hospitals where patients were randomly assigned to CGA consultation or usual care by the attending physician, and a non-equivalent control group (NCG) at two hospitals. SETTING: Six hospitals in a multi-specialty group practice model health maintenance organization (HMO). PARTICIPANTS: 3593 patients age 65 years or older meeting at least one of 13 inclusionary criteria at admission. INTERVENTION: Screening by hospital staff and standardized CGA consultation conducted by a nurse practitioner, social worker, and geriatrician at the four RCT hospitals. MAIN OUTCOME MEASURES: Functional and health status, mortality, rehospitalization, and cost-effectiveness of the CGA program at 1 year post-randomization; validation of targeting (inclusionary) criteria that identify subgroups of patients deriving benefit from CGA; and physician contamination (learning from CGA and changing treatment provided to control patients). CONCLUSIONS: A number of methodological issues need to be considered when conducting effectiveness trials of CGA. The concurrent design of a multi-center RCT, coupled with the NCG to determine physician contamination, is an innovative approach intended to determine more precisely the cost-effectiveness of CGA for frail hospitalized elderly persons. The large and heterogeneous patient population and the broad array of inclusionary criteria will permit the evaluation of the benefit of CGA for subgroups. All these features are intended to enhance the generalizability of study results.

Women who stop smoking spontaneously prior to prenatal care and predictors of relapse before delivery.

This study explores the experience of pregnant women who quit smoking prior to initiating prenatal care. These "spontaneous quitters" comprised 41% of a socioeconomically and ethnically diverse population of prepregnancy smokers enrolled in a health maintenance organization. Compared to women who were smoking at the start of prenatal care, spontaneous quitters had been lighter smokers, were less likely to have another smoker in their household, indicated a stronger belief in the harmful effect of maternal smoking, had a history of fewer miscarriages, and entered prenatal care earlier. Biochemical validation of smoking status over the course of pregnancy found that 21% of the spontaneous quitters relapsed prior to delivery. Characteristics reported at the first prenatal visit that were associated with maintenance included having achieved cessation for a longer period of time without smoking even a puff, higher self-efficacy for maintenance, stronger belief in the harmful effect of maternal smoking, primigravida, and greater frequency of nausea. The identification of spontaneous quitters and selected intervention for those at greatest risk of relapse is recommended for inclusion in routine prenatal care.

Maintenance of nonsmoking postpartum by women who stopped smoking during pregnancy.

This paper describes self-reported maintenance of nonsmoking at six months postpartum by women whose abstinence was verified beginning before the 20th week of pregnancy and continuing through delivery (n = 134). The overall maintenance rate of 37 percent was not related to sociodemographic characteristics, smoking and obstetric history, the time when quitting occurred, or a prenatal smoking cessation program. Although this rate is encouraging, more attention should be directed to sustaining prenatal abstinence from smoking beyond delivery.

Pregnancy and medical cost outcomes of a self-help prenatal smoking cessation program in a HMO.

The results of a randomized clinical trial of a prenatal self-help smoking cessation program are reported in terms of the pregnancy and cost outcomes. The study population were the socioeconomically and ethnically diverse members of a large health maintenance organization (HMO) who reported that they were smoking at the time of their first prenatal visit. The intervention consisted predominantly of printed materials received through the mail. Compared with the usual care control group, women assigned to the self-help program were more likely to achieve cessation for the majority of their pregnancy (22.2 percent versus 8.6 percent), gave birth to infants weighing on average 57 grams more, and were 45 percent less likely to deliver a low birth weight infant. An economic evaluation of the self-help program was conducted from the perspective of the sponsoring HMO. Based upon the expenditures associated with the neonates' initial hospital episode, the intervention had a benefit-cost ratio of 2.8:1. These findings provide strong evidence to support widespread incorporation of smoking cessation interventions as a standard component of prenatal care.

A randomized trial of a serialized self-help smoking cessation program for pregnant women in an HMO.

We report the results of a population-based randomized clinical trial that tested the effectiveness of a prenatal self-help smoking cessation program. The intervention consisted predominantly of printed materials received through the mail. The population (n = 242) consisted of a socioeconomically and ethnically diverse group of pregnant women enrolled in a large health maintenance organization (HMO) who reported they were smoking at the time of their first prenatal visit. Biochemical confirmation of continuous abstinence achieved prior to the 20th completed week of pregnancy and lasting through delivery revealed 22.2 per cent of the women in the eight-week serialized program quit versus 8.6 per cent of controls with usual care. The adjusted odds ratio was 2.80 (95 per cent CI = 1.17, 6.69). We conclude that a low-cost prenatal self-help intervention can significantly affect the public health problem of smoking during pregnancy and its associated risks for maternal and child health.

Smoking cessation in pregnancy: a self-help approach.

During a 3-month recruitment period, a smoking cessation program was provided to all pregnant women who attended an HMO prenatal clinic and reported either that they were currently smokers (n = 35) or that they had quit at pregnancy onset (n = 23). Except for its in-clinic introduction, the behavioral smoking cessation program used a home-correspondence format with seven weekly mailings and a telephone answering system adjunct. At follow-up, all 23 women who identified themselves at baseline as self-initiated quitters reported continued abstinence from smoking. Urine thiocyanate assays confirmed these self-report data in 82% of the cases. Results of a multivariate analysis identified three factors--gravida, number of years a smoker, and number of friends who smoke--as significant predictors of self-initiated quitting. Of the 35 women who indicated that they were still smoking at baseline, 10 (28.5%) reported that they had stopped smoking at the time of the postprogram assessment. Available urine thiocyanate assays confirmed a nonsmoking status in all cases. The multivariate results indicated that four variables--gravida, severe nausea, baseline smoking rate, and spouse's smoking status--were significant predictors of quitting following exposure to the program. The majority of both self-initiated quitters and postprogram quitters reported that the program was useful in helping them to quit smoking and/or to remain abstinent over time. These results lend support to the viability of a home-correspondence, self-help program as a means for facilitating smoking cessation and continued abstinence from smoking during pregnancy.

Behavioral, health, and cost outcomes of an HMO-based prenatal health education program.

This report presents the results of an evaluation of a prenatal health education program conducted within a health maintenance organization (HMO) setting. Specifically, the behavioral, birth, and treatment-cost outcomes for 57 women in an experimental group who received individual nutrition counseling and a home-correspondence smoking cessation program were evaluated against the outcomes for 72 women in a control group who received standard prenatal care. In comparison with the controls, a greater percentage of women in the experimental group quit smoking during pregnancy (49.1 percent versus 37.5 percent). Of those who smoked throughout their pregnancy, women in the experimental group had a greater reduction in their mean rate of daily smoking. A significantly greater percentage of experimental group women adjusted their diets during the prenatal period (91 percent versus 68 percent), and particular success was achieved in increased consumption of dairy products and vegetables, decreased consumption of coffee, and adequate weight gain during pregnancy. Analysis of birth outcome data revealed that infants born to the experimental group had a significantly higher mean birth weight than infants born to the controls (121.34 oz versus 113.64 oz). The experimental group also had fewer low birth weight infants (7.0 percent versus 9.7 percent for controls). Hospital treatment cost savings associated with the reduced incidence of low birth weight infants among experimental group women yielded an overall benefit-cost ratio for the prenatal program of approximately 2:1.

A critique of project evaluations.

In recent years an increased stress has been placed on the evaluation of mental health, education, and welfare service programs. The majority of studies readily available to most evaluators represent local project evaluations which usually contain diverse references to different aspects of the evaluative process. For evaluative results to be even minimally useful to other projects, however, certain requirements must be met. These are: (1) internal validity, (2) external validity, (3) specification of the population and treatment being implemented, and (4) standardization of indicators of treatment impact. To determine the extent to which published project impact evaluations meet these criteria, a study was undertaken to "evaluate the evaluations" themselves within heroin addiction treatment programs. Six high-yield journals and 100 random sources were systematically searched for reports of evaluations which provided measures of success in terms of the consumer. Articles were analyzed in regard to our four prerequisites for cross-project comparisons regarding process variables, impact variables, and methodologies. It became clear, however, that our original objectives in evaluating either the usefulness of published project evaluations or testing any specific impact hypotheses were not achievable due to the state of evaluative measurement and reporting practices at this time. The major problems we eoncountered in our inability to complete a necessary and potentially fruitful comparative assessment of project evaluations are discussed in detail with recommendations for future work.