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*Department of Family and Community Medicine, University of Toronto;
Ray D. Wolfe Department of Family Medicine, Mount Sinai Hospital;
Inner City Health Research Unit and Department of Family and Community Medicine, St. Michael's Hospital;
Department of Family and Community Medicine, St. Joseph's Health Centre; ¶Canadian Family Physician, College of Family Physicians of Canada; **Department of Women's Health, University Health Network and University of Toronto
Correspondence to: Dr.June Carroll, Mount Sinai Hospital, 600 University Ave., Suite 413, Toronto ON M5G 1X5; jcarroll{at}mtsinai.on.ca
| Abstract |
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Methods: A randomized controlled trial was conducted in 4 communities in Ontario. Family physicians, obstetricians and midwives who see at least 10 prenatal patients a year enrolled 5 eligible women each. Providers in the intervention group attended an educational workshop on using the ALPHA form and completed the form with enrolled women. The control group provided usual care. After the women delivered, both groups of providers identified concerns related to the 15 risk factors on the ALPHA form for each patient and rated the level of concern. The primary outcome was the number of psychosocial concerns identified. Results were controlled for clustering.
Results: There were 21 (44%) providers randomly assigned to the ALPHA group and 27 (56%) to the control group. A total of 227 patients participated: 98 (43%) in the ALPHA group and 129 (57%) in the control group. ALPHA group providers were more likely than control group providers to identify psychosocial concerns (odds ratio [OR] 1.8, 95% confidence interval [CI] 1.13.0; p = 0.02) and to rate the level of concern as "high" (OR 4.8, 95% CI 1.120.2; p = 0.03). ALPHA group providers were also more likely to detect concerns related to family violence (OR 4.8, 95% CI 1.912.3; p = 0.001).
Interpretation: Using the ALPHA form helped health care providers detect more psychosocial risk factors for poor postpartum outcomes, especially those related to family violence. It is a useful prenatal tool, identifying women who would benefit from additional support and interventions.
Clinicians have indicated that a practical tool to help them systematically collect and record prenatal psychosocial information would be helpful.6Although specific and often well-validated tools are available to predict or detect child abuse, woman abuse or depression,7,8,9,10 clinicians are unlikely to use them because of time constraints.1 Other forms aid in collecting more comprehensive antenatal psychosocial data,11,12,13,14 but they are not evidence-based, and were developed to predict obstetric or newborn rather than psychosocial outcomes.
In contrast, the Antenatal Psychosocial Health Assessment (ALPHA) form (Appendix 1) was designed to identify antenatal psychosocial risk factors for poor postnatal psychosocial outcomes. It incorporates 15 risk factors found through critical literature review5 to be associated with woman abuse, child abuse, postpartum depression and couple dysfunction.15 These risk factors are grouped intuitively by topic, with suggested questions, into 4 categories: family factors, maternal factors, substance use and family violence. The ALPHA form has been field-tested by obstetricians, family physicians, midwives and nurses,15,16 who have found using it to be feasible and useful.15 Pregnant women appreciate and feel comfortable with the psychosocial enquiry.15 The ALPHA form was developed as a screening tool to help providers systematically identify areas of psychosocial concern. Once feasibility was established,15 the next step was to determine whether using it in regular practice would increase the number of concerns identified.
We sought to determine whether health care providers using the ALPHA form detected more antenatal psychosocial concerns in their pregnant patients than clinicians practising usual prenatal care. A secondary objective was to determine women's and providers' satisfaction with the ALPHA form.
| Methods |
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To obtain a balanced sample, each participating provider was paired to the greatest extent possible with another provider by practice location, type of provider, sex and age. One member of each pair was randomly assigned to the ALPHA or control group by a biostatistician using computer-generated random numbers.
Providers were asked to enroll 5 consecutive pregnant women who were between 12 and 30 weeks' gestation, able to read and write English and give consent. Women were excluded if they were at high obstetric risk as defined by the Ontario Antenatal Record, such as those with pre-existing diabetes, renal disease, severe hypertension or heart disease.
Interested women received an explanatory brochure and consent form from their provider and a phone call from the study nurse to further explain the study and secure consent. Participants completed a questionnaire on demographic and obstetric details along with several psychosocial instruments (not reported in this paper).8,17,18,19,20,21,22
Intervention group providers attended a 1-hour workshop on the ALPHA form given by 1 or more of the investigators. This interactive session included a review of the evidence for the ALPHA form, specific interview questions, role play, management strategies for partner violence and a summary of community resources for psychosocial problems. Once trained, providers completed the ALPHA form with enrolled women at a prenatal visit of the provider's choice between 20 and 32 weeks' gestation. Risk factors were rated as being of concern if they raised concern in the woman, her family or the provider. Women whose providers were in the control group continued to receive usual care.
All of the providers completed a data collection sheet entitled "Psychosocial concerns" on each of the enrolled women within 1 month after the last woman delivered. They were asked whether they had any concerns about the women, with specific reference to the psychosocial risk factors on the ALPHA form. For each patient, providers identified whether each of the 15 risk factors raised concern and, using their clinical judgment, rated the level of concern as "low," "some" or "high." Providers were advised that concerns rated as "high" would be those they were more likely to act on. For the study, issues were considered to be of concern if the level of concern was rated as "some" or "high." Both groups could refer to their antenatal records to fill out the form, and the intervention group could also refer to their antenatal ALPHA forms. Providers in the intervention group were also given a questionnaire about their experience using the ALPHA form.
At 4 months postpartum, the study nurse contacted all women in the trial to again complete a number of psychosocial instruments.17,18,19,20,21,22,23 Women with providers in the ALPHA group were asked to give feedback about the ALPHA form.
At completion of the study, ALPHA group providers received $50 per woman and control group providers $20 per woman for time spent completing the documentation. Women received $25 to help defray their expenses. The study took place between 1998 and 2002, with staggered participation by each site. Ethics approval was obtained from the University of Toronto Research Ethics Board and the McMaster University Research Ethics Board.
The intracluster correlation coefficient (ICC) in primary care settings for process variables is of the order of 0.05 0.15,24 whereas the ICCs for outcome variables are generally lower than 0.05. We assumed an estimate of the ICC of 0.05 for the outcome variables. From previous work, it was estimated that a significant psychosocial concern would be detected in 5% of women. A 10% increase in detection (from baseline of 5%15%) was considered clinically significant. A sample of 33 providers and 5 women per provider, which translates into 165 women in each group, was chosen to detect a 10% difference between the 2 groups (type I error = 0.05, power = 0.80) after adjustment for clustering of women by provider.25
We limited the analysis to patients who completed the study. However, we also did a sensitivity analysis by intention to treat to account for the 9 providers in the ALPHA group and the 3 providers in the control group who dropped out. Each missing provider was imputed with 5 patients, each with 0 psychosocial concerns.
All of the available data are reported for each question.
2 tests were used to compare proportions, and t tests and nonparametric tests were used to compare means of continuous variables between the 2 groups. For the analysis of the primary study question and the response to ALPHA categories, a 2-sided p value less than 0.05 was taken to indicate a statistically significant finding, but for the analysis of the 15 risk factors, significance was set at 0.01. Hierarchical logistic regression was used to control for clustering of women per provider.
| Results |
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ALPHA group providers identified 115 psychosocial concerns in 98 women, whereas control group providers identified 96 concerns in 129 women (odds ratio [OR] 1.8, 95% confidence interval [CI] 1.13.0; p = 0.02). Of the 115 concerns identified by ALPHA group providers, 23 were rated as high; of 96 concerns identified by control group providers, 7 were rated as high (OR 4.8, 95% CI 1.120.2; p = 0.03). The intracluster correlation based on the fitted model was 0.16.
ALPHA group providers identified at least 1 psychosocial concern in 38 of 98 (39%) women, and control group providers identified at least 1 psychosocial concern in 38 of 129 (29%) women (p = 0.14). Providers indicated a high level of concern about psychosocial issues in 11 (11.2%) women in the ALPHA group and 3 (2.3%) in the control group (p = 0.006). In the ALPHA group, 18 of 21 (86%) providers found at least 1 issue of concern in 1 of their patients compared with 22 of 27 (81%) providers in the control group. For continuous variables, nonparametric tests gave the same conclusions as t tests.
Table 3 shows the number of women in the 2 groups identified as having an antenatal risk factor of concern for each of the 15 items on the "Psychosocial concerns" form.
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When data for the 15 risk factors were grouped into the 4 categories of the ALPHA form (family factors, maternal factors, substance use and family violence), the only category that was significant was family violence (Table 4). Women with providers in the ALPHA group were almost 5 times as likely to be identified with risk factors related to family violence than women with providers in the control group. Adjusting for marital status and education did not change the results.
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Women with providers in the ALPHA group were asked for feedback on their experience with the ALPHA form. The majority of women felt comfortable discussing personal issues (72.7%) and felt that this was part of their provider's job (76.3%).
Only 14 of 21 (67%) of the ALPHA group providers completed the feedback form. Most found the ALPHA form easy to use (64%) and would use it if recommended as standard practice (86%). They all reported finding at least "a little" new psychosocial information using the ALPHA form; 86% reported uncovering "a lot" or a "moderate amount." When asked if they would prefer to use the ALPHA form or have women complete a "self-report" version that our group has developed and evaluated,16 the provider-completed ALPHA was preferred by 28%, a woman self-report by 36% and a choice of either by 36%.
| Interpretation |
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Our study has limitations. Use of the ALPHA form resulted in detection of more psychosocial concerns overall but did not show striking results for each factor. Small numbers limited the strength of the analysis, and provider dropout may have played a factor. A sensitivity analysis, performed to account for provider dropouts, changed the odds ratio for identifying a concern to 1.005 (95% CI 0.61.7, p = 0.98) and for identifying an issue with a high level of concern to 2.8 (95% CI 0.711.7, p = 0.16). Family violence remained significant as a category (OR 2.7, 95% CI 1.16.9, p = 0.04) in this "worst case" scenario. Participating providers were potentially those who were willing to enquire about psychosocial issues and may not reflect most caregivers; this may have diminished the differences in outcomes. The majority of participants were family physicians, and therefore the results are more reflective of their practice style and may not be generalizable to midwives and obstetricians. The greater loss to follow-up of providers and patients in the intervention group may be the result of the increased time involved completing the form. A self-report version of the ALPHA form has been developed in response to providers' concerns about time constraints and has been found to be acceptable to women and providers, and effective in gathering information.16
The ALPHA form has been demonstrated to increase detection of the antenatal psychosocial risk factors that are associated with woman abuse, child abuse, postpartum depression and couple dysfunction. It was well accepted by women and clinicians. Studies are underway to demonstrate the reliability of the ALPHA form, and future studies are needed to show whether using the form leads to improved psychosocial outcomes. We suggest that the ALPHA form is a useful addition to routine prenatal care.
ß See related article page 267
| Appendix 1 |
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| Footnotes |
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Contributors: June Carroll, Anthony Reid, Anne Biringer, Deana Midmer, Donna Stewart, Lynn Wilson, Beverley Chalmers, Patricia Pugh and Freda Seddon contributed substantially to the conception and design of the study. June Carroll, Anthony Reid, Anne Biringer and Patricia Pugh were responsible for the acquisition of data. June Carroll, Anthony Reid, Anne Biringer, Rick Glazier, Deana Midmer, Joanne Permaul and Donna Stewart were responsible for the analysis and interpretation of the data and drafting of the article. All of the authors revised the manuscript critically for important intellectual content and approved the final version.
Acknowledgements: We thank the many family physicians, obstetricians, midwives and women who helped us with this study. We would also especially like to thank the site coordinators, Gerda Halliday, Myrna Henry, Mary Ann Van Os and Debbie Sheehan. We also thank Dr. Rahim Moinnedin and Dr. Preeti Prakash for their help with the analysis. This study was funded by the Ontario Ministry of Health and Long Term Care and the Ontario Women's Health Council.
Competing interests: None declared.
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