Warm Handoffs and Attendance at Initial Integrated Behavioral Health Appointments.

Though integrated behavioral health programs often encourage primary care physicians to refer patients by means of a personal introduction (warm handoff), data are limited regarding the benefits of warm handoffs. We conducted a retrospective study of adult primary care patients referred to behavioral health clinicians in an urban, safety-net hospital to investigate the association between warm handoffs and attendance rates at subsequent initial behavioral health appointments. In multivariable analyses, patients referred via warm handoffs were not more likely to attend initial appointments (OR = 0.96; 95% CI, 0.79-1.18; P = .71). A prospective study is necessary to confirm the role of warm handoffs.

In the Clinic. Substance Use Disorders.

This issue provides a clinical overview of substance use disorders, focusing on epidemiology, prevention, diagnosis, complications, and management. The content of In the Clinic is drawn from the clinical information and education resources of the American College of Physicians (ACP), including MKSAP (Medical Knowledge and Self-Assessment Program). Annals of Internal Medicine editors develop In the Clinic in collaboration with the ACP's Medical Education and Publishing divisions and with the assistance of additional science writers and physician writers.

The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries.

OBJECTIVE: Some researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries. To evaluate this assumption, we reviewed the available data on the quality of consent in both settings. METHODS: We conducted a comprehensive PubMed search, examined bibliographies and literature reviews, and consulted with international experts on informed consent in order to identify studies published from 1966 to 2010 that used quantitative methods, surveyed participants or parents of paediatric participants in actual trials, assessed comprehension and/or voluntariness, and did not involve testing particular consent interventions. Forty-seven studies met these criteria. We compared data about participant comprehension and voluntariness. The paucity of data and variation in study methodology limit comparison and preclude statistical aggregation of the data. RESULTS AND DISCUSSION: This review shows that the assertion that informed consent is worse in developing countries than in developed countries is a simplification of a complex picture. Despite the limitations of comparison, the data suggest that: (1) comprehension of study information varies among participants in both developed and developing countries, and comprehension of randomisation and placebo controlled designs is poorer than comprehension of other aspects of trials in both settings; and (2) participants in developing countries appear to be less likely than those in developed countries to say they can refuse participation in or withdraw from a trial, and are more likely to worry about the consequences of refusal or withdrawal.

Implementation of Integrated Behavioral Health Care in a Large Medical Center: Benefits, Challenges, and Recommendations.

Integrated behavioral health care (IBHC) models in primary care are positioned to address the unmet needs of traditional behavioral health models. However, research support is limited to specific populations, settings, and behavioral health conditions. Empirical evidence is lacking for expansion to larger health systems and diverse behavioral health conditions. This study examines perspectives on IBHC implementation in a large medical center. Semi-structured interviews were conducted with 24 health providers and administrators in two primary care clinics with IBHC. Thematic analysis demonstrated that participants had an overall favorable perception of IBHC, but also perceived implementation challenges, including difficulties with access, underutilization, team dynamics, and financial and interdepartmental issues. The findings suggest that IBHC implementation barriers in existing large health systems risk diminishing potential benefits and successful adoption. These barriers can be combated by incorporating systems change strategies into implementation frameworks, with a focus on barrier prevention and detection and long-term sustainability.

Alcohol use and sex risk behaviors among HIV-infected female sex workers (FSWs) and HIV-infected male clients of FSWs in India.

Unprotected heterosexual transactional sex plays a central role in the spread of HIV in India. Given alcohol's association with risky sex in other populations and alcohol's role in HIV disease progression, we investigated patterns of alcohol use in HIV-infected female sex workers (FSWs) and HIV-infected male clients of FSWs in Mumbai. Analyses identified factors associated with heavy alcohol use and evaluated the relationship between alcohol use and risky sex. We surveyed 211 female and 205 male individuals; 80/211 FSWs (38%) and 127/205 male clients (62%) drank alcohol in the last 30 days. Among females, 32 and 11% drank heavily and were alcohol-dependent, respectively; among males the respective proportions were 44 and 29%. Men's heavy alcohol use was significantly associated with inconsistent condom use over the last year (AOR 2.40, 95% CI 1.21-4.77, P = 0.01); a comparable association was not seen in women. These findings suggest a need to address alcohol use both to avoid the medical complications of its heavy use in this population and to mitigate inconsistent condom use, the latter issue possibly requiring gender specific approaches. Such efforts to reduce drinking will be an important dimension to secondary HIV prevention in India.

Addressing Unhealthy Substance Use in Primary Care.

Unhealthy substance use is common in primary care populations and is a major contributor to morbidity and mortality. Two key strategies to address unhealthy substance use in primary care are the process of screening, brief intervention, and referral to treatment (SBIRT), and integration of treatment for substance use disorders into primary care. Implementation of SBIRT requires buy-in from practice leaders, careful planning, and staff and primary care provider training. Primary care-based treatment of opioid and alcohol use disorders can be effective; more data are needed to better understand the benefits of these models and identify means of treating other substance use disorders in primary care.

Improving Provider Experience and Increasing Patient Access Through Nurse Practitioner-Physician Primary Care Teams.

Team-based care may address burnout in primary care; few studies have examined the impact of nurse practitioner-physician (NP-MD) teams on provider burnout. This article describes a model of NP-MD care teams in an urban safety-net primary care practice. Average time to third next available appointment with a team provider (either NP or MD) decreased by nearly 20 days after implementation of the model. In total, 79% of MDs reported that the model was very or extremely helpful in reducing the burden of work between visits and 100% of NPs reported that they were very or extremely satisfied with their current job.

Post-trial access to tested interventions: the views of IRB/REC chair, investigators, and research participants in a multinational HIV/AIDS study.

Controversy exists regarding an ethical requirement to make products proven effective in research available after the trial. Little is known about the views of several stakeholders. Phone or self-administered questionnaires were completed by 65 IRB/REC chairs, 117 investigators, and 500 research participants in a multinational HIV trial to assess their views about posttrial access to interventions proven effective in the study. A total of 83% of research participants, 29% of IRB/REC chairs, and 42% of researchers (p = 0.046) thought IL-2 should be guaranteed for every HIV-infected person in the world if proven effective. Most European and Latin American research participants thought IL-2 should be provided free, while North American, Australian, and Thai participants commonly said at a price the average person could afford (p < 0.001). Most IRB/REC chairs and researchers thought the CIOMS "reasonable availability" requirement applied to people in the country where the study was conducted and meant a drug should be available at a price the average person could afford and that host country governments had primary responsibility for making it available. Most research participants believe an HIV drug proven effective in research should be made available to everyone in the world who needs it. IRB/REC chairs and researchers were less expansive both in who and how they thought a drug should be guaranteed.

Postpartum changes in methadone maintenance dose.

The optimal approach to postpartum dosing among women treated with methadone maintenance is unclear. We examined doses among 101 methadone-maintained pregnant women 2, 6 and 12 weeks postpartum, and compared the incidence of having doses held for oversedation during pregnancy and postpartum. The average dose at delivery was 83.3mg, and the mean change from delivery to 12 weeks postpartum was -3.7 mg (95% CI -6.3, -1.1). The incidence of oversedation events per 10,000 days was 2.8 among pregnant women and 5.6 for postpartum women (incidence rate ratio [IRR] 2.04, 95% CI 0.66, 6.28). After adjusting for benzodiazepine prescriptions, the IRR of an oversedation event among postpartum women compared to pregnant women was 1.74 (95% CI 0.56, 5.30). In conclusion, postpartum dose changes were small in a methadone clinic using clinical assessments to determine dose. Although the incidence of oversedation events remained low postpartum, the clinically important but not statistically significant increase in events among postpartum women and those prescribed benzodiazepines requires further research. While there are not yet adequate data to support pre-specified postpartum dose reductions, the findings suggest that more frequent clinical assessments continuing as late as 12 weeks postpartum may be warranted.

Quality of parental consent in a Ugandan malaria study.

OBJECTIVES: We surveyed Ugandan parents who enrolled their children in a randomized pediatric malaria treatment trial to evaluate the parents' levels of understanding about the treatment trial and the quality of the parents' consents to allow their children to participate in the study. METHODS: We conducted 347 interviews immediately following enrollment at 4 Ugandan sites. RESULTS: A majority (78%) of the parents, most of whom where mothers (86%) had at most a primary school education. Of the participating mothers, a substantial percentage reported that they remembered being told about the study's purpose (77%), the required number of visits (88%), the risks involved (61%), treatment allocation (84%), and their ability to discontinue their children's participation (64%). In addition, most reported knowing the trial's purpose (80%) and the required number of visits (78%); however, only 18% could name possible side effects from the drugs being administered, and only 19% knew that children would not all be administered identical treatments. Ninety-four percent reported that they made the enrollment decision themselves, but 58% said they felt pressure to participate because of their child's illness, and 15% said they felt some type of pressure to participate from others; 41% reported knowing that they did not have to participate. CONCLUSIONS: The consent Ugandan parents provided to allow their children to participate in the malaria study was of mixed quality. Parents understood many of the study details, but they were not very aware of the risks involved or of randomization. Many parents felt that they could not have refused to participate because their child was sick and they either did not know or did not believe that their child would receive treatment outside of the study. Our results indicate that further debate is needed about informed consent in treatment studies of emergent illnesses in children.

Enrolling the uninsured in clinical trials: an ethical perspective.

Research participation by individuals who lack health insurance raises significant but seldom-discussed ethical issues for clinical investigators. Of particular concern are the possibility that their lack of options for getting care at the time of enrollment makes the uninsured susceptible to undue inducement to join trials and the possibility that their inability to access research products after trials leads to their exploitation. In tension with these concerns, however, is the right of the uninsured to fair consideration for research participation. We discuss these competing issues and make recommendations for how investigators can both protect uninsured research participants and provide the uninsured with fair access to research in their recruitment and enrollment strategies.