Browsing by Author "Gilbert, Amy Lewis"
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Item Adolescent Self-Consent for Biomedical HIV Prevention Research: Implications for Institutional Review Board Approval and Implementation(Elsevier, 2015-07) Gilbert, Amy Lewis; Knopf, Amelia S.; Fortenberry, J. Dennis; Hosek, Sybil G.; Kapogiannis, Bill G.; Zimet, Gregory D.; IU School of NursingPurpose The Adolescent Medicine Trials Network Protocol 113 (ATN113) is an open-label, multisite demonstration project and Phase II safety study of human immunodeficiency virus (HIV) preexposure prophylaxis with 15- to 17-year-old young men who have sex with men that requires adolescent consent for participation. The purpose of this study was to examine factors related to the process by which Institutional Review Boards (IRBs) and researchers made decisions regarding whether to approve and implement ATN113 so as to inform future biomedical HIV prevention research with high-risk adolescent populations. Methods Participants included 17 researchers at 13 sites in 12 states considering ATN113 implementation. Qualitative descriptive methods were used. Data sources included interviews and documents generated during the initiation process. Results A common process for initiating ATN113 emerged, and informants described how they identified and addressed practical, ethical, and legal challenges that arose. Informants described the process as responding to the protocol, preparing for IRB submission, abstaining from or proceeding with submission, responding to IRB concerns, and reacting to the outcomes. A complex array of factors impacting approval and implementation were identified, and ATN113 was ultimately implemented in seven of 13 sites. Informants also reflected on lessons learned that may help inform future biomedical HIV prevention research with high-risk adolescent populations. Conclusions The results illustrate factors for consideration in determining whether to implement such trials, demonstrate that such protocols have the potential to be approved, and highlight a need for clearer standards regarding biomedical HIV prevention research with high-risk adolescent populations.Item Altered standards of care for health care providers in the pandemic influenza(Indiana University, 2009) Kinney, Eleanor D.; McCabe, Heather A.; Gilbert, Amy Lewis; Shisler, Janna JoPandemic influenza will pose tremendous challenges to health care providers, state public health authorities, and the public. All will have to conduct business under the most adverse of circumstances. It will be difficult for providers to meet the customary legal standards of care imposed by state and federal regulatory authorities, as well as the common law tort system. This white paper will explore the legal issues associated with altered standards of care in pandemic influenza.Item Caregiver Comfort in Adolescents Independently Completing Screening Tablet-Based Questionnaires at Primary Care Visits(Elsevier, 2019-09-12) Ferrin, Stephanie N.; Grout, Randall W.; Gilbert, Amy Lewis; Wilkinson, Tracey A.; Cheng, Erika R.; Downs, Stephen M.; Aalsma, Matthew C.; Pediatrics, School of MedicineObjectives The objective of this study was to assess caregiver comfort regarding adolescent completion of computerized health screening questionnaires created for adolescents. Design We conducted a mixed method, cross-sectional survey of caregivers of adolescent patients (n=104) ages 12–18 years that had a medical visit between June and August of 2017. Topics assessed included who completed the questionnaire, caregiver comfort and concern regarding questionnaire data, and caregiver reasons for involvement in completing the questionnaire. A one-way ANOVA was used to compare age of the adolescent and caregiver involvement in the questionnaire. Results The majority of adolescents (64%) reported independent completion of the questionnaire. Thirteen percent of caregivers completed the questionnaire with no involvement of the adolescent and 23% reported that caregivers and adolescents completed the questionnaire in tandem. The majority of caregivers (84%) were comfortable with adolescents completing the questionnaire. A variety of reasons were identified for caregivers completing the questionnaire (time constraints, 22%; adolescent requested caregiver help, 19%; caregiver desired to answer questions, 14%; caregiver did not realize that the questionnaire was intended for the adolescent, 11%; caregiver believed that the adolescent was too young to respond alone, 11%. Caregiver comfort with adolescent completing the questionnaire increase with age. Conclusion We found the reason most caregivers gave for completing the questionnaires were related to clinic processes (e.g. time constraints) Caregivers were more likely to complete the questionnaire with younger adolescents. Thus, pediatricians should consider how to best prepare families for initial questionnaires in primary care.Item Characteristics Associated with Confidential Consultation for Adolescents in Primary Care(Elsevier, 2018-08) Gilbert, Amy Lewis; McCord, Allison L.; Ouyang, Fangqian; Etter, Dillon J.; Williams, Rebekah L.; Hall, James A.; Tu, Wanzhu; Downs, Stephen M.; Aalsma, Matthew C.; Pediatrics, School of MedicineOBJECTIVE: To examine how provider report of confidential consultation in the electronic health record is associated with adolescent characteristics, health risk factors, and provider training. STUDY DESIGN: This prospective cohort study was conducted as part of a larger study implementing computerized clinical decision support in 2 urban primary care clinics. Adolescents used tablets to complete screening questions for specified risk factors in the waiting room. Adolescent-reported risk factors included sexual activity, substance use, and depressive symptoms. Providers were prompted on encounter forms to address identified risk factors and indicate whether confidential consultation was provided. Provider types included adolescent medicine board certified pediatrics and general pediatrics. Differences in proportions of adolescents reporting risk factors by provider type were assessed using χ2 tests. Associations between adolescent characteristics, risk factors, and provider-reported confidential consultation were examined using logistic regression analyses. RESULTS: The sample included 1233 English and Spanish-speaking adolescents 12-20 years of age (52% female; 60% black; 50% early adolescent). Patients seen by adolescent medicine board certified providers reported sexual activity, depressive symptoms, and substance use significantly more often than those seen by general pediatric providers. Among patients seen by board certified adolescent medicine providers, confidential consultation was provided to 90%. For those seen by general pediatric providers, confidential consultation was provided to 53%. Results of multiple logistic regression demonstrated that female sex, later adolescence, and clinic location were significantly associated with confidential consultation. CONCLUSIONS: Provider training is needed to reinforce the importance of confidential consultation for all adolescents.Item Child exposure to parental violence and psychological distress associated with delayed milestones(American Academy of Pediatrics (AAP), 2013-12) Gilbert, Amy Lewis; Bauer, Nerissa S.; Carroll, Aaron E.; Downs, Stephen M.; Department of Pediatrics, IU School of MedicineOBJECTIVE: To examine the association between parental report of intimate partner violence (IPV) and parental psychological distress (PPD) with child attainment of developmental milestones. METHODS: By using data collected from a large cohort of primary care patients, this cross-sectional study examined the relationship between parental report of IPV and/or PPD and the attainment of developmental milestones within the first 72 months of a child's life. Multivariate logistic regression analyses were used to adjust for parental report of child abuse concern and sociodemographic characteristics. RESULTS: Our study population included 16 595 subjects. Children of parents reporting both IPV and PPD (n = 88; 0.5%) were more likely to fail at least 1 milestone across the following developmental domains: language (adjusted odds ratio [aOR] 2.1; 95% confidence interval [CI] 1.3-3.3), personal-social (aOR 1.9; 95% CI 1.2-2.9), and gross motor (aOR 3.0; 95% CI 1.8-5.0). Significant associations for those reporting IPV-only (n = 331; 2.0%) were found for language (aOR 1.4; 95% CI 1.1-1.9), personal-social (aOR 1.7; 95% CI 1.4-2.2), and fine motor-adaptive (aOR 1.7; 95% CI 1.0-2.7). Significant associations for those reporting PPD-only (n = 1920; 11.6%) were found for: language (aOR 1.5; 95% CI 1.3-1.7), personal-social (aOR 1.6; 95% CI 1.5-1.8), gross motor (aOR 1.6; 95% CI 1.4-1.8), and fine-motor adaptive (aOR 1.6; 95% CI 1.3-2.0). CONCLUSIONS: Screening children for IPV and PPD helps identify those at risk for poor developmental outcomes who may benefit from early intervention.Item Making the Legal and Ethical Case for Universal Screening for Postpartum Mood and Anxiety Disorders in Pediatric Primary Care(Elsevier, 2017) Gilbert, Amy Lewis; Balio, Casey; Bauer, Nerissa S.; Pediatrics, School of MedicinePostpartum depression (PPD), part of a larger spectrum of perinatal mood and anxiety disorders, affects up to 15% of women following the birth of an infant. Fathers may also be affected. PPD not only affects caregivers, but also impacts infants through mechanisms such as inadequate caregiver–infant interactions and non-adherence to safety practices. The negative impact on infants may extend across the life course through adulthood. This article seeks to move the needle toward universal screening for PPD using validated tools in pediatric primary care settings for new caregivers by making the legal and ethical case for this course of action in a manner that is both compelling and accessible for clinicians. Toward this end, we summarize current literature as it applies to provider responsibilities, liabilities and perspectives; and caregiver autonomy, confidentiality, and privacy. We then assess utility by balancing the benefits and burdens of this approach to practices, providers, and caregivers; and take the analysis one step further by looking across multiple populations to assess distributive justice. We conclude that there is a strong ethical case for universal screening for PPD in pediatric primary care settings using validated tools when informed consent can be obtained and appropriate follow-up services are available and accessible. Clinical considerations, practical resources, and areas ripe for future research are also addressed.Item Medical legal partnership and health informatics impacting child health: Interprofessional innovations(Taylor and Francis, 2015-06) Gilbert, Amy Lewis; Downs, Stephen M.; Department of Pediatrics, IU School of MedicineDramatic differences in health are closely related to degrees of social and economic disadvantage. Poverty-induced hardships such as food insecurity, utility shut-offs, and substandard housing, all have the potential to negatively impact the health of families. In an effort to better address social determinants of health in pediatric primary health care settings using the Medical Legal Partnership (MLP) model of health care delivery, an interprofessional team of investigators came together to design an innovative process for using computerized clinical decision support to identify health-harming legal and social needs, improve the delivery of appropriate physician counseling, and streamline access to legal and social service professionals when non-medical remedies are required. This article describes the interprofessional nature of the MLP model itself, illustrates the work that was done to craft this innovative health informatics approach to implementing MLP, and demonstrates how pediatricians, social workers and attorneys may work together to improve child health outcomes.Item Moral conflict and competing duties in the initiation of a biomedical HIV prevention trial with minor adolescents(Taylor & Francis, 2017-07) Knopf, Amelia S.; Gilbert, Amy Lewis; Zimet, Gregory D.; Kapogiannis, Bill G.; Hosek, Sybil G.; Fortenberry, J. Dennis; Ott, Mary A.; The Adolescent Medicine Trials Network for HIV/AIDS Interventions; School of NursingBACKGROUND: Biomedical HIV prevention research with minors is complicated by the requirement of parental consent, which may disclose sensitive information to parents. We examine the experience of principal investigators (PIs) and study personnel who faced this complex ethical issue in the first biomedical HIV prevention study that allowed minors to self-consent for enrollment. METHODS: We conducted in-depth interviews with PIs and study personnel from 13 medical trial sites in cities across the United States. Data were analyzed using a conventional content analysis. RESULTS: Participants experienced moral conflict as they struggled to fulfill conflicting duties in this trial involving minor adolescents with multiple vulnerabilities. Our participants experienced conflict between the two types of duties-protective and scientific-previously identified by Merritt. Protective duties were owed to the child, the parents, and the institution, and participants expressed tension between the actions that would protect these subgroups and the actions necessary to fulfill their scientific duties. CONCLUSIONS: Moral conflict was resolved in a variety of ways, including reflecting on the protocol's alignment with federal regulations, modifying consent language, considering each individual for enrollment carefully, and accepting institutional review board (IRB) decisions. Potential solutions for future studies are discussed, and include flexible protocol consent procedures and centralized IRB reviews.Item Physician Intervention to Positive Depression Screens Among Adolescents in Primary Care(Elsevier, 2018-02) Aalsma, Matthew C.; Zerr, Ashley M.; Etter, Dillon J.; Ouyang, Fangqian; Gilbert, Amy Lewis; Williams, Rebekah L.; Hall, James A.; Downs, Stephen M.; Pediatrics, School of MedicinePurpose The objective of this study was to determine the effectiveness of computer-based screening and physician feedback to guide adolescent depression management within primary care. Methods We conducted a prospective cohort study within two clinics of the computer-based depression screening and physician feedback algorithm among youth aged 12–20 years between October 2014 and October 2015 in Marion County (Indianapolis), Indiana. Results Our sample included 2,038 youth (51% female; 60% black; mean age = 14.6 years [standard deviation = 2.1]). Over 20% of youth screened positive for depression on the Patient Health Questionnaire-2 and 303 youth (14.8%) screened positive on the Patient Health Questionnaire-9 (PHQ-9). The most common follow-up action by physicians was a referral to mental health services (34.2% mild, 46.8% moderate, and 72.2% severe range). Almost 11% of youth in the moderate range and 22.7% of youth in the severe range were already prescribed a selective serotonin reuptake inhibitor. When predicting mental health service referral, significant predictors in the multivariate analysis included clinic site (40.2% vs. 73.9%; p < .0001) and PHQ-9 score (severe range 77.8% vs. mild range 47.5%; p < .01). Similarly, when predicting initiation of selective serotonin reuptake inhibitors, only clinic site (28.6% vs. 6.9%; p < .01) and PHQ-9 score (severe range 46.7% vs. moderate range 10.6%; p < .001) were significant. Conclusions When a computer-based decision support system algorithm focused on adolescent depression was implemented in two primary care clinics, a majority of physicians utilized screening results to guide clinical care.Item Suicide Screening in Primary Care: Use of an Electronic Screener to Assess Suicidality and Improve Provider Follow-Up for Adolescents(Elsevier, 2018-02) Etter, Dillon J.; McCord, Allison; Ouyang, Fangqian; Gilbert, Amy Lewis; Williams, Rebekah L.; Hall, James A.; Tu, Wanzhu; Downs, Stephen M.; Aalsma, Matthew C.; Pediatrics, School of MedicinePurpose The purpose of this study was to assess the feasibility of using an existing computer decision support system to screen adolescent patients for suicidality and provide follow-up guidance to clinicians in a primary care setting. Predictors of patient endorsement of suicidality and provider documentation of follow-up were examined. Methods A prospective cohort study was conducted to examine the implementation of a CDSS that screened adolescent patients for suicidality and provided follow-up recommendations to providers. The intervention was implemented for patients aged 12–20 years in two primary care clinics in Indianapolis, Indiana. Results The sample included 2,134 adolescent patients (51% female; 60% black; mean age = 14.6 years [standard deviation = 2.1]). Just over 6% of patients screened positive for suicidality. A positive endorsement of suicidality was more common among patients who were female, depressed, and seen by an adolescent−medicine board-certified provider as opposed to general pediatric provider. Providers documented follow-up action for 83% of patients who screened positive for suicidality. Documentation of follow-up action was correlated with clinic site and Hispanic race. The majority of patients who endorsed suicidality (71%) were deemed not actively suicidal after assessment by their provider. Conclusions Incorporating adolescent suicide screening and provider follow-up guidance into an existing computer decision support system in primary care is feasible and well utilized by providers. Female gender and depressive symptoms are consistently associated with suicidality among adolescents, although not all suicidal adolescents are depressed. Universal use of a multi-item suicide screener that assesses recency might more effectively identify suicidal adolescents.