Improving the use of hospice services in nursing homes: a randomized controlled trial

Context  Hospice care may improve the quality of end-of-life care for nursing home residents, but hospice is underutilized by this population, at least in part because physicians are not aware of their patients’ preferences. Objective  To determine whether it is possible to increase hospice utilization and improve the quality of end-of-life care by identifying residents whose goals and preferences are consistent with hospice care. Design, Setting, and Participants  Randomized controlled trial (December 2003-December 2004) of nursing home residents and their surrogate decision makers (N=205) in 3 US nursing homes. Intervention  A structured interview identified residents whose goals for care, treatment preferences, and palliative care needs made them appropriate for hospice care. These residents’ physicians were notified and asked to authorize a hospice informational visit. Main Outcome Measures  The primary outcome measures were (1) hospice enrollment within 30 days of the intervention and (2) families’ ratings of the quality of care for residents who died during the 6-month follow-up period. Results  Of the 205 residents in the study sample, 107 were randomly assigned to receive the intervention, and 98 received usual care. Intervention residents were more likely than usual care residents to enroll in hospice within 30 days (21/107 [20%] vs 1/98 [1%]; P<.001 [Fisher exact test]) and to enroll in hospice during the follow-up period (27/207 [25%] vs 6/98 [6%]; P<.001). Intervention residents had fewer acute care admissions (mean: 0.28 vs 0.49; P = .04 [Wilcoxon rank sum test]) and spent fewer days in an acute care setting (mean: 1.2 vs 3.0; P = .03 [Wilcoxon rank sum test]). Families of intervention residents rated the resident’s care more highly than did families of usual care residents (mean on a scale of 1-5: 4.1 vs 2.5; P = .04 [Wilcoxon rank sum test]). Conclusion  A simple communication intervention can increase rates of hospice referrals and families’ ratings of end-of-life care and may also decrease utilization of acute care resources.      

Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial

Context  Past studies of the efficacy of hip protectors to prevent hip fracture in nursing home residents have had conflicting results, possibly due to potential biases from clustered randomization designs and modest adherence to intervention. Objective  To determine whether an energy-absorbing and energy-dispersing hip protector would reduce the risk of hip fracture when worn by nursing home residents. Design, Setting, and Participants  Multicenter, randomized controlled clinical trial in which 37 nursing homes were randomly assigned to having residents wear a 1-sided hip protector on the left or right hip. Participants were 1042 nursing home residents (mean [SD] aged 85 [7] years; 79% women) who consented and adhered to the hip protector use during a 2-week run-in period and were enrolled. Participating facilities were in greater Boston, Massachusetts, St Louis, Missouri, and Baltimore, Maryland from October 2002 to October 2004. Mean duration of participation for nursing home residents was 7.8 months. None were withdrawn because of adverse effects. Intervention(s)  Undergarments with a 1-sided hip protector made of a 0.32-cm outer layer of polyethylene (2.7 kg/m³) backed by a hard high-density polyethylene shield (0.95 cm) that was backed by 0.9 kg/m³ of 1.27-kg ethylene vinyl acetate foam. Each facility was visited 3 times per week to assess adherence and provide staff support. Main Outcome Measure  Adjudicated hip fracture occurrences on padded vs unpadded hips. Results  After a 20-month follow-up (676 person-years of observation), the study was terminated due to a lack of efficacy. The incidence rate of hip fracture on protected vs unprotected hips did not differ (3.1%; 95% confidence interval [CI], 1.8%-4.4% vs 2.5%; 95% CI, 1.3%-3.7%; P = .70). For the 334 nursing home residents with greater than 80% adherence to hip protector use, the incidence rate of hip fracture on protected vs unprotected hips did not differ (5.3%; 95% CI, 2.6%-8.8% vs 3.5%; 95% CI, 1.3%-5.7%; P = .42). Overall adherence was 73.8%. Conclusions  In this clinical trial of an energy-absorbing/shunting hip protector conducted in US nursing homes, we were unable to detect a protective effect on the risk of hip fracture, despite good adherence to protocol. These results add to the increasing body of evidence that hip protectors, as currently designed, are not effective for preventing hip fracture among nursing home residents. Trial Registration  clinicaltrials.gov Identifier: NCT00058864      

Effect of a clinical pathway to reduce hospitalizations in nursing home residents with pneumonia: a randomized controlled trial

Context  Nursing home residents with pneumonia are frequently hospitalized. Such transfers may be associated with multiple hazards of hospitalization as well as economic costs. Objective  To assess whether using a clinical pathway for on-site treatment of pneumonia and other lower respiratory tract infections in nursing homes could reduce hospital admissions, related complications, and costs. Design, Setting, and Participants  A cluster randomized controlled trial of 680 residents aged 65 years or older in 22 nursing homes in Hamilton, Ontario, Canada. Nursing homes began enrollment between January 2, 2001, and April 18, 2002, with the last resident follow-up occurring July 4, 2005. Residents were eligible if they met a standardized definition of lower respiratory tract infection. Interventions  Treatment in nursing homes according to a clinical pathway, which included use of oral antimicrobials, portable chest radiographs, oxygen saturation monitoring, rehydration, and close monitoring by a research nurse, or usual care. Main Outcome Measures  Hospital admissions, length of hospital stay, mortality, health-related quality of life, functional status, and cost. Results  Thirty-four (10%) of 327 residents in the clinical pathway group were hospitalized compared with 76 (22%) of 353 residents in the usual care group. Adjusting for clustering of residents in nursing homes, the weighted mean reduction in hospitalizations was 12% (95% confidence interval [CI], 5%-18%; P = .001). The mean number of hospital days per resident was 0.79 in the clinical pathway group vs 1.74 in the usual care group, with a weighted mean difference of 0.95 days per resident (95% CI, 0.34-1.55 days; P = .004). The mortality rate was 8% (24 deaths) in the clinical pathway group vs 9% (32 deaths) in the usual care group, with a weighted mean difference of 2.9% (95% CI, –2.0% to 7.9%; P = .23). There were no significant differences between the groups in health-related quality of life or functional status. The clinical pathway resulted in an overall cost savings of US $1016 per resident (95% CI, $207-$1824) treated. Conclusion  Treating residents of nursing homes with pneumonia and other lower respiratory tract infections with a clinical pathway can result in comparable clinical outcomes, while reducing hospitalizations and health care costs. Trial Registration  clinicaltrials.gov Identifier: NCT00157612      

Clinical and organizational factors associated with feeding tube use among nursing home residents with advanced cognitive impairment

Context  Empiric data and expert opinion suggest that use of feeding tubes is not beneficial for older persons with advanced dementia. Previous research has shown a 10-fold variation in this practice across the United States. Objective  To identify the facility and resident characteristics associated with feeding tube use among US nursing homes residents with severe cognitive impairment. Design, Setting, and Participants  Cross-sectional study of all residents with advanced cognitive impairment who had Minimum Data Set assessments within 60 days of April 1, 1999, (N = 186 835) and who resided in Medicare- or Medicaid-certified US nursing homes. Main Outcomes Measures  Facility and resident characteristics described in the 1999 On-line Survey Certification of Automated Records and the 1999 Minimum Data Set. Multivariate analysis using generalized estimating equations determined the facility and resident factors independently associated with feeding tube use. Results  Thirty-four percent of residents with advanced cognitive impairment had feeding tubes (N = 63 101). Resident characteristics associated with a greater likelihood of feeding tube use included younger age, nonwhite race, male sex, divorced marital status, lack of advance directives, a recent decline in functional status, and no diagnosis of Alzheimer disease. Controlling for these patient factors, residents living in facilities that were for profit (adjusted odds ratio [OR], 1.09; 95% confidence interval [CI], 1.06-1.12); located in an urban area (OR, 1.14; 95% CI, 1.11-1.16); having more than 100 beds (OR, 1.04; 95% CI, 1.01-1.07); and lacking a special dementia care unit (OR, 1.11; 95% CI, 1.07-1.15) had a higher likelihood of having a feeding tube. Additionally, feeding tube use was more likely among residents living in facilities that had a smaller proportion of residents with do-not-resuscitate orders, had a higher prevalence of nonwhite residents, and lacked a nurse practitioner or physician assistant on staff. Conclusions  More than one third of severely cognitively impaired residents in US nursing homes have feeding tubes. Feeding tube use is independently associated with both the residents' clinical characteristics and the nursing homes' fiscal, organizational, and demographic features.      

Effectiveness of a quality improvement intervention for adolescent depression in primary care clinics: a randomized controlled trial

Context  Depression is a common condition associated with significant morbidity in adolescents. Few depressed adolescents receive effective treatment for depression in primary care settings. Objective  To evaluate the effectiveness of a quality improvement intervention aimed at increasing access to evidence-based treatments for depression (particularly cognitive-behavior therapy and antidepressant medication), relative to usual care, among adolescents in primary care practices. Design, Setting, and Participants  Randomized controlled trial conducted between 1999 and 2003 enrolling 418 primary care patients with current depressive symptoms, aged 13 through 21 years, from 5 health care organizations purposively selected to include managed care, public sector, and academic medical center clinics in the United States. Intervention  Usual care (n = 207) or 6-month quality improvement intervention (n = 211) including expert leader teams at each site, care managers who supported primary care clinicians in evaluating and managing patients’ depression, training for care managers in manualized cognitive-behavior therapy for depression, and patient and clinician choice regarding treatment modality. Participating clinicians also received education regarding depression evaluation, management, and pharmacological and psychosocial treatment. Main Outcome Measures  Depressive symptoms assessed by Center for Epidemiological Studies-Depression Scale (CES-D) score. Secondary outcomes were mental health–related quality of life assessed by Mental Health Summary Score (MCS-12) and satisfaction with mental health care assessed using a 5-point scale. Results  Six months after baseline assessments, intervention patients, compared with usual care patients, reported significantly fewer depressive symptoms (mean [SD] CES-D scores, 19.0 [11.9] vs 21.4 [13.1]; P = .02), higher mental health–related quality of life (mean [SD] MCS-12 scores, 44.6 [11.3] vs 42.8 [12.9]; P = .03), and greater satisfaction with mental health care (mean [SD] scores, 3.8 [0.9] vs 3.5 [1.0]; P = .004). Intervention patients also reported significantly higher rates of mental health care (32.1% vs 17.2%, P<.001) and psychotherapy or counseling (32.0% vs 21.2%, P = .007). Conclusions  A 6-month quality improvement intervention aimed at improving access to evidence-based depression treatments through primary care was significantly more effective than usual care for depressed adolescents from diverse primary care practices. The greater uptake of counseling vs medication under the intervention reinforces the importance of practice interventions that include resources to enable evidence-based psychotherapy for depressed adolescents.      

Influence of patient literacy on the effectiveness of a primary care-based diabetes disease management program

Context  Low literacy is an important barrier for patients with diabetes, but interventions to address low literacy have not been well examined. Objective  To examine the role of literacy on the effectiveness of a comprehensive disease management program for patients with diabetes. Design, Setting, and Participants  Analysis of the influence of literacy on glycemic control and systolic blood pressure using data from a randomized controlled trial (conducted from February 2001 through April 2003) of a comprehensive diabetes management program. Participants were 217 patients aged 18 years or older with type 2 diabetes and poor glycemic control (glycosylated hemoglobin [HbA_1c] levels 8.0%) and presenting to a US academic general internal medicine practice. Interventions  All communication to patients was individualized and delivered to enhance comprehension among patients with low literacy. Intervention patients received intensive disease management from a multidisciplinary team. Control patients received an initial management session and continued with usual care. Main Outcome Measures  Achievement of goal HbA_1c levels and systolic blood pressure at 12-month follow-up for control and intervention patients stratified by literacy status. Results  Complete 12-month data were available for 193 patients (89%). Among patients with low literacy, intervention patients were more likely than control patients to achieve goal HbA_1c levels (7.0%) (42% vs 15%, respectively; adjusted odds ratio [OR], 4.6; 95% confidence interval [CI], 1.3 to 17.2; P = .02). Patients with higher literacy had similar odds of achieving goal HbA_1c levels regardless of intervention status (24% vs 23%; adjusted OR, 1.0; 95% CI, 0.4 to 2.5; P = .98). Improvements in systolic blood pressure were similar by literacy status. Conclusions  Literacy may be an important factor for predicting who will benefit from an intervention for diabetes management. A diabetes disease management program that addresses literacy may be particularly beneficial for patients with low literacy, and increasing access to such a program could help reduce health disparities.      

Barriers to health care research for children and youth with psychosocial problems

Context  The 1999 surgeon general's report on mental health concluded that insufficient attention to mental health disorders is being paid in children's primary medical care services. This lack of attention has occurred despite considerable attention to this issue in the planning documents of many federal agencies. Objective  To assess the extent to which federal agencies' portfolios of funded research grants were consistent with the directives for primary care–based mental health services for children and adolescents featured in their planning documents. Data Source  A cross-sectional review of the 66 749 abstracts listed in the April 2001 Computer Retrieval of Information on Scientific Projects (CRISP) database of currently funded research grants supported by the US Department of Health and Human Services. Abstracts were rated by whether they targeted primary care, examined behavioral or emotional issues, and examined or modified a facet of primary care. Data Synthesis  Of the 45 022 research abstracts in the CRISP database, 2720 (6%) contained the words children, adolescents, or youth. Sixty-three abstracts contained work on children, adolescents, or youth in primary care (0.14% of the portfolio). Of these 63 abstracts, only 21 (0.05% of the portfolio) addressed behavioral or emotional issues. Of the 21 projects, only 11 examined aspects of the primary care process. When the distribution of child and adult studies on the treatment of depression within primary care settings was examined, it was found that adults received 15 times the research attention compared with children. Conclusion  Even though the importance of primary care as a system for identifying and treating behavioral and emotional problems in children has been recognized for more than 20 years, little attention is being paid to this topic in the research portfolios of the National Institutes of Health and other federal agencies that support research.      

Estimating prognosis for nursing home residents with advanced dementia

Context  Survival varies for patients with advanced dementia, and accurate prognostic tools have not been developed. A small proportion of patients admitted to hospice have dementia, in part because of the difficulty in predicting survival. Objectives  To identify factors associated with 6-month mortality in newly admitted nursing home residents with advanced dementia and to create a practical risk score to predict 6-month mortality in this population. Design, Setting, and Participants  This was a retrospective cohort study of data from the Minimum Data Set (MDS). All Medicare or Medicaid licensed nursing homes in New York and Michigan were included. Participants had advanced dementia and were admitted to New York nursing homes between June 1, 1994, and December 30, 1998 (derivation cohort, n = 6799), and to Michigan nursing homes from October 1, 1998, through July 30, 2000 (validation cohort, n = 4631). Main Outcome Measures  MDS factors associated with 6-month mortality were determined in the derivation group, and the resulting mortality risk score was evaluated in the validation cohort. Risk score performance was compared with the cut point of 7c on the Functional Assessment Staging (FAST) scale. Results  Among residents with advanced dementia, 28.3% (n = 1922) died within 6 months of nursing home admission in the derivation cohort; 35.1% (n = 1626) died in the validation cohort. The 6-month mortality rate increased across risk scores (possible range, 0-19): 0 points, 8.9% mortality; 1 to 2, 10.8%; 3 to 5, 23.2%; 6 to 8, 40.4%; 9 to 11, 57.0%; and at least 12, 70.0% in the validation cohort. The area under the receiver operating characteristic (AUROC) curve for predicting 6-month mortality was 0.74 and 0.70 in the derivation and validation cohorts, respectively. Our risk score demonstrated better discrimination to predict 6-month mortality (AUROC, 0.64 for a cutoff of =" BORDER="0">6 points vs 0.51 for FAST stage 7c). Conclusion  A risk score based on 12 variables from the MDS estimates 6-month mortality for nursing home residents with advanced dementia with greater accuracy than existing prognostic guidelines.      

Differences in Preferences for Neonatal Outcomes Among Health Care Professionals, Parents, and Adolescents

Context  In neonatal intensive care, parents make important clinical management decisions in conjunction with health care professionals. Yet little information is available on whether preferences of health care professionals and parents for the resulting health outcomes differ. Objective  To measure and compare preferences for selected health states from the perspectives of health care professionals (ie, neonatologists and neonatal nurses), parents of extremely low-birth-weight (ELBW) or normal birth-weight infants, and adolescents who were either ELBW or normal birth-weight infants. Design  Cross-sectional cohort study. Setting and Participants  A total of 742 participants were recruited and interviewed between 1993 and 1995, including 100 neonatologists from hospitals throughout Canada; 103 neonatal nurses from 3 regional neonatal intensive care units; 264 adolescents (aged 12-16 years), including 140 who were ELBW infants and 124 sociodemographically matched term controls; and 275 parents of the recruited adolescents. Main Outcome Measure  Preferences (utilities) for 4 to 5 hypothetical health states of children were obtained by direct interviews using the standard gamble method. Results  Overall, neonatologists and nurses had similar preferences for the 5 health states, and a similar proportion rated some health states as worse than death (59% of neonatologists and 68% of nurses;P=.20). Health care professionals rated the health states lower than did parents of ELBW and term infants (P<.001). Overall, 64% of health care professionals and 45% of parents rated 1 or more health states to be worse than death (P<.001). Differences in mean utility scores between health care professionals and parents and adolescent respondents were most pronounced for the 2 most severely disabled health states (P<.001). Conclusions  When asked to rate the health-related quality of life for the hypothetical conditions of children, health care professionals tend to provide lower utility scores than do adolescents and their parents. These findings have implications for decision making in the neonatal intensive care unit.      

Geriatric care management for low-income seniors: a randomized controlled trial

Steven R. Counsell, MD; Christopher M. Callahan, MD; Daniel O. Clark, PhD; Wanzhu Tu, PhD; Amna B. Buttar, MD, MS; Timothy E. Stump, MS; Gretchen D. Ricketts, BSW

JAMA. 2007;298(22):2623-2633.

Context  Low-income seniors frequently have multiple chronic medical conditions for which they often fail to receive the recommended standard of care.

Objectives  To test the effectiveness of a geriatric care management model on improving the quality of care for low-income seniors in primary care.

Design, Setting, and Patients  Controlled clinical trial of 951 adults 65 years or older with an annual income less than 200% of the federal poverty level, whose primary care physicians were randomized from January 2002 through August 2004 to participate in the intervention (474 patients) or usual care (477 patients) in community-based health centers.

Intervention  Patients received 2 years of home-based care management by a nurse practitioner and social worker who collaborated with the primary care physician and a geriatrics interdisciplinary team and were guided by 12 care protocols for common geriatric conditions.

Main Outcome Measures  The Medical Outcomes 36-Item Short-Form (SF-36) scales and summary measures; instrumental and basic activities of daily living (ADLs); and emergency department (ED) visits not resulting in hospitalization and hospitalizations.

Results  Intention-to-treat analysis revealed significant improvements for intervention patients compared with usual care at 24 months in 4 of 8 SF-36 scales: general health (0.2 vs –2.3, P = .045), vitality (2.6 vs –2.6, P < .001), social functioning (3.0 vs –2.3, P = .008), and mental health (3.6 vs –0.3, P = .001); and in the Mental Component Summary (2.1 vs –0.3, P < .001). No group differences were found for ADLs or death. The cumulative 2-year ED visit rate per 1000 was lower in the intervention group (1445 [n = 474] vs 1748 [n = 477], P = .03) but hospital admission rates per 1000 were not significantly different between groups (700 [n = 474] vs 740 [n = 477], P = .66). In a predefined group at high risk of hospitalization (comprising 112 intervention and 114 usual-care patients), ED visit and hospital admission rates were lower for intervention patients in the second year (848 [n = 106] vs 1314 [n = 105]; P = .03 and 396 [n = 106] vs 705 [n = 105]; P = .03, respectively).

Conclusions  Integrated and home-based geriatric care management resulted in improved quality of care and reduced acute care utilization among a high-risk group. Improvements in health-related quality of life were mixed and physical function outcomes did not differ between groups. Future studies are needed to determine whether more specific targeting will improve the program's effectiveness and whether reductions in acute care utilization will offset program costs.

Trial Registration  clinicaltrials.gov Identifier: NCT00182962

     

Family perspectives on end-of-life care at the last place of care

Context  Over the past century, nursing homes and hospitals increasingly have become the site of death, yet no national studies have examined the adequacy or quality of end-of-life care in institutional settings compared with deaths at home. Objective  To evaluate the US dying experience at home and in institutional settings. Design, Setting, and Participants  Mortality follow-back survey of family members or other knowledgeable informants representing 1578 decedents, with a 2-stage probability sample used to estimate end-of-life care outcomes for 1.97 million deaths from chronic illness in the United States in 2000. Informants were asked via telephone about the patient's experience at the last place of care at which the patient spent more than 48 hours. Main Outcome Measures  Patient- and family-centered end-of-life care outcomes, including whether health care workers (1) provided the desired physical comfort and emotional support to the dying person, (2) supported shared decision making, (3) treated the dying person with respect, (4) attended to the emotional needs of the family, and (5) provided coordinated care. Results  For 1059 of 1578 decedents (67.1%), the last place of care was an institution. Of 519 (32.9%) patients dying at home represented by this sample, 198 (38.2%) did not receive nursing services; 65 (12.5%) had home nursing services, and 256 (49.3%) had home hospice services. About one quarter of all patients with pain or dyspnea did not receive adequate treatment, and one quarter reported concerns with physician communication. More than one third of respondents cared for by a home health agency, nursing home, or hospital reported insufficient emotional support for the patient and/or 1 or more concerns with family emotional support, compared with about one fifth of those receiving home hospice services. Nursing home residents were less likely than those cared for in a hospital or by home hospice services to always have been treated with respect at the end of life (68.2% vs 79.6% and 96.2%, respectively). Family members of patients receiving hospice services were more satisfied with overall quality of care: 70.7% rated care as "excellent" compared with less than 50% of those dying in an institutional setting or with home health services (P<.001). Conclusions  Many people dying in institutions have unmet needs for symptom amelioration, physician communication, emotional support, and being treated with respect. Family members of decedents who received care at home with hospice services were more likely to report a favorable dying experience.      

Effectiveness of a nurse-based outreach program for identifying and treating psychiatric illness in the elderly

Context  Elderly persons with psychiatric disorders are less likely than younger adults to be diagnosed as having a mental disorder and receive needed mental health treatment. Lack of access to care is 1 possible cause of this disparity. Objective  To determine whether a nurse-based mobile outreach program to seriously mentally ill elderly persons is more effective than usual care in diminishing levels of depression, psychiatric symptoms, and undesirable moves (eg, nursing home placement, eviction, board and care placement). Design  Prospective randomized trial conducted between March 1993 and April 1996 to assess the effectiveness of the Psychogeriatric Assessment and Treatment in City Housing (PATCH) program. Setting  Six urban public housing sites for elderly persons in Baltimore, Md. Participants  A total of 945 (83%) of 1195 residents in the 6 sites underwent screening for psychiatric illness. Among those screened, 342 screened positive and 603 screened negative. All screen-positive subjects aged 60 years and older (n=310) and a 10% random sample of screen-negative subjects aged 60 years and older (n=61) were selected for a structured psychiatric interview. Eleven subjects moved or died; 245 (82%) of those who screened positive and 53 (88%) of those who screened negative were evaluated to determine who had a psychiatric disorder. Data were weighted to estimate the prevalence of psychiatric disorders at the 6 sites. Intervention  Among the 6 sites, residents in 3 buildings were randomized to receive the PATCH model intervention, which included educating building staff to be case finders, performing assessment in residents' apartments, and providing care when indicated; and residents in the remaining 3 buildings were randomized to receive usual care (comparison group). Main Outcome Measures  Number of undesirable moves and scores on the Montgomery-Asberg Depression Rating Scale (MADRS), a measure of depressive symptoms, and the Brief Psychiatric Rating Scale (BPRS), a measure of psychiatric symptoms and behavioral disorder, in intervention vs comparison sites. Results  Based on weighted data, at 26 months of follow-up, psychiatric cases at the intervention sites had significantly lower (F₁=31.18; P<.001) MADRS scores (9.1 vs 15.2) and significantly lower (F₁=17.35; P<.001) BPRS scores (27.4 vs 33.9) than those at the nontreatment comparison sites. There was no significant difference between the groups in undesirable moves (relative risk, 0.97; 95% confidence interval, 0.44-2.17). Conclusions  These results indicate that the PATCH intervention was more effective than usual care in reducing psychiatric symptoms in persons with psychiatric disorders and those with elevated levels of psychiatric symptoms.      

Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial

Context  It is estimated that half of unintended pregnancies could be averted if emergency contraception (EC) were easily accessible and used. Objective  To evaluate the effect of direct access to EC through pharmacies and advance provision on reproductive health outcomes. Design, Setting, and Participants  A randomized, single-blind, controlled trial (July 2001-June 2003) of 2117 women, ages 15 to 24 years, attending 4 California clinics providing family planning services, who were not desiring pregnancy, using long-term hormonal contraception or requesting EC. Intervention  Participants were assigned to 1 of the following groups: (1) pharmacy access to EC; (2) advance provision of 3 packs of levonorgestrel EC; or (3) clinic access (control). Main Outcome Measures  Primary outcomes were use of EC, pregnancies, and sexually transmitted infections (STIs) assessed at 6 months; secondary outcomes were changes in contraceptive and condom use and sexual behavior. Results  Women in the pharmacy access group were no more likely to use EC (24.2%) than controls (21.0%) (P = .25). Women in the advance provision group (37.4%) were almost twice as likely to use EC than controls (21.0%) (P<.001) even though the frequency of unprotected intercourse was similar (39.8% vs 41.0%, respectively, P = .46). Only half (46.7%) of study participants who had unprotected intercourse used EC over the study period. Eight percent of participants became pregnant and 12% acquired an STI; compared with controls, women in the pharmacy access and advance provision groups did not experience a significant reduction in pregnancy rate (pharmacy access group: adjusted odds ratio [OR], 0.98; 95% confidence interval [CI], 0.58-1.64; P = .93; advance provision group: OR, 1.10; 95% CI, 0.66-1.84, P = .71) or increase in STIs (pharmacy access group: adjusted OR, 1.08, 95% CI, 0.71-1.63, P = .73; advance provision group: OR, 0.94, 95% CI, 0.62-1.44, P = .79). There were no differences in patterns of contraceptive or condom use or sexual behaviors by study group. Conclusions  While removing the requirement to go through pharmacists or clinics to obtain EC increases use, the public health impact may be negligible because of high rates of unprotected intercourse and relative underutilization of the method. Given that there is clear evidence that neither pharmacy access nor advance provision compromises contraceptive or sexual behavior, it seems unreasonable to restrict access to EC to clinics.      

Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial

Context  Most older adults with dementia will be cared for by primary care physicians, but the primary care practice environment presents important challenges to providing quality care. Objective  To test the effectiveness of a collaborative care model to improve the quality of care for patients with Alzheimer disease. Design, Setting, and Patients  Controlled clinical trial of 153 older adults with Alzheimer disease and their caregivers who were randomized by physician to receive collaborative care management (n = 84) or augmented usual care (n = 69) at primary care practices within 2 US university-affiliated health care systems from January 2002 through August 2004. Eligible patients (identified via screening or medical record) met diagnostic criteria for Alzheimer disease and had a self-identified caregiver. Intervention  Intervention patients received 1 year of care management by an interdisciplinary team led by an advanced practice nurse working with the patient's family caregiver and integrated within primary care. The team used standard protocols to initiate treatment and identify, monitor, and treat behavioral and psychological symptoms of dementia, stressing nonpharmacological management. Main Outcome Measures  Neuropsychiatric Inventory (NPI) administered at baseline and at 6, 12, and 18 months. Secondary outcomes included the Cornell Scale for Depression in Dementia (CSDD), cognition, activities of daily living, resource use, and caregiver's depression severity. Results  Initiated by caregivers' reports, 89% of intervention patients triggered at least 1 protocol for behavioral and psychological symptoms of dementia with a mean of 4 per patient from a total of 8 possible protocols. Intervention patients were more likely to receive cholinesterase inhibitors (79.8% vs 55.1%; P = .002) and antidepressants (45.2% vs 27.5%; P = .03). Intervention patients had significantly fewer behavioral and psychological symptoms of dementia as measured by the total NPI score at 12 months (mean difference, –5.6; P = .01) and at 18 months (mean difference, –5.4; P = .01). Intervention caregivers also reported significant improvements in distress as measured by the caregiver NPI at 12 months; at 18 months, caregivers showed improvement in depression as measured by the Patient Health Questionnaire-9. No group differences were found on the CSDD, cognition, activities of daily living, or on rates of hospitalization, nursing home placement, or death. Conclusions  Collaborative care for the treatment of Alzheimer disease resulted in significant improvement in the quality of care and in behavioral and psychological symptoms of dementia among primary care patients and their caregivers. These improvements were achieved without significantly increasing the use of antipsychotics or sedative-hypnotics. Trial Registration  clinicaltrials.gov Identifier: NCT00246896      

Telephone psychotherapy and telephone care management for primary care patients starting antidepressant treatment: a randomized controlled trial

Context  Both antidepressant medication and structured psychotherapy have been proven efficacious, but less than one third of people with depressive disorders receive effective levels of either treatment. Objective  To compare usual primary care for depression with 2 intervention programs: telephone care management and telephone care management plus telephone psychotherapy. Design  Three-group randomized controlled trial with allocation concealment and blinded outcome assessment conducted between November 2000 and May 2002. Setting and Participants  A total of 600 patients beginning antidepressant treatment for depression were systematically sampled from 7 group-model primary care clinics; patients already receiving psychotherapy were excluded. Interventions  Usual primary care; usual care plus a telephone care management program including at least 3 outreach calls, feedback to the treating physician, and care coordination; usual care plus care management integrated with a structured 8-session cognitive-behavioral psychotherapy program delivered by telephone. Main Outcome Measures  Blinded telephone interviews at 6 weeks, 3 months, and 6 months assessed depression severity (Hopkins Symptom Checklist Depression Scale and the Patient Health Questionnaire), patient-rated improvement, and satisfaction with treatment. Computerized administrative data examined use of antidepressant medication and outpatient visits. Results  Treatment participation rates were 97% for telephone care management and 93% for telephone care management plus psychotherapy. Compared with usual care, the telephone psychotherapy intervention led to lower mean Hopkins Symptom Checklist Depression Scale depression scores (P = .02), a higher proportion of patients reporting that depression was "much improved" (80% vs 55%, P<.001), and a higher proportion of patients "very satisfied" with depression treatment (59% vs 29%, P<.001). The telephone care management program had smaller effects on patient-rated improvement (66% vs 55%, P = .04) and satisfaction (47% vs 29%, P = .001); effects on mean depression scores were not statistically significant. Conclusions  For primary care patients beginning antidepressant treatment, a telephone program integrating care management and structured cognitive-behavioral psychotherapy can significantly improve satisfaction and clinical outcomes. These findings suggest a new public health model of psychotherapy for depression including active outreach and vigorous efforts to improve access to and motivation for treatment.      

Impact of the Mexican program for education, health, and nutrition (Progresa) on rates of growth and anemia in infants and young children: a randomized effectiveness study

Context  Malnutrition causes death and impaired health in millions of children. Existing interventions are effective under controlled conditions; however, little information is available on their effectiveness in large-scale programs. Objective  To document the short-term nutritional impact of a large-scale, incentive-based development program in Mexico (Progresa), which included a nutritional component. Design, Setting, and Participants  A randomized effectiveness study of 347 communities randomly assigned to immediate incorporation to the program in 1998 (intervention group; n = 205) or to incorporation in 1999 (crossover intervention group; n = 142). A random sample of children in those communities was surveyed at baseline and at 1 and 2 years afterward. Participants were from low-income households in poor rural communities in 6 central Mexican states. Children (N = 650) 12 months of age or younger (n = 373 intervention group; n = 277 crossover intervention group) were included in the analyses. Intervention  Children and pregnant and lactating women in participating households received fortified nutrition supplements, and the families received nutrition education, health care, and cash transfers. Main Outcome Measures  Two-year height increments and anemia rates as measured by blood hemoglobin levels in participating children. Results  Progresa was associated with better growth in height among the poorest and younger infants. Age- and length-adjusted height was greater by 1.1 cm (26.4 cm in the intervention group vs 25.3 cm in the crossover intervention group) among infants younger than 6 months at baseline and who lived in the poorest households. After 1 year, mean hemoglobin values were higher in the intervention group (11.12 g/dL; 95% confidence interval [CI], 10.9-11.3 g/dL) than in the crossover intervention group (10.75 g/dL; 95% CI, 10.5-11.0 g/dL) who had not yet received the benefits of the intervention (P = .01). There were no differences in hemoglobin levels between the 2 groups at year 2 after both groups were receiving the intervention. The age-adjusted rate of anemia (hemoglobin level <11 g/dL) in 1999 was higher in the crossover intervention group than in the intervention group (54.9% vs 44.3%; P = .03), whereas in 2000 the difference was not significant (23.0% vs 25.8%, respectively; P = .40). Conclusion  Progresa, a large-scale, incentive-based development program with a nutritional intervention, is associated with better growth and lower rates of anemia in low-income, rural infants and children in Mexico.      

Quality of care for children in commercial and Medicaid managed care

Context  Many states have turned to commercial health plans to serve Medicaid beneficiaries and to achieve cost-containment goals. Assumptions that the quality of care provided to Medicaid beneficiaries through these programs is acceptable have not been tested. Objective  To compare the quality of care provided to children and adolescents in commercial and Medicaid managed care in the United States. Design, Setting, and Population  Using 1999 data collected through the Health Plan Employer Data and Information Set, we examined reported quality-of-care indicators for children and adolescents. Results from 423 commercial and 169 Medicaid plans were compared. Matched pairs analyses were performed using data from each of the 81 companies serving both populations to control for corporate differences. Correlation coefficients and regression procedures were used to examine observed variations in health plan performance. Main Outcome Measures  Quality indicators including prenatal care, childhood immunizations, well-child visits, adolescent immunizations, and myringotomy and tonsillectomy rates. Results  Using standard indicators of clinical performance, children and adolescents enrolled in Medicaid received worse care compared with their commercial counterparts. For most of the 81 health plans serving both populations, Medicaid enrollees had statistically significantly (P<.001) lower rates than commercial plans for clinical quality indicators (eg, childhood immunization rates of 69% vs 54%); for clinical access indicators (eg, well-child visits in the first 15 months of life, 53% vs 31%); and for common procedures (eg, myringotomies for children aged 0-4 years, 35 vs 2 per 1000 members). Conversely, some plans demonstrated equal and high-quality care for both populations. Regression models failed to identify consistent plan characteristics that explained the observed differences in quality of care. Conclusions  Most commercial health plans do not deliver high-quality care on a number of performance indicators for children enrolled in Medicaid. Policy makers and the public need plan-specific quality information to inform purchasing decisions.      

Behavior problems and mental health referrals of international adoptees: a meta-analysis

Context  International adoption involves more than 40 000 children a year moving among more than 100 countries. Before adoption, international adoptees often experience insufficient medical care, malnutrition, maternal separation, and neglect and abuse in orphanages. Objective  To estimate the effects of international adoption on behavioral problems and mental health referrals. Data Sources  We searched MEDLINE, PsychLit, and ERIC from 1950 to January 2005 using the terms adopt* combined with (behavior) problem, disorder, (mal)adjustment, (behavioral) development, clinical or psychiatric (referral), or mental health; conducted a manual search of the references of articles, books, book chapters, and reports; and consulted experts for relevant studies. The search was not limited to English-language publications. Study Selection  Studies that provided sufficient data to compute differences between adoptees (in all age ranges) and nonadopted controls were selected, resulting in 34 articles on mental health referrals and 64 articles on behavior problems. Data Extraction  Data on international adoption, preadoption adversity, and other moderators were extracted from each study and inserted in the program Comprehensive Meta-analysis (CMA). Effect sizes (d) for the overall differences between adoptees and controls regarding internalizing, externalizing, total behavior problems, and use of mental health services were computed. Homogeneity across studies was tested with the Q statistic. Data Synthesis  Among 25 281 cases and 80 260 controls, adoptees (both within and between countries) presented more behavior problems, but effect sizes were small (d, 0.16-0.24). Adoptees (5092 cases) were overrepresented in mental health services and this effect size was large (d, 0.72). Among 15 790 cases and 30  450 controls, international adoptees showed more behavior problems than nonadopted controls, but effect sizes were small (d, 0.07-0.11). International adoptees showed fewer total, externalizing and internalizing behavior problems than domestic adoptees. Also, international adoptees were less often referred to mental health services (d, 0.37) than domestic adoptees (d, 0.81). International adoptees with preadoption adversity showed more total problems and externalizing problems than international adoptees without evidence of extreme deprivation. Conclusions  Most international adoptees are well-adjusted although they are referred to mental health services more often than nonadopted controls. However, international adoptees present fewer behavior problems and are less often referred to mental health services than domestic adoptees.      

Effectiveness of influenza vaccine in health care professionals: a randomized trial

Context  Data are limited and conflicting regarding the effectiveness of influenza vaccine in health care professionals. Objective  To determine the effectiveness of trivalent influenza vaccine in reducing infection, illness, and absence from work in young, healthy health care professionals. Design  Randomized, prospective, double-blind, controlled trial over 3 consecutive years, from 1992-1993 to 1994-1995. Setting  Two large teaching hospitals in Baltimore, Md. Participants  Two hundred sixty-four hospital-based health care professionals without chronic medical problems were recruited; 49 participated for 2 seasons; 24 participated for 3 seasons. The mean age was 28.4 years, 75% were resident physicians, and 57% were women. Intervention  Participants were randomly assigned to receive either an influenza vaccine or a control (meningococcal vaccine, pneumococcal vaccine, or placebo). Serum samples for antibody assays were collected at the time of vaccination, 1 month after vaccination, and at the end of the influenza season. Active weekly surveillance for illness was conducted during each influenza epidemic period. Main Outcome Measures  Serologically defined influenza infection (4-fold increase in hemagglutination-inhibiting antibodies), days of febrile respiratory illness, and days absent from work. Results  We conducted 359 person-winters of serologic surveillance (99.4% follow-up) and 4746 person-weeks of illness surveillance (100% follow-up). Twenty-four (13.4%) of 179 control subjects and 3 (1.7%) of 180 influenza vaccine recipients had serologic evidence of influenza type A or B infection during the study period. Vaccine efficacy against serologically defined infection was 88% for influenza A (95% confidence interval [CI], 47%-97%; P=.001) and 89% for influenza B (95% CI, 14%-99%; P=.03). Among influenza vaccinees, cumulative days of reported febrile respiratory illness were 28.7 per 100 subjects compared with 40.6 per 100 subjects in controls (P=.57) and days of absence were 9.9 per 100 subjects vs 21.1 per 100 subjects in controls (P=.41). Conclusions  Influenza vaccine is effective in preventing infection by influenza A and B in health care professionals and may reduce reported days of work absence and febrile respiratory illness. These data support a policy of annual influenza vaccination of health care professionals.