Optimized antidepressant therapy and pain self-management in primary care patients with depression and musculoskeletal pain: a randomized controlled trial.

CONTEXT: Pain and depression are the most common physical and psychological symptoms in primary care, respectively. Moreover, they co-occur 30% to 50% of the time and have adverse effects on quality of life, disability, and health care costs. OBJECTIVE: To determine if a combined pharmacological and behavioral intervention improves both depression and pain in primary care patients with musculoskeletal pain and comorbid depression. DESIGN, SETTING, AND PATIENTS: Randomized controlled trial (Stepped Care for Affective Disorders and Musculoskeletal Pain [SCAMP]) conducted at 6 community-based clinics and 5 Veterans Affairs general medicine clinics in Indianapolis, Indiana. Recruitment occurred from January 2005 to June 2007 and follow-up concluded in June 2008. The 250 patients had low back, hip, or knee pain for 3 months or longer and at least moderate depression severity (Patient Health Questionnaire 9 score > or = 10). INTERVENTION: Patients were randomly assigned to the intervention (n = 123) or to usual care (n = 127). The intervention consisted of 12 weeks of optimized antidepressant therapy (step 1) followed by 6 sessions of a pain self-management program over 12 weeks (step 2), and a continuation phase of therapy for 6 months (step 3). MAIN OUTCOME MEASURES: Depression (20-item Hopkins Symptom Checklist), pain severity and interference (Brief Pain Inventory), and global improvement in pain at 12 months. RESULTS: At 12 months, 46 of the 123 intervention patients (37.4%) had a 50% or greater reduction in depression severity from baseline compared with 21 of 127 usual care patients (16.5%) (relative risk [RR], 2.3; 95% confidence interval [CI], 1.5-3.2), corresponding to a much lower number of patients with major depression (50 [40.7%] vs 87 [68.5%], respectively; RR, 0.6 [95% CI, 0.4-0.8]). Also, a clinically significant (> or = 30%) reduction in pain was much more likely in intervention patients (51 intervention patients [41.5%] vs 22 usual care patients [17.3%]; RR, 2.4 [95% CI, 1.6-3.2]), as was global improvement in pain (58 [47.2%] vs 16 [12.6%], respectively; RR, 3.7 [95% CI, 2.3-6.1]). More intervention patients also experienced benefits in terms of the primary outcome, which was a combined improvement in both depression and pain (32 intervention patients [26.0%] vs 10 usual care patients [7.9%]; RR, 3.3 [95% CI, 1.8-5.4]). CONCLUSION: Optimized antidepressant therapy followed by a pain self-management program resulted in substantial improvement in depression as well as moderate reductions in pain severity and disability. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00118430.

Pharmacist intervention to improve medication adherence in heart failure: a randomized trial.

BACKGROUND: Patients with heart failure who take several prescription medications sometimes have poor adherence to their treatment regimens. Few interventions designed to improve adherence to therapy have been rigorously tested. OBJECTIVE: To determine whether a pharmacist intervention improves medication adherence and health outcomes compared with usual care for low-income patients with heart failure. DESIGN: Randomized, controlled trial conducted from February 2001 to June 2004. SETTING: University-affiliated, inner-city, ambulatory care practice. PATIENTS: 314 low-income patients 50 years of age or older with heart failure confirmed by their primary care physician. INTERVENTION: Patients were randomly assigned to intervention (39% [n = 122]) or usual care (61% [n = 192]) groups and were followed for 12 months. A pharmacist provided a 9-month multilevel intervention, with a 3-month poststudy phase. An interdisciplinary team of investigators designed the intervention to support medication management by patients who have low health literacy and limited resources. MEASUREMENTS: Primary outcomes were adherence, as measured by using electronic prescription monitors, and exacerbations requiring emergency department care or hospital admission. Secondary outcomes included health-related quality of life, patient satisfaction with pharmacy services, and total direct costs. RESULTS: During the 9-month intervention period, medication adherence was 67.9% and 78.8% in the usual care and intervention groups, respectively (difference, 10.9 percentage points [95% CI, 5.0 to 16.7 percentage points]). However, these salutary effects dissipated in the 3-month postintervention follow-up period, in which adherence was 66.7% and 70.6%, respectively (difference, 3.9 percentage points [CI, -5.9 to 6.5 percentage points]). Medications were taken on schedule 47.2% of the time in the usual care group and 53.1% of the time in the intervention group (difference, 5.9 percentage points [CI, 0.4 to 11.5 percentage points]), but this effect also dissipated at the end of the intervention (48.9% vs. 48.6%, respectively; difference, 0.3 percentage point [CI, -5.9 to 6.5 percentage points]). Emergency department visits and hospital admissions were 19.4% less (incidence rate ratio, 0.82 [CI, 0.73 to 0.93]) and annual direct health care costs were lower ($-2960 [CI, $-7603 to $1338]) in the intervention group. LIMITATIONS: Because electronic monitors were used to ascertain adherence, patients were not permitted to use medication container adherence aids. The intervention involved 1 pharmacist and a single study site that served a large, indigent, inner-city population of patients. Because the intervention had several components, intervention effects could not be attributed to a single component. CONCLUSIONS: A pharmacist intervention for outpatients with heart failure can improve adherence to cardiovascular medications and decrease health care use and costs, but the benefit probably requires constant intervention because the effect dissipates when the intervention ceases. ClinicalTrials.gov registration number: NCT00388622.

Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study: design and practical implications of an intervention for comorbid pain and depression.

OBJECTIVE: Depression and pain are common comorbid conditions that have reciprocal adverse effects on disability and treatment outcomes. The objective of this article is to describe a study that tests the effectiveness of a stepped-care approach using a combined medication-behavioral intervention. METHOD: Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) is an NIMH-sponsored randomized clinical trial nested within a prospective cohort study. A total of 250 patients with clinically significant depression (PHQ-9 scores > or =10) and musculoskeletal pain of the lower back or legs (hip or knee) and 250 nondepressed patients with similar pain are enrolled, with baseline and serial follow-up assessments to be conducted over 12 months. The depressed patients are randomized to either a stepped-care intervention group or a usual-care control group. Stepped-care patients receive 12 weeks of optimized antidepressant management (Step 1) followed by six sessions of a pain self-management (PSM) program over the next 12 weeks (Step 2), all delivered by a nurse care manager who is supervised by a physician specialist. Approximately two thirds of the care manager contacts are by telephone. RESULTS: The target sample of 500 subjects has been successfully enrolled, and randomization of the depressed patients has resulted in balanced groups of patients with moderately severe pain and depression. Mean SCL-20 depression severity in the clinical trial group is 1.9, with most meeting DSM-IV criteria for major depression (76.3%) and the rest having dysthymia only (18.4%) or minor depression (5.3%). Pain is about equally distributed between lower back (53%) and hip or knee (47%). A rational algorithmic approach to antidepressant selection and dosing, as well as an overview of the PSM program, is provided. CONCLUSIONS: When completed, SCAMP will test whether optimized antidepressant management improves outcomes in patients with comorbid depression and pain and whether PSM produces additional benefits. The findings will be important for both primary care and mental health clinicians confronted by the prevalent depression-pain dyad.

Methodology of an ongoing, randomized, controlled trial to improve drug use for elderly patients with chronic heart failure.

BACKGROUND: Medications can improve the functioning and health-related quality of life of patients with chronic heart failure (CHF) and reduce morbidity, mortality, and costs of treatment. However, patients may not adhere to therapy. Patients with complex medication regimens and low health literacy are at risk for nonadherence. OBJECTIVE: The primary goal of this project is to develop and assess a multilevel pharmacy-based program to improve patient medication adherence and health outcomes for elderly CHF patients with low health literacy. METHODS: In this 4-year, controlled trial, patients aged 50 years with a diagnosis of CHF who are being treated at Wishard Health Services (Indianapolis, Indiana) are randomly assigned to pharmacist intervention or usual care. Intervention patients receive 9 months of pharmacist support and 3 months of postintervention follow-up. The intervention involves a pharmacist providing verbal and written education, icon-based labeling of medication containers, and therapeutic monitoring. The pharmacist identifies patients' barriers to appropriate drug use, coaches them on overcoming these barriers, and coordinates medication use issues with their primary care providers. Daily updates of relevant monitoring data are delivered via an electronic medical record system and stored in a personal computer system designed to support pharmacist monitoring and facilitate documentation of interventions. To measure medication adherence objectively, electronic monitoring lids are used on all CHF medications for patients in both study groups. Other assessments include self-reported medication adherence, results of echocardiography (eg, ejection fraction), brain natriuretic peptide concentrations, and health-related quality of life. Health services utilization, refill adherence, and cost data derive from electronic medical records. After completion of this study, the data can be used to assess the effectiveness and cost-effectiveness of our intervention. RESULTS: One hundred twenty-two patients have been assigned to receive the intervention and 192 to receive usual care. CONCLUSIONS: Our study aims to improve patients' knowledge and self-management of their medication and to improve medication monitoring in a multilevel pharmacy-based intervention. By doing so, we intend that the intervention will improve the health outcomes of elderly patients with CHF.

Multihospital infection prevention collaborative: informatics challenges and strategies to prevent MRSA.

We formed a collaborative to spread effective MRSA prevention strategies. We conducted a two-phase, multisite, quasi-experimental study of seven hospital systems (11 hospitals) in IN, MT, ME and Ontario, Canada over six years. Patients with prior MRSA were identified at admission using regional health information exchange data. We developed a system to return an alert message indicating a prior history of MRSA, directed to infection preventionists and admissions. Alerts indicated the prior anatomic site, and the originating institution. The combined approach of training and coaching, implementation of MRSA registries, notifying hospitals on admission of previously infected or colonized patients, and change strategies was effective in reducing MRSA infections over 80%. Further research and development of electronic surveillance tools is needed to better integrate the varied data source and support preventing MRSA infections. Our study supports the importance of hospitals collaborating to share data and implement effective strategies to prevent MRSA.

Reducing health care-associated infections (HAIs): lessons learned from a national collaborative of regional HAI programs.

BACKGROUND: Health care-associated infections (HAIs) are a leading cause of death in United States health care settings, with an overall estimated annual incidence of 1.7 million. As antimicrobial resistance has increased, so too have efforts to reduce HAI rates. The objective of this study was to identify commonly cited lessons learned across a wide variety of HAI projects and hospital settings. METHODS: Thirty-three hospitals participated in 5 different regional collaboratives supported by the Agency for Healthcare Research and Quality (AHRQ). Data on hospitals' successes, challenges, and lessons learned were collected via key informant interviews and structured, standardized case report forms. RESULTS: Seven commonly cited themes were identified: foster change by first understanding resistance; commit to regular strategic communication and join a collaborative; start small and tailor implementation to local needs and cultures; engage frontline staff by involving them in the project and enlisting champions; educate and reeducate; convince administration to provide leadership, funds, and dedicated staff and assign accountability; and provide timely, relevant feedback and celebrate successes. CONCLUSION: Despite the diversity of hospital settings, cultures, personnel, and HAI reduction projects, we found that hospitals encounter similar challenges and facilitators across projects. We offer a model of 7 process elements shown to be important to successful implementation.

A national collaborative for reducing health care‒associated infections: current initiatives, challenges, and opportunities.

There has been increasing interest and an upsurge in efforts to prevent hospital-associated infections (HAIs), a leading cause of death in the United States. This study was conducted to assess current strategies and efforts of HAI reduction initiatives in hospitals. HAI reduction initiatives and factors influencing institutional participation in these initiatives were categorized. Data were collected via open-ended questions on surveys performed in 5 different HAI collaboratives. Thematic analysis of the coded qualitative data was conducted. A total of 1,212 health care professionals from 33 different hospitals participated. Improving hand hygiene was the most frequently mentioned HAI reduction initiative implemented in the previous year. Initiatives for reducing central line or central venous catheter infections and ventilator-associated pneumonia also were commonly cited. The most frequently mentioned challenges to implementing HAI reduction initiatives included poor adherence, insufficient resources, staffing problems, lack of culture change, no impetus to change, and issues related to staff and patient education. Many respondents identified engaging physicians as particularly challenging.These findings suggest that consistently improving hand hygiene remains a widespread problem for reducing HAIs and sustaining this type of behavioral change is difficult. Furthermore, ensuring staff and physician engagement and compliance in HAI reduction efforts remains challenging for most hospitals.