Gregory Patts

Elucidating Reasons for Resident Underutilization of Electronic Adverse Event Reporting

Reasons for resident underutilization of adverse event (AE) reporting systems are unclear, particularly given frequent resident exposure to AEs and near misses (NMs). Residents at an academic medical center were surveyed about AEs/NMs, barriers to reporting, patient safety climate, and educational interventions. A total of 350 of 527 eligible residents (66%) completed the survey; 77% of respondents reported involvement in an AE/NM, though only 43% had used the reporting system. Top barriers to reporting were not knowing what or how to report. Surgeons reported more than other residents (surgery, 61%; medical, 38%; hospital-based, 15%; P < .01), yet more often felt that systems were unlikely to change after reporting (surgery, 49%; medical, 28%; hospital-based. 18%; P < .01). Residents preferred discussions with supervisors (52%) and department-led conferences (46%) to increased reporting. Efforts to increase resident reporting should address common barriers to reporting as well as department-specific differences in resident knowledge, perceptions of system effectiveness, and educational preferences.

Postoperative Venous Thromboembolism in Patients Undergoing Abdominal Surgery for IBD: A Common but Rarely Addressed Problem.

BACKGROUND: Venous thromboembolism after abdominal surgery occurs in 2% to 3% of patients with Crohn’s disease and ulcerative colitis. However, no evidence-based guidelines currently exist to guide postdischarge prophylactic anticoagulation. OBJECTIVE: We sought to determine the use of postoperative postdischarge venous thromboembolism chemical prophylaxis, 90-day venous thromboembolism rates, and factors associated with 90-day thromboembolic events in IBD patients following abdominal surgery. DESIGN: This was a retrospective evaluation of an administrative database. DATA SOURCE: Data were obtained from Optum Labs Data Warehouse, a large administrative database containing claims on privately insured and Medicare Advantage enrollees. PATIENTS: Seven thousand seventy-eight patients undergoing surgery for Crohn’s disease or ulcerative colitis were included in the study. MAIN OUTCOME MEASURES: Primary outcomes were rates of postdischarge venous thromboembolism prophylaxis and 90-day rates of postdischarge thromboembolic events. In addition, patient clinical characteristics were identified to determine predictors of postdischarge venous thromboembolism. RESULTS: Postdischarge chemical prophylaxis was given to only 0.6% of patients in the study. Two hundred thirty-five patients (3.3%) developed a postdischarge thromboembolic complication. Postdischarge thromboembolism was more common in patients with ulcerative colitis than with Crohn’s disease (5.8% vs 2.3%; p < 0.001). Increased rates of venous thromboembolism were seen in patients undergoing colectomy or proctectomy with simultaneous stoma creation compared with colectomy or proctectomy alone (5.8% vs 2.1%; p < 0.001). The strongest predictors of thromboembolic complications were stoma creation (adjusted OR, 1.95; 95% CI, 1.34–2.84), J-pouch reconstruction (adjusted OR, 2.66; 95% CI, 1.65–4.29), preoperative prednisone use (adjusted OR, 1.57; 95% CI, 1.19–2.08), and longer length of stay (adjusted OR, 1.89; 95% CI, 1.41–2.52). LIMITATIONS: This study is limited by its retrospective design. CONCLUSIONS: The use of postdischarge venous thromboembolism prophylaxis in this patient sample was infrequent. Development of evidence-based guidelines, particularly for high-risk patients, should be considered to improve the outcomes of IBD patients undergoing abdominal surgery.

Lifetime and recent alcohol use and bone mineral density in adults with HIV infection and substance dependence.

Abstract Low bone mineral density (BMD) is common in people living with HIV infection (PLWH), increasing fracture risk. Alcohol use is also common in PLWH and is a modifiable risk factor for both HIV disease progression and low BMD. In PLWH, alcohols effect on BMD is not well understood. We studied adult PLWH with substance dependence. We measured lifetime alcohol use (kg) and recent (i.e., past 30-day) alcohol use (categorized as: abstinent, low risk, or high risk). In adjusted multivariable regression analyses, we tested associations between lifetime and recent alcohol use and (i) mean BMD (g/cm2) at the femoral neck, total hip, and lumbar spine and (ii) low BMD diagnosis (i.e., osteopenia or osteoporosis). We also examined associations between 2 measures of past alcohol use (i.e., total consumption [kg] and drinking intensity [kg/year]) and BMD outcome measures during 3 periods of the HIV care continuum: (i) period before first positive HIV test, (ii) period from first positive HIV test to antiretroviral therapy (ART) initiation, and (iii) period following ART initiation. We found no significant associations between lifetime alcohol use and mean femoral neck (&bgr; −0.000, P = .62), total hip (&bgr; −0.000, P = .83) or lumbar spine (&bgr; 0.001, P = .65) BMD (g/cm2), or low BMD diagnosis (adjusted odds ratio [aOR] = 0.98, 95% Confidence Interval [CI]: 0.95–1.01). There was no significant correlation between past 30-day alcohol use and mean BMD (g/cm2). Past 30-day alcohol use was associated with low BMD diagnosis (P = .04); compared to abstainers, the aOR for high risk alcohol use was 1.94 (95% CI: 0.91–4.12), the aOR for low risk alcohol use was 4.32 (95% CI: 1.30–14.33). Drinking intensity (kg/year) between first positive HIV test and ART initiation was associated with lower mean BMD (g/cm2) at the femoral neck (&bgr; −0.006, P = .04) and total hip (&bgr; −0.007, P = .02) and increased odds of low BMD (aOR = 1.18, 95% CI = 1.03–1.36). In this sample of PLWH, we detected no association between lifetime alcohol use and BMD. However, recent drinking was associated with low BMD diagnosis, as was drinking intensity between first positive HIV test and ART initiation. Longitudinal studies should confirm these associations.

Efficacy of a Maternal Depression Prevention Strategy in Head Start: A Randomized Clinical Trial

Importance Low-income and minority mothers experience a disproportionate incidence of depression and lack access to treatment services. Development of prevention strategies in accessible community-based venues is a potentially important public health strategy. Objective To determine the efficacy of a depression prevention strategy embedded in Head Start. Design, Setting, and Participants This randomized clinical trial was performed from February 15, 2011, through May 9, 2016, at 6 Head Start agencies serving families at or below the federal poverty level. Participants included mothers with depressed mood, anhedonia, or depression history but who were not in a current major depressive episode. Participants were followed up for 12 months with masked outcome assessments. Final follow-up was completed on May 9, 2016. Interventions Participants were randomized to a problem-solving education (PSE) intervention (n = 111) or usual Head Start services (n = 119). Main Outcomes and Measures Primary outcomes were problem-solving skills and depressive symptoms. To capture the chronicity and intensity of symptoms, the Quick Inventory of Depressive Symptoms was administered bimonthly, and rates of clinically significant symptom elevations were compared across groups. Secondarily, the presence of a major depressive episode was assessed using the Structured Clinical Interview for DSM-IV Axis I Disorders. Results Among the 230 participants, 152 (66.1%) were Hispanic, with a mean (SD) age of 31.4 (7.3) years. An intention-to-treat analysis among 223 participants contributing follow-up data found no differences in problem-solving skills across groups. The mean (SD) number of depressive symptom elevations among the PSE participants was 0.84 (1.39) compared with 1.12 (1.47) among the usual service participants (adjusted incident rate ratio [aIRR], 0.60; 95% CI, 0.41-0.90). In analyses stratified according to baseline depressive symptoms, PSE exerted a preventive effect among those with lower-level baseline symptoms, with a mean (SD) of 0.39 (0.84) elevations among PSE participants compared with 0.88 (1.37) among usual service participants (aIRR, 0.39; 95% CI, 0.21-0.75). However, no difference was observed among those with higher-level baseline symptoms (mean [SD] elevations, 2.06 [1.92] for PSE and 2.00 [1.91] for usual service; aIRR, 1.10; 95% CI, 0.67-1.80). Analysis of symptom scores followed the same pattern, with an adjusted mean reduction of 1.33 (95% CI, 0.36-2.29) among participants with lower-level baseline symptoms. Conclusions and Relevance The PSE intervention is efficacious in preventing depressive symptom episodes and performs optimally among those with initial low-level symptoms. Additional effectiveness studies in Head Start are necessary to develop meaningful public health programs. Trial Registration clinicaltrials.gov Identifier: NCT01298804

HIV-infected individuals who use alcohol and other drugs, and virologic suppression

ABSTRACT People living with HIV (PLWH) on antiretroviral therapy (ART) who use substances were examined to (a) describe those with virologic control and (b) determine which substance use-factors are associated with lack of virologic control. Participants were adult PLWH taking ART with either past 12-month DSM-IV substance dependence or past 30-day alcohol or illicit drug use. Substance use factors included number of DSM-IV alcohol or drug dependence criteria and past 30-day specific substance use. Associations with HIV viral load (HVL) (<200 vs. ≥200 copies/mL) were tested using logistic regression models. Multivariable analyses adjusted for age, sex, homelessness and anxiety or depression. Participants (n = 202) were median age 50 years, 66% male, 51% African American and 75% self-reported ≥90% past 30-day ART adherence. Though HVL suppression (HVL <200 copies/mL) was achieved in 78% (158/202), past 30-day substance use was common among this group: 77% cigarette use; 51% heavy alcohol use; 50% marijuana; 27% cocaine; 16% heroin; and 15% illicit prescription opioid use. After adjusting for covariates, specific substance use was not associated with a detectable HVL, however number of past 12-month DSM-IV drug dependence criteria was (adjusted odds ratio = 1.23 for each additional criterion, 95% CI: 1.04–1.46). Three-quarters of a substance-using cohort of PLWH receiving ART had virologic control and ≥90% ART adherence. Substance dependence criteria (particularly drug dependence), not specifically substance use, were associated with lack of virologic control. Optimal HIV outcomes can be achieved by individuals who use alcohol or drugs and addressing symptoms of substance dependence may improve HIV-related outcomes.

Polypharmacy and risk of non-fatal overdose for patients with HIV infection and substance dependence

INTRODUCTION People living with HIV (PLWH) are at risk of both polypharmacy and unintentional overdose yet there are few data on whether polypharmacy increases risk of overdose. The study objective was to determine if the number and type of medication (e.g., sedating) were associated with non-fatal overdose (OD) among PLWH with past-year substance dependence or a lifetime history of injection drug use. MATERIALS AND METHODS This was a longitudinal study of adults recruited from two urban, safety-net HIV clinics. Outcomes were i) lifetime and ii) past-year non-fatal OD assessed at baseline and a 12-month follow-up. We used logistic regression to examine the association between each outcome and the number of medications (identified from the electronic medical record) in the following categories: i) overall medications, ii) non-antiretroviral (non-ARV), iii) sedating, iv) non-sedating, as well as any vs no opioid medication and any vs no non-opioid sedating medication. Covariates included demographics, medical comorbidities, depressive and anxiety symptoms, and substance use. RESULTS Among 250 participants, 80% were prescribed a sedating medication, 50% were prescribed an opioid; 51% exceeded risky drinking limits. In the past month, 23% reported illicit opioid use and 9% illicit opioid sedative use; 37% reported lifetime non-fatal OD and 7% past-year non-fatal OD. The median number (interquartile range) of total medications was 10 (7, 14) and 2 (1, 3) sedating. The odds of lifetime non-fatal OD were significantly higher with each additional sedating medication (OR 1.26, 95% CI 1.08, 1.46) and any opioid medication (OR 2.31; 95% CI 1.37, 3.90), but not with each overall, non-ARV, or non-sedating medication. The odds of past year non-fatal OD were greater with each additional sedating medication (OR 1.18; 95% CI 1.00, 1.39, p=0.049), each additional non-ARV medication (OR 1.07; 95% CI 1.00, 1.15, p=0.048), and non-significantly for any opioid medication (OR 2.23; 95% CI 0.93, 5.35). CONCLUSIONS In this sample of PLWH with substance dependence and/or injection drug use, number of sedating medications and any opioid were associated with non-fatal overdose; sedating medications were prescribed to the majority of patients. Polypharmacy among PLWH and substance dependence warrants further research to determine whether reducing sedating medications, including opioids, lowers overdose risk.

Engaging Mothers With Depressive Symptoms in Care: Results of a Randomized Controlled Trial in Head Start

OBJECTIVE The authors sought to determine whether a multicomponent, community-based program for preventing maternal depression also promotes engagement with mental health services for individuals with persistent symptoms. METHODS Mothers of children enrolled in Head Start were randomly assigned between February 2011 and May 2016 to Problem-Solving Education (PSE) (N=111) or usual services (N=119) and assessed every two months for 12 months. RESULTS Among 230 participants, 66% were Hispanic; 223 participants were included in the analysis. For all PSE participants, engagement with specialty mental health services increased from approximately 10% to 21% between two and 12 months. The PSE group was more likely than the control group to be engaged in specialty services at 12 months (adjusted odds ratio [AOR]=2.36, 95% confidence interval [CI]=1.07-5.20), and the rate of engagement with specialty services over time (treatment × time interaction) favored PSE (p=.016). Among PSE participants with persistent depressive symptoms over the follow-up period, engagement with specialty services increased from 12% (two months) to approximately 46% (12 months), whereas among control group participants, engagement fluctuated between 24% and 33%, without a clear trajectory pattern. At 12 months, PSE participants with persistent symptoms were more likely to engage with specialty care compared with their counterparts in the control group (AOR=6.95, CI=1.50-32.19). The treatment × time interaction was significant for the persistently symptomatic subgroup (p=.029) but not for the episodically symptomatic or the asymptomatic subgroups. CONCLUSIONS Embedding mental health programs in Head Start is a promising strategy to engage parents with depressive symptoms in care, especially those with persistent symptoms.

Antibody Response to Hepatitis B Virus Vaccine is Impaired in Patients With Inflammatory Bowel Disease on Infliximab Therapy

Background Studies have demonstrated an association between anti-TNF/immunomodulator agents used in inflammatory bowel disease (IBD) and impaired hepatitis B virus (HBV) vaccine immunogenicity, but little data exist on whether specific medication types affect protective HBsAb titers. Our aim was to analyze this association. Methods This is a retrospective cohort study. Inclusion criteria: age ≥18, diagnosis of Crohns disease (CD) or ulcerative colitis (UC), previous HBV vaccination series and/or ≥1 positive HBsAb, and record of IBD therapy in 6 months before titer level. Patients were stratified based upon medication exposures: anti-TNF, immunomodulator, combination anti-TNF and immunomodulatory, and a reference arm. Titer levels following vaccination and specific medication types given in the 6 months before titer were recorded. Seroprotection was defined as HBsAb ≥10 IU/l and ≥100 IU/l. Results The study cohort (N = 391) was 70.8% white, 51.4% female and 64.2% had CD and 35.8% had UC. The mean age was 45.8 years. A significantly lower percentage of patients exposed to anti-TNF, immunomodulator or dual therapy had titers ≥10 (P < 0.01). Regarding specific medications, only patients exposed to infliximab (P < 0.01) were less likely to have titer levels ≥10, after controlling for other medication exposures, age at titer level, and interval time between vaccination/titer level. This was not found for patients exposed to adalimumab, methotrexate, 6-mercaptopurine, or azathioprine. Conclusions Patients exposed to infliximab were significantly less likely to have protective HBsAb titer levels following vaccination, a trend not seen in patients on adalimumab. Efforts to vaccinate IBD patients against HBV before use of immunomodulators and anti-TNFs, infliximab specifically, and screen periodically thereafter must be reinforced.

Use of an android phone application for automated text messages in international settings: A case study in an HIV clinical trial in St. Petersburg, Russia:

Background/aims: Reproducible outcomes in clinical trials depend on adherence to study protocol. Short message service (also known as text message) reminders have been shown to improve clinical trial adherence in the United States and elsewhere. However, due to systematic differences in mobile data plans, languages, and technology, these systems are not easily translated to international settings. Methods: To gauge technical capabilities for international projects, we developed SMSMessenger, an automated Android application that uses a US server to send medication reminders to participants in a clinical trial in St. Petersburg, Russia (Zinc for HIV disease among alcohol users—a randomized controlled trial in the Russia Alcohol Research Collaboration on HIV/AIDS cohort). The application is downloaded once onto an Android study phone. When it is time for the text message reminders to be sent, study personnel access the application on a local phone, which in turn accesses the existing clinical trial database hosted on a US web server. The application retrieves a list of participants with the following information: phone number, whether a message should be received at that time, and the appropriate text of the message. The application is capable of storing multiple outgoing messages. With a few clicks, text messages are sent to study participants who can reply directly to the message. Study staff can check the local phone for incoming messages. The SMSMessenger application uses an existing clinical trial database and is able to receive real-time updates. All communications between the application and server are encrypted, and phone numbers are stored in a secure database behind a firewall. No sensitive data are stored on the phone, as outgoing messages are sent through the application and not by messaging features on the phone itself. Messages are sent simultaneously to study participants, which reduces the burden on local study staff. Costs and setup are minimal. The only local requirements are an Android phone and data plan. Conclusion: The SMSMessenger technology could be modified to be applied anywhere in the world, in any language, script, or alphabet, and for many different purposes. The novel application of this existing low-cost technology can improve the usefulness of text messaging in advancing the goals of international clinical trials.

Polypharmacy and risk of falls and fractures for patients with HIV infection and substance dependence

ABSTRACT Although people with HIV infection (PLWH) are at higher risk of polypharmacy and substance use, there is limited knowledge about potential harms associated with polypharmacy such as falls and fractures in this population. The study objective was to determine whether polypharmacy, as measured by the number and type of medication, is associated with falls and fractures among PLWH and DSM-IV substance dependence in the past year or ever injection drug use (IDU). We identified the number of medications by electronic medical record review in the following categories: (i) systemically active, (ii) non-antiretroviral (non-ARV), (iii) sedating, (iv) non-sedating as well as any opioid medication and any non-opioid sedating medication. Outcomes were self-reported (1) fall/accident requiring medical attention and (2) fracture in the previous year. Separate logistic regression models were fitted for medications in each category and each outcome. Among 250 participants, the odds of a fall requiring medical attention were higher with each additional medication overall (odds ratio [OR] 1.12, 95% Confidence Interval [CI] = 1.05, 1.18), each additional non-ARV medication (OR 1.13, 95%CI = 1.06, 1.20), each additional sedating medication (OR 1.36, 95%CI = 1.14, 1.62), and a non-opioid sedating medication (OR 2.89, 95%CI = 1.06, 7.85) but not with an additional non-sedating medication or opioid medication. In receiver operating characteristic (ROC) curve analyses, optimal cutoffs for predicting falls were: ≥8 overall and ≥2 sedating medications. Odds ratios for fracture in the previous year were OR 1.05, 95%CI = 0.97, 1.13 for each additional medication overall and OR 1.11, 95%CI = 0.89, 1.38 for each additional sedating medication. In PLWH and substance dependence or ever IDU, a higher number of medications was associated with greater odds of having a fall requiring medical attention. The association appeared to be driven largely by sedating medications. Future studies should determine if reducing such polypharmacy, particularly sedating medications, lowers the risk of falls.