Standard Counseling Research Articles

Effects of a Pharmacist-Led Educational Interventional Program on Electronic Monitoring–assessed Adherence to Direct Oral Anticoagulants: A Randomized, Controlled Trial in Patients with Nonvalvular Atrial Fibrillation

PurposeSeveral landmark trials have reported that direct oral anticoagulants (DOACs) are more effective in preventing stroke and systemic embolism than vitamin K antagonists. However, nonadherence to DOACs worsens prognosis in patients with nonvalvular atrial fibrillation (NVAF) despite the effectiveness of the drugs. The purpose of this study was to evaluate the effects of a pharmacist-led educational interventional program involving motivational interviewing on medication adherence, as assessed by electronic monitoring, in patients receiving DOACs for the treatment of NVAF. MethodsThis prospective, randomized, interventional study was conducted at outpatient cardiology clinics at general hospitals and pharmacies in Japan. Patients with NVAF who were treated with a once-daily DOAC (edoxaban) or a twice-daily DOAC (apixaban) were randomized to receive either: (1) an educational interventional program involving motivational interviewing regarding adherence to anticoagulants; or (2) standard medication counseling. The primary end point was the change in the medication adherence rate, calculated as the number of days that patients appropriately took the drug, as assessed by an electronic monitoring device, divided by the total number of days that the drug was prescribed, from a 12-week observation period to a 12-week intervention period. The secondary end points were tolerability outcomes. The effect of the educational interventional program on the primary end point was analyzed in subgroups stratified by gender and type of DOAC received. FindingsA total of 268 patients completed the observation period and were randomly assigned to one of the two study groups. The difference in the primary end point between the educational interventional program group and the standard medication counseling group was not significant (mean [SD], 2.9% [7.5%] vs 3.4% [8.3%]). On multiple linear regression analysis, the difference in DOAC adherence between the two groups was not significant, but that adherence to apixaban was significantly improved among men in the educational interventional program (β = 0.219; P = 0.012). Two patients died of causes considered unrelated to treatment; no stroke/systemic embolism or major bleeding events were observed. ImplicationsIn this randomized, controlled study of the effects of a pharmacist-led educational interventional program using motivational interviewing on adherence to DOACs among patients with NVAF, adherence to DOACs, as assessed using an electronic monitoring device, was not improved with the educational interventional program compared to standard medication counseling . However, adherence to twice-daily apixaban was improved among men, but not among women, in the educational interventional program group. In this study, the selection of DOACs was not randomized, and the lack of assessment of the association between adherence to DOACs and clinical outcomes was a limitation. Japan Registry of Clinical Trials (jRCT) indentifier: jRCTs031180142.

Acceptance of a Prescription for Smoking Cessation Utilizing an iPad Educational Application

Tobacco use, especially smoking, poses an enormous threat to public health. Research indicates tobacco use is linked to many illnesses and premature death. It also has unhealthy consequences in non-smokers through second-hand exposure. Primary care clinicians have the “golden opportunities” to intervene during office visit encounters. This study examined the use of an iPad educational application in tobacco cessation counseling that would increase acceptance of a prescription to aid with cessation, compared to the traditional method of counseling only. Utilizing smoking cessation guidelines, a descriptive quantitative exploratory methodology was used in two phases to assess the effectiveness of tobacco cessation education in a traditional verbal counseling versus the additional use of a mobile application along with standard tobacco cessation counseling in a primary care clinical setting. Total of 49 participants were recruited in two different groups. The standard cessation counseling had 29 subjects for Phase I and 20 participants in the enhanced tobacco cessation education group in Phase II. The enhanced tobacco cessation education with an iPad was more effective in smoking education than the traditional standard verbal counseling on smoking cessation. The addition of a mobile device with relevant educational materials shared with smokers by clinicians have shown an increase in acceptance of a prescription to aid tobacco cessation. Clinicians are strongly encouraged to find innovative ways to help smoking patients accept aids in successful cessation attempts.

Behavioural Intervention for People Living with HIV/AIDS with Ambivalent Attitudes toward the COVID-19 Vaccine

The COVID-19 vaccination program was made available in Romania first to vulnerable and at-risk groups in specific state-run centers, where people could get an appointment and receive the shot. People Living with HIV/AIDS (PLWHA) represent such a group. In the context of widespread misinformation and debate about the need for vaccination, our team took a proactive approach to assess vaccination levels and intentions among the unvaccinated. 100 PLWHA who declared ambivalent or unprepared to take the vaccine were offered one online or in-person counseling session. As part of the standard counseling protocol, psychologists asked patients about their intention to get vaccinated on a scale from 1 to 10 at the beginning of the session and again at the end. The protocol imposed that the counselor uses any combination of one or more of the following five behavior change techniques (BCTs): information about social and environmental consequences, credible sources, comparative imagining of future outcomes, anticipated regret, and action planning. Additionally, counselors could use other techniques on an ad-hoc basis if they evaluated this as necessary. Out of the 100 PLWHA at the end of the evaluation, 43 reported they took the vaccine. Sixteen patients in the sample said they took the vaccine by their own decision before the counselor reached out. For the entire group, the intention to get vaccinated increased by 3.36 points (t= -13.25, p< .05). At the follow-up evaluation, there was a 3.16-point increase for the group that did not vaccinate (t= -11.38, p< .05); and 4-point increase for PLWHA who did vaccinate (-6.92, p<.05). Overall, the people in the unvaccinated group started with a significantly lower intention at the beginning of the session than those who eventually got the shot (mean 1.96 versus 3.25). The number of BCTs used was similar in the groups, regardless of vaccination status at the end of the assessment. Our experience shows that an increase in the intention to be vaccinated is possible among ambivalent patients, even when the intervention is limited to one session. The intervention helped approximately 32% of the patients. They were able to act and take the steps necessary to receive the COVID vaccine, while the ones who did not yet act reported a higher intention at the end of the intervention. The baseline intention could indicate the necessary number of follow-up sessions until a successful outcome. Health psychologists must further define the set of BCTs needed for subsequent interventions.

Effectiveness of birth plan counselling based on shared decision making: A cluster randomized controlled trial (APLANT).

A birth plan (BP) is a written document in which the pregnant woman explains her wishes and expectations about childbirth to the health professionals and aims to facilitate her decision-making. Midwives' support to women during the development of the BP is essential, but it's unknown if shared decision making (SDM) is effective in birth plan counselling. We hypothesized that women who receive counselling based on SDM during their pregnancy are more likely to present their BP to the hospital, more satisfied with the childbirth experience, and have better obstetric outcomes than women who receive standard counselling. We also aimed to identify if women who presented BP to the hospital have better obstetric outcomes and more satisfied with the childbirth experience. This was a randomised cluster trial involving four Primary Care Units. Midwives provided BP counselling based on SDM to the women in the intervention group (IG) during their pregnancy, along with a leaflet with evidence-based recommendations. Women in the control group (CG) only received the standard birth plan counselling from midwives. The primary outcomes were birth plan presentation to the hospital, obstetrics outcomes and satisfaction with childbirth experience. The Mackey Satisfaction with Childbirth Scale (MCSRS) was used to measure childbirth satisfaction. A total of 461 (95.5%) pregnant women received BP counselling (IG n = 214 and CG n = 247). Fewer women in the intervention group presented their BP to the hospital compared to those in the control group (57.8% vs 75.1%; p <0.001). Mean satisfaction with childbirth experience was high in the IG as well as the CG: 150.2 (SD:22.6) vs. 153.4 (SD:21.8); p = 0.224). The information received about childbirth during pregnancy was high in both groups (95.1% vs 94.8%; p = 1.0). Fewer women in the IG used analgesia epidural compared to those in the CG (84.7% vs 91.7%; p = 0.034); women who combined non-pharmacological and pharmacological methods for pain relief were more in number in the IG (48.9% vs 29.5%; p = 0.001) and women who began breastfeeding in the delivery room were more in number in the IG (83.9% vs 66.3%; p = 0.001). Women who presented their BP had a greater probability of using combined non-pharmacological and pharmacological methods for pain relief aOR = 2.06 (95% CI: 1.30-4.30) and early skin-to-skin contact aOR = 2.08 (95% CI: 1.07-4.04). This counselling intervention was not effective to increase the presentation of the BP to the hospital and women's satisfaction with childbirth; however, it was related to a lower usage of analgesia epidural, a higher combination of pharmacological and non-pharmacological methods for pain relief and the initiation of breastfeeding in the delivery room. Presenting the BP to the hospital increased the likelihood of using pharmacological and non-pharmacological methods for pain relief, and early skin-to-skin contact.

P78. Assessment of preoperative barriers to appropriate opioid use and the ability of these barriers to change after elective spine surgery

<h3>BACKGROUND CONTEXT</h3> Various barriers to appropriate postoperative opioid use have been identified in patients undergoing spine surgery. However, knowledge is limited on whether or not these barriers change as a result of going through the experience of surgery. <h3>PURPOSE</h3> The aim of this study is to assess how barriers to appropriate opioid use change in patients following elective spine surgery. <h3>STUDY DESIGN/SETTING</h3> Retrospective chart review. <h3>PATIENT SAMPLE</h3> Adult patients (18 years old) who underwent elective spine surgery and completed the short version of the Barriers Questionnaire Taiwan (S-BQT) and Patient Reported Outcomes Measures Information System (PROMIS) questionnaires preoperatively and at 1-year postoperative followup. <h3>OUTCOME MEASURES</h3> Opioid barriers score (OBS) derived from the summation of subscores within the S-BQT questionnaire, patient reported comfort with the use of naloxone and confidence in nonopioid medications to effectively manage postoperative pain. <h3>METHODS</h3> A preoperative and 1-year postoperative OBS (0-35) was calculated for each patient using their S-BQT surveys. A high opioid barriers score (hOBS) was defined as a score above the sample 75th percentile (OBS > 16). Postoperative changes in patient reported confidence in nonopioid medications and comfort with the use of naloxone were assessed. Abnormal PROMIS scores were defined as: high pain interference, sleep disturbance, anxiety, depression, fatigue for scores 60; and low physical function and social roles satisfaction for scores 40. Bivariate statistics and multivariate regression were used to assess for factors associated with high OBS and postoperative changes, while controlling for age, sex, Charlson Comorbidity Index (CCI), prior opioid use, procedure and spinal region. <h3>RESULTS</h3> Within 98 patients who met inclusion criteria, there were no differences in preoperative versus postoperative OBS (11.9 ± 6.4 vs 12.2 ± 7.1, p = 0.80). At both time points, fear of addiction was the highest S-BQT subdomain score. Postoperatively, there was an increase in patient reported confidence in nonopioid medications for pain control (p = 0.01), but no changes were observed in confidence with the use of naloxone (p = 0.70). Preoperatively, the odds of having hOBS (OBS >16) were increased with high anxiety (Odds Ratio [OR] 9.8, 95% Confidence Interval [CI] 1.8 - 66.7) and decreased with prior opioid use (OR 0.10, 95%CI 0.02-0.40). Postoperatively, high sleep interference (OR 7.0, 95%CI 1.2 - 44.9), depression (OR 8.7, 95%CI 1.2-82) and low social satisfaction (OR 7.5, 95%CI 1.3 -54.3) were associated with increased odds of developing hOBS in patients with previously normal barrier scores (OBS <16). <h3>CONCLUSIONS</h3> No significant changes in barriers to appropriate opioid use or patient reported comfort with naloxone were observed following the experience of spine surgery. These findings underscore the need for standardized preoperative opioid counseling to promote safe and appropriate opioid use following surgery. Patients with high levels of anxiety are likely to benefit most from these sessions as they may be predisposed to having significant barriers to appropriate postoperative opioid use. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

A Telehealth Intervention for Nutritional Counseling in Amyotrophic Lateral Sclerosis Patients.

Nutritional status is one of the most relevant prognostic factors in Amyotrophic Lateral Sclerosis (ALS), and close monitoring can help avoid severe weight loss over the disease course. We describe the impact of a Chatbot webapp on improving the communications between physicians, patients, and/or caregivers for dietary monitoring. We developed a chatbot that provides patients with a tool to register their meals through an intuitive and carefully designed conversational interface. Patients recorded their dietary intake twice weekly and received an adequate nutritional recommendation monthly. We monitored their functional and nutritional parameters. The data were compared with a control group followed up by standard counseling. We enrolled 26 patients. Regarding feasibility, 96% of participants completed the three-month follow-up, and 77% ended the six months. Regarding the change in weight in the Chatbot group, we observed a weight stabilization (F = 1.874, p-value: 0.310 for changes) over the telehealth compared to the control group (F = 1.710, p-value: 0.024 for changes). A telehealth approach for nutritional support is feasible and reproducible in an ALS setting: frequent monitoring turned out to help prevent further weight loss, allowing an early nutritional strategy adjustment.

Prescribing Time in Nature for Human Health and Well-Being: Study Protocol for Tailored Park Prescriptions.

BackgroundeHealth technologies offer an efficient method to integrate park prescriptions into clinical practice by primary health care (PHC) providers to help patients improve their health via tailored, nature-based health behavior interventions. This paper describes the protocol of the GoalRx Prescription Intervention (GPI) which was designed to leverage community resources to provide tailored park prescriptions for PHC patients.MethodsThe GPI study was designed as a 3-arm, multi-site observational study. We enrolled low-income, rural adults either at-risk of or living with hypertension or diabetes (n = 75) from Federally Qualified Health Centers (FQHC) in two counties in North Carolina, USA into the 3-month intervention. Eligible participants self-selected to receive (1) a tailored park prescription intervention; (2) a tailored home/indoor PA prescription intervention; or (3) a healthy eating prescription (with no PA prescription beyond standard PA counseling advice that is already routinely provided in PHC) as the comparison group. The GPI app paired patient health data from the electronic health record with stated patient preferences and triggered app-integrated SMS motivation and compliance messaging directly to the patient. Patients were assessed at baseline and at a 3-month follow-up upon the completion of the intervention. The primary outcome (mean difference in weekly physical activity from baseline (T0) to post-intervention (T1) as measured by the Fitbit Flex 2) was assessed at 3 months. Secondary outcomes included assessment of the relationship between the intervention and biological markers of health, including body mass index (BMI), systolic and diastolic blood pressure, HbA1c or available glucose test (if applicable), and a depression screen score using the Patient Health Questionnaire 9. Secondary outcomes also included the total number of SMS messages sent, number of SMS messages responded to, number of SMS messages ignored, and opt-out rate.DiscussionThe goal was to create a protocol utilizing eHealth technologies that addressed the specific needs of rural low-income communities and fit into the natural rhythms and processes of the selected FQHC clinics in North Carolina. This protocol offered a higher standard of health care by connecting patients to their PHC teams and increasing patient motivation to make longer-lasting health behavior changes.

A prospective randomized trial of standard versus multimedia-supplemented counseling in patients undergoing endometrial cancer staging surgery

ObjectivesA patient's understanding of surgery is often limited, especially in the setting of complex oncologic procedures. The use of supplemental materials can improve patients' knowledge of their procedure and satisfaction with decision making. We sought to determine if a multimedia-supplemented approach in patients undergoing robotic endometrial cancer staging improves satisfaction with preoperative counseling. Secondary objectives were patient comprehension, physician satisfaction, and visit length. MethodsFrom 2018 to 2019, patients were randomized to standard physician education (SPE) or multimedia-based education (MBE), which included watching two novel videos followed by focused physician counseling. Basic demographic information was collected. Patient satisfaction was assessed using the Client Satisfaction Questionnaire-8 (CSQ-8, a validated satisfaction survey, scored 8–32) and a global satisfaction score (GGS, 10-point scale). Physician satisfaction was assessed using a GGS. Comprehension was assessed with a study-specific 9-question survey at three time points. t-tests and linear mixed models were used to compare groups. ResultsOf the 75 patients included in the analysis, the majority were white (70%), 50–70 years old (72%), and had at least some college education (74%). The MBE group reported higher satisfaction on the CSQ-8 (31.69 vs 30.69, p < 0.01) and global satisfaction score (9.95 vs 9.74, p = 0.04). There was no difference in comprehension scores over time (p = 0.84) or between groups (p = 0.23). Visit lengths were significantly longer in the MBE group (90.36 vs 80.46 min, p = 0.04). ConclusionsPatients had high satisfaction and comprehension with both SPE and MBE. Multimedia education may be implemented in preoperative counseling based on provider preference and consideration should be made for further study of satisfaction, both patient and physician, and visit length after the initial implementation period.

Dehydration Reduction in Head and Neck Cancer (DRIHNC) Trial: Daily Oral Fluid and Electrolyte Maintenance to Prevent Acute Care Clinic and Emergency Department Visits for Patients Receiving Radiation for Head and Neck and Esophageal Cancer

PurposePatients with head and neck (H&N) and esophageal cancer are at high risk for treatment-related symptomatic dehydration, often leading to interventions and hospital admissions. We tested the hypothesis that preemptive daily oral hydration during curative-intent radiation therapy would decrease dehydration as measured by intravenous fluid (IVF) delivery, acute care clinic (ACC) visits, and emergency department (ED) presentations. Methods and MaterialsPatients with H&N or esophageal cancer undergoing definitive radiation therapy were enrolled in this prospective pilot study. Beyond standard nutritional counseling, patients were given one 20-oz bottle of an electrolyte-infused solution (EIS) daily throughout treatment. Compliance, presentations to the hospital ACC and/or ED for dehydration-related indications, and IVF infusions were documented and compared with a matched contemporary control cohort. The incidence and frequency of outcomes were compared with the Fisher exact test and Wilcoxon rank-sum test, respectively. ResultsThirty-one patients were compared during a 6-month period. Mean and median compliance rates were 87.4% and 100%, respectively. There were 0 unplanned dehydration-related ED presentations in the study group versus 3 (9.7%) among controls (P = .08). Of patients in the intervention cohort, 32.3% required presentation to the ACC, versus 64.5% in the control cohort (P = .02), with a total of 26 versus 117 visits, respectively (P = .002). On multivariable analysis, receipt of the EIS in the intervention cohort was the only significantly associated factor (P = .02). Among patients in the intervention cohort, 35.5% required IVF during treatment, versus 64.5% among controls (P = .004). The difference in ACC visits (P = .003) and IVF received (P = .008) was especially notable among patients with esophageal cancer. Patients with ≥60% EIS compliance had slightly fewer ACC visits versus those with <60% compliance (P = .067). ConclusionsRegimented oral hydration during radiation for H&N and esophageal cancer was associated with a significant decrease in ACC visits and IVF delivery during definitive radiation therapy. This noninvasive and inexpensive preventative program in a high-risk cohort warrants further study.

In vivo Experience With NRT to Increase Adherence and Smoking Abstinence Among Individuals in the Criminal Legal System: Study Protocol for a Randomized Clinical Trial.

BackgroundWhile tobacco use among individuals involved in the criminal legal system remains 3–4 times higher than the general population, few interventions have been targeted for this population to aid in smoking cessation. Nicotine replacement therapy (NRT) is a relatively effective and accessible smoking cessation aid; however, individuals frequently stop use of NRT early due to side effects and misperceptions about the products. The present study aims to address low medication adherence by examining the efficacy of an “in vivo” NRT sampling experience in individuals under community criminal legal supervision.MethodsFollowing recruitment through community legal outlets, participants (N = 517) are randomized to either an “in vivo NRT sampling” group or a standard smoking cessation behavioral counseling group. The in vivo group uses NRT in session and discusses perceptions and experiences of using NRT in real time while the standard smoking cessation counseling group receives four sessions of standard behavioral smoking cessation counseling. Both groups receive four intervention sessions and 12 weeks of NRT following the intervention. The 6-month post-intervention primary outcome measures are smoking point-prevalence abstinence and medication adherence.ConclusionThis is a novel smoking cessation intervention specifically aimed at increasing NRT adherence and smoking cessation among those involved in the criminal legal system, a group of individuals with high smoking rates and low rates of pharmacotherapy use. If proven effective, the present treatment could be a novel intervention to implement in criminal legal settings given the minimal requirement of resources and training.This trial is registered with www.clinicaltrials.gov-NCT02938403

Determining concordance of LFSPRO TP53 germline carrier risk predictions to standard genetic counseling practice.

10593 Background: Li-Fraumeni Syndrome (LFS) is a hereditary cancer syndrome associated with a germline mutation in the TP53 tumor suppressor gene and an increased risk of developing a spectrum of cancers throughout a carrier’s lifetime. Early cancer detection in patients with TP53 mutations can dramatically improve cancer survival rates. However, it can be difficult to identify patients at risk of LFS due to the overlap of the multiple cancer types with other inherited cancer syndromes. Risk prediction modeling has been widely accepted by the clinical community, however, currently there is not an available tool to assist in risk prediction of LFS during genetic counseling sessions. LFSPRO is a statistical model that has previously been validated on large research cohorts in predicting the likelihood of a proband having LFS based off detailed patient and family history information. To improve the clinical utility of LFSPRO, a user-friendly interface is still needed. Additionally, we aim to evaluate concordance between LFSPRO’s abilities in predicting the likelihood of a proband having LFS and currently established clinical testing criteria. Methods: We developed a Shiny App to create a user-friendly interface for genetic counselors (GCs) to run LFSPRO. Determining concordance of LFSPRO to standard germline testing criteria and the clinical utility of the LFSPRO Shiny App is underway by GCs within the Department of Clinical Cancer Genetics at MD Anderson Cancer Center through prospective data collection and completion of user surveys. Following a standard genetic counseling session, individuals identified as concerning for a potential germline TP53 mutation are evaluated with LFSPRO to compare performance of the model to established TP53 testing guidelines. Concordance is then evaluated in prediction of TP53 mutation carrier status from LFSPRO, current clinical criteria and clinical judgment. Data collection began 12/21/2021 and is currently ongoing. Results: Close collaboration with GCs and clinicians on the development of the LFSPRO Shiny App has achieved automated de-identified input data, clear pedigree drawing, important demographic data, interpretable risk results and risk visualizations to be used at the GC's discretion. To date, 29 individual’s family data have been run through LFSPRO. Of these, 11 have not currently completed TP53 testing and concordance cannot be determined. Of the 18 remaining, 14 individuals’ LFSPRO results were concordant with current clinical criteria. Further data collection is needed to appropriately analyze concordance. Conclusions: The LFSPRO Shiny App aims to provide an additional tool for GCs and clinical providers to assess patient risk for LFS. This ongoing study will help establish the clinical utility of LFSPRO in a single institution’s genetic counseling practice with the potential to be applied to other patient care settings in the future.

Acceptability, Adaptability, and Feasibility of a Novel Computer-Based Virtual Counselor-Delivered Alcohol Intervention: Focus Group and In-depth Interview Study Among Adults With HIV or Tuberculosis in Indian Clinical Settings.

BackgroundUnhealthy alcohol use is associated with increased morbidity and mortality among persons with HIV and tuberculosis (TB). Computer-based interventions (CBIs) can reduce unhealthy alcohol use, are scalable, and may improve outcomes among patients with HIV or TB.ObjectiveWe assessed the acceptability, adaptability, and feasibility of a novel CBI for alcohol reduction in HIV and TB clinical settings in Pune, India.MethodsWe conducted 10 in-depth interviews with persons with alcohol use disorder (AUD): TB (6/10), HIV (2/10), or HIV-TB co-infected (1/10) selected using convenience sampling method, no HIV or TB disease (1/10), 1 focus group with members of Alcoholics Anonymous (AA; n=12), and 2 focus groups with health care providers (HCPs) from a tertiary care hospital (n=22). All participants reviewed and provided feedback on a CBI for AUD delivered by a 3D virtual counselor. Qualitative data were analyzed using structured framework analysis.ResultsThe majority (9/10) of in-depth interview respondents were male, with median age 42 (IQR 38-45) years. AA focus group participants were all male (12/12), and HCP focus group participants were predominantly female (n=15). Feedback was organized into 3 domains: (1) virtual counselor acceptability, (2) intervention adaptability, and (3) feasibility of the CBI intervention in clinic settings. Overall, in-depth interview participants found the virtual counselor to be acceptable and felt comfortable honestly answering alcohol-related questions. All focus group participants preferred a human virtual counselor to an animal virtual counselor so as to potentially increase CBI engagement. Additionally, interaction with a live human counselor would further enhance the program’s effectiveness by providing more flexible interaction. HCP focus group participants noted the importance of adding information on the effects of alcohol on HIV and TB outcomes because patients were not viewed as appreciating these linkages. For local adaptation, more information on types of alcoholic drinks, additional drinking triggers, motivators, and activities to substitute for drinking alcohol were suggested by all focus group participants. Intervention duration (about 20 minutes) and pace were deemed appropriate. HCPs reported that the CBI provides systematic, standardized counseling. All focus group and in-depth interview participants reported that the CBI could be implemented in Indian clinical settings with assistance from HIV or TB program staff.ConclusionsWith cultural tailoring to patients with HIV and TB in Indian clinical care settings, a virtual counselor–delivered alcohol intervention is acceptable and appears feasible to implement, particularly if coupled with person-delivered counseling.

The impact of an interactive multimedia educational platform on patient comprehension and anxiety during fertility treatment: a randomized controlled trial

ObjectiveTo assess the impact of an interactive multimedia educational platform and consent process on patient comprehension and anxiety state compared with standard fertility counseling and paper consents in patients undergoing ovulation induction–intrauterine insemination (OI-IUI) or in vitro fertilization (IVF) throughout their first infertility treatment cycle.DesignProspective randomized controlled trial.SettingA university-affiliated reproductive endocrinology and infertility clinic.Patient(s)Patients aged 18–45 years undergoing their first OI-IUI or IVF cycle.Intervention(s)An interactive multimedia educational and consent platform (EngagedMD-[EMD]) before and during the first infertility treatment, in addition to standard fertility counseling by the physician and nurse team.Main Outcome Measure(s)Three survey time points: before the start of treatment (T1), at the start of treatment (T2), and at the completion of the treatment cycle (IUI or oocyte retrieval; T3). The main outcome measure was the comprehension score on a 15-question assessment administered at 2 times points (T2 and T3). The anxiety state at all 3 time points was assessed using a modified Spielberger State-Trait Anxiety Inventory score.Result(s)Eighty-six patients were included: 21 in the OI-IUI conventional (i.e., standard fertility counseling group) group, 22 in the IVF conventional group, 21 in the OI-IUI EMD group, and 22 in the IVF EMD group. Overall, the average number correct on the 15-question comprehension assessment was significantly higher in the EMD groups than in the conventional groups at T2 (EMD: 13.2 ± 1.8 vs. conventional: 11.7 ± 1.8) but not at T3. For those undergoing IVF, the average number correct was significantly higher at both T2 and T3 in the EMD vs. the conventional group (T2: 14.1 ± 1.3 vs. 12.4 ± 1.8; T3: 14.1 ± 1.7 vs. 12.5 ± 1.5). The average State-Trait Anxiety Inventory scores at each time point were similar between the EMD and conventional groups for both OI-IUI and IVF groups. Age ≤35 years and IVF treatment were significant predictors of increased State-Trait Anxiety Inventory scores.Conclusion(s)The addition of an interactive multimedia educational platform significantly improved patient comprehension at the initiation of OI-IUI and IVF cycles for patients undergoing fertility treatment for the first time. Those undergoing IVF with access to EMD had sustained, improved comprehension at the end of their treatment. The supplementation of a multimedia platform did not alter anxiety throughout the treatment. Younger patients undergoing IVF may benefit from increased psychological resources.Clinical Trial Registration NumberNCT03962257.

Optimizing an mHealth Intervention to Improve Uptake and Adherence to HIV Pre-exposure Prophylaxis in Young Transgender Women: Protocol for a Multi-Phase Trial.

BackgroundVulnerable adolescents and emerging adults (aged 18-29 years), particularly young transgender women, are among the fastest-growing HIV positive populations worldwide. Thailand has the highest adult HIV seroprevalence in Asia, with a rate of infection among this population of 18%. Widespread technology offers opportunities for innovative mobile health (mHealth) interventions. Pre-exposure prophylaxis (PrEP) is an efficacious HIV prevention strategy recommended for at-risk individuals. PrEP is highly effective when taken as prescribed, but uptake and adherence have been low, with high discontinuation rates among youth.ObjectiveWe propose to develop and pilot a multi-component, technology-based intervention to promote PrEP usage. We will adapt an existing 2-session, technology-delivered, motivational interviewing-based intervention to focus on PrEP use in transgender women in Thailand. We call this the Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP). We will also refine and enhance YaCool, a mobile app with integrated text messaging developed and used clinically by our Thai team. The new version of the app is called Enhanced YaCool, and it enables self-management of gender and sexual health (including PrEP). Our primary aim is to develop and assess the preliminary efficacy of this mHealth intervention.MethodsWe will utilize a multiphase optimization strategy (MOST) to identify the most effective intervention component or combination of components to improve PrEP usage in Thai transgender women. The study includes two phases: phase I (R21) includes qualitative interviews with key stakeholders to explore barriers and facilitators of PrEP usage through thematic analysis to inform intervention adaptation. Following this, we will adapt and beta-test MES-PrEP and Enhanced YaCool for functionality and feasibility using a community advisory board of HIV-negative Thai transgender women. In phase II (R33), we will conduct a MOST design-based trial to evaluate the feasibility, acceptability, and preliminary efficacy of MES-PrEP and Enhanced YaCool. Eighty HIV-negative participants who are currently taking PrEP and 80 participants who are not will be randomized to four conditions: (1) standard PrEP counseling (the control condition); (2) MES-PrEP and standard PrEP counseling; (3) Enhanced YaCool and standard PrEP counseling; and (4) MES-PrEP, Enhanced YaCool, and standard PrEP counseling. Feasibility and acceptability of the intervention will be assessed through usage patterns and the System Usability Scale. Preliminary impact will be assessed by evaluating the proportion of participants who initiate PrEP and their level of adherence to PrEP. Assessments will be at baseline and 1, 3, 6, 9, and 12 months postintervention. Biomarkers of adherence to PrEP, HIV, and other sexually transmitted infections will be collected.ResultsUpon project completion, we will have an optimized mHealth intervention to support the use of PrEP by transgender women that will be ready for testing in a larger efficacy trial.ConclusionsEven though transgender women in Thailand face increasing risks of HIV, few interventions have targeted them. Effective developmentally and culturally tailored interventions are needed to prevent HIV transmission in this high-risk population.Trial RegistrationClinicalTrials.gov NCT05262426; https://clinicaltrials.gov/ct2/show/NCT05262426International Registered Report Identifier (IRRID)PRR1-10.2196/37659

Maternal and child surveillance in peri-urban communities: Perceptions of women and community health workers from Pakistan.

Community health workers (CHWs) in maternal, newborn, and child health (MNCH) programs play an important role in demographic surveillance activities; however, there is lack of literature regarding the community and CHWs' perceptions about these activities. The purpose of this study was to explore perceptions of married women of reproductive age (MWRA) regarding the role of CHWs involved in maternal and child surveillance and explore facilitators and barriers for CHWs involved in surveillance activities. A qualitative study was conducted in five peri-urban surveillance sites along the coastal belt of Bin Qasim Town, Karachi, Pakistan. In-depth interviews were conducted with 25 randomly selected MWRAs and 15 CHWs. A thematic analysis was performed to explore perceptions, barriers, and facilitators of the study participants about maternal and child surveillance activities. The results showed that MWRAs perceived surveillance CHWs as service providers with regards to standard counselling i.e. importance of antenatal care, nutrition, immunization, and distribution of iron and folic acid tablets to pregnant women, child growth assessment, and referral of sick children to the health facility. Trust in the CHWs was an enabler for MWRAs, whereas lack of incentives was cited as a barrier to share their health data. CHWs perceived themselves as a bridge in liaising community with the primary health care facility. They highlighted an enabling environment such as appreciation, supportive supervision, training, and utilization of digital data collection tools as facilitators for their work. Low health literacy of the communities, lack of provision of incentives by CHWs to the community, and facility-based experiences of the community were reported as barriers. Surveillance CHWs are an integral link between the health facility and MWRAs. Hence an enabling environment may lead to improved health service delivery, translating into meaningful impact for the mother and child.

Addressing opioid medication misuse at point of service in community pharmacy: A study protocol for an interdisciplinary behavioral health trial

Background>1 in 3 of the 9 million individuals engaged in opioid medication misuse obtain legitimate opioid prescriptions and fill these in community pharmacies, which are subsequently misused. This study is testing the efficacy of a pharmacist-led intervention—Brief Intervention-Medication Therapy Management (BI-MTM)—compared to standard medication counseling (SMC) to address opioid medication misuse. MethodsDesign. This study is a single-blinded 2-group parallel randomized trial within 13 community pharmacies that will enroll 350 individuals. Participant Recruitment. Pharmacy staff approach patients and ask about interest in completing a brief confidential screening tool, which includes opioid medication misuse assessment. Interested patients who report misuse are asked to provide informed consent. Enrolled patients are assessed for behavioral and physical health at enrollment, 2-months post-enrollment, and 6-months post-enrollment. Interventions. Following baseline assessment, participants are randomized (1:1 ratio) to: SMC, a medication information/counseling intervention or BI-MTM, an intervention comprised by 4 evidence-based components: medication therapy management, brief intervention, naloxone dispensing, and patient navigation. Analyses. Primary analyses involve estimating 3-level generalized linear mixed models to relate repeated assessments across time of opioid medication misuse (i.e., the Prescription Opioid Misuse Index) to the intervention. ConclusionStudy results will provide the first critical step towards integrating a highly accessible, low-cost approach to managing risks related to opioid use. Community pharmacies provide an incredibly important setting in which patients can receive high quality care to support health behavior change. Successfully completing this project sets the stage for a large-scale effectiveness study. (NCT#: NCT05141266).

Participatory Ergonomics Intervention to Prevent Work Disability Among Workers with Low Back Pain: A Randomized Clinical Trial in Workplace Setting

Purpose In order to support people with low back pain (LBP) to stay at work, work arrangements are regarded important. This study aimed to evaluate the effectiveness of a workplace intervention using a participatory approach on work disability of workers with ongoing or recurrent LBP. Methods A total of 107 workers with LBP, with duration of pain for at least two consecutive weeks or recurrent pain of any duration during the last year, were randomized either to the intervention (n = 51) or control group (n = 56). The intervention included arrangements at the workplace, along with individual guidance provided by an occupational physiotherapist (OPT). The randomized intervention study used standard counselling and guidance by an OPT without workplace intervention as a comparison. Surveys were completed at baseline, and 6 and 12 months after baseline. Results There were no statistically significant differences between the intervention and control groups on the primary outcome measure, i.e. self-assessed work ability. We found no between-group differences in perceived health, self-assessed work productivity, number of sickness absence days and severity of back pain. However, there were significant positive within-group changes in the intervention group in the intensity of LBP, perceived health and the number of sickness absence days due to LBP. Conclusion Workplace arrangements are feasible using participatory ergonomics, but more quantitative and qualitative research is needed on its utilization and effectiveness among workers with LBP.

Effect of drug use calendar on adherence to iron chelation therapy in young thalassemia patients.

Background:Regular blood transfusions in thalassemia patients can lead to severe complications and iron chelation therapy is required as a treatment. Thalassemia is common in Thailand and the drugs used in iron chelation therapy are deferoxamine and deferiprone. Adherence to the therapy is a key factor for treatment success.Objective:To assess the impact of a drug use calendar on deferiprone and deferoxamine adherence in young thalassemia patients.Methods:A total of 86 young thalassemia outpatients at a Thai tertiary care hospital were recruited into the study. Patients were stratified into two groups based on self-assessment of adherence using a visual analogue scale. One group (n=41) was given a calendar with the schedule of drug use in addition to counselling as standard pharmaceutical care. The second group (n=45) only received the counselling. Adherence to iron chelation therapy was assessed by deferiprone pill or deferoxamine vial counts on six visits (V1 to V6) and results were compared between visits and groups using a multilevel linear regression model. Change in serum ferritin levels after 6 visits (n = 81) were compared using a linear regression model.Results:Adherence significantly increased in both the calendar and non-calendar groups for deferiprone mono- and combination-therapy and for deferoxamine monotherapy. In the calendar groups, average adherence increased by between 2.05 and 5.66% per visit compared to increases of 0.31 to3.92% per visit in the non-calendar groups. A significant difference in the increase in adherence per visit between the calendar and non-calendar groups was only observed for deferiprone monotherapy (3.03% SEM = 0.49vs 1.42% SEM =0.49, respectively, P-value = 0.0078). The serum ferritin level decreased in the calendar group by 20.25ng/mL (SEM = 23.80) and increased in the non-calendar group by 59.63 ng/mL (SEM = 23.01, P-value = 0.0147).Conclusion:Provision of a drug use calendar improved adherence to deferoxamine and deferiprone and decreased serum ferritin levels in young Thai thalassemia patients over the improvements obtained from standard counselling.

Effect of Home-Based Education Program on Mothers’ Postpartum Quality of Life After Cesarean Delivery

The aim of this study was to determine the effect of a home-based educational program on postpartum quality of life in puerperant women after caesarean delivery. The study was designed as a prospective, controlled, single-blinded study. It was conducted in a family health centre in Istanbul with 60 women, including 30 home-based educational group and 30 standard counselling as a control group woman who had a caesarean delivery. The study data were collected by using a questionnaire, namely, the Maternal Postpartum Quality of Life (MAPP-QOL) Tool. The mothers’s mean age was 29.55 years. The post- intervention means and standard deviations (SDs) in the total scores of the MAPP-QOL were 17.93 (SD: 1.09) and 19.27 (SD: 0.90) for the control and home-based education groups, respectively, and we found that the difference was statistically significant (p

The effects of the Green-Mediterranean diet on cardiometabolic health are linked to gut microbiome modifications: a randomized controlled trial

BackgroundPrevious studies have linked the Mediterranean diet (MED) with improved cardiometabolic health, showing preliminary evidence for a mediating role of the gut microbiome. We recently suggested the Green-Mediterranean (Green-MED) diet as an improved version of the healthy MED diet, with increased consumption of plant-based foods and reduced meat intake. Here, we investigated the effects of MED interventions on the gut microbiota and cardiometabolic markers, and the interplay between the two, during the initial weight loss phase of the DIRECT-PLUS trial.MethodsIn the DIRECT-PLUS study, 294 participants with abdominal obesity/dyslipidemia were prospectively randomized to one of three intervention groups: healthy dietary guidelines (standard science-based nutritional counseling), MED, and Green-MED. Both isocaloric MED and Green-MED groups were supplemented with 28g/day walnuts. The Green-MED group was further provided with daily polyphenol-rich green tea and Mankai aquatic plant (new plant introduced to a western population). Gut microbiota was profiled by 16S rRNA for all stool samples and shotgun sequencing for a select subset of samples.ResultsBoth MED diets induced substantial changes in the community structure of the gut microbiome, with the Green-MED diet leading to more prominent compositional changes, largely driven by the low abundant, “non-core,” microorganisms. The Green-MED diet was associated with specific microbial changes, including enrichments in the genus Prevotella and enzymatic functions involved in branched-chain amino acid degradation, and reductions in the genus Bifidobacterium and enzymatic functions responsible for branched-chain amino acid biosynthesis. The MED and Green-MED diets were also associated with stepwise beneficial changes in body weight and cardiometabolic biomarkers, concomitantly with the increased plant intake and reduced meat intake.Furthermore, while the level of adherence to the Green-MED diet and its specific green dietary components was associated with the magnitude of changes in microbiome composition, changes in gut microbial features appeared to mediate the association between adherence to the Green-MED and body weight and cardiometabolic risk reduction.ConclusionsOur findings support a mediating role of the gut microbiome in the beneficial effects of the Green-MED diet enriched with Mankai and green tea on cardiometabolic risk factors.Trial registrationThe study was registered on ClinicalTrial.gov (NCT03020186) on January 13, 2017.