Delivering an mHealth Adherence Support Intervention for Patients With HIV: Mixed Methods Process Evaluation of the Philippines Connect for Life Study.

BACKGROUND: The Philippines HIV epidemic is one of the fastest growing epidemics globally, and infections among men who have sex with men are increasing at an alarming rate. Connect for Life Philippines is a mobile health (mHealth) intervention that supports antiretroviral therapy (ART) adherence in this key population through individualized voice calls and SMS text messages. OBJECTIVE: The objective of this process evaluation is to assess the intervention reach, dose delivered and received, fidelity, and acceptability and to describe contextual factors affecting the implementation of an mHealth adherence support intervention for patients on ART in a clinic in Metro Manila, Philippines. METHODS: A mixed methods process evaluation approach was used in an observational cohort study. Quantitative data sources for the process evaluation were call and SMS text message logs obtained from the mHealth platform and questionnaires collected at 12-, 24-, and 48-week study visits. Qualitative data were collected from process reports and through a series of focus group discussions conducted with a subset of participants during the intervention development phase, after an initial 8-week pilot phase, and at the end of the study. RESULTS: The 462 study participants received 31,095 interactive voice calls and 8234 SMS text messages during the study. Owing to technical issues, intervention fidelity was low, with only 22.1% (102/462) of the participants receiving reminders via voice calls and others (360/462, 77.9%) receiving only SMS text messages during the intervention. After 48 weeks in the study, 63.5% (293/462) of the participants reported that they would be quite likely or very likely to recommend the program to a friend, and 53.8% (249/462) of the participants reported that they benefited quite a bit or very much from the intervention. Participants who were on ART for <6 months at the beginning of the study and those who received the daily or weekly pill reminders were more likely to report that they benefited from the intervention (P=.02 and P=.01, respectively). CONCLUSIONS: The Connect for Life intervention had high participant satisfaction and acceptability, especially among those who received high dose of the intervention. However, poor reliability of local telecommunication networks had a large impact on the intervention's usability, fidelity, and dose received.

Interactive Mobile Phone HIV Adherence Support for Men Who Have Sex With Men in the Philippines Connect for Life Study: Mixed Methods Approach to Intervention Development and Pilot Testing.

BACKGROUND: The HIV epidemic in the Philippines is one of the fastest growing epidemics globally, and infections among men who have sex with men are rising at an alarming rate. The World Health Organization recommends the use of mobile health (mHealth) technologies to engage patients in care and ensure high levels of adherence to antiretroviral therapy (ART). Existing mHealth interventions can be adapted and tailored to the context and population served. OBJECTIVE: This study aims to create a locally tailored intervention using a mobile phone platform to support treatment adherence for HIV patients on ART in the Philippines. METHODS: A mixed methods approach guided by the Behavior Change Wheel framework was used to adapt an existing mHealth adherence support platform for the local setting and target population. A literature review, retrospective clinical record review, and focus group discussions with patients were conducted to understand the drivers of ART adherence and tailor the intervention accordingly. The resulting intervention was pilot-tested for 8 weeks, followed by focus group discussions with patients who received the intervention to assess the acceptability of the design. RESULTS: Key issues contributing to nonadherence included side effects, lack of behavioral skills for pill taking, social support, mental health, and substance use. Patients identified mHealth as an acceptable mode of intervention delivery and wanted mHealth services to be highly personalizable. The study team, clinicians, and software developers integrated these findings into the intervention, which included a menu of services as follows: pill reminders, health tips, adherence feedback, appointment reminders, and symptom reporting. During the pilot phase, technical issues in the interactive voice response system (IVRS) were identified and addressed. Patients who participated in the pilot phase expressed a preference for SMS text messaging over the IVRS. Patients responded positively to the appointment reminders and health tips, whereas patient feedback on daily and weekly pill reminders and adherence feedback was mixed. CONCLUSIONS: The mobile phone-based SMS text messaging and IVRS intervention was acceptable to men who have sex with men in Manila, the Philippines, and qualitative analysis suggested that the intervention helped promote ART adherence and appointment attendance.

Risk factors affecting adherence to antiretroviral therapy among HIV patients in Manila, Philippines: a baseline cross-sectional analysis of the Philippines Connect for Life Study.

Background The Philippines HIV epidemic is one of the fastest growing, globally. Infections among men who have sex with men (MSM) are rising at an alarming rate, necessitating targeted evidence-based interventions to reach epidemic control. Treatment as prevention is a key strategy to end AIDS, making it a priority to explore novel approaches to retain people living with HIV (PLHIV) in care, support adherence, and reach viral suppression. METHODS: This cross-sectional analysis describes HIV-related risk behaviours and adherence to antiretroviral therapy (ART) in a population of HIV-positive patients at a clinic in Metro Manila, Philippines participating in the Philippines Connect for LifeTM cohort study. RESULTS: Among 426 HIV-positive adults taking ART, 79% reported ≥95% adherence over the prior 30 days. Longer time on treatment was associated with reduced adherence to ART (adjusted odds ratio (AOR) = 0.87 per year, P = 0.027). Being in a serodiscordant relationship, in which the subject's primary partner was HIV negative, increased adherence (AOR = 3.19, P = 0.006). Inconsistent condom use (AOR = 0.50, P = 0.103) and injection drug use (AOR = 0.54, P = 0.090) are potentially associated with reduced adherence to ART. Patients used drugs and alcohol at significantly higher rates than the general population.? CONCLUSIONS: The study found that patients in this setting require intervention to address treatment fatigue. Interventions to improve social support of PLHIV, as well as harm-reduction approaches for drug and alcohol use, could improve adherence in this population, strengthening the test-and-treat strategy to control the epidemic.

The perioperative handoff protocol: evaluating impacts on handoff defects and provider satisfaction in adult perianesthesia care units.

STUDY OBJECTIVE: To evaluate a new perioperative handoff protocol in the adult perianesthesia care units (PACUs). DESIGN: Prospective, unblinded cross-sectional study. SETTING: Perianesthesia care unit in a tertiary care facility serving 55,000 patients annually. PATIENTS: One hundred three surgery patients. INTERVENTIONS: During a 4-week preintervention phase, 53 perioperative handoffs were observed, and data were collected daily by a trained observer. Educational sessions were conducted to train perioperative practitioners on the new protocol. Two weeks after implementation, 50 consecutive handoffs were observed, and practitioners were surveyed with the same methodology as in the preintervention phase. MEASUREMENTS: Type of information shared, type and duration of procedure, total duration of handoff, number and type of providers at the bedside, number of report interruptions, environmental distractions, and any other disruptive events. Observers also tracked technical/equipment problems to include malfunctioning or compromised operation of medical equipment, such as the cardiac monitor, transducer, oxygen tank, and pulse oximeter. MAIN RESULTS: A total of 103 handoffs were observed (53 preintervention and 50 postintervention). The mean number of defects per handoff decreased from 9.92 to 3.68 (P < .01). The mean number of missed information items from the surgery report decreased from 7.57 to 1.2 items per handoff and from 2.02 to 0.94 (P < .01) for the anesthesia report. Technical defects reported by unit nurses decreased from 0.34 to 0.10 (P = .04). Verbal reports delivered by surgeons increased from 21.2% to 83.3%. Although the mean duration of handoffs increased by 2 minutes (P = .01), the average time from patient arrival at PACU to handoff start was reduced by 1.5 minutes (P = .01). Satisfaction with the handoff improved significantly among PACU nurses. CONCLUSIONS: The perioperative handoff protocol implementation was associated with improved information sharing and reduced handoff defects.

Dexmedetomidine preserves attention/calculation when used for cooperative and short-term intensive care unit sedation.

PURPOSE: Differential effects on cognition were recently demonstrated between dexmedetomidine (DEX) and propofol (PRO) when used for cooperative sedation. Propofol was found to reduce cognition, whereas DEX improved cognition. To further discriminate these effects, we evaluated the effect of PRO vs DEX in selected areas of cognition. METHODS: This is a post hoc analysis of the Acute Neurologic Intensive Care Unit Sedation Trial and an investigator-initiated, prospective, randomized, double-blinded, crossover study, comparing the effect of PRO and DEX on cognition measure by the Johns Hopkins Adapted Cognitive Exam (ACE). A linear model analysis accounting for within-patient correlation of measures was used to estimate differences in ACE subscales between drugs. RESULTS: Propofol diminished adjusted scores on all ACE subscales (P < .05), whereas DEX improved adjusted scores selectively for attention/calculation (3.55; 95% confidence interval, 1.49-5.61; P < .01). The positive and significant difference in ACE scores between agents was present across subscales. CONCLUSIONS: Our findings indicate that DEX improved ACE attention/calculation subscale in awake patients receiving cooperative sedation. This is in contrast to the deterioration in all mean ACE subscale scores observed using PRO, suggesting DEX preserved cognitive function with specific preservation of focus and attention and allows for greater cognition compared with PRO across all cognitive domains.

Falling temperature and colder weather are associated with an increased risk of aneurysmal subarachnoid hemorrhage.

OBJECTIVE: To use weather data to predict increased incidence of aneurysmal subarachnoid hemorrhage (aSAH) at a large institution with an extensive referral network in response to falling temperatures. METHODS: In a retrospective study, 1175 prospectively collected aSAH cases accrued over 18 years from one hospital were reviewed to determine if season, maximum ambient temperature (MAT), average relative humidity, and atmospheric pressure were related to incidence of aSAH at that institution on a given day. A Poisson regression model was used to assess daily risk of incident aSAH based on daily MAT and 1-day change in MAT. RESULTS: A MAT decrease of 1°F from one day to the next was associated with a 0.6% increase in risk of aSAH (relative risk [RR]=1.006, P=0.016). The increased risk associated with MAT decrease from the previous day was especially strong for female patients (RR=1.008/°F, P=0.007) and drove the overall model, representing 72% of cases. In addition, warmer temperatures were associated with a decreased risk of aSAH; each 1°F increase in temperature compared with the previous day was associated with a 0.3% decrease in risk of aSAH (RR=0.997; P<0.001). CONCLUSIONS: A 1-day decrease in temperature and colder daily temperatures were associated with an increased risk of incident aSAH at a single institution with a large referral network. These variables appeared to act synergistically and independently of season. These relationships were particularly predominant in the fall when the transition from warmer to colder temperatures occurred.

Perceived benefit of a telemedicine consultative service in a highly staffed intensive care unit.

PURPOSE: The aim of this study was to evaluate whether a nocturnal telemedicine service improves culture, staff satisfaction, and perceptions of quality of care in a highly staffed university critical care system. METHODS: We conducted an experiment to determine the effect of telemedicine on nursing-staff satisfaction and perceptions of the quality of care in an intensive care unit (ICU). We surveyed ICU nurses using a modified version of a previously validated tool before deployment and after a 2-month experimental program of tele-ICU. Nurses in another, similar ICU within the same hospital academic medical center served as concurrent controls for the survey responses. RESULTS: Survey responses were measured using a 5-point Likert scale, and results were analyzed using paired t testing. Survey responses of the nurses in the intervention ICU (n = 27) improved significantly after implementation of the tele-ICU program in the relations and communication subscale (2.99 ± 1.13 pre vs 3.27 ± 1.27 post, P < .01), the psychological working conditions and burnout subscale (3.10 ± 1.10 pre vs 3.23 ± 1.11 post, P < .02), and the education subscale (3.52 ± 0.84 pre vs 3.76 ± 0.78 post, P < .03). In contrast, responses in the control ICU (n = 11) declined in the patient care and perceived effectiveness (3.94 ± 0.80 pre vs 3.48 ± 0.86 post, P < .01) and the education (3.95 ± 0.39 pre vs 3.50 ± 0.80 post, P < .05) subscales. CONCLUSION: Telemedicine has the potential to improve staff satisfaction and communication in highly staffed ICUs.

Validity and reliability of The Johns Hopkins Adapted Cognitive Exam for critically ill patients.

OBJECTIVE: To validate The Johns Hopkins Adapted Cognitive Exam designed to assess and quantify cognition in critically ill patients. DESIGN: Prospective cohort study. SETTING: Neurosciences, surgical, and medical intensive care units at The Johns Hopkins Hospital. PATIENTS: One hundred six adult critically ill patients. INTERVENTIONS: One expert neurologic assessment and four measurements of the Adapted Cognitive Exam (all patients). Four measurements of the Folstein Mini-Mental State Examination in nonintubated patients only. Adapted Cognitive Exam and Mini-Mental State Examination were performed by 76 different raters. MEASUREMENTS AND MAIN RESULTS: One hundred six patients were assessed, 46 intubated and 60 nonintubated, resulting in 424 Adapted Cognitive Exam and 240 Mini-Mental State Examination measurements. Criterion validity was assessed by comparing Adapted Cognitive Exam with a neurointensivist's assessment of cognitive status (ρ = 0.83, p < .001). Ordinal logistic regression established optimal predicted cut points for cognitive status classification (≤ 28 = severely impaired, 29-55 = moderately impaired, ≥ 56 = mildly impaired or normal). Using these cut points, the Adapted Cognitive Exam appropriately classified cognitive status 90% of the time. Construct validity was assessed by comparing Adapted Cognitive Exam with Mini-Mental State Examination in nonintubated patients (ρ = 0.81, p < .001). Face validity was assessed by surveying raters who used both the Adapted Cognitive Exam and Mini-Mental State Examination and indicated the Adapted Cognitive Exam was an accurate reflection of the patient's cognitive status, more sensitive a marker of cognition than the Mini-Mental State Examination, and easy to use. The Adapted Cognitive Exam demonstrated excellent interrater reliability (intraclass correlation coefficient = 0.997; 95% confidence interval 0.997-0.998) and interitem reliability of each of the five subscales of the Adapted Cognitive Exam and Mini-Mental State Examination (Cronbach's α: range for Adapted Cognitive Exam = 0.83-0.88; range for Mini-Mental State Examination = 0.72-0.81). CONCLUSION: The Adapted Cognitive Exam is the first valid and reliable examination for the assessment and quantification of cognition in critically ill patients. It provides a useful, objective tool that can be used by any member of the interdisciplinary critical care team to support clinical assessment and research efforts.

The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial.

BACKGROUND: Data from 12-week placebo-controlled trials have led to mounting concerns about increased mortality in patients with Alzheimer's disease (AD) who are prescribed antipsychotics; however, there are no mortality data from long-term placebo-controlled trials. We aimed to assess whether continued treatment with antipsychotics in people with AD is associated with an increased risk of mortality. METHODS: Between October, 2001, and December, 2004, patients with AD who resided in care facilities in the UK were enrolled into a randomised, placebo-controlled, parallel, two-group treatment discontinuation trial. Participants were randomly assigned to continue with their antipsychotic treatment (thioridazine, chlorpromazine, haloperidol, trifluoperazine, or risperidone) for 12 months or to switch their medication to an oral placebo. The primary outcome was mortality at 12 months. An additional follow-up telephone assessment was done to establish whether each participant was still alive 24 months after the enrollment of the last participant (range 24-54 months). Causes of death were obtained from death certificates. Analysis was by intention to treat (ITT) and modified intention to treat (mITT). This trial is registered with the Cochrane Central Registry of Controlled Trials/National Research Register, number ISRCTN33368770. FINDINGS: 165 patients were randomised (83 to continue antipsychotic treatment and 82 to placebo), of whom 128 (78%) started treatment (64 continued with their treatment and 64 received placebo). There was a reduction in survival in the patients who continued to receive antipsychotics compared with those who received placebo. Cumulative probability of survival during the 12 months was 70% (95% CI 58-80%) in the continue treatment group versus 77% (64-85%) in the placebo group for the mITT population. Kaplan-Meier estimates of mortality for the whole study period showed a significantly increased risk of mortality for patients who were allocated to continue antipsychotic treatment compared with those allocated to placebo (mITT log rank p=0.03; ITT p=0.02). The hazard ratio for the mITT group was 0.58 (95% CI 0.35 to 0.95) and 0.58 (0.36 to 0.92) for the ITT population. The more pronounced differences between groups during periods of follow up longer than 12 months were evident at specific timepoints (24-month survival 46%vs 71%; 36-month survival 30%vs 59%). INTERPRETATION: There is an increased long-term risk of mortality in patients with AD who are prescribed antipsychotic medication; these results further highlight the need to seek less harmful alternatives for the long-term treatment of neuropsychiatric symptoms in these patients. FUNDING: UK Alzheimer's Research Trust.