Laxative use in adults with intellectual disabilities: development of prescribing guidelines.

BACKGROUND: Constipation is overrepresented in people with intellectual disabilities. Around 40% of people with intellectual disabilities who died prematurely were prescribed laxatives. A quarter of people with intellectual disabilities are said to be on laxatives. There are concerns that prescribing is not always effective and appropriate. There are currently no prescribing guidelines specific to this population. AIMS: To develop guidelines to support clinicians with their decision-making when prescribing laxatives to people with intellectual disabilities. METHOD: A modified Delphi methodology, the RAND/UCLA Appropriateness Method, was used. Step 1 comprised development of a bespoke six-item, open-ended questionnaire from background literature and its external validation. Relevant stakeholders, including a range of clinical experts and experts by experience covering the full range of intellectual disability and constipation, were invited to participate in an expert panel. Panel members completed the questionnaire. Responses were divided into 'negative consensus' and 'positive consensus'. Members were then invited to two panel meetings, 2 weeks apart, held virtually over Microsoft Teams, to build consensus. The expert-by-experience group were included in a separate face-to-face meeting. RESULTS: A total of 20 people (ten professional experts and ten experts by experience, of whom seven had intellectual disability) took part. There were five main areas of discussion to reach a consensus i.e. importance of diagnosis, the role of prescribing, practicalities of medication administration, importance of reviewing and monitoring, and communication. CONCLUSIONS: Laxative prescribing guidelines were developed by synthesising the knowledge of an expert panel including people with intellectual disabilities with the existing evidence base, to improve patient care.

Pandemic Effects on Stability of End-of-Life Preferences and Patient-Surrogate Dyad Congruence.

CONTEXT: Whether a largescale disaster alters people's previous decisions about their end-of-life care is unknown. OBJECTIVES: We examined the effects of a disaster, the COVID-19 pandemic, on stability of end-of-life care preferences among dialysis patients and on patient-surrogate goals-of-care congruence. METHODS: We used a natural experimental design to examine goals-of-care preferences pre- and postexposure to the pandemic during a pragmatic trial testing SPIRIT (sharing patient's illness representations to increase trust), an evidence-based advance care planning (ACP) intervention. There were 151 patient-surrogate dyads who prior to the pandemic lockdown had completed baseline (T1) and postintervention assessments (T2) regarding their goals-of-care preferences in two end-of-life scenarios. Of those 151 dyads, 59 intervention, and 51 usual care dyads consented to be in the present study and completed the goals-of-care tool two additional times, at enrollment (T3) and six months later (T4), along with the COVID stress scale (CSS). Dyad congruence was ascertained by comparing patient and surrogate responses to the goals-of-care tool. RESULTS: There were no changes over time in the proportions of patients who chose comfort-care-only in the goals-of-care tool. The proportion of patients who chose comfort-care-only and dyad congruence were higher in SPIRIT compared to usual care, but there was no interaction between that treatment effect and exposure to the pandemic. CSS was associated with neither patients' preferences nor dyad congruence. CONCLUSIONS: The pandemic alone did not appear to influence patients' goals-of-care preferences or dyad congruence. This finding supports the stability of value-based end-of-life preferences in general, even during a disaster.

Measures of Patient and Surrogate Preparedness for End-of-Life Decision-Making.

CONTEXT: Reliable and valid measures are critical in accurately assessing outcomes of advance care planning interventions (ACP) for end-of-life (EOL) decision-making. OBJECTIVES: To develop measures of preparedness for EOL decision-making for patients with end-stage renal disease and their surrogates (an exemplar population). METHODS: In this 3-phase study, Phases 1 and 2 included a cross-discipline concept analysis of the preparedness construct, item generation for patient and surrogate scales (82 items), evaluation of content validity and readability, cognitive interviewing, and item reduction. In phase 3, the retained 26 patient and 25 surrogate items were administered to 426 patients and 426 surrogates during a multisite trial of an ACP intervention versus care-as-usual and evaluated internal consistency, 2-week test-retest reliability, and construct validity. RESULTS: Scales were reduced to 20 patient and 19 surrogate items during phase 3. Cronbach's alphas were 0.86 (patient) and 0.90 (surrogate). There was a strong correlation between preparedness at baseline and two weeks for both scales (r = 0.66-0.69, P < 0.001). Confirmatory factor analysis and item-response analyses suggested unidimensionality. A significant correlation was shown between patient preparedness and patient decisional conflict (r = -0.53, P < 0.001), and surrogate preparedness and surrogate decision-making confidence (r = 0.44, P < 0.001). Among those who received the ACP intervention, the effect size of change was medium: Cohen's d = 0.54, P < 0.001 for patients and d = 0.57, P < 0.001 for surrogates. CONCLUSIONS: The preparedness scales demonstrated strong psychometric properties. Future studies should examine scale performance in other populations.

Effectiveness of an Advance Care Planning Intervention in Adults Receiving Dialysis and Their Families: A Cluster Randomized Clinical Trial.

Importance: Evidence of effectiveness of advance care planning (ACP) strategies for patients receiving dialysis and their families is needed. Objectives: To test the effectiveness of an ACP intervention to prepare patients and their surrogates for end-of-life (EOL) decision-making and to improve surrogate bereavement outcomes. Design, Setting, and Participants: This cluster randomized clinical trial, An Effectiveness-Implementation Trial of SPIRIT (Sharing Patients' Illness Representations to Increase Trust) in ESRD, was conducted from December 2017 to March 2023 and included 42 dialysis clinics in 5 US states (Georgia, New Mexico, North Carolina, Pennsylvania, and Virginia) randomized to provide intervention or usual care. Recruitment was from February 15, 2018, to January 31, 2022, and patient-surrogate dyads were followed up for 21 months (until January 17, 2023) or until patient death. Intervention: Each clinic selected 1 or 2 health care workers (eg, nurse practitioner, registered nurse, or social worker) to conduct 45- to 60-minute ACP discussions with dyads in the clinic or remotely. After March 13, 2020 (commencement of the COVID-19 emergency declaration), all discussions were conducted remotely. An ACP summary was placed in patients' medical records. Main Outcomes and Measures: The primary, 2-week preparedness outcomes were dyad congruence on EOL goals of care, patient decisional conflict, surrogate decision-making confidence, and a composite of dyad congruence and surrogate decision-making confidence. Secondary bereavement outcomes were anxiety, depression, and posttraumatic distress 3 months after patient death. To adjust for COVID-19 pandemic effects on bereavement outcomes, a variable to indicate the timing of baseline and 3-month assessment relative to the COVID-19 emergency declaration was created. Results: Of the 426 dyads enrolled, 231 were in the intervention clinics, and 195 were in the control clinics. Among all dyads, the mean (SD) patient age was 61.9 (12.7) years, and the mean (SD) surrogate age was 53.7 (15.4) years. At 2 weeks, after adjusting for baseline values, dyad congruence (odds ratio [OR], 1.61; 95% CI, 1.12-2.31; P = .001), decisional conflict scores (ß, -0.10; 95% CI, -0.13 to -0.07; P < .001), and the composite (OR, 1.57; 95% CI, 1.06-2.34; P = .03) were higher in the intervention group than in the control group. Surrogate decision-making confidence was similar between groups (ß, 0.06; 95% CI, -0.01 to 0.13; P = .12). Among 77 bereaved surrogates, after adjusting for baseline values and assessment timing, intervention group anxiety was lower than control group anxiety (ß, -1.55; 95% CI, -3.08 to -0.01; P = .05); however, depression (ß, -0.18; 95% CI, -2.09 to 1.73; P = .84) and posttraumatic distress (ß, -0.96; 95% CI, -7.39 to 5.46; P = .75) were similar. Conclusions and Relevance: In this randomized clinical trial, the ACP intervention implemented by health care workers at dialysis centers improved preparation for EOL decision-making but showed mixed effectiveness on bereavement outcomes. The ACP intervention implemented in dialysis centers may be an effective strategy to the dyad preparation for end-of-life care as opposed to the current focus on advance directives. Trial Registration: ClinicalTrials.gov Identifier: NCT03138564.

Determinants of COVID-19 Vaccine Acceptance and Uptake in a Transborder Population at the Mexico-Guatemala Border, September-November 2021.

Assessing COVID-19 vaccination uptake of transborder populations is critical for informing public health policies. We conducted a probability (time-venue) survey of adults crossing from Mexico into Guatemala from September to November 2021, with the objective of describing COVID-19 vaccination status, willingness to get vaccinated, and associated factors. The main outcomes were receipt of ≥1 dose of a COVID-19 vaccine, being fully vaccinated, and willingness to get vaccinated. We assessed the association of outcomes with sociodemographic characteristics using logistic regressions. Of 6518 participants, 50.6% (95%CI 48.3,53.0) were vaccinated (at least one dose); 23.3% (95%CI 21.4,25.2) were unvaccinated but willing to get vaccinated, and 26.1% (95%CI 24.1,28.3) were unvaccinated and unwilling to get vaccinated. Those living in Mexico, independent of country of birth, had the highest proportion vaccinated. The main reason for unwillingness was fear of side effects of COVID-19 vaccines (47.7%, 95%CI 43.6,51.9). Education level was positively associated with the odds of partial and full vaccination as well as willingness to get vaccinated. People identified as Catholic had higher odds of getting vaccinated and being fully vaccinated than members of other religious groups or the non-religious. Further studies should explore barriers to vaccination among those willing to get vaccinated and the motives of the unwilling.

Effects of the WRITE Symptoms Interventions on Symptoms and Quality of Life Among Patients With Recurrent Ovarian Cancers: An NRG Oncology/GOG Study (GOG-0259).

PURPOSE: GOG-259 was a 3-arm randomized controlled trial of two web-based symptom management interventions for patients with recurrent ovarian cancer. Primary aims were to compare the efficacy of the nurse-guided (Nurse-WRITE) and self-directed (SD-WRITE) interventions to Enhanced Usual Care (EUC) in improving symptoms (burden and controllability) and quality of life (QOL). METHODS: Patients with recurrent or persistent ovarian, fallopian, or primary peritoneal cancer with 3+ symptoms were eligible for the study. Participants completed baseline (BL) surveys (symptom burden and controllability and QOL) before random assignment. WRITE interventions lasted 8 weeks to develop symptom management plans for three target symptoms. All women received EUC: monthly online symptom assessment with provider reports; online resources; and every 2-week e-mails. Outcomes were evaluated at 8 and 12 weeks after BL. Repeated-measures modeling with linear contrasts evaluated group by time effects on symptom burden, controllability, and QOL, controlling for key covariates. RESULTS: Participants (N = 497) reported mean age of 59.3 ± 9.2 years. At BL, 84% were receiving chemotherapy and reported a mean of 14.2 ± 4.9 concurrent symptoms, most commonly fatigue, constipation, and peripheral neuropathy. Symptom burden and QOL improved significantly over time (P < .001) for all three groups. A group by time interaction (P < .001) for symptom controllability was noted whereby both WRITE intervention groups had similar improvements from BL to 8 and 12 weeks, whereas EUC did not improve over time. CONCLUSION: Both WRITE Intervention groups showed significantly greater improvements in symptom controllability from BL to 8 and BL to 12 weeks compared with EUC. There were no significant differences between Nurse-WRITE and SD-WRITE. SD-WRITE has potential as a scalable intervention for a future implementation study.

Glutathione sensitive vesicles prepared from supramolecular amphiphiles.

Glutathione (GSH) sensitive vesicles were prepared by the self-assembly of amphiphilic inclusion complexes. These novel chemically sensitive supramolecular amphiphiles are anticipated to have applications in drug delivery; the nanocarriers can protect the encapsulated cargo and release it via triggered degradation in high concentrations of GSH. Additionally, the sensitivity of the vesicles to GSH indicates that the dynamic covalent disulfide bond at the vesicle surface can be used for post-modification of the nanocarrier via a thiol-disulfide exchange, a strategy that can be exploited to introduce targeting moieties to increase treatment specificity. Supramolecular amphiphiles containing a dynamic covalent disulfide bond were prepared via the host-guest inclusion complexes between alkylated ß-cyclodextrin (ß-CD) hosts and adamantane terminated polyethylene glycol derivatives. The significant difference between the critical micelle concentrations of the supramolecular amphiphiles and the individual host and guest components confirmed that a unique supramolecular amphiphile was formed. Fluorescence experiments and dynamic light scattering (DLS) revealed that the supramolecular amphiphiles self-assembled into vesicles of 130 nm diameter which were stable for 8 months. Degradation of the vesicles after incubation with GSH was monitored using DLS and by the release of encapsulated 5,6-carboxyfluorescein (CF), observed by an increase in fluorescence intensity. Degradation of the nanocarrier was faster at intracellular GSH concentrations than at extracellular GSH concentrations.

Revisiting patient-related barriers to cancer pain management in the context of the US opioid crisis.

ABSTRACT: Patient fear of addiction is a well-documented barrier to the use of analgesic medications for cancer pain control. Over the past 2 decades in the United States, an "opioid crisis" has arisen, accompanied by risk messages delivered through news outlets, public health education, and patient-provider communication. The purpose of this study was to determine if patient-related barriers to cancer pain management-specifically, fears of addiction-and related pain outcomes (pain severity, pain interference with daily life, and adequacy of pain management) have worsened over the last 20 years. A sample of 157 outpatients with active recurrent or active metastatic cancer completed the Barriers Questionnaire-II (BQ-II) and measures of pain and analgesic use. We identified 7 comparison studies published between 2002 and 2020 that reported patient-related barriers using the BQ-II. Significant linear relationships were found between later year of publication and greater fear of addiction (harmful effect subscale score, B = 0.0350, R2 = 0.0347, F1,637 = 23.19, P < 0.0001) and between year of publication and more pain management barriers overall (total BQ-II score, B = 0.039, R2 = 0.065, F1,923 = 73.79, P < 0.0001). Relationships between BQ-II scores (harmful effect and total) and pain outcomes did not change over time. Despite worsening in patient-related barriers, the proportion of patients with adequate vs inadequate analgesic use did not differ over time. Notably, 40% of participants reported inadequate analgesic use, a statistic that has not improved in 20 years. Additional research is necessary to clarify factors contributing to changing beliefs. Findings indicate a continuing need for clinical and possibly system/policy-level interventions to support adequate cancer pain management.

Can Persons with Dementia Meaningfully Participate in Advance Care Planning Discussions? A Mixed-Methods Study of SPIRIT.

Background: Despite the importance of persons with dementia (PWDs) engaging in advance care planning (ACP) at a time when they are still competent to appoint a surrogate decision maker and meaningfully participate in ACP discussions, studies of ACP in PWDs are rare. Objective: We conducted an intervention development study to adapt an efficacious ACP intervention, SPIRIT (sharing patient's illness representations to increase trust), for PWDs in early stages (recent Montreal Cognitive Assessment [MoCA] score ≥13) and their surrogates and assess whether SPIRIT could help PWDs engage in ACP. Design: A formative expert panel review of the adapted SPIRIT, followed by a randomized trial with qualitative interviews, was conducted. Patient-surrogate dyads were randomized to SPIRIT in person (in a private room in a memory clinic) or SPIRIT remote (via videoconferencing from home). Setting/Subjects: Twenty-three dyads of PWDs and their surrogates were recruited from an outpatient brain health center. Participants completed preparedness outcome measures (dyad congruence on goals of care, patient decisional conflict, and surrogate decision-making confidence) at baseline and two to three days post-intervention, plus a semistructured interview. Levels of articulation of end-of-life wishes of PWDs during SPIRIT sessions were rated (3 = expressed wishes very coherently, 2 = somewhat coherently, and 1 = unable to express coherently). Results: All 23 were able to articulate their end-of-life wishes very or somewhat coherently during the SPIRIT session; of those, 14 PWDs had moderate dementia. While decision-making capacity was higher in PWDs who articulated their wishes very coherently, MoCA scores did not differ by articulation levels. PWDs and surrogates perceived SPIRIT as beneficial, but the preparedness outcomes did not change pre-post. Conclusions: SPIRIT engaged PWDs and surrogates in meaningful ACP discussions, but requires testing of efficacy and long-term outcomes.

Control Conditions That Are Neither Usual Care Nor No Treatment in Randomized Trials of Psychoeducational Palliative Care Interventions: A Systematic Review.

BACKGROUND:: Determining intervention efficacy depends as much on the control group as on the intervention, but little attention has been given to the control condition in psychoeducational trials in palliative care. OBJECTIVES:: To examine (1) research practice regarding control conditions that are neither usual care nor no-treatment controls in randomized trials of psychoeducational palliative care interventions and (2) the rationale and completeness of the descriptions of control conditions in trial reports. METHODS:: PubMed, EMBASE, PsycINFO, and Web of Science were searched. After screening 1603 articles, 70 full-text articles were assessed for eligibility. The final sample included 9 trial reports. We used the Delphi list for quality assessment and the modified intervention taxonomy checklist to assess active intervention and control conditions. RESULTS:: Four trials used an attention control designed to be equivalent to the structure of the active intervention. In another 4, the control condition included some aspects of attention control such that the mode of contact was similar to that in the active intervention, but either the amount or the intensity of attention was not similar. Only 3 trial reports explicitly stated the rationale for the choice of control condition. Although most reports contained delivery mode, materials, duration, frequency, and sequence, none described the qualifications or training required to deliver the control condition. Only 1 report mentioned the fidelity monitoring method, and none included fidelity data. CONCLUSION:: Our review of psychoeducational trials in palliative care calls for researchers' attention to appropriate selection, design, conduct and report of control conditions.

Randomized controlled trial of a brief cognitive-behavioral strategies intervention for the pain, fatigue, and sleep disturbance symptom cluster in advanced cancer.

OBJECTIVE: Patients receiving treatment for advanced cancer suffer significant symptom burden, including co-occurring pain, fatigue, and sleep disturbance. There is limited evidence for effective interventions targeting this common symptom cluster. METHODS: A randomized controlled trial of a brief cognitive-behavioral strategies (CBS) intervention was conducted. A sample of 164 patients with advanced cancer receiving chemotherapy practiced imagery, relaxation, and distraction exercises or listened to cancer education recordings (attention-control) to manage co-occurring pain, fatigue, and sleep disturbance over a 9-week period. Symptom cluster severity, distress, and interference with daily life were measured at baseline and 3, 6, and 9 weeks. We also evaluated the moderating influence of imaging ability and number of concurrent symptoms, and mediating effects of changes in stress, anxiety, outcome expectancy, and perceived control over symptoms. RESULTS: Compared with the cancer education condition, participants receiving the CBS intervention reported less symptom cluster distress at week 6 (M = 1.82 vs 2.15 on a 0-4 scale, P < .05). No other group differences were statistically significant. The number of concurrent symptoms moderated the intervention effect on symptom cluster interference. Changes in stress, outcome expectancy, and perceived control mediated the extent of intervention effects on symptom outcomes, primarily at weeks 6 and 9. CONCLUSIONS: The brief CBS intervention had limited effects in this trial. However, findings regarding potential mediators affirm hypothesized mechanisms and provide insight into ways to strengthen future interventions to reduce the suffering associated with co-occurring pain, fatigue, and sleep disturbance.

SPIRIT advance care planning intervention in early stage dementias: An NIH stage I behavioral intervention development trial.

People in the early stages of Alzheimer's disease and related dementias (ADRD) are encouraged to engage in advance care planning (ACP) while they are still competent to appoint a surrogate decision maker and meaningfully participate in ACP discussions with the surrogate. In this NIH Stage I behavioral intervention development trial, we will adapt and test an efficacious ACP intervention, SPIRIT (Sharing Patient's Illness Representation to Increase Trust), with people with mild dementia and their surrogates to promote open, honest discussions while such discussions about end-of-life care are possible. We will first adapt SPIRIT (in person) to target people with mild dementia and their surrogates through a process of modification-pretesting-refinement using stakeholders (persons with mild dementia, family caregivers, and clinicians) and experts, including adapting the delivery mode to interactive web-based videoconference format (SPIRIT-remote). Then in a 3-group RCT with 120 patient-surrogate dyads, we will evaluate the feasibility and acceptability of SPIRIT in-person and SPIRIT remote, and preliminary efficacy of SPIRIT compared to usual care on preparedness outcomes for end-of-life decision making (dyad congruence on goals of care, patient decisional conflict, and surrogate decision-making confidence) shortly after the intervention. This Stage I research of SPIRIT will generate valuable insights regarding how to improve ACP for people with mild dementia who will progress to an advanced stage of the disease in the foreseeable future. TRIAL REGISTRATION: ClinicalTrials.gov NCT03311711, Registered 10/12/2017.

One-Year Linear Trajectories of Symptoms, Physical Functioning, Cognitive Functioning, Emotional Well-being, and Spiritual Well-being Among Patients Receiving Dialysis.

BACKGROUND: This study evaluated 1-year linear trajectories of patient-reported dimensions of quality of life among patients receiving dialysis. STUDY DESIGN: Longitudinal observational study. SETTING & PARTICIPANTS: 227 patients recruited from 12 dialysis centers. FACTORS: Sociodemographic and clinical characteristics. MEASUREMENTS/OUTCOMES: Participants completed an hour-long interview monthly for 12 months. Each interview included patient-reported outcome measures of overall symptoms (Edmonton Symptom Assessment System), physical functioning (Activities of Daily Living/Instrumental Activities of Daily Living), cognitive functioning (Patient's Assessment of Own Functioning Inventory), emotional well-being (Center for Epidemiologic Studies Depression Scale, State Anxiety Inventory, and Positive and Negative Affect Schedule), and spiritual well-being (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale). For each dimension, linear and generalized linear mixed-effects models were used. Linear trajectories of the 5 dimensions were jointly modeled as a multivariate outcome over time. RESULTS: Although dimension scores fluctuated greatly from month to month, overall symptoms, cognitive functioning, emotional well-being, and spiritual well-being improved over time. Older compared with younger participants reported higher scores across all dimensions (all P<0.05). Higher comorbidity scores were associated with worse scores in most dimensions (all P<0.01). Nonwhite participants reported better spiritual well-being compared with their white counterparts (P<0.01). Clustering analysis of dimension scores revealed 2 distinctive clusters. Cluster 1 was characterized by better scores than those of cluster 2 in nearly all dimensions at baseline and by gradual improvement over time. LIMITATIONS: Study was conducted in a single region of the United States and included mostly patients with high levels of function across the dimensions of quality of life studied. CONCLUSIONS: Multidimensional patient-reported quality of life varies widely from month to month regardless of whether overall trajectories improve or worsen over time. Additional research is needed to identify the best approaches to incorporate patient-reported outcome measures into dialysis care.

The Role of Inflammation in the Pain, Fatigue, and Sleep Disturbance Symptom Cluster in Advanced Cancer.

CONTEXT: Symptom researchers have proposed a model of inflammatory cytokine activity and dysregulation in cancer to explain co-occurring symptoms including pain, fatigue, and sleep disturbance. OBJECTIVES: We tested the hypothesis that psychological stress accentuates inflammation and that stress and inflammation contribute to one's experience of the pain, fatigue, and sleep disturbance symptom cluster (symptom cluster severity, symptom cluster distress) and its impact (symptom cluster interference with daily life, quality of life). METHODS: We used baseline data from a symptom cluster management trial. Adult participants (N = 158) receiving chemotherapy for advanced cancer reported pain, fatigue, and sleep disturbance on enrollment. Before intervention, participants completed measures of demographics, perceived stress, symptom cluster severity, symptom cluster distress, symptom cluster interference with daily life, and quality of life and provided a blood sample for four inflammatory biomarkers (interleukin-1ß, interleukin-6, tumor necrosis factor-α, and C-reactive protein). RESULTS: Stress was not directly related to any inflammatory biomarker. Stress and tumor necrosis factor-α were positively related to symptom cluster distress, although not symptom cluster severity. Tumor necrosis factor-α was indirectly related to symptom cluster interference with daily life, through its effect on symptom cluster distress. Stress was positively associated with symptom cluster interference with daily life and inversely with quality of life. Stress also had indirect effects on symptom cluster interference with daily life, through its effect on symptom cluster distress. CONCLUSION: The proposed inflammatory model of symptoms was partially supported. Investigators should test interventions that target stress as a contributing factor in co-occurring pain, fatigue, and sleep disturbance and explore other factors that may influence inflammatory biomarker levels within the context of an advanced cancer diagnosis and treatment.

SPIRIT trial: A phase III pragmatic trial of an advance care planning intervention in ESRD.

Advance care planning (ACP) is a central tenet of dialysis care, but the vast majority of dialysis patients report never engaging in ACP discussions with their care providers. Over the last decade, we have developed and iteratively tested SPIRIT (Sharing Patient's Illness Representation to Increase Trust), a theory-based, patient- and family-centered advance care planning intervention. SPIRIT is a six-step, two-session, face-to-face intervention to promote cognitive and emotional preparation for end-of-life decision making for patients with ESRD and their surrogates. In these explanatory trials, SPIRIT was delivered by trained research nurses. Findings consistently revealed that patients and surrogates in SPIRIT showed significant improvement in preparedness for end-of-life decision making, and surrogates in SPIRIT reported significantly improved post-bereavement psychological outcomes after the patient's death compared to a no treatment comparison condition. As a critical next step, we are conducting an effectiveness-implementation study. This study is a multicenter, clinic-level cluster randomized pragmatic trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics, compared to usual care plus delayed SPIRIT implementation. Simultaneously, we will evaluate the implementation of SPIRIT, including sustainability. We will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from 30 dialysis clinics in four states. This trial of SPIRIT will generate novel, meaningful insights about improving ACP in dialysis care. TRIAL REGISTRATION: ClinicalTrials.govNCT03138564, registered 05/01/2017.

The effectiveness of the Pain Resource Nurse Program to improve pain management in the hospital setting: A cluster randomized controlled trial.

BACKGROUND: The Pain Resource Nurse program is a widely disseminated, evidence-based, nursing staff development program, designed to improve pain management in hospitals. The program has shown promising results, but has never been tested with a rigorous research design. OBJECTIVES: Our objective was to test the effectiveness of the Pain Resource Nurse program. Hypothesized outcomes included improvements in nurses' knowledge, attitudes, and assessment practices, and in patients' participation in decision-making, adequacy of pain management, pain severity, time spent in severe pain, pain interference, and satisfaction. DESIGN: Cluster randomized controlled trial. SETTING: A 650-bed university hospital in Iceland Participants: The sample consisted of a) patients ≥18 years of age, native speaking, hospitalized for at least 24h, alert and able to participate; and b) registered nurses who worked on the participating units. METHODS: Twenty three surgical and medical inpatient units were randomly assigned to the Pain Resource Nurse program (n=12) or to wait list control (n=11). The American Pain Society Outcome Questionnaire and the Knowledge and Attitudes Survey were used to collect data from patients and nurses respectively. Baseline data (T1) for patients were collected simultaneously on all units, followed by data collection from nurses. Then randomization took place, and the Pain Resource Nurse program was instituted. Ten months later, follow up (T2) data were collected, after which the nurses on the control group units received the Pain Resource Nurse program. RESULTS: At baseline, data were collected from 305 of the 396 eligible patients and at follow up from 326 of the 392 eligible patients, a 77% and 83% response rate respectively. At baseline, 232 of 479 eligible nurses responded and at follow-up 176 of the eligible 451 nurses responded, a 49% and 39% response rate, respectively. A nested mixed model analysis of covariance revealed that the intervention was successful in changing pain assessment practices, with pain assessment using standardized measures increasing from 13% to 25% in the intervention group while decreasing from 21% to 16% in the control group. None of the other hypothesized improvements were found. CONCLUSIONS: The Pain Resource Nurse program was successful in improving nurses' use of standardized measures for pain assessment. No effects were found on patient outcomes; pain was both prevalent and severe at both time points. Only minimal improvements were noted in response to this evidence-based staff development program. Changes in pain management practices remain a challenge in clinical settings.

Process and impact of an advance care planning intervention evaluated by bereaved surrogate decision-makers of dialysis patients.

BACKGROUND: Few studies have examined the process and impact of an advance care planning intervention experienced by surrogate decision-makers of dialysis patients. AIM: To explore the perspectives of the bereaved surrogates of dialysis patients on the process and impact of an advance care planning intervention and to compare the perceived impacts of the intervention between African Americans and Whites. DESIGN: Qualitative interviews and thematic analysis. SETTING/PARTICIPANTS: 24 bereaved surrogates of patients from outpatient dialysis centers were interviewed. Both patients and surrogates had been participants in a larger efficacy study and had received an advance care planning intervention, SPIRIT (Sharing Patient's Illness Representations to Increase Trust). RESULTS: Two themes related to the process of SPIRIT were as follows: (1) SPIRIT provided a welcome opportunity to think about and discuss topics that had been avoided and (2) SPIRIT helped patients and surrogates to share their feelings. Four themes of the SPIRIT's impact were as follows: (1) SPIRIT was an eye-opening experience, acquiring knowledge and understanding of the patient's illness and end-of-life care, (2) SPIRIT helped strengthen relationships between patients and surrogates, (3) SPIRIT helped surrogates feel prepared during the time leading up to end-of-life decision-making, and (4) SPIRIT helped surrogates have peace of mind during and after actual end-of-life decision-making. Themes related to SPIRIT's impact on feeling prepared for end-of-life decision-making and the actual decision-making experience more frequently occurred in African Americans than in Whites. CONCLUSION: Our data may help explain the beneficial effects of SPIRIT on surrogates, but future trials should include data on control surrogates' perspectives.

Coping With Pain Severity, Distress, and Consequences in Women With Ovarian Cancer.

BACKGROUND: Self-regulation can be useful in understanding pain management efforts in women with ovarian cancer. Self-regulation is a parallel process of problem- and emotion-focused coping; problem-focused coping involves efforts aimed at solving/reducing the problem directly, whereas emotion-focused coping is aimed at managing negative emotions. OBJECTIVES: The aims of this study were to describe the types of problem- and emotion-focused coping strategies used to manage pain severity, distress, and consequences and to evaluate whether there was evidence of parallel processing (ie, use of a combination of both problem- and emotion-focused strategies). METHODS: Women (n = 162) from a cross-sectional study of cancer symptoms who reported pain as a most noticed symptom in the past week were included. Pearson correlations and t tests were used to evaluate relationships among the variables. RESULTS: Mean pain severity was 5.5 (SD, 2.7) on a 0- to 10-point scale. An average of 4.6 (SD, 2.1) coping strategies were reported. Actively manage and planning were the most frequent problem-focused strategies; relaxation was the most frequent emotion-focused strategy. Higher total number of coping strategies attempted, expressing emotions, and seeking emotional support were associated with higher pain distress and consequences scores, and actively managing pain was associated with higher pain severity. CONCLUSION: Women with a history of ovarian cancer continue to experience severe pain. Partial support for parallel processing was found. IMPLICATIONS FOR PRACTICE: The relative benefits of the 2 types of coping strategies are unclear. Thorough assessment of pain and the effectiveness of coping strategies is needed to help women identify strategies that work best for them.

A Family of Amphiphilic Cyclodextrin Liquid Crystals Governed by Dipole-Dipole Interactions.

A novel family of amphiphilic cyclodextrin(CD)-based liquid crystals that bear O-acetylated oligoethylene glycol chains at the secondary face is reported. Unlike most of the previously reported liquid crystals (LC) based on chemically modified CDs, which depend on H-bonding as the primary intermolecular forces, the present CD derivatives self-assemble into highly ordered smectic liquid crystal phases via the weaker dipole-dipole intermolecular interactions. The obtained materials are found to display much improved properties such as improved thermostability, reduced clearing temperatures, and better fluidity. The present work opens up new possibilities to design CD-based LC materials.