Part Of Usual Care Research Articles

A community health worker–led intervention to improve patient knowledge and receipt of precision medicine: Updated ALCANCE randomized clinical trial findings.

181 Background: Inequitable access to precision medicine limits its impact. To address disparities, we co-developed the Addressing Latinx Cancer Care Equity Study (NCT04843332), a multi-level intervention with community stakeholders. ALCANCE was designed for low-income and Latinx adults with cancer in rural Monterey County, California. We provided annual training for clinicians about testing guidelines and precision medicine disparities. Trained CHWs educated patients about precision medicine and encouraged them to raise the topic with their oncologist. We tested whether the intervention improved patient knowledge and receipt of precision medicine. Methods: Patients with newly diagnosed or recurrent cancer, age ≥ 18 years, able to consent in English or Spanish, and who self-identified as a racial and ethnic minority OR low-income status OR were insured by public or agricultural company insurance OR uninsured and receiving cancer care at Pacific Cancer Care, a rural community oncology practice in Monterey County, were randomized 1:1 to usual care (control group) or usual care augmented with the multi-level intervention for 12 months (intervention group). The primary outcome was whether the multilevel intervention could increase patient knowledge of precision medicine using a validated 6 question survey from time of enrollment (baseline) to 6-months post-enrollment between groups. A secondary outcome was receipt of precision medicine. CHWs and clinicians completed semi-structured interviews. Results: 110 participants were randomized; 70% (n = 67) reported Spanish as their primary language; 81% (n = 89) identified as Hispanic. Median age was 55 years (55.4 ± 14.3, mean± SD); majority had annual household incomes (USD) ≤ $34,999 (59.0%, n = 46); majority obtained a high school diploma/GED or less (67.3%, n = 74). Most had gastrointestinal (35.5%, n = 39) and breast (24.5%, n = 27) cancers and were diagnosed with stage 3 or 4 (64.5%, n = 71) disease. Precision medicine knowledge was low at baseline across both the control and intervention groups (23.5 ± 19.3 versus 23.0 ± 17.7, respectively). Intervention group participants had greater precision medicine knowledge at 6-months (39.2 ± 23.0) than control group participants (24.2 ± 20.0) with greater increase in knowledge overtime than control group participants (p < 0.001). More intervention group participants (n=46, 79.3%) received precision medicine testing than control (n=34, 60.7%). Across both groups, 26 of those tested had an actionable mutation. Of those 26, 66.7% (n=6 of 9) in the control group and 94.1% (n=16 of 17) in the intervention group received targeted therapy (p=0.065). Interviews with the care team indicated the model was acceptable and has been sustained as part of usual care. Conclusions: CHW-facilitated interventions may reduce disparities in precision medicine cancer care. Clinical trial information: NCT04843332

Staff perspectives on fall prevention activities in long-term care facilities for older residents: "Brief but often" staff education is key.

Falls are a serious health problem in long-term care facilities (LTCFs), affecting more than 50% of residents. A key role of LTCF staff is to assess fall risks and implement fall prevention activities. Understanding the barriers and facilitators is key to successful implementation. This descriptive qualitative study involving four LTCF facilities (varied provider types and sizes) in southwest Ireland. We recruited a convenience sample of 17 LTCF staff, who participated in semi-structured online 1:1 interviews (n = 7) or small group interviews (n = 10). The data were analysed using Braun and Clarke's reflective thematic analysis. The participants included two directors of nursing, three therapists, one ward manager, one general practitioner, five nurses and five healthcare assistants. Six main themes were identified, reflecting factors that influenced fall prevention: a need for sufficient staff and appropriate skill mix; fall policy, documentation and leadership; equipment and safe environments; person-centred care; staff knowledge, skills and awareness in falls prevention; and staff communication and collaborative working. A wide range of approaches that supported LTCF staff to overcome barriers were identified, including audits and feedback, falls champions, fall prevention leaders, daily communication (e.g., safety pauses) and staff collaboration. Formal multidisciplinary meetings and identification systems to highlight residents at high risk of falling were not considered helpful. Staff suggested that education should be briefer, ongoing and practice-based ("brief but often") to promote ownership and responsibility. LTCF staff identified several approaches to prevent falls in LTCFs as part of usual care, rather than lengthy, formal meetings and training. The potential role of families in fall prevention was under-appreciated and should be investigated further.

Falls experienced by adult cancer survivors: a scoping review

Purpose Accidental falls among adult cancer survivors are a health concern. Falls impose economic burdens and detrimental consequences to cancer survivors. This review aimed to synthesize findings from published research to explore the relationship between falls and cancer diagnosis and treatment among cancer survivors. Materials and methods A scoping review was conducted using four databases (Medline, EMBASE, CINAHL, and Scopus) for the years 2001–2021. A total of 425 abstracts were identified after removing duplicates. A second search for the years 2022–2023 was completed where 80 abstracts were identified. screening, full-text review, and data extraction were conducted. Study characteristics and key findings were extracted from full texts. Descriptive numerical summaries were presented, and narrative analyses were performed. Results and conclusions A total of 42 articles were included in the scoping review which demonstrated (1) an increased prevalence of falls among cancer survivors, (2) the presence of cancer-specific fall risk factors, (3) a lack of cancer-specific fall prediction tools, and (4) few fall prevention interventions as part of usual care among cancer survivors. Younger cancer survivors were underrepresented. Cancer survivors should be aware of their risk of falls, and health professionals should ensure that fall prevention is part of usual care.

Proactive review for people with diabetes in hospital: a cluster randomised feasibility trial with process evaluation, protocol V3.1

BackgroundDiabetes inpatient specialist services vary across the country, with limited evidence to guide service delivery. Currently, referrals to diabetes inpatient specialists are usually ‘reactive’ after diabetes-related events have taken place, which are associated with an increased risk of morbidity/mortality and increased length of hospital stay. We propose that a proactive diabetes review model of care, delivered by diabetes inpatient specialist nurses, may contribute to the prevention of such diabetes-related events and result in a reduction in the risk of harm.MethodWe will conduct a cluster randomised feasibility study with process evaluation. The proactive diabetes review model (PDRM) is a complex intervention that focuses on the prevention of potentially modifiable diabetes-related harms. All eligible patients will receive a comprehensive, structured diabetes review that aims to identify and prevent potentially modifiable diabetes-related harms through utilising a standardised review structure. Reviews are undertaken by a diabetes inpatient specialist nurse within one working day of admission. This differs from usual care where patients are often only seen after diabetes-related harms have taken place. The trial duration will be approximately 32 weeks, with intervention delivery throughout. There will be an initial 8-week run-in phase, followed by a 24-week data collection phase. Eight wards will be equally randomised to either PDRM or usual care. Adult patients with a known diagnosis of diabetes admitted to an included ward will be eligible. Data collection will be limited to that typically collected as part of usual care. Data collected will include descriptive data at both the ward and patient level and glucose measures, such as frequency and results of capillary glucose testing, ketonaemia and hypoglycaemic events. The analysis aims to determine the fidelity and acceptability of the intervention and the feasibility of a future definitive trial. Whilst this study is primarily about trial feasibility, the findings of the process evaluation may lead to changes to both trial processes and modifications to the intervention. A qualitative process evaluation will be conducted in parallel to the trial. A minimum of 22 patients, nurses, doctors, and managers will be recruited with methods including direct non-participant observation and semi-structured interviews. The feasibility of a future definitive trial will be assessed by evaluating recruitment and randomisation processes, staffing resources and quality of available data.DiscussionThe aim of this cluster randomised feasibility trial with a process evaluation is to explore the feasibility of a definitive trial and identify appropriate outcome measures. If a trial is feasible and the effectiveness of PDRM can be evaluated, this could inform the future development of inpatient diabetes services nationally.Trial registrationUK Clinical Research Network, 51,167. ISRCTN, ISRCTN70402110. Registered on 21 February 2022.

Comparing emergency department and oncology urgent care for non-emergent acute care.

e23107 Background: Adults with cancer often visit the emergency department (ED) during treatment for commonly anticipated issues (e.g. pain, nausea). Some providers have created oncology urgent care clinics (OUCC) to manage these non-emergent issues. Evidence suggests that they are associated with lower ED use. Little is known about the care delivered at OUCCs, and how it compares to ED care. We compared visits from our OUCC to ED visits at our comprehensive cancer center. Methods: We studiedvisits from Jan 1 – June 30, 2023. To limit selection bias, we excluded ED visits if patients were referred by an outpatient clinician, including phone triage. Triage nurses document a validated Emergency Severity Index (ESI, version 4) as part of usual care in the ED, but not the OUCC. The ESI ranks high-severity (level 1 – “patient dying”; 2 – “shouldn’t wait”) to lower-severity (level 5), with the three lower levels distinguished by vital signs and clinical resources needed to stabilize a patient. Two clinicians reviewed OUCC visits and recorded ESIs. We assessed inter-rater reliability of OUCC ESI coding. We used multivariate, mixed-effects methods (visits clustered to patient) to model two outcomes: care escalation (OUCC to ED/inpatient; ED to inpatient) and length of stay (LOS). We excluded visits with ESI at the extremes (1 and 5). We adjusted for sex, age, comorbidities, cancer type and stage, date/time of arrival, and ESI. We then used marginal effects methods to report adjusted outcomes, stratified by ESI. Results: We analyzed 904 OUCC visits (580 patients) and 4,115 ED visits (2,866 patients). Over half (55.5%) of ED arrivals occurred after business hours. Median patient age was 67 (IQR 57 - 74), 48% were female, and 58% non-Hispanic white. Cancer types included 18% hematologic, 17% GI/colorectal, 12% breast, and 7% lung; 11% were advanced-stage. Unweighted inter-rater reliability for ESI was high for a subset of 164 OUCC visits (k = 0.81, 95% CI: 0.72 - 0.89). Although OUCC had a sizable portion of level 2 visits, ED had significantly higher severity. At each ESI level, adjusted rates of care escalation were significantly higher for ED than OUCC (overall aOR 5.6, 95% CI: 4.4 - 7.2), and LOS was longer for ED than OUCC (5.2 hours longer, 95% CI 4.8 – 5.6). Conclusions: The severity of OUCC visits was high, though patient self-referred ED visit severity was higher. OUCC may be more efficient than the ED for managing non-emergency care in this population. Future work should further investigate the quality of care delivered at each site, including cost of care. [Table: see text]

#1722 Shared decision making and dialysis choice: an observational longitudinal cohort study

Abstract Background and Aims Shared decision-making is recommended for dialysis choice, whereby patients are supported in making decisions regarding dialysis modality together with healthcare professionals. The intervention ‘Shared decision making and dialysis choice’ has been a part of usual care at two hospitals in Denmark since 2018. The aim of this study was to describe the choice of dialysis modality and the outcomes for patients with kidney failure, who received a Shared decision-making intervention. Method An observational longitudinal cohort study was conducted. Data was collected retrospectively from 2018 to 2023 involving 484 patients with kidney failure from two Danish hospitals one regional hospital and one university hospital. Fisher's exact tests and Wilcoxon rank-sum tests were used to assess whether choice of dialysis modality differed significantly. Additionally, Aalen-Johansen estimation assessed time from the shared decision making intervention to treatment initiation, concordance between chosen and initiated treatment, and mortality before treatment initiation. Logistic regression and Cox proportional hazards evaluated the patient characteristics predicting these three outcomes. Results After the intervention, 68% chose home-based treatment, while 32% chose hospital-based treatment. With significant difference, more patients age ≤70 years, at university hospital and living with a partner chose home-based treatment. Half of the patients initiated treatment within 11 months, and predictors for initiating dialysis later than 11 months after the intervention were age ≥70 years (OR 2.52) and eGFR >15 ml/min/1.73 m² (2.80). 83% of the patients received the treatment chosen and predictors for concordance were center-based dialysis (HR 1.54), regional hospital (HR 1.52) and very mild to mild frailty (HR 1.55). Furthermore, 12% of the patients died before treatment initiation predicted by very mild (HR 3.67) to severe frailty (HR 6.42) and BMI <25 kg/m² (HR 2.84). Conclusion A high proportion of patient chose a home-based treatment after receiving the intervention ‘Shared decision making and dialysis choice’ and also initiated the dialysis choice chosen. Patients received the intervention timely and only few patients died before initiating dialysis. Our study has demonstrated that many factors influence patient choices and outcomes. Maybe routinely assessment of frailty and BMI prior to shared decision making intervention could improve the patient pathway.

INDIVIDUAL ARTICLE: Sarecycline Improves Acne Severity, Symptoms, and Psychosocial Burden in Non-nodular Acne Vulgaris: PROSES Study.

Patient-reported outcomes (PROs) are emerging as a fundamental component of disease impact assessment in acne vulgaris (AV), complementing clinician-reported outcomes. No data is available on PROs for patients with AV using sarecycline in real-world settings. A single-arm, prospective cohort study that included patients ≥9 years old diagnosed with moderate or severe non-nodular AV was implemented as part of routine care in clinical practices (N=30). Patients received oral sarecycline (60 mg, 100 mg, or 150 mg) for 12 weeks, as part of usual care. The primary endpoint was Acne Symptom and Impact Scale (ASIS) responses from patients (≥12 years) and caregivers (for patients 9-11 years) at week 12 and change from baseline (CFB). Investigator’s Global Assessment (IGA) of AV severity and adverse events (AEs) were also recorded. A total of 253 patients with AV completed the study (adults: 60.1%, females: 77.6%). ASIS mean scores significantly decreased (P <.0001) at week 12 for: signs (mean CFB ± standard deviation [SD]: –0.8 ± 0.7), impact (–1.0 ± 1.0), emotional impact (–1.2 ± 1.1), and social impact (0.6 ± 1.1). Significant reductions in AV severity (P <.0001) were reported by patients and caregivers. The IGA success rate was 58.9% and physician satisfaction with treatment outcomes was 88.1%. A total of 31 (10.3%) patients reported ≥1 AE during the study. Patients with moderate-to-severe AV receiving acne management with an oral antibiotic for 12 weeks experienced a significant improvement in AV-related symptoms and psychosocial burden. J Drugs Dermatol. 2024;23:1(Suppl 1):s12-18.

Patient- and Clinician-Reported Outcomes of Tirbanibulin 1% in the Treatment of Actinic Keratosis on the Face and Scalp (PROAK Study)

Introduction: Actinic Keratosis (AK) has been shown to negatively affect emotional and social functioning and skin-related quality of life [1]. The objective was to evaluate clinician- and patient-reported outcomes (ClinRO; PRO) for tirbanibulin treatment satisfaction and effectiveness among patients administered tirbanibulin in routine clinical practice across the U.S.
 Methods: A single-arm, prospective cohort study (PROAK: NCT05260073) was conducted in adults with AKs on the face or scalp as part of usual care. Patients and clinicians completed surveys and clinical assessments at baseline, Week-8, and Week-24. ClinRO and PRO comprised Treatment Satisfaction Questionnaire for Medication (TSQM-9) (with 3 domains: treatment effectiveness, convenience of use, and global satisfaction with treatment) and Expert Panel Questionnaire (EPQ) (assessing overall skin appearance, satisfaction with improvement in “skin texture” and “how skin looks”, and likelihood to consider tirbanibulin again). Clinicians assessed AK responses using Investigator's Global Assessment (IGA) and patient’s skin photodamage severity scale. IGA success was defined as achieving IGA score of 0-1 (≥75% AK lesions clearance). Data at Week-8 was already published [1]. Here we present the results obtained at Week-24.
 Results: A total of 278 patients completed study assessments at Week-24 (mean age: 66.3 years; 68.6% males; Fitzpatrick skin type II: 71.4%). Mean (standard deviations [SD]) TSQM-9 score in effectiveness, convenience and global satisfaction was 74.3 (21.2), 84.5 (15.6) and 74.9 (23.9) for clinicians and 73.4 (21.4), 85.0 (14.7) and 71.9 (24.7) for patients. 77.3% of clinicians and 78.4% of patients reported a high likelihood for considering tirbanibulin treatment in the future. At Week-24, 83.6% of clinicians and 78.5% of patients rated overall skin appearance after tirbanibulin treatment to be mostly somewhat/much improved. At Week-24, the proportion of patients with completely/partially cleared AK (IGA 0/1) was 71.9%, similar to that obtained at Week-8 (73.8%) [1].
 Conclusions: Effectiveness ≥75% clearance was achieved by 71.9% of patients, consistent with the results of the Phase III trials [2]. ClinRO and PRO demonstrated high satisfaction with once-daily tirbanibulin treatment for 5 consecutive days at Week-24, and both clinicians and patients reported a desire to consider tirbanibulin treatment in the future.
 [1] Schlesinger T et al. Skin. 2023;7(3):771-787.
 [2] Blauvelt A et al. N Engl J Med. 2021;384(6):512–20.

Safety and Tolerability of Tirbanibulin 1% Treatment of Actinic Keratosis on Face and Scalp in Routine Clinical Practice Across the U.S. (PROAK Study)

Introduction: Actinic Keratosis (AK) has been shown to negatively affect emotional and social functioning and skin-related quality of life of patients [1]. The objective of this analysis was to evaluate safety and tolerability of tirbanibulin in AK treatment, among patients administered tirbanibulin in routine clinical practice across the U.S.
 Methods: A single-arm, multicenter, prospective cohort study (PROAK: NCT05260073) was conducted in adult patients with AKs on 25 cm2 on the face or scalp who were newly initiated with once-daily tirbanibulin 1% ointment treatment (5 consecutive days course) as part of usual care. Safety and tolerability endpoints were assessed at Week-8 and Week-24 and included adverse events (AEs), serious AEs (SAE), adverse drug reactions (ADRs), serious ADRs, local skin reactions (LSR), skin scarring and pigmentation (hypo/hyperpigmentation). Number of patients discontinuing treatment because of AEs, ADRs and for any other reasons were also reported. LSR (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) were scored 0-3 (absent-severe) and summed to a composite score (0-18).
 Results: A total of 300 patients were included in the safety analysis population (males: 68%; mean age: 67 years; Fitzpatrick skin type II: 89%; AK on the face: 78%). A total of 98% of patients completed the 5-day treatment course. During the study, 5% of patients reported at least one AE, 4% of patients at least 1 SAE, and no patients reported serious ADR. Basal Cell Carcinoma was reported in 1% of patients and Squamous Cell Carcinoma in 2% of patients; all cases were considered not related to treatment. No patients discontinued the study due to AEs or ADRs. At Week-8, the most reported LSR were erythema (48% mild-moderate, 5% severe) and flaking/scaling (50% mild-moderate, 3% severe). The rest of LSR were reported in 2-8% of patients (8% crusting, 5% swelling, 2% vesiculation/pustulation, and 2% erosion/ulceration) and all were mild-moderate in severity. Mean (min-max) LSR composite score was 0.94 (0-11). At Week-8, scarring or hypo/hyperpigmentation was observed in 1%, 5% and 3% of patients, respectively. 
 Conclusions: Once-daily tirbanibulin 1% ointment for 5 consecutive days showed a favorable safety and tolerability profile in the treatment of AK of the face or scalp.
 [1] Schlesinger T et al. Skin. 2023;7(3):771-787.

Availability of family caregiver support in U.S. cancer centers.

218 Background: Family caregivers provide the majority of health care to the 18 million persons with cancer in the U.S. Yet despite providing complex medical and nursing care, a large proportion report no formal support or training. Recognizing this gap, many interventions to support cancer caregivers have been developed and tested over the past two decades and many have demonstrated effectiveness. However, there is little system-level data on whether U.S. cancer centers have adopted and implemented these interventions. We conducted the first national survey of Commission on Cancer (CoC)-accredited U.S. cancer centers to characterize the availability and types of family caregiver support programs. Methods: We conducted a mail and web-based survey of staff from CoC-accredited U.S. cancer centers regarding their family caregiver support programs (09/2021-03/2023). “Family caregiver programs” were defined as structured, planned, coordinated groups of activities and procedures aimed specifically at supporting family caregivers as part of usual care. Survey questions about 11 types of family caregiver programs (e.g., peer-mentoring, education classes, psychosocial programs) were developed after literature review, assessment of similar program evaluation surveys, and discussions among a 13-member national expert advisory committee. Results: Surveys were sent to potential respondents at 971 adult cancer centers and 238 were completed (response rate: 25%). Most cancer centers had at least 1 family caregiver program (178/238, 75.1%), which was most commonly “Information and Referral Services” (53.4%). Cancer centers with no programs were more likely to have smaller annual outpatient volumes (p<.05). Few centers had caregiver programs on: training in medical and/or nursing tasks (21.8%), caregiver self-care (20.3%), caregiver-specific distress screening (19.3%), peer mentoring (18.5%), and minor children caregiving for a parent (8.4%). Very few programs were developed from published evidence in a journal (7.9%). The top reason why cancer centers chose their programs was community members requesting the program (26.5%); only 11.8% chose their programs based on scientific evidence. Most programs were funded by the cancer center or hospital (58.0%) or by philanthropy (42.4%). Conclusions: While most U.S. cancer centers had some family caregiver programs, a quarter had none. Furthermore, the scope of programming was limited and rarely evidence-based, with few centers offering caregiver education and training. Implementation strategies are critically needed to foster uptake of evidence-based caregiver interventions.

Availability of Family Caregiver Programs in US Cancer Centers

Family caregivers provide the majority of health care to the 18 million patients with cancer in the US. Yet despite providing complex medical and nursing care, a large proportion of caregivers report no formal support or training. In recognition of this gap, many interventions to support cancer caregivers have been developed and tested over the past 2 decades. However, there are few system-level data on whether US cancer centers have adopted and implemented these interventions. To describe and characterize the availability of family caregiver support programs in US cancer centers. This cross-sectional national survey study was conducted between September 1, 2021, and April 30, 2023. Participants comprised clinical and administrative staff of Commission on Cancer-accredited US cancer centers. Data analysis was performed in May and June 2023. Survey questions about the availability of 11 types of family caregiver programs (eg, peer mentoring, education classes, and psychosocial programs) were developed after literature review, assessment of similar program evaluation surveys, and discussions among a 13-member national expert advisory committee. Family caregiver programs were defined as structured, planned, and coordinated groups of activities and procedures aimed at specifically supporting family caregivers as part of usual care. Survey responses were tabulated using standard descriptive statistics, including means, proportions, and frequencies. Of the surveys sent to potential respondents at 971 adult cancer centers, 238 were completed (response rate, 24.5%). After nonresponse weight adjustment, most cancer centers (75.4%) had at least 1 family caregiver program; 24.6% had none. The most common program type was information and referral services (53.6%). Cancer centers with no programs were more likely to have smaller annual outpatient volumes (χ2 = 11.10; P = .011). Few centers had caregiver programs on training in medical and/or nursing tasks (21.7%), caregiver self-care (20.2%), caregiver-specific distress screening (19.3%), peer mentoring (18.9%), and children caregiving for parents (8.3%). Very few programs were developed from published evidence in a journal (8.1%). The top reason why cancer centers selected their programs was community members requesting the program (26.3%); only 12.3% of centers selected their programs based on scientific evidence. Most programs were funded by the cancer center or hospital (58.6%) or by philanthropy (42.4%). In this survey study, most cancer centers had family caregiver programs; however, a quarter had none. Furthermore, the scope of programming was limited and rarely evidence based, with few centers offering caregiving education and training. These findings suggest that implementation strategies are critically needed to foster uptake of evidence-based caregiver interventions.

Taking AIM at serious illness: implementing an access to investigational medicines expanded access program.

When seriously ill patients have exhausted all treatment options available as part of usual care, the use of investigational agents may be warranted. Food and Drug Administration's (FDA) Expanded Access (EA) pathway provides a mechanism for these patient's physicians to pursue use of an investigational agent outside of a clinical trial when trial enrollment is not a feasible option. Though FDA has recently implemented processes to significantly streamline the regulatory portion of the process, the overall pathway has several time-consuming components including communication with the pharmaceutical company and the associated institutional requirements for EA use (contracting, Institutional Review Board [IRB], pharmacy, billing). Here, we present our experience building infrastructure at the Vanderbilt University Medical Center (VUMC) to support physicians and patients in pursuing EA, called the Access to Investigational Medicines (AIM) Platform, aligning the needs and responsibilities of institutional stakeholders and streamlining to ensure efficiency and regulatory compliance. Since its launch, the AIM team has experienced steady growth, supporting 40 EA cases for drugs/biologics, including both single patient cases and intermediate-size EA protocols in the emergent and non-emergent setting. As the EA pathway is a complex process that requires expert facilitation, we propose prioritizing EA support infrastructure at major academic medical centers as an essential regulatory knowledge function.

A randomized controlled trial of recovery management checkups for primary care patients: Twelve-month results.

Primary care settings like federally qualified health centers (FQHC) are optimal locations to identify individuals with substance use disorders (SUD) and link them to SUD treatment, yet successful linkage has proven difficult. Recovery management checkups for primary care (RMC-PC) is a promising method for increasing linkage to care, engagement in treatment, and reducing substance use. Participants (n = 266) who received screening, brief intervention, and referral to treatment (SBIRT) at four FQHC sites and needed SUD treatment were randomized to receive SBIRT only or SBIRT+RMC-PC. All participants received SBIRT prior to randomization as part of usual care while those in the experimental group also received quarterly checkups. All participants completed research interviews at enrollment and 3, 6, 9, and 12 months post-enrollment. The primary outcome was whether participants received any days of SUD treatment. Key secondary outcomes were days of SUD treatment (total and by SUD level of care), days of alcohol or drug abstinence, and a reduction in days of specific substance use, all based on self-report. Relative to participants receiving SBIRT only, participants assigned to SBIRT+RMC-PC were significantly more likely to have received any SUD treatment over 12 months (adjusted odds ratio [AOR] = 3.85) and more days of SUD treatment over 12 months (Cohen's effect size d = +0.41). The SBIRT+RMC-PC group also reported significantly more days of abstinence over 12 months (d = +0.30), fewer days of alcohol use (d = -0.20) and cannabis use (d = -0.20), and lower combined substance use frequency (d = -0.25). Days of treatment were found to positively mediate the direct effect of SBIRT+RMC-PC on days of abstinence. This study provides further evidence of the effectiveness of the "referral to treatment" component of SBIRT when combined with RMC for patients in primary care settings, including those with drug use problems. Moreover, results demonstrate the value of repeated checkups on longer-term treatment and substance use outcomes.

Electronic health record (EHR)-based PROMIS measures among neurology clinic decedents and survivors: a retrospective cohort analysis

BackgroundIn addition to their standard use to assess real-time symptom burden, patient-reported outcomes (PROs), such as the Patient-Reported Outcomes Measurement Information System (PROMIS), measures offer a potential opportunity to understand when patients are experiencing meaningful clinical decline. If PROs can be used to assess decline, such information can be used for informing medical decision making and determining patient-centered treatment pathways. We sought to use clinically implemented PROMIS measures to retrospectively characterize the final PROMIS report among all patients who completed at least one PROMIS assessment from December 2017-March 2020 in one large health system, stratified by decedents vs. survivors. We conducted a retrospective cohort analysis of decedents (N = 1,499) who received care from outpatient neurology clinical practice within a single, large health system as part of usual care. We also compared decedents to survivors (360 + days before death; N = 49,602) on PROMIS domains and PROMIS-Preference (PROPr) score, along with demographics and clinical characteristics. We used electronic health record (EHR) data with built-in PROMIS measures. Linear regressions assessed differences in PROMIS domains and aggregate PROPr score by days before death of the final PROMIS completion for each patient.ResultsAmong decedents in our sample, in multivariable regression, only fatigue (range 54.48–59.38, p < 0.0029) and physical function (range 33.22–38.38, p < 0.0001) demonstrated clinically meaningful differences across time before death. The overall PROPr score also demonstrated statistically significant difference comparing survivors (0.19) to PROPr scores obtained 0–29 days before death (0.29, p < 0.0001).ConclusionsAlthough clinic completion of PROMIS measures was near universal, very few patients had more than one instance of PROMIS measures reported, limiting longitudinal analyses. Therefore, patient-reported outcomes in clinical practice may not yet be robust enough for incorporation in prediction models and assessment of trajectories of decline, as evidenced in these specialty clinics in one health system. PROMIS measures can be used to effectively identify symptoms and needs in real time, and robust incorporation into EHRs can improve patient-level outcomes, but further work is needed for them to offer meaningful inputs for defining patient trajectories near the end of life.Plain English SummaryAssessing symptom burden provides an opportunity to understand clinical decline, particularly as people approach the end of life. We sought to understand whether symptoms reported by patients can be used to assess decline in health. Such information can inform decision-making about care and treatments. Of eight symptoms that we assessed, patient reports of fatigue and physical function were associated with clinical decline, as was an overall score of symptom burden. Because few symptoms were associated with decline, patient-reported outcomes in clinical practice may not yet be robust enough for incorporation in prediction models and assessment of trajectories of decline.

Accuracy of medication labels on community pharmacy-prepared dose administration aids: An observational study

BackgroundHospital prescribers often use the labels on multicompartment compliance aids or monitored dosage systems, known in Australia as dose administration aids (DAAs), as a trusted source of information about patients' medication regimens taken in the community. AimThe primary aim was to explore the prevalence and nature of labelling incidents on community pharmacy-prepared DAAs. MethodsA convenience sample of 100 adult patients admitted to a metropolitan teaching hospital who used a community pharmacy-prepared DAA at home was recruited. Patients were excluded if their DAAs were not brought to hospital. As part of usual care, a pharmacist took a best possible medication history (BPMH) using multiple information sources. This ‘gold standard’ BPMH was compared to the regimen listed on the DAA summary label and the DAA contents. The primary outcome was the percentage of patients whose DAA summary label(s) had one or more incidents for DAA packed medications. DAA label incident was defined as incorrect, missing or illegible/ambiguous medication name, strength, dose or dose-form when compared to the BPMH and DAA contents. Secondary outcomes were compliance with best-practice guidelines for labelling DAAs; and percentage of patients with a DAA packing error. ResultsThe 100 patients used 110 DAAs, packed by 75 community pharmacies. Four (4.0%) patients had no medication summary label on their DAAs. Of the 96 patients whose DAA(s) had a summary label, 82 (85.4%) had one or more summary label incidents. The most prevalent incidents were ‘illegible, ambiguous or missing medication details’, ‘truncated medication name’ and ‘omission of a medication’. The most prevalent guideline non-compliance was not including generic medication names (68% DAA-packed medications). Two DAA packing errors were identified. ConclusionA high prevalence of DAA labelling incidents was identified. Improved DAA labelling software functionality, more robust pharmacy procedures and pharmacy staff education are required.

Recommendations for the holistic care of patients with hereditary ATTR amyloidosis: an international Delphi consensus of patient advocates and multidisciplinary healthcare professionals

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Alnylam Pharmaceuticals Background Hereditary transthyretin-mediated amyloidosis (ATTRv) is a rare, progressive, and potentially life-limiting multisystem disease, with cardiac manifestations, managed in a specialist settings by a multidisciplinary team (MDT) and supported by allied healthcare professionals (HCPs). Purpose This online international Delphi survey aimed to evolve clinical-patient-led practical guidance for the delivery of patient-centred holistic care based on the needs and priorities of affected patients and their families. Methods A 14-member joint patient−HCP Primary Panel was convened including patient advocacy groups (PAGs) and key clinical specialties (neurology, cardiology, physiotherapy, psychology, nutrition and nursing). All members of the Primary Panel had a role in identifying the challenges and opportunities which could be addressed by the recommendations (Figure) and in the writing and reviewing of the recommendations, using published evidence/guidelines to support each recommendation. Guidance evolved on the care provision needed to support seven core goals: early diagnosis and treatment; disease monitoring and organisation of care; maintenance of physical rehabilitation and mental health; family-centred care and caregiver support; patient−doctor dialogue; access to social support; and social networking. Results Between June−October 2022, 100 HCPs and 22 PAG representatives from 27 countries took part in anonymised online Delphi voting to establish the level of agreement (≥75% group agreement) and feasibility in practice for 50 recommendations. The clinical–patient community endorsed all but one of the primary panel’s recommendations. However, only 34% (17 of 50) of the recommendations were identified by most HCPs as a core part of routine care at their institutions, with the remainder of the recommendations identified as either part of usual care (by &amp;lt;50% HCPs respondents) or as largely achievable (by a further 30%-45% of HCPs) with current resources. The highest level of agreement amongst PAG representatives was for the regular referral and assessment of patients by a nutritionist, patient education and information for families; the role of specialist centres in providing information on national patient associations; the option for interim review (telemedicine) between scheduled tertiary centre visits for patients with worsening of symptoms; the need for treatment decisions informed by discussion with the MDT and patients; and training of HCPs to increase disease awareness and early diagnosis/intervention. Conclusions This research highlights the challenges associated with the holistic care of patients, particularly in rare diseases, recognising the roles of PAGs and allied HCPs, including those in the cardiovascular specialty, in supporting patients and their families as part of a comprehensive care plan. Figure: Opportunities and challenges for the delivery of care for patients with ATTRv amyloidosis and their caregivers

Longitudinal adherence to breast cancer surveillance following cancer genetic testing in an integrated health care system.

Screening with mammography and breast magnetic resonance imaging (MRI) is an important risk management strategy for individuals with inherited pathogenic variants (PVs) in genes associated with increased breast cancer risk. We describe longitudinal screening adherence in individuals who underwent cancer genetic testing as part of usual care in a vertically integrated health system. We determined the proportion time covered (PTC) by annual mammography and breast MRI for individuals with PVs in TP53, BRCA1, BRCA2, PALB2, NF1, CHEK2, and ATM. We determined time covered by biennial mammography beginning at age 50years for individuals who received negative results, uncertain results, or with PVs in genes without specific breast cancer screening recommendations. One hundred and forty individuals had PVs in TP53, BRCA1, BRCA2, PALB2, NF1, CHEK2, or ATM. Among these individuals, average PTC was 48% (range 0-99%) for annual screening mammography and 34% (range 0-100%) for annual breast MRI. Average PTC was highest for individuals with PVs in CHEK2 (N = 14) and lowest for individuals with PVs in TP53 (N = 3). Average PTC for biennial mammography (N = 1,027) was 49% (0-100%). Longitudinal screening adherence in individuals with PVs in breast cancer associated genes, as measured by the proportion of time covered, is low; adherence to annual breast MRI falls below that of annual mammography. Additional research should examine screening behavior in individuals with PVs in breast cancer associated genes with a goal of developing interventions to improve adherence to recommended risk management.

The Ultrashort Mental Health Screening Tool Is a Valid and Reliable Measure With Added Value to Support Decision-making.

Mental health influences symptoms, outcomes, and decision-making in musculoskeletal healthcare. Implementing measures of mental health in clinical practice can be challenging. An ultrashort screening tool for mental health with a low burden is currently unavailable but could be used as a conversation starter, expectation management tool, or decision support tool. (1) Which items of the Pain Catastrophizing Scale (PCS), Patient Health Questionnaire (PHQ-4), and Brief Illness Perception Questionnaire (B-IPQ) are the most discriminative and yield a high correlation with the total scores of these questionnaires? (2) What is the construct validity and added clinical value (explained variance for pain and hand function) of an ultrashort four-item mental health screening tool? (3) What is the test-retest reliability of the screening tool? (4) What is the response time for the ultrashort screening tool? This was a prospective cohort study. Data collection was part of usual care at Xpert Clinics, the Netherlands, but prospective measurements were added to this study. Between September 2017 and January 2022, we included 19,156 patients with hand and wrist conditions. We subdivided these into four samples: a test set to select the screener items (n = 18,034), a validation set to determine whether the selected items were solid (n = 1017), a sample to determine the added clinical value (explained variance for pain and hand function, n = 13,061), and a sample to assess the test-retest reliability (n = 105). Patients were eligible for either sample if they completed all relevant measurements of interest for that particular sample. To create an ultrashort screening tool that is valid, reliable, and has added value, we began by picking the most discriminatory items (that is, the items that were most influential for determining the total score) from the PCS, PHQ-4, and B-IPQ using chi-square automated interaction detection (a machine-learning algorithm). To assess construct validity (how well our screening tool assesses the constructs of interest), we correlated these items with the associated sum score of the full questionnaire in the test and validation sets. We compared the explained variance of linear models for pain and function using the screening tool items or the original sum scores of the PCS, PHQ-4, and B-IPQ to further assess the screening tool's construct validity and added value. We evaluated test-retest reliability by calculating weighted kappas, ICCs, and the standard error of measurement. We identified four items and used these in the screening tool. The screening tool items were highly correlated with the PCS (Pearson coefficient = 0.82; p < 0.001), PHQ-4 (0.87; p < 0.001), and B-IPQ (0.85; p < 0.001) sum scores, indicating high construct validity. The full questionnaires explained only slightly more variance in pain and function (10% to 22%) than the screening tool did (9% to 17%), again indicating high construct validity and much added clinical value of the screening tool. Test-retest reliability was high for the PCS (ICC 0.75, weighted kappa 0.75) and B-IPQ (ICC 0.70 to 0.75, standard error of measurement 1.3 to 1.4) items and moderate for the PHQ-4 item (ICC 0.54, weighted kappa 0.54). The median response time was 43 seconds, against more than 4 minutes for the full questionnaires. Our ultrashort, valid, and reliable screening tool for pain catastrophizing, psychologic distress, and illness perception can be used before clinician consultation and may serve as a conversation starter, an expectation management tool, or a decision support tool. The clinical utility of the screening tool is that it can indicate that further testing is warranted, guide a clinician when considering a consultation with a mental health specialist, or support a clinician in choosing between more invasive and less invasive treatments. Future studies could investigate how the tool can be used optimally and whether using the screening tool affects daily clinic decisions. Level II, diagnostic study.

Modified-release morphine or placebo for chronic breathlessness: the MABEL trial protocol.

Chronic breathlessness, a persistent and disabling symptom despite optimal treatment of underlying causes, is a frightening symptom with serious and widespread impact on patients and their carers. Clinical guidelines support the use of morphine for the relief of chronic breathlessness in common long-term conditions, but questions remain around clinical effectiveness, safety and longer term (>7 days) administration. This trial will evaluate the effectiveness of low-dose oral modified-release morphine in chronic breathlessness. This is a multicentre, parallel group, double-blind, randomised, placebo-controlled trial. Participants (n=158) will be opioid-naïve with chronic breathlessness due to heart or lung disease, cancer or post-coronavirus disease 2019. Participants will be randomised 1:1 to 5 mg oral modified-release morphine/placebo twice daily and docusate/placebo 100 mg twice daily for 56 days. Non-responders at Day 7 will dose escalate to 10 mg morphine/placebo twice daily at Day 15. The primary end-point (Day 28) measure will be worst breathlessness severity (previous 24 h). Secondary outcome measures include worst cough, distress, pain, functional status, physical activity, quality of life, and early identification and management of morphine-related side-effects. At Day 56, participants may opt to take open-label, oral modified-release morphine as part of usual care and complete quarterly breathlessness and toxicity questionnaires. The study is powered to be able to reject the null hypothesis and an embedded normalisation process theory-informed qualitative substudy will explore the adoption of morphine as a first-line pharmacological treatment for chronic breathlessness in clinical practice if effective.

Experience and acceptability of a carer-focussed intervention in acute oncology settings: A qualitative study of people with advanced cancer and their carers.

Providing optimal support for carers of people with advanced cancer is critical to facilitating discharge home from hospital. Carer Support Needs Assessment Tool-Intervention (CSNAT-I) has shown promise in supporting carers' needs in this context. This study aimed to explore patient and carers experiences with and views on the acceptability of the CSNAT-I delivered by occupational therapists in an acute oncology setting. People with advanced cancer and their carers who had previously received the CSNAT-I as part of usual care while admitted to an Australian specialist cancer centre or acute hospital were invited to participate in interviews exploring their perceptions of the intervention. Data were analysed thematically. Two patients and 10 carers participated in semi-structured interviews. Three themes were constructed from the data: Carers viewed the CSNAT-I as comprehensive process that (1) 'covered everything' related to discharge planning; (2) generated an 'increased awareness of needs' for themselves, patients, and clinicians; and (3) triggered an emotional response of feeling 'wrapped up in care' that was maintained as they moved from hospital to home. This study has demonstrated that the CSNAT-I was highly acceptable to carers as part of existing discharge processes supporting them through the transition from hospital to home and can be delivered by occupational therapists and other clinicians with a natural synergy to discharge planning. These findings will inform further development and testing of the delivery model of the CSNAT-I in future trials.