Colon Age: A Metric for Whether and How to Screen Male Veterans for Early-Onset Colorectal Cancer.

We aimed to develop a metric for estimating risk for early-onset colorectal cancer (EOCRC) to help decide whether and how to screen persons < age 50. We used risk prediction models derived and validated on male Veterans to calculate the relative risks (RRs) for 6 scenarios: one low-risk scenario (no risk factors present), four intermediate risk scenarios (some factors present), and one high-risk scenario (all factors present) for three age groups (35-39, 40-44, and 45-49 years). For each scenario, we estimated absolute CRC risk using SEER CRC incidence rates and each scenario's RR. We identified the current SEER 5-year age group to which the revised estimate was closest and refer to the midpoint of this group as the "colon age". When the revised estimate was ≥ that for 50-54-year-olds and for 70-74-year-olds, respective recommendations were made for (any) CRC screening and screening with colonoscopy. Among the scenarios, there was inconsistency between the two models for the 35-39 and 40-44 age groups, with only the 15-variable model recommending screening for the higher-risk 35-to-39-year-olds. Both models recommended screening for some intermediate risk and high-risk 40-44-year-olds. The models were well-aligned on whether and how to screen most 45-49-year-olds. Using risk factors for EOCRC with CRC incidence rates, "colon age" may be useful for shared decision making about whether and how to screen male Veterans < 50 years. For 45-49-year-olds, the 7-variable model may be preferred by patients, providers, and health systems.

Comparative effectiveness of two interventions to increase colorectal cancer screening among females living in the rural Midwest.

PURPOSE: To assess the comparative effectiveness of a tailored, interactive digital video disc (DVD) intervention versus DVD plus patient navigation (PN) intervention versus usual care (UC) on the uptake of colorectal cancer (CRC) screening among females living in Midwest rural areas. METHODS: As part of a larger study, 663 females (ages 50-74) living in rural Indiana and Ohio and not up-to-date (UTD) with CRC screening at baseline were randomized to one of three study groups. Demographics , health status/history, and beliefs and attitudes about CRC screening were measured at baseline. CRC screening was assessed at baseline and 12 months from medical records and self-report. Multivariable logistic regression was used to determine whether females in each group were UTD for screening and which test they completed. RESULTS: Adjusted for covariates, females in the DVD plus PN group were 3.5× more likely to complete CRC screening than those in the UC group (odds ratio [OR] 3.62; 95% confidence interval [CI]: 2.09, 6.47) and baseline intention to receive CRC screening (OR 3.45, CI: 2.21,5.42) at baseline. Adjusting for covariates, there was no difference by study arm whether females who became UTD for CRC screening chose to complete a colonoscopy or fecal occult blood test/fecal immunochemical test. CONCLUSIONS: Many females living in the rural Midwest are not UTD for CRC screening. A tailored intervention that included an educational DVD and PN improved knowledge, addressed screening barriers, provided information about screening test options, and provided support was more effective than UC and DVD-only to increase adherence to recommended CRC screening.

An Electronic Medical Record Intervention to Increase Pharmacologic Prophylaxis for Venous Thromboembolism in Emergency Department Observation Patients.

STUDY OBJECTIVE: The role of venous thromboembolism (VTE) prophylaxis among patients receiving emergency department (ED) observation unit care is unclear. We investigated an electronic health record-based clinical decision support tool aimed at increasing pharmacologic VTE prophylaxis use among at-risk patients placed in ED observation units. METHODS: We conducted an interrupted time-series study of an Epic-based best practice advisory implemented in May 2019 at a health care system comprising 2 academic medical centers and 4 community hospitals with dedicated ED observation units. The best practice advisory alerted staff at 24 hours to conduct a risk assessment and linked to a VTE prophylaxis order set. We used an interrupted time series, Bayesian structured time series, and a multivariable mixed-effect regression model to estimate the intervention effect. RESULTS: Prior to the best practice advisory implementation, there were 8,895 ED observation unit patients with a length of stay more than or equal to 24 hours, and 0.9% received pharmacologic VTE prophylaxis. Afterward, there were 12,664 ED observation unit patients with a length of stay more than or equal to 24 hours, and 4.8% received pharmacologic VTE prophylaxis. The interrupted time series and causal impact analysis showed a statistically significant increase in VTE prophylaxis (eg, absolute percent difference 3.8%, 95% confidence interval 3.5 to 4.1). In a multivariable model, only the intervention was significantly associated with receiving VTE prophylaxis (odds ratio 4.56, 95% confidence interval 2.22 to 9.37). CONCLUSION: An electronic health record-based alert helped to prompt staff caring for ED observation unit patients at risk for VTE with prolonged visits to order recommended pharmacologic prophylaxis. The best risk assessment model to use and the true incidence of VTE events in this population are unclear.

Comparable Minimally Important Differences and Responsiveness of Brief Pain Inventory and PEG Pain Scales across 6 Trials.

The 3-item pain intensity (P), interference with the enjoyment of life (E), and interference with general activity (G), or PEG, has become one of the most widely used measures of pain severity and interference. The minimally important differences (MID) and responsiveness of the PEG are essential metrics for solidifying its role in research and clinical care. The current study aims to establish the MID and responsiveness of the PEG by synthesizing data from 1,710 participants across 6 controlled trials. MIDs were estimated using absolute score changes among individuals reporting their pain was "a little better" on a retrospective global change anchor as well as distribution-based estimates using standard deviation thresholds and 1 and 2 standard errors of measurement. Responsiveness was assessed using standardized response means, area under the curve, and treatment effect sizes. MID estimates for the PEG ranged from 0.60 to 1.1 when using 0.35 SD, and 0.78 to 1.22 using 1 standard error of measurement. MID estimates using the global anchor had somewhat more variability but most estimates ranged from 1.0 to 1.75. Responsiveness effect sizes were generally large (>.80) for standardized response means and moderate (>.50) for treatment effect. Similarly, the most area under the curve values demonstrated an acceptable level of scale responsiveness (≥.70). Importantly, MID estimates and responsiveness of the PEG and BPI scales were largely comparable when aggregating data across trials. Our synthesis indicates that 1 point is a reasonable MID estimate on these 0- to 10-point pain scales, with 2 points being an upper bound. PERSPECTIVE: This article synthesizes data from 6 clinical trials to establish the minimally important difference (MID) and responsiveness of the 3-item PEG pain scale. The PEG demonstrated good responsiveness, and 1 to 2 points proved to be reasonable estimates for the lower and upper bounds of the MID.

Mediators and Moderators of Active Music Engagement to Reduce Traumatic Stress Symptoms and Improve Well-being in Parents of Young Children With Cancer.

OBJECTIVE: This trial examined the effects of proximal/distal mediators and moderators of an Active Music Engagement (AME) intervention on young child/parent distress, quality of life, and family function outcomes. METHODS: Child/parent dyads (n = 125) were randomized to AME or Audio-storybooks attention control condition. Each group received 3 sessions with a credentialed music therapist for 3 consecutive days with data collection at baseline, post-intervention (T2), and 30-days later (T3). Potential proximal mediators included within session child and parent engagement. Potential distal mediators included changes in perceived family normalcy, parent self-efficacy, and independent use of play materials. Potential moderators included parent/child distress with prior hospitalizations, parent traumatic stress screener (PCL-6), and child age. Outcomes included child emotional distress and quality of life; parent emotion, traumatic stress symptoms (IES-R), well-being; and family function. Mediation effects were estimated using ANCOVA, with indirect effects estimated using the percentile bootstrap approach. Moderation effects were tested by including appropriate interaction terms in models. RESULTS: No significant mediation effects were observed. Child distress with prior hospitalizations moderated AME effects for IES-R intrusion subscale scores at T2 (P = .01) and avoidance subscale scores at T3 (P = .007). Traumatic stress screener scores (PCL-6) moderated intervention effects for IES-R hyperarousal subscale scores at T2 (P = .01). There were no moderation effects for child age. CONCLUSIONS: AME is a promising intervention for mitigating traumatic stress symptoms and supporting well-being in parents of children with cancer, particularly for parents who screen high for traumatic stress and whose children are more highly distressed with hospitalization.

Patient awareness, perceptions, and attitudes towards pharmacists prescribing tobacco cessation medications.

BACKGROUND: Recent legislative advances now permit pharmacists to prescribe tobacco cessation medications in 17 states. While national initiatives are underway to prepare the pharmacy profession for this expanded role, patient perceptions of this role have not been explored. OBJECTIVE: The objective of this study was to characterize patient perceptions, attitudes, and awareness of pharmacists prescribing for tobacco cessation medications. METHODS: A cross-sectional survey of English and Spanish-speaking patients was conducted at 12 locations of a federally-qualified health center in Northwest Indiana. Survey measures assessed sociodemographics, tobacco use history and interest in quitting, prior interactions with pharmacists and awareness of pharmacists' ability to prescribe tobacco cessation medications, and perceptions of pharmacists assisting with cessation. The Theory of Planned Behavior (TPB) served as a framework for item development. Multivariable logistic regression was used for modeling. RESULTS: A total of 2082 individuals (1878 English, 204 Spanish) completed the survey (42.4%). Among current users (n = 592; 28.4%), 46.2% had made a quit attempt in the past year, and 41.0% reported having used a tobacco cessation medication in the past. Over half (60.5%) of current users would be comfortable talking with a pharmacist about quitting, 31.9% intended to talk with a pharmacist about quitting, and 31.7% intended to ask a pharmacist to prescribe a medicine to help with quitting. In multivariable modeling, intention to (a) talk with a pharmacist about quitting and (b) ask a pharmacist to prescribe a medication were significantly associated with TPB constructs. Current tobacco users were receptive to pharmacist-facilitated assistance with quitting, including prescribing of tobacco cessation medications. CONCLUSIONS: Patients' attitudes, subjective norms, and perceived behavioral control, from the Theory of Planned Behavior, were important predictors of intention to engage with pharmacists for quitting and intention to ask a pharmacist to prescribe a cessation medication.

Receipt, uptake, and satisfaction with tailored DVD and patient navigation interventions to promote cancer screening among rural women.

Process evaluation is essential to understanding and interpreting the results of randomized trials testing the effects of behavioral interventions. A process evaluation was conducted as part of a comparative effectiveness trial testing a mailed, tailored interactive digital video disc (DVD) with and without telephone-based patient navigation (PN) to promote breast, cervical and colorectal cancer screening among rural women who were not up-to-date (UTD) for at least one screening test. Data on receipt, uptake, and satisfaction with the interventions were collected via telephone interviews from 542 participants who received the tailored interactive DVD (n = 266) or the DVD plus telephone-based PN (n = 276). All participants reported receiving the DVD and 93.0% viewed it. The most viewed sections of the DVD were about colorectal, followed by breast, then cervical cancer screening. Most participants agreed the DVD was easy to understand, helpful, provided trustworthy information, and gave information needed to make a decision about screening. Most women in the DVD+PN group, 98.2% (n = 268), reported talking with the navigator. The most frequently discussed cancer screenings were colorectal (86.8%) and breast (71.3%); 57.5% discussed cervical cancer screening. The average combined length of PN encounters was 22.2 minutes with 21.7 additional minutes spent on coordinating activities. Barriers were similar across screening tests with the common ones related to the provider/health care system, lack of knowledge, forgetfulness/too much bother, and personal issues. This evaluation provided information about the implementation and delivery of behavioral interventions as well as challenges encountered that may impact trial results.

Two interventions to promote cervical, breast, and colorectal cancer screening among rural women who were not up-to-date (UTD) for at least one screening test were evaluated by rural women who received them as part of the randomized trial. Participants who received the tailored interactive digital video disc (DVD; n = 266) or the DVD plus telephone-based patient navigation (PN; n = 276) were interviewed by phone about their engagement and satisfaction with the interventions. All participants reported receiving the DVD and 93.0% viewed it. Most agreed the DVD was easy to understand, helpful, provided trustworthy information, and gave information needed to get screened. Almost all women in the DVD+PN group, 98.2% (n = 268) talked with the navigator. The most common cancer screenings discussed with navigators were colorectal (86.8%), followed by breast (71.3%) and cervical (57.5%). The average length of encounters with the navigators was 22.2 minutes; navigators spent 21.7 additional minutes on coordinating activities. Barriers discussed were similar across screening tests. The most common were related to the healthcare provider/system, lack of knowledge, forgetfulness/too much bother, and personal issues. This study provided important information about receipt, uptake, and satisfaction with two behavioral interventions, along with challenges encountered that may impact results.

Risk Factors for Early-onset Sporadic Colorectal Cancer in Male Veterans.

Identifying risk factors for early-onset colorectal cancer (EOCRC) could help reverse its rising incidence through risk factor reduction and/or early screening. We sought to identify EOCRC risk factors that could be used for decisions about early screening. Using electronic databases and medical record review, we compared male veterans ages 35 to 49 years diagnosed with sporadic EOCRC (2008-2015) matched 1:4 to clinic and colonoscopy controls without colorectal cancer, excluding those with established inflammatory bowel disease, high-risk polyposis, and nonpolyposis syndromes, prior bowel resection, and high-risk family history. We ascertained sociodemographic and lifestyle factors, family and personal medical history, physical measures, vital signs, medications, and laboratory values 6 to 18 months prior to case diagnosis. In the derivation cohort (75% of the total sample), univariate and multivariate logistic regression models were used to derive a full model and a more parsimonious model. Both models were tested using a validation cohort. Among 600 cases of sporadic EOCRC [mean (SD) age 45.2 (3.5) years; 66% White], 1,200 primary care clinic controls [43.4 (4.2) years; 68% White], and 1,200 colonoscopy controls [44.7 (3.8) years; 63% White], independent risk factors included age, cohabitation and employment status, body mass index (BMI), comorbidity, colorectal cancer, or other visceral cancer in a first- or second-degree relative (FDR or SDR), alcohol use, exercise, hyperlipidemia, use of statins, NSAIDs, and multivitamins. Validation c-statistics were 0.75-0.76 for the full model and 0.74-0.75 for the parsimonious model, respectively. These independent risk factors for EOCRC may identify veterans for whom colorectal cancer screening prior to age 45 or 50 years should be considered. PREVENTION RELEVANCE: Screening 45- to 49-year-olds for colorectal cancer is relatively new with uncertain uptake thus far. Furthermore, half of EOCRC occurs in persons < 45 years old. Using risk factors may help 45- to 49-year-olds accept screening and may identify younger persons for whom earlier screening should be considered. See related Spotlight, p. 479.

Comparative Effectiveness of 2 Interventions to Increase Breast, Cervical, and Colorectal Cancer Screening Among Women in the Rural US: A Randomized Clinical Trial.

Importance: Women living in rural areas have lower rates of breast, cervical, and colorectal cancer screening compared with women living in urban settings. Objective: To assess the comparative effectiveness of (1) a mailed, tailored digital video disc (DVD) intervention; (2) a DVD intervention plus telephonic patient navigation (DVD/PN); and (3) usual care with simultaneously increased adherence to any breast, cervical, and colorectal cancer screening that was not up to date at baseline and to assess cost-effectiveness. Design, Setting, and Participants: This randomized clinical trial recruited and followed up women from rural Indiana and Ohio (community based) who were not up to date on any or all recommended cancer screenings. Participants were randomly assigned between November 28, 2016, and July 1, 2019, to 1 of 3 study groups (DVD, DVD/PN, or usual care). Statistical analyses were completed between August and December 2021 and between March and September 2022. Intervention: The DVD interactively assessed and provided messages for health beliefs, including risk of developing the targeted cancers and barriers, benefits, and self-efficacy for obtaining the needed screenings. Patient navigators counseled women on barriers to obtaining screenings. The intervention simultaneously supported obtaining screening for all or any tests outside of guidelines at baseline. Main Outcomes and Measures: Receipt of any or all needed cancer screenings from baseline through 12 months, including breast, cervical, and colorectal cancer, and cost-effectiveness of the intervention. Binary logistic regression was used to compare the randomized groups on being up to date for all and any screenings at 12 months. Results: The sample included 963 women aged 50 to 74 years (mean [SD] age, 58.6 [6.3] years). The DVD group had nearly twice the odds of those in the usual care group of obtaining all needed screenings (odds ratio [OR], 1.84; 95% CI, 1.02-3.43; P = .048), and the odds were nearly 6 times greater for DVD/PN vs usual care (OR, 5.69; 95% CI, 3.24-10.5; P < .001). The DVD/PN intervention (but not DVD alone) was significantly more effective than usual care (OR, 4.01; 95% CI, 2.60-6.28; P < .001) for promoting at least 1 (ie, any) of the needed screenings at 12 months. Cost-effectiveness per woman who was up to date was $14 462 in the DVD group and $10 638 in the DVD/PN group. Conclusions and Relevance: In this randomized clinical trial of rural women who were not up to date with at least 1 of the recommended cancer screenings (breast, cervical, or colorectal), an intervention designed to simultaneously increase adherence to any or all of the 3 cancer screening tests was more effective than usual care, available at relatively modest costs, and able to be remotely delivered, demonstrating great potential for implementing an evidence-based intervention in remote areas of the midwestern US. Trial Registration: ClinicalTrials.gov Identifier: NCT02795104.

Mortality After Postcolonoscopy Colorectal Cancer in the Veterans Affairs Health Care System.

Importance: Postcolonoscopy colorectal cancer (PCCRC) refers to colorectal cancer (CRC) diagnosed after a colonoscopy in which no cancer was found and is reflective of colonoscopy quality at the individual and system levels. Colonoscopy is widely performed in the Veterans Affairs (VA) health care system, but the prevalence of PCCRC and its associated mortality are unknown. Objective: To examine PCCRC prevalence and its all-cause mortality (ACM) and CRC-specific mortality (CSM) within the VA health care system. Design, Setting, and Participants: This retrospective cohort study used VA-Medicare administrative data to identify 29 877 veterans aged 50 to 85 years with newly diagnosed CRC between January 1, 2003, and December 31, 2013. Patients whose colonoscopy occurred less than 6 months before CRC diagnosis with no other colonoscopy within the previous 36 months were categorized as having detected CRC (DCRC). Those who had a colonoscopy that did not detect CRC between 6 and 36 months before CRC diagnosis were categorized as having postcolonoscopy CRC (PCCRC-3y). A third group included patients with CRC and no colonoscopy within the prior 36 months. The final analysis of the data was performed in September 2022. Exposures: Prior receipt of colonoscopy. Main Outcomes and Measures: Cox proportional hazards regression (with censoring, last follow-up December 31, 2018) analyses were conducted to compare PCCRC-3y and DCRC for 5-year ACM and CSM after CRC diagnosis. Results: Of 29 877 patients with CRC (median [IQR] age, 67 [60-75] years; 29 353 [98%] male; 5284 [18%] Black, 23 971 [80%] White, and 622 [2%] other), 1785 (6%) were classified as having PCCRC-3y and 21 811 (73%) as having DCRC. The 5-year ACM rates were 46% vs 42% for patients with PCCRC-3y vs patients with DCRC. The 5-year CSM rates were 26% vs 25% for patients with PCCRC-3y vs patients with DCRC. In multivariable Cox proportional hazards regression analysis, there was no significant difference in ACM and CSM between patients with PCCRC-3y (adjusted hazard ratio [aHR], 1.04; 95% CI, 0.98-1.11; P = .18) and patients with DCRC (aHR, 1.04; 95% CI, 0.95-1.13; P = .42). However, compared with patients with DCRC, patients with no prior colonoscopy had significantly higher ACM (aHR, 1.76; 95% CI, 1.70-1.82; P < .001) and CSM (aHR, 2.22; 95% CI, 2.12-2.32; P < .001). Compared with patients with DCRC, patients with PCCRC-3y had significantly lower odds of having undergone colonoscopy performed by a gastroenterologist (odds ratio, 0.48; 95% CI, 0.43-0.53; P < .001). Conclusions and Relevance: This study found that PCCRC-3y constituted 6% of CRCs in the VA system, which is similar to other settings. Compared with patients with CRC detected by colonoscopy, those with PCCRC-3y have comparable ACM and CSM.

Implementation of an Electronic Alert to Improve Timeliness of Second Dose Antibiotics for Patients With Suspected Serious Infections in the Emergency Department: A Quasi-Randomized Controlled Trial.

STUDY OBJECTIVE: Delays in the second dose of antibiotics in the emergency department (ED) are associated with increased morbidity and mortality in patients with serious infections. We analyzed the influence of clinical decision support to prevent delays in second doses of broad-spectrum antibiotics in the ED. METHODS: We allocated adult patients who received cefepime or piperacillin/tazobactam in 9 EDs within an integrated health care system to an electronic alert that reminded ED clinicians to reorder antibiotics at the appropriate interval vs usual care. The primary outcome was a median delay in antibiotic administration. Secondary outcomes were rates of intensive care unit (ICU) admission, hospital mortality, and hospital length of stay. We included a post hoc secondary outcome of frequency of major delay (>25% of expected interval for second antibiotic dose). RESULTS: A total of 1,113 ED patients treated with cefepime or piperacillin/tazobactam were enrolled in the study, of whom 420 remained under ED care when their second dose was due and were included in the final analysis. The clinical decision support tool was associated with reduced antibiotic delays (median difference 35 minutes, 95% confidence interval [CI], 5 to 65). There were no differences in ICU transfers, inpatient mortality, or hospital length of stay. The clinical decision support tool was associated with decreased probability of major delay (absolute risk reduction 13%, 95% CI, 6 to 20). CONCLUSIONS: The implementation of a clinical decision support alert reminding clinicians to reorder second doses of antibiotics was associated with a reduction in the length and frequency of antibiotic delays in the ED. There was no effect on the rates of ICU transfers, inpatient mortality, or hospital length of stay.

Opioid Legislation in Patients With Inflammatory Bowel Disease: A State-wide Retrospective Cohort Study.

BACKGROUND: Indiana State opioid prescription legislation has been shown to decrease overall opioid prescriptions. However, this effect has not been studied in specific diseases associated with chronic pain such as inflammatory bowel disease (IBD). We aimed to determine the effect of state opioid prescription legislation on opioid prescribing patterns in IBD. METHODS: A retrospective cohort analysis using an interrupted time-series from December 15, 2010 to July 1, 2018, with 2 time periods separated by Title 844 of the Indiana Administrative Code, in a statewide health care system capturing the majority of the state's population including all adult patients with IBD. The primary outcome was opioid prescription rate per person-year. RESULTS: In total, 9436 patients met inclusion criteria. After legislation, the total number of opioid orders per patient-year continued to increase (0.543, 95% CI, 0.528-0.558, to 0.663, 95% CI, 0.654-0.672), with fewer scripts from the emergency department (0.113, 95% CI, 0.106-0.120, to 0.092, 95% CI, 0.088-0.095) and more from outpatient providers (0.303, 95% CI, 0.292-0.314 to 0.432, 95% CI, 0.424-0.439). There were increases in biologic (0.206, 95% CI, 0.197-0.215 to 0.517, 95% CI, 0.509-0.525) and steroid (0.182, 95% CI, 0.173-0.190 to 0.237, 95% CI, 0.232-0.243) prescriptions per person-year following legislation. Factors associated with heavy opioid use included chronic steroids (odds ratio, 5.030; 95% CI, 4.176-6.054), history of IBD-related surgery (odds ratio, 2.807; 95% CI, 2.367-3.323) and current smoking (odds ratio, 2.650; 95% CI, 2.223-3.158). CONCLUSIONS: Despite legislation and the increased use of disease-modifying drugs, statewide opioid prescriptions continued to increase. The increase in opiate use, high steroid use, and significant health care utilization suggests poor underlying disease control.

State legislation, which has decreased opioid prescribing in the general population, has not had similar effects in patients with inflammatory bowel disease. This is the first study assessing opioid legislation and its effects in a chronic pain condition.

Measuring Medication Use, Obstacles, and Knowledge in Individuals With Cirrhosis.

BACKGROUND & AIMS: Although patient knowledge is modifiable, there are no widely accepted tools to measure patient understanding during cirrhosis care. We aimed to develop and validate "My Cirrhosis Coach" (MCC), a personalized, self-administered questionnaire to evaluate cirrhosis-related medication use, obstacles, and understanding. METHODS: Adults with cirrhosis were prospectively enrolled at 3 tertiary centers from July 2016 through July 2020. Psychometrics including confirmatory factor analysis was used to develop and validate a final questionnaire. Content validity was measured via the content validity index and expert performance. Discriminant validity was assessed by comparing scores between groups hypothesized to have varying performance. RESULTS: The MCC was tested in a diverse cohort (n = 713) with cirrhosis and its complications including ascites (45%) and hepatic encephalopathy (33%) with median Model for End-Stage Liver Disease-Sodium 10 (interquartile range, 9-15). A 6-factor model of the MCC fit the data well (root mean square error of approximation, 0.22; comparative fit index, 0.96; standardized root mean squared residual, 0.104; final domains: Medication Use & Accessibility, Medication Obstacles, Lactulose Use, Diuretic Use, Beta Blocker Use, and Dietary Sodium Use). The MCC had excellent content validity (content validity index, 81%-94%) and accuracy (91%-100%) ratings by experts. Mean domain scores ranged from 1.1 to 2.6 (range, 0-3; 3 indicating better performance). Those with a cirrhosis complication scored higher in the relevant medication domain (ie, diuretic use score in ascites). Compared with outpatients, inpatients scored higher in all knowledge domains except salt use and reported more medication obstacles. Scores differed by income, education level, and having an adult at home. CONCLUSIONS: In a large, diverse cohort, we validated the MCC, which can serve to standardize medication use and knowledge measurement in clinical practice and education-based studies in cirrhosis.

Improving Communication in Nursing Homes Using Plan-Do-Study-Act Cycles of an SBAR Training Program.

BACKGROUND: Incomplete communication between staff and providers may cause adverse outcomes for nursing home residents. The Situation-Background-Assessment-Recommendation (SBAR) tool is designed to improve communication around changes in condition (CIC). An adapted SBAR was developed for the Centers for Medicare and Medicaid Services demonstration project, OPTIMISTIC, to increase its use during a resident CIC and to improve documentation. METHODS: Four Plan-Do-Study-Act (PDSA) cycles to develop and refine successive protocol implementation of the OPTIMISTIC SBAR were deployed in four Indiana nursing homes. Use of SBAR, documentation quality, and participant surveys were assessed pre- and post-intervention implementation. RESULTS: OPTIMISTIC SBAR use and documentation quality improved in three of the four buildings. Participants reported improved collaboration between nurses and providers after SBAR intervention. CONCLUSION: Successive PDSA cycles implementing changes in an OPTIMISTIC SBAR protocol for resident CIC led to an increase in SBAR use, improved documentation, and better collaboration between nursing staff and providers.

Factors associated with the accurate self-report of cancer screening behaviors among women living in the rural Midwest region of the United States.

This study examines the accuracy of the self-report of up-to-date cancer screening behaviors (Mammography, Papanicolaou (Pap)/Human Papillomavirus (HPV) tests, Fecal Occult Blood Test (FOBT)/Fecal Immunochemical Test (FIT), Colonoscopy) compared to medical record documentation prior to eligibility determination and enrollment in a randomized controlled trial of an intervention to increase cancer screening among women living in rural counties of Indiana and Ohio. Women (n = 1,641) completed surveys and returned a medical record release form from November 2016-June 2019. We compared self-report to medical records for up-to-date cancer screening behaviors to determine the validity of self-report. Logistic regression models identified variables associated with accurate reporting. Women were up-to-date for mammography (75 %), Pap/HPV test (54 %), colonoscopy (53 %), and FOBT/FIT (6 %) by medical record. Although 39.6 % of women reported being up-to-date for all three anatomic sites (breast, cervix, and colon), only 31.8 % were up to date by medical records. Correlates of accurate reporting of up-to-date cancer screening varied by screening test. Approximately-one-third of women in rural counties in the Midwest are up-to-date for all three anatomic sites and correlates of the accurate reporting of screening varied by test. Although most investigators use medical records to verify completion of cancer screening behaviors as the primary outcome of intervention trials, they do not usually use medical records for the routine verification of study eligibility. Study results suggest that future research should use medical record documentation of cancer screening behaviors to determine eligibility for trials evaluating interventions to increase cancer screening.

Increasing breast, cervical, and colorectal cancer screening among rural women: Baseline characteristics of a randomized control trial.

BACKGROUND: Rural women suffer disproportionately from breast, cervical, and colorectal cancer mortality compared to those in urban areas. Screening behaviors for these three cancers share many similar beliefs and barriers. Unfortunately, published interventions have not attempted to simultaneously bring women up to date with screening for three cancers (breast, cervical, and colorectal) even though multiple behavior change interventions are effective. The aim of this randomized controlled study was to compare the effectiveness of a mailed interactive and tailored DVD vs. DVD plus telephonic patient navigation (DVD + PN) vs. Usual Care (UC) to increase the percentage of rural women (aged 50-74) up to date for breast, cervical, and colorectal cancer screening. METHODS: Nine hundred eighty-three participants needing one, two, or three cancer screening tests were consented and randomized to one of three groups. Prior to randomization, women were assessed for baseline characteristics including sociodemographics, health status, and cancer screening test beliefs. Screening status was assessed by medical record review. RESULTS: At baseline, the average age of participants was 58.6 years. Nineteen percent of the sample was not up to date with screenings for all three cancers. Colorectal cancer had the highest percentage of women (69%) who were not up to date with screening followed by cervical (57%) and then breast cancer (41%). Sixty percent of women reported receiving a reminder for mammography; 30%, for cervical cancer screening; 15% for colonoscopy; and 6% for FOBT/FIT. DISCUSSION: Increasing adherence to colorectal cancer screening may be the most urgent need among all screening tests. This clinical trial is registered at clinicaltrials.gov with identifier NCT02795104.

The Effect of Two Interventions to Increase Breast Cancer Screening in Rural Women.

Guideline-based mammography screening is essential to lowering breast cancer mortality, yet women residing in rural areas have lower rates of up to date (UTD) breast cancer screening compared to women in urban areas. We tested the comparative effectiveness of a tailored DVD, and the DVD plus patient navigation (PN) intervention vs. Usual Care (UC) for increasing the percentage of rural women (aged 50 to 74) UTD for breast cancer screening, as part of a larger study. Four hundred and two women who were not UTD for breast cancer screening, eligible, and between the ages of 50 to 74 were recruited from rural counties in Indiana and Ohio. Consented women were randomly assigned to one of three groups after baseline assessment of sociodemographic variables, health status, beliefs related to cancer screening tests, and history of receipt of guideline-based screening. The mean age of participants was 58.2 years with 97% reporting White race. After adjusting for covariates, 54% of women in the combined intervention (DVD + PN) had a mammogram within the 12-month window, over 5 times the rate of becoming UTD compared to UC (OR = 5.11; 95% CI = 2.57, 10.860; p < 0.001). Interactions of the intervention with other variables were not significant. Significant predictors of being UTD included: being in contemplation stage (intending to have a mammogram in the next 6 months), being UTD with other cancer screenings, having more disposable income and receiving a reminder for breast screening. Women who lived in areas with greater Area Deprivation Index scores (a measure of poverty) were less likely to become UTD with breast cancer screening. For rural women who were not UTD with mammography screening, the addition of PN to a tailored DVD significantly improved the uptake of mammography. Attention should be paid to certain groups of women most at risk for not receiving UTD breast screening to improve breast cancer outcomes in rural women.

The design and conduct of a pragmatic cluster randomized trial of an advance care planning program for nursing home residents with dementia.

BACKGROUND/AIMS: A significant number of people with Alzheimer's disease or related dementia diagnoses will be cared for in nursing homes near the end of life. Advance care planning (ACP), the process of eliciting and documenting patient-centered preferences for care, is considered essential to providing high quality care for this population. Nursing homes are currently required by regulations to offer ACP to residents and families, but no training requirements exist for nursing home staff, and approaches to fulfilling this regulatory and ethical responsibility vary. As a result, residents may receive care inconsistent with their goals, such as unwanted hospitalizations. Pragmatic trials offer a way to develop and test ACP in real-world settings to increase the likelihood of adoption of sustainable best practices. METHODS: The "Aligning Patient Preferences-a Role Offering Alzheimer's patients, Caregivers, and Healthcare Providers Education and Support (APPROACHES)" project is designed to pragmatically test and evaluate a staff-led program in 137 nursing homes (68 = intervention, 69 = control) owned by two nursing home corporations. Existing nursing home staff receive standardized training and implement the ACP Specialist program under the supervision of a corporate lead. The primary trial outcome is the annual rate of hospital transfers (admissions and emergency department visits). Consistent with the spirit of a pragmatic trial, study outcomes rely on data already collected for quality improvement, clinical, or billing purposes. Configurational analysis will also be performed to identify conditions associated with implementation. RESULTS: Partnerships with large corporate companies enable the APPROACHES trial to rely on corporate infrastructure to roll out the intervention, with support for a corporate implementation lead who is charged with the initial introduction and ongoing support for nursing home-based ACP Specialists. These internal champions connect the project with other company priorities and use strategies familiar to nursing home leaders for the initiation of other programs. Standardized data collection across nursing homes also supports the conduct of pragmatic trials in this setting. DISCUSSION: Many interventions to improve care in nursing homes have failed to demonstrate an impact or, if successful, maintain an impact over time. Pragmatic trials, designed to test interventions in real-world contexts that are evaluated through existing data sources collected routinely as part of clinical care, are well suited for the nursing home environment. A robust program that increases access to ACP for nursing home residents has the potential to increase goal-concordant care and is expected to reduce hospital transfers. If successful, the ACP Specialist Program will be primed for rapid translation into nursing home practice to reduce unwanted, burdensome hospitalizations and improve the quality of care for residents with dementia.

The Avoidable Transfer Scale: A New Tool for Identifying Potentially Avoidable Hospital Transfers of Nursing Home Residents.

Background and Objectives: Prior approaches to identifying potentially avoidable hospital transfers (PAHs) of nursing home residents have involved detailed root cause analyses that are difficult to implement and sustain due to time and resource constraints. They relied on the presence of certain conditions but did not identify the specific issues that contributed to avoidability. We developed and tested an instrument that can be implemented using review of the electronic medical record. Research Design and Methods: The OPTIMISTIC project was a Centers for Medicare and Medicaid Services demonstration to reduce avoidable hospital transfers of nursing home residents. The OPTIMISTIC team conducted a series of root cause analyses of transfer events, leading to development of a 27-item instrument to identify common characteristics of PAHs (Stage 1). To refine the instrument, project nurses used the electronic medical record (EMR) to score the avoidability of transfers to the hospital for 154 nursing home residents from 7 nursing homes from May 2019 through January 2020, including their overall impression of whether the transfer was avoidable (Stage 2). Each transfer was rated independently by 2 nurses and assessed for interrater reliability with a kappa statistic. Results: Kappa scores ranged from -0.045 to 0.556. After removing items based on our criteria, 12 final items constituted the Avoidable Transfer Scale. To assess validity, we compared the 12-item scale to nurses' overall judgment of avoidability of the transfer. The 12-item scale scores were significantly higher for submissions rated as avoidable than those rated unavoidable by the nurses (mean 5.3 vs 2.6, p < .001). Discussion and Implications: The 12-item Avoidable Transfer Scale provides an efficient approach to identify and characterize PAHs using available data from the EMR. Increased ability to quantitatively assess the avoidability of resident transfers can aid nursing homes in quality improvement initiatives to treat more acute changes in a resident's condition in place.

Agreement between older adult patient and caregiver proxy symptom reports.

BACKGROUND: Proxy report is essential for patients unable to complete patient-reported outcome (PRO) measures themselves and potentially beneficial when the caregiver perspective can complement patient report. In this study, we examine agreement between self-report by older adults and proxy report by their caregivers when completing PROs for pain, anxiety, depression, and other symptoms/impairments. METHODS: Four PROs were administered by telephone to older adults and their caregivers followed by re-administration within 24 h in a random subgroup. The PROs included the PHQ-9 depression, GAD-7 anxiety, PEG pain, and SymTrak multi-dimensional symptom and functional status scales. RESULTS: The sample consisted of 576 older adult and caregiver participants (188 patient-caregiver dyads, 200 patients without identified caregiver). The four measures had good internal (Cronbach's alpha, 0.76 to 0.92) and test-retest (ICC, 0.63 to 0.92) reliability whether completed by patients or caregivers. Total score and item-level means were relatively similar for both patient and caregiver reports. Agreement for total score as measured by intraclass correlation coefficient (ICC) was better for SymTrak-23 (0.48) and pain (0.58) than for anxiety (0.28) and depression (0.25). Multinomial modeling showed higher (worse) patient-reported scale scores were associated with caregiver underreporting, whereas higher caregiver task difficulty was associated with overreporting. CONCLUSION: When averaged over individuals at the group level, proxy reports of PRO scores by caregivers tend to approximate patient reports. For individual patients, proxy report should be interpreted more cautiously for psychological symptoms as well as when patient-reported symptoms are more severe, or caregiver task difficulty is high.

Assessment of patient-reported outcomes (e.g., symptoms, functional status, and other quality of life domains) by a proxy on behalf of the patient is helpful when patient self-report is not possible or when a complementary perspective may inform care. Determining how well older adult patients and their caregivers agree on the patient's pain, depression, anxiety, and functioning is important in investigating and managing these core clinical domains. In this study, patient-caregiver agreement was evaluated for four commonly-used scales that assess depression (PHQ-9), anxiety (GAD-7), pain (PEG), and multi-dimensional symptom and functional impairment (SymTrak). Total score and item-level scores were similar between patients and caregivers when averaged at the group level. Agreement was higher for more physically oriented domains (pain and SymTrak) than psychological conditions (depression and anxiety). Higher (worse) patient-reported scale scores were associated with caregiver underreporting, whereas higher caregiver task difficulty was associated with overreporting. Proxy report may be sufficiently accurate in research when studying group differences. However, proxy reports should be interpreted more cautiously in individual patients with psychological symptoms or higher symptom severity, or where there is caregiver diffficulty.