Use of Sequential Hot-Deck Imputation for Missing Health Care Systems Data for Population Health Research.

Electronic medical record (EMR) data present many opportunities for population health research. The use of EMR data for population risk models can be impeded by the high proportion of missingness in key patient variables. Common approaches like complete case analysis and multiple imputation may not be appropriate for some population health initiatives that require a single, complete analytic data set. In this study, we demonstrate a sequential hot-deck imputation (HDI) procedure to address missingness in a set of cardiometabolic measures in an EMR data set. We assessed the performance of sequential HDI within the individual variables and a commonly used composite risk score. A data set of cardiometabolic measures based on EMR data from 2 large urban hospitals was used to create a benchmark data set with simulated missingness. Sequential HDI was applied, and the resulting data were used to calculate atherosclerotic cardiovascular disease risk scores. The performance of the imputation approach was assessed using a set of metrics to evaluate the distribution and validity of the imputed data. Of the 567,841 patients, 65% had at least 1 missing cardiometabolic measure. Sequential HDI resulted in the distribution of variables and risk scores that reflected those in the simulated data while retaining correlation. When stratified by age and sex, risk scores were plausible and captured patterns expected in the general population. The use of sequential HDI was shown to be a suitable approach to multivariate missingness in EMR data. Sequential HDI could benefit population health research by providing a straightforward, computationally nonintensive approach to missing EMR data that results in a single analytic data set.

Identifying Racial and Ethnic Disparities in Acute Inpatient Rehabilitation.

OBJECTIVE: To investigate whether racial, ethnic, and linguistic disparities exist at discharge from an acute inpatient rehabilitation facility (IRF) by examining change in Functional Independence Measure (FIM) scores and discharge destination. DESIGN: This is a retrospective study using our IRF's data from the Uniform Data System for Medical Rehabilitation from 2013-2019. FIM scores and discharge destination were compared between race, language, and ethnic groups, with adjustment for patient characteristics. SETTING: An urban hospital with a level 1 trauma center, comprehensive stroke center, and IRF with Commission on Accreditation of Rehabilitation Facilities (CARF) certification. PARTICIPANTS: 2518 patients admitted to the IRF from 2013-2019 (N=2518). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Change in FIM score and discharge destination. RESULTS: After adjusting for covariates, non-White patients and patients with limited English proficiency had significantly lower functional recovery, as measured by smaller changes in FIM scores from IRF admission to discharge. Additionally, both groups were more likely to be discharged home with home health care than to a skilled nursing facility, compared with White and English-speaking patients. Disparities in discharge destination persisted within patients with noncommercial insurance (Medicaid or Medicare) and a stroke diagnosis but not within those who had commercial insurance or a nonstroke diagnosis. CONCLUSIONS: Racial and linguistic disparities were identified within our CARF certified IRF; however, the organization is committed to reducing health care disparities. Next steps will include investigating interventions to reduce disparities.

Improving Access to Yoga for Chronic Pain in a Spanish-Speaking Community: A Quality Improvement Initiative.

BACKGROUND: The recent increase in opioid misuse and overdose among the Hispanic population signifies the need for an initiative to increase efforts in pain management in the Hispanic population. Yoga is an evidence-based therapeutic intervention that is effective for several pain-associated disorders. However, in the United States, it is primarily taught in English and not always accessible. This quality improvement (QI) project aimed to assess the outcome of implementing a yoga program on pain and quality of life in the Hispanic population. METHODS: Twenty Spanish-speaking community center members participated in a linguistically-tailored yoga program over the course of 10 weeks that included educational, demonstration, and practice videos. Outcome measures of the QI program included changes in pain interference, physical function, opioid medication use, the overall impression of change in pain, satisfaction with the program, and the likelihood of continuation of yoga practice. RESULTS: Data collected from participants (n = 16) after the 10-week period indicated that nearly 60% experienced an improvement in their overall impression of change in pain; their reported likelihood of continuation of yoga practice at home or another location were 6.8 and 7.4, respectively, on a 10-point scale. While pain interference was unaffected, there was an improvement in markers of physical function, including a two-fold improvement in general activity without limitations. The mean average intensity of pain decreased by 33%. CONCLUSION: The use of a linguistically-tailored yoga program improved self-reported overall pain, physical function, average intensity of pain, and initiated an interest in participants in utilizing yoga practice for self-management of pain. This QI project provides results that can be used for further implementation initiatives at other sites and consideration of use in diverse populations.

Factor Analysis in Distinguishing Coronavirus Disease 2019 From Other Influenza-like Illness Using a Validated Patient-Reported Outcome Instrument FLU-PRO Plus: A Prospective Real-world Cohort Study.

BACKGROUND/OBJECTIVE: InFLUenza Patient-reported Outcome (FLU-PRO Plus) is a 34-item patient-reported outcome instrument designed to capture the intensity and frequency of viral respiratory symptoms. This study evaluates whether FLU-PRO Plus responses could discriminate between symptoms of coronavirus disease 2019 (COVID-19) and influenza-like illness (ILI) with no COVID diagnosis, as well as forecast disease progression. METHODS: FLU-PRO Plus was administered daily for 14 days. Exploratory factor analysis was used to reduce the FLU-PRO Plus responses on the first day to 3 factors interpreted as "symptom clusters." The 3 clusters were used to predict COVID-19 versus ILI diagnosis in logistic regression. Correlation between the clusters and quality of life (QoL) measures was used to assess concurrent validity. The timing of self-reported return to usual health in the 14-day period was estimated as a function of the clusters within COVID-19 and ILI groups. RESULTS: Three hundred fourteen patients completed day 1 FLU-PRO Plus, of which 65% had a COVID-19 diagnosis. Exploratory factor analysis identified 3 symptom clusters: (1)general Body, (2) tracheal/bronchial, and (3) nasopharyngeal. Higher nasopharyngeal scores were associated with higher odds of COVID-19 compared with ILI diagnosis [adjusted odds ratio = 1.61 (1.21, 2.12)]. Higher tracheal/bronchial scores were associated with lower odds of COVID-19 [0.58 (0.44, 0.77)]. The 3 symptom clusters were correlated with multiple QoL measures ( r = 0.14-0.56). Higher scores on the general body and tracheal/bronchial symptom clusters were associated with prolonged time to return to usual health [adjusted hazard ratios: 0.76 (0.64, 0.91), 0.80 (0.67, 0.96)]. CONCLUSION: Three symptom clusters identified from FLU-PRO Plus responses successfully discriminated patients with COVID-19 from non-COVID ILI and were associated with QoL and predicted symptom duration.

Primary care clinicians' opinions before and after implementation of cancer screening and prevention clinical decision support in a clinic cluster-randomized control trial: a survey research study.

BACKGROUND: Electronic health record (EHR)-linked clinical decision support (CDS) may impact primary care clinicians' (PCCs') clinical care opinions. As part of a clinic cluster-randomized control trial (RCT) testing a cancer prevention and screening CDS system with patient and PCC printouts (with or without shared decision-making tools [SDMT]) for patients due for breast, cervical, colorectal, and lung cancer screening and/or human papillomavirus (HPV) vaccination compared to usual care (UC), we surveyed PCCs at study clinics pre- and post-CDS implementation. Our primary aim was to learn if PCCs' opinions changed over time within study arms. Secondary aims including examining whether PCCs' opinions in study arms differed both pre- and post-implementation, and gauging PCCs' opinions on the CDS in the two intervention arms. METHODS: This study was conducted within a healthcare system serving an upper Midwestern population. We administered pre-implementation (11/2/2017-1/24/2018) and post-implementation (2/2/2020-4/9/2020) cross-sectional electronic surveys to PCCs practicing within a RCT arm: UC; CDS; or CDS + SDMT. Bivariate analyses compared responses between study arms at both time periods and longitudinally within study arms. RESULTS: Pre-implementation (53%, n = 166) and post-implementation (57%, n = 172) response rates were similar. No significant differences in PCC responses were seen between study arms on cancer prevention and screening questions pre-implementation, with few significant differences found between study arms post-implementation. However, significantly fewer intervention arm clinic PCCs reported being very comfortable with discussing breast cancer screening options with patients compared to UC post-implementation, as well as compared to the same intervention arms pre-implementation. Other significant differences were noted within arms longitudinally. For intervention arms, these differences related to CDS areas like EHR alerts, risk calculators, and ordering screening. Most intervention arm PCCs noted the CDS provided overdue screening alerts to which they were unaware. Few PCCs reported using the CDS, but most would recommend it to colleagues, expressed high CDS satisfaction rates, and thought patients liked the CDS's information and utility. CONCLUSIONS: While appreciated by PCCs with high satisfaction rates, the CDS may lower PCCs' confidence regarding discussing patients' breast cancer screening options and may be used irregularly. Future research will evaluate the impact of the CDS on cancer prevention and screening rates. TRIAL REGISTRATION: clinicaltrials.gov , NCT02986230, December 6, 2016.

What Do Orthopaedists Believe is Needed for Incorporating Patient-reported Outcome Measures into Clinical Care? A Qualitative Study.

BACKGROUND: Patient-reported outcome measures (PROMs) are increasingly promoted for use in routine orthopaedic care with the expectation that if they are made available during encounters, they will be incorporated into clinical practice. We investigated an initiative in which PROMs were systematically collected and provided via the electronic health record but were infrequently used. QUESTIONS/PURPOSES: In a qualitative study, we asked: (1) Why are PROM results not being used in clinical care when they are available to surgeons? (2) What aspects of PROMs are seen as useful for clinical care? (3) How are PROMs generally perceived by surgeons and orthopaedic leaders? METHODS: A cross-sectional qualitative study was conducted in a single health system in an urban setting using semistructured interviews with a purposive sample of orthopaedic surgeons and leaders who would have substantial knowledge of and experience with the organization's PROM system, which was embedded in the electronic health record and developed for use in clinical care but was not being used. We included surgeons whose practices consisted of at least 90% patients with osteoarthritis, including surgical and nonsurgical management, and thus their patients would be completing PROMs surveys, or surgeons who were leaders in one of the three orthopaedic divisions in the health plan. The senior research manager for orthopaedics identified 14 potential participants meeting these criteria, 11 of whom agreed to study participation. Participants included nine surgeons and two orthopaedic leaders; the majority were men, with a median of 13 years of clinical practice. Study interviews were conducted by an experienced interviewer not known to participants, in private conference rooms in the healthcare setting, and a median (range) of 27 minutes (16 to 40) in length. A content analysis approach was employed for data analysis, with thematic inductive saturation reached in the analysis and attention to trustworthiness and rigor during the analytic process. RESULTS: Interviewees reported that PROM scores are not being used in patient clinical care because of logistical barriers, such as access and display issues and the time required, and perceptual barriers, such as concerns about patient understanding and the validity and reliability of measures. Surgeons preferred talking with patients about the personal outcomes patients had identified as important; most patients preferred to assess progress toward their own goals than PROMs scores for other people. Surgeons also identified changes that could facilitate PROM use and reduce barriers in clinical care, including pushing PROM scores to physicians' inboxes, developing inserts for physician notes, using easy-to-understand graphical displays, and engaging patients about PROMs earlier in the care process. Participants all agreed that PROMs in aggregate use are valuable for the organization, department, and individual surgeons, but individual patient scores are not. CONCLUSION: Despite the availability of PROMs, there are important barriers to incorporating and using PROMs in clinical care. Providing access to PROM scores without clearly understanding how and why surgeons may consider using or incorporating them into their clinical practice can result in expensive and underused systems that add little value for the clinician, patient, or organization. CLINICAL RELEVANCE: Involving front-line orthopaedic surgeons and leaders in shaping the design and structure of PROM systems is important for use in clinical care, but these interviewees seemed to see aggregate data as more valuable than individual patient scores.

Is Shared Decision-making Associated with Better Patient-reported Outcomes? A Longitudinal Study of Patients Undergoing Total Joint Arthroplasty.

BACKGROUND: Although shared decision-making (SDM) has knowledge and satisfaction benefits for patients and is promising, we lack data demonstrating that SDM is associated with better patient-reported functional outcomes. Such data would support the integration and prioritization of SDM into all aspects of orthopaedic care. QUESTIONS/PURPOSES: (1) Is a measure of SDM before total joint arthroplasty associated with better patient-reported outcome measures (PROMs) 1 year postoperatively? (2) What is the relationship between the measure of SDM and two measures of patient experience (patient rating of the provider and patient likelihood of recommending the provider) at 1 year postoperatively? METHODS: In this observational longitudinal survey-based study, patients receiving an initial THA or TKA from a large, multispecialty medical group in the Midwestern United States were surveyed after they were scheduled for surgery and again at 12 months after their procedure. The three-item collaboRATE measure of SDM was added to existing patient surveys of PROMs. However, the surgeons and their department had no organized approach to SDM during this time. The surveys also included the Oxford knee or hip score and two validated measures of patient experience (patient rating of the provider and whether a patient would recommend the provider). Of the 2779 eligible primary joint arthroplasties that occurred from April 23, 2018 to May 1, 2019, 48% (1334 procedures; 859 TKAs and 485 THAs) of the patients responded to both the preoperative and 12-month postoperative surveys. Most of the patients who were included in the analytic sample were white (93%; 1255 of 1344), with only 3% (37) using Medicaid benefits at the time of surgery. Differences between responders and nonresponders were present and explored in an analysis. Patient responses were analyzed in regression models to estimate the association between preoperative collaboRATE scores and the Oxford knee or hip scores, and patient experience measures 12 months postoperatively. RESULTS: There was a moderate, positive association between preoperative collaboRATE scores and the Oxford scores at 12 months, after adjustment for potential confounders such as patient age and preoperative functional score (ß = 0.58; 95% CI 0.14-1.02; p = 0.01). Similarly, patients with preoperative collaboRATE scores had marginally higher patient experience scores at 12 months postoperatively (ß = 0.14; 95% CI 0.05-0.24; p = 0.003) and were more likely to recommend their surgeon (OR 1.43; 95% CI 1.11-1.84; p = 0.005). The patient experience measures were also modestly correlated with collaboRATE scores in cross-sectional associations, both preoperatively and at 12 months postoperatively (0.29 ≤ r ≤ 0.54; p < 0.01). CONCLUSION: The association between preoperative collaboRATE scores and Oxford hip or knee scores suggests that SDM could be one tool to encourage better outcomes. Although previous studies have shown that SDM can improve patient experience, the lack of a strong correlation in our study suggests that PROMs and experience measures are separate domains, at least partly. Improving preoperative SDM between the surgeon and patient might help improve surgical outcomes for patients undergoing TKA and THA. LEVEL OF EVIDENCE: Level II, therapeutic study.

Rate and Predictors of Acute Care Encounters in the First Month After Stroke.

OBJECTIVES: The purpose of this quality improvement project is to understand the burden of acute care, including inpatient readmission and emergency department (ED) visits, in the month following hospital discharge after stroke. MATERIALS AND METHODS: We identified patients discharged from our hospitals between 2015 and 2018 with any stroke diagnosis who had an unplanned readmission or ED visit within the first month after discharge, and those who had primary care (PC) visits before or after their stroke. Patients were compared regarding demographics, clinical characteristics, and PC visits. Independent predictors of acute care encounters were examined using logistic regression. RESULTS: A total of 166 patients (19%) had an acute care encounter one month after discharge. Eighty-eight (10%) patients were readmitted and 78 (9%) patients had an ED visit. Encounter diagnoses were different between the two groups; inpatient readmission had more frequent acute stroke/TIA and pneumonia/pulmonary indications, while ED visits had more non-specific neurologic symptoms and more frequent cardiovascular complaints. Independent predictors of any acute care encounter and inpatient readmission were younger age, longer length of stay (LOS), and lack of PC visit after discharge. Predictors of ED visits were the same except for LOS. CONCLUSIONS: 30-day acute care encounters after stroke hospitalization are common, affecting 19% of patients and usually occurring in the first week after discharge. Post discharge PC visit was associated with a decreased need for acute care. Efforts should be made to facilitate a PC visit within a week after discharge, especially in high risk patients.

The impact of personalized clinical decision support on primary care patients' views of cancer prevention and screening: a cross-sectional survey.

BACKGROUND: Few studies have assessed the impact of clinical decision support (CDS), with or without shared decision-making tools (SDMTs), on patients' perceptions of cancer screening or prevention in primary care settings. This cross-sectional survey was conducted to understand primary care patient's perceptions on cancer screening or prevention. METHODS: We mailed surveys (10/2018-1/2019) to 749 patients aged 18 to 75 years within 15 days after an index clinical encounter at 36 primary care clinics participating in a clinic-randomized control trial of a CDS system for cancer prevention. All patients were overdue for cancer screening or human papillomavirus vaccination. The survey compared respondents' answers by study arm: usual care; CDS; or CDS + SDMT. RESULTS: Of 387 respondents (52% response rate), 73% reported having enough time to discuss cancer prevention options with their primary care provider (PCP), 64% reported their PCP explained the benefits of the cancer screening choice very well, and 32% of obese patients reported discussing weight management, with two-thirds reporting selecting a weight management intervention. Usual care respondents were significantly more likely to decide on colorectal cancer screening than CDS respondents (p < 0.01), and on tobacco cessation than CDS + SDMT respondents (p = 0.02) and both CDS and CDS + SDMT respondents (p < 0.001). CONCLUSIONS: Most patients reported discussing cancer prevention needs with PCPs, with few significant differences between the three study arms in patient-reported cancer prevention care. Upcoming research will assess differences in screening and vaccination rates between study arms during the post-intervention follow-up period. TRIAL REGISTRATION: clinicaltrials.gov , NCT02986230 , December 6, 2016.

The Impact of Stimulant Medications on Blood Pressure and Body Mass Index in Children with Attention Deficit Hyperactivity Disorder.

OBJECTIVE: To describe changes in blood pressure (BP) and body mass index (BMI) associated with stimulant medication fills in children. METHODS: Observational, retrospective matched cohort study of children 6-17.9 years initiating stimulant medication between 7/1/2010-6/30/2017 matched 1:3 by age, race, ethnicity, and sex to children with no stimulant use during this period. All BPs and BMIs recorded during ambulatory visits were identified. Generalized linear models were used to estimate differences in change in systolic BP (SBP), diastolic BP (DBP), and BMI over time. RESULTS: The 686 children with stimulant prescription fills and 2048 matched controls did not differ by baseline SBP or BMI. The matched control group (30.5% female, mean age 11.2 ± 3.4 years 79.7% white) was more likely to be publicly insured (35% vs. 21%, P < .01). After adjusting for baseline values, over a mean follow-up of 144 days change in SBP or DBP did not differ significantly between patients with stimulant medication fills and matched controls. Stimulant use was associated with a 4.7 percentile decrease in BMI percentile compared to matched controls (95% CI: 3.69, 5.71; P < .01). CONCLUSIONS: In a pediatric primary care cohort, stimulant prescription fills were associated with marked decreases in BMI but no significant changes in BP over time.

Factors Associated With Increased Health Care Utilization for Patients With Dementia With Lewy Bodies: A Narrative Review.

Numerous studies have demonstrated that dementia is associated with increased utilization of health care services, which in turn results in increased costs of care. Dementia with Lewy bodies (DLB) is associated with greater costs of care relative to other forms of dementia due to higher rates of hospitalization and nursing home placement directly related to neuropsychiatric symptoms, parkinsonism, increased susceptibility to delirium, and elevated rates of caregiver burden. There is a critical need for researchers to identify potentially modifiable factors contributing to increased costs of care and poor clinical outcomes for patients with DLB, which may include comorbidities, polypharmacy/contraindicated medications, and access to specialty care. Previous research has utilized Medicare claims data, limiting the ability to study patients with early-onset (ie, prior to age 65) DLB. Integrated health systems offer the ability to combine electronic medical record data with Medicare, Medicaid, and commercial claims data and may therefore be ideal for utilization research in this population. The goals of this narrative review are to 1) synthesize and describe the current literature on health care utilization studies for patients with DLB, 2) highlight the current gaps in the literature, and 3) provide recommendations for stakeholders, including researchers, health systems, and policymakers. It is important to improve current understanding of potentially modifiable factors associated with increased costs of care among patients with DLB to inform public health policies and clinical decision-making, as this will ultimately improve the quality of patient care.

Potentially Preventable Readmissions After Acute Inpatient Rehabilitation.

OBJECTIVE: The aim of the study is to identify causes and risk factors for potentially preventable readmissions of patients discharged from an inpatient rehabilitation facility. DESIGN: Our hospital billing database was used to identify patients discharged from our inpatient rehabilitation facility between 2013 and 2018 and experienced a potentially preventable readmission within 90 days ( n = 75). Retrospective chart review was completed to obtain clinical data. Of the patients discharged from the inpatient rehabilitation facility who did not experience a potentially preventable readmission, a group of age- and sex-matched controls ( n = 75) was randomly selected. The two study groups were compared using univariate and multivariate analyses. RESULTS: Our study found that individuals who discharged from acute inpatient rehabilitation were more likely to be readmitted with a potentially preventable readmission if they have a greater number of comorbidities, were admitted initially with a spinal cord injury, or have lower admission or discharge Functional Independence Measure motor scores. The most common potentially preventable readmission diagnoses were sepsis, renal failure, respiratory problems, and urinary tract infection. CONCLUSIONS: Identifying patients with the common causes for potentially preventable readmissions, in addition to the noted risk factors, is an important consideration for inpatient rehabilitation discharge planning.

Care coordination in primary care: mapping the territory.

OBJECTIVE: To document the current approaches to care coordination among different types of care systems in Minnesota. STUDY DESIGN: Observational survey of leaders of most of the care systems in Minnesota that have implemented care coordination. METHODS: Survey questions about organizational structure, size, and approach to care coordination were sent to the leaders of 42 care systems with a total of 327 primary care clinics. RESULTS: Surveys were completed by leaders at every care system participating in this study (100% response rate); 16 small care systems (each with 1-2 clinics) had a total of 26 primary care clinics, 15 medium care systems (3-9 clinics) had 57 clinics, and 11 large care systems (> 9 clinics) had 244 clinics. The large care systems had larger clinics (clinicians per clinic, 8.6 in large vs 4.3 in small and 5.2 in medium; P = .03) and more clinicians per care coordinator (5.7 vs 3.3 and 4.0; P = .04). They also more frequently included a social worker in their care coordination team: 82% vs 25% of small and 40% of medium care systems (P = .01). However, the services provided and complexity tools used were similar. Nearly all reported addressing both medical and social needs for their complex patients with multiple chronic conditions. CONCLUSIONS: Although there are large differences in resources and capabilities between large and small care systems, they were not associated with much difference in the approach taken to care coordination. This map of the care coordination territory in Minnesota has the potential to be valuable to researchers and care system leaders for understanding current implementation trends and directing further evaluations.

Readmission to an Acute Care Hospital During Inpatient Rehabilitation After Stroke.

OBJECTIVE: The aim of the study was to identify causes for readmission to acute care of patients admitted to inpatient rehabilitation facility after stroke. DESIGN: The institutional Uniform Data System for Medical Rehabilitation database was used to identify stroke patients who experienced readmission to acute care and an equal number of age-/sex-matched group of patients who successfully completed their inpatient rehabilitation facility stay during 2005-2018. Retrospective chart review was used to extract clinical data. The two study groups were compared using univariate and multivariate analyses. RESULTS: The rate of readmission to acute care was 4.7% (n = 89; age = 65 ± 14 yrs; 37% female; 65% White; 73% ischemic stroke). The most common indications for transfer were neurological (31%) and cardiovascular (28%). Compared with control group, the readmission to acute care group had statistically higher rates of comorbid conditions, lower median (interquartile range) Functional Independence Measure score on inpatient rehabilitation facility admission (55 [37-65] vs. 64 [51-78], P < 0.001), and a higher rate of sedative/hypnotic prescription (82% vs. 23%, P < 0.001). CONCLUSIONS: Readmission to acute care is not common in our cohort. Patients who experienced readmission to acute care had higher medical complexity and were prescribed more sedative/hypnotic medications than the control group. Practitioners should be vigilant in patients who meet these criteria.

Is the Promise of PROMs Being Realized? Implementation Experience in a Large Orthopedic Practice.

Patient-reported outcome measures (PROMs), increasingly used for research and quality measurement, are lauded for their potential to improve patient-centered care, both through aggregate reporting and when integrated into clinical practice. However, there are few published studies of the resultant use of PROMs in clinical practice. This case study describes the implementation and use of PROMS in a Midwestern multispecialty medical group orthopedic practice among patients undergoing total knee and hip surgery. Specifically, rates of PROMs use by care teams are tracked over time once made available in the electronic health record. During this time, the orthopedics department achieved a patient PROMS survey response rate of 68% at baseline, 58% 3 months post-surgery, and 55% 12 months post-surgery. However, these data were only accessed by the care teams for fewer than 1% of associated clinical encounters. This suggests that making PROMs available for care team review in the electronic health record, even when coupled with relatively high response rates from patients and departmental leadership support is not enough to encourage integration of PROMs into clinical care for patients. Additional effort is required to identify barriers to PROMs use in clinical care and to test methods to enhance use.

Clinical Decision Support with or without Shared Decision Making to Improve Preventive Cancer Care: A Cluster-Randomized Trial.

BACKGROUND: Innovative interventions are needed to address gaps in preventive cancer care, especially in rural areas. This study evaluated the impact of clinical decision support (CDS) with and without shared decision making (SDM) on cancer-screening completion. METHODS: In this 3-arm, parallel-group, cluster-randomized trial conducted at a predominantly rural medical group, 34 primary care clinics were randomized to clinical decision support (CDS), CDS plus shared decision making (CDS+SDM), or usual care (UC). The CDS applied web-based clinical algorithms identifying patients overdue for United States Preventive Services Task Force-recommended preventive cancer care and presented evidence-based recommendations to patients and providers on printouts and on the electronic health record interface. Patients in the CDS+SDM clinic also received shared decision-making tools (SDMTs). The primary outcome was a composite indicator of the proportion of patients overdue for breast, cervical, or colorectal cancer screening at index who were up to date on these 1 y later. RESULTS: From August 1, 2018, to March 15, 2019, 69,405 patients aged 21 to 74 y had visits at study clinics and 25,198 were overdue for 1 or more cancer screening tests at an index visit. At 12-mo follow-up, 9,543 of these (37.9%) were up to date on the composite endpoint. The adjusted, model-derived percentage of patients up to date was 36.5% (95% confidence interval [CI]: 34.0-39.1) in the UC group, 38.1% (95% CI: 35.5-40.9) in the CDS group, and 34.4% (95% CI: 31.8-37.2) in the CDS+SDM group. For all comparisons, the screening rates were higher than UC in the CDS group and lower than UC in the CDS+SDM group, although these differences did not reach statistical significance. CONCLUSION: The CDS did not significantly increase cancer-screening rates. Exploratory analyses suggest a deeper understanding of how SDM and CDS interact to affect cancer prevention decisions is needed. Trial registration: ClinicalTrials.gov ID: NCT02986230, December 6, 2016.

Human Papillomavirus vaccination clinical decision support for young adults in an upper midwestern healthcare system: a clinic cluster-randomized control trial.

INTRODUCTION: Human papillomavirus (HPV) vaccination rates are low in young adults. Clinical decision support (CDS) in primary care may increase HPV vaccination. We tested the treatment effect of algorithm-driven, web-based, and electronic health record-linked CDS with or without shared decision-making tools (SDMT) on HPV vaccination rates compared to usual care (UC). METHODS: In a clinic cluster-randomized control trial conducted in a healthcare system serving a largely rural population, we randomized 34 primary care clinic clusters (with three clinics sharing clinicians randomized together) to: CDS; CDS+SDMT; UC. The sample included young adults aged 18-26 due for HPV vaccination with a study index visit from 08/01/2018-03/15/2019 in a study clinic. Generalized linear mixed models tested differences in HPV vaccination status 12 months after index visits by study arm. RESULTS: Among 10,253 patients, 6,876 (65.2%) were due for HPV vaccination, and 5,054 met study eligibility criteria. In adjusted analyses, the HPV vaccination series was completed by 12 months in 2.3% (95% CI: 1.6%-3.2%) of CDS, 1.6% (95% CI: 1.1%-2.3%) of CDS+SDMT, and 2.2% (95% CI: 1.6%-3.0%) of UC patients, and at least one HPV vaccine was received by 12 months in 13.1% (95% CI: 10.6%-16.1%) of CDS, 9.2% (95% CI: 7.3%-11.6%) of CDS+SDMT, and 11.2% (95% CI: 9.1%-13.7%) of UC patients. Differences were not significant between arms. Females, those with prior HPV vaccinations, and those seen at urban clinics had significantly higher odds of HPV vaccination in adjusted models. DISCUSSION: CDS may require optimization for young adults to significantly impact HPV vaccination. TRIAL REGISTRATION: clinicaltrials.gov NCT02986230, 12/6/2016.

Design and rationale of an intervention to improve cancer prevention using clinical decision support and shared decision making: A clinic-randomized trial.

BACKGROUND: Despite decades of research the gap in primary and secondary cancer prevention services in the U. S. remains unacceptably wide. Innovative interventions are needed to address this persistent challenge. Electronic health records linked with Web-based clinical decision support may close this gap, especially if delivered to both patients and their providers. OBJECTIVES: The Cancer Prevention Wizard (CPW) study is an implementation, clinic-randomized trial designed to achieve these aims: 1) assess impact of the Cancer Prevention Wizard-Clinical Decision Support (CPW-CDS) alone and CPW-CDS plus Shared Decision Making Tools (CPW + SDMTs) compared to usual care (UC) on tobacco cessation counseling and drugs, HPV vaccinations, and screening tests for breast, cervical, colorectal, or lung cancer; 2) assess cost of the CPW-CDS intervention; and 3) describe critical facilitators and barriers for CPW-CDS implementation, use, and clinical impact using a mixed-methods approach supported by the CFIR and RE-AIM frameworks. METHODS: 34 predominantly rural, primary care clinics were randomized to CPW-CDS, CPW + SMDTs, or UC. Between August 2018 and October 2020, primary care providers and their patients who met inclusion criteria in intervention clinics were exposed to the CPW-CDS with or without SDMTs. Study outcomes at 12 months post index visit include patients up to date on screening tests and HPV vaccinations, overall healthcare costs, and diagnostic codes and billing levels for cancer prevention services. CONCLUSIONS: We will test in rural primary care settings whether CPW-CDS with or without SDMTs can improve delivery of primary and secondary cancer prevention services. The trial and analyses are ongoing with results expected in 2021.