Effectiveness and Cost of an Enhanced Mailed Fecal Test Outreach Colorectal Cancer Screening Program: Findings from the PROMPT Stepped-Wedge Trial.

BACKGROUND: Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer screening rates, yet little is known about how to optimize these programs for effectiveness and cost. METHODS: PROMPT was a pragmatic, stepped-wedge, cluster-randomized effectiveness trial of mailed FIT outreach. Participants in the standard condition were mailed a FIT and received live telephone reminders to return it. Participants in the enhanced condition also received a tailored advance notification (text message or live phone call) and two automated phone call reminders. The primary outcome was 6-month FIT completion; secondary outcomes were any colorectal cancer screening completion at 6 months, implementation, and program costs. RESULTS: The study included 27,585 participants (80% ages 50-64, 82% Hispanic/Latino; 68% preferred Spanish). A higher proportion of enhanced participants completed FIT at 6 months than standard participants, both in intention-to-treat [+2.8%, 95% confidence interval (CI; 0.4-5.2)] and per-protocol [limited to individuals who were reached; +16.9%, 95% CI (12.3-20.3)] analyses. Text messages and automated calls were successfully delivered to 91% to 100% of participants. The per-patient cost for standard mailed FIT was $10.84. The enhanced program's text message plus automated call reminder cost an additional $0.66; live phone calls plus an automated call reminder cost an additional $10.82 per patient. CONCLUSIONS: Adding advance notifications and automated calls to a standard mailed FIT program boosted 6-month FIT completion rates at a small additional per-patient cost. IMPACT: Enhancements to mailed FIT outreach can improve colorectal cancer screening participation. Future research might test the addition of educational video messaging for screening-naïve adults.

Promoting equity, inclusion, and efficiency: A team science approach to the development of authorship guidelines for a multi-disciplinary research team.

Large research teams and consortia present challenges for authorship. The number of disciplines involved in the research can further complicate approaches to manuscript development and leadership. The CHARM team, representing a multi-disciplinary, multi-institutional genomics implementation study, participated in facilitated discussions inspired by team science methodologies. The discussions were centered on team members' past experiences with authorship and perspectives on authorship in a large research team context. Team members identified challenges and opportunities that were used to create guidelines and administrative tools to support manuscript development. The guidelines were organized by the three values of equity, inclusion, and efficiency and included eight principles. A visual dashboard was created to allow all team members to see who was leading or involved in each paper. Additional tools to promote equity, inclusion, and efficiency included providing standardized project management for each manuscript and making "concept sheets" for each manuscript accessible to all team members. The process used in CHARM can be used by other large research teams and consortia to equitably distribute lead authorship opportunities, foster coauthor inclusion, and efficiently work with large authorship groups.

Laboratory-related outcomes from integrating an accessible delivery model for hereditary cancer risk assessment and genetic testing in populations with barriers to access.

PURPOSE: This study aimed to evaluate the laboratory-related outcomes of participants who were offered genomic testing based on cancer family history risk assessment tools. METHODS: Patients from clinics that serve populations with access barriers, who are screened at risk for a hereditary cancer syndrome based on adapted family history collection tools (the Breast Cancer Genetics Referral Screening Tool and PREMM5), were offered exome-based panel testing for cancer risk and medically actionable secondary findings. We used descriptive statistics, electronic health record review, and inferential statistics to explore participant characteristics and results, consultations and actions related to pathogenic/likely pathogenic variants identified, and variables predicting category of findings, respectively. RESULTS: Of all the participants, 87% successfully returned a saliva kit. Overall, 5% had a pathogenic/likely pathogenic cancer risk variant and 1% had a secondary finding. Almost all (14/15, 93%) participants completed recommended consultations with nongenetics providers after an average of 17 months. The recommended actions (eg, breast magnetic resonance imaging) were completed by 17 of 25 participants. Participant personal history of cancer and PREMM5 score were each associated with the category of findings (history and colon cancer finding, Fisher's exact P = .02; history and breast cancer finding, Fisher's exact P = .01; PREMM5TM score; and colon cancer finding, Fisher's exact P < .001). CONCLUSION: This accessible model of hereditary cancer risk assessment and genetic testing yielded results that were often acted upon by patients and physicians.

Economic Evaluation: A Randomized Pragmatic Trial of a Primary Care-based Cognitive Behavioral Intervention for Adults Receiving Long-term Opioids for Chronic Pain.

BACKGROUND: Chronic pain is prevalent and costly; cost-effective nonpharmacological approaches that reduce pain and improve patient functioning are needed. OBJECTIVE: Report the incremental cost-effectiveness ratio (ICER), compared with usual care, of cognitive behavioral therapy aimed at improving functioning and pain among patients with chronic pain on long-term opioid treatment. DESIGN: Economic evaluation conducted alongside a pragmatic cluster randomized trial. SUBJECTS: Adults with chronic pain on long-term opioid treatment (N=814). INTERVENTION: A cognitive behavioral therapy intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team (behaviorists, nurses) with additional support from physical therapists, and pharmacists. OUTCOME MEASURES: Cost per quality adjusted life year (QALY) gained, and cost per additional responder (≥30% improvement on standard scale assessment of Pain, Enjoyment, General Activity, and Sleep). Costs were estimated as-delivered, and replication. RESULTS: Per patient intervention replication costs were $2145 ($2574 as-delivered). Those costs were completely offset by lower medical care costs; inclusive of the intervention, total medical care over follow-up was $1841 lower for intervention patients. Intervention group patients also had greater QALY and responder gains than did controls. Supplemental analyses using pain-related medical care costs revealed ICERs of $35,000, and $53,000 per QALY (for replication, and as-delivered intervention costs, respectively); the ICER when excluding patients with outlier follow-up costs was $106,000. LIMITATIONS: Limited to 1-year follow-up; identification of pain-related utilization potentially incomplete. CONCLUSION: The intervention was the optimal choice at commonly accepted levels of willingness-to-pay for QALY gains; this finding was robust to sensitivity analyses.

Adaptation and early implementation of the PREdiction model for gene mutations (PREMM5™) for lynch syndrome risk assessment in a diverse population.

Lynch syndrome (LS) is the most common inherited cause of colorectal and endometrial cancers. Identifying individuals at risk for LS without personal cancer history requires detailed collection and assessment of family health history. However, barriers exist to family health history collection, especially in historically underserved populations. To improve LS risk assessment in historically underserved populations, we adapted the provider-facing PREdiction Model for gene Mutations (PREMM5™ model), a validated LS risk assessment model, into a patient-facing electronic application through an iterative development process involving expert and patient stakeholders. We report on preliminary findings based on the first 500 individuals exposed to the adapted application in a primary care population enriched for low-literacy and low-resource patients. Major adaptations to the PREMM5™ provider module included reduction in reading level, addition of interactive literacy aids, incorporation of family history assessment for both maternal and paternal sides of the family, and inclusion of questions about individual relatives or small groups of relatives to reduce cognitive burden. In the first 500 individuals, 90% completed the PREMM5™ independently; of those, 94% did so in 5 min or less (ranged from 0.2 to 48.8 min). The patient-facing application was able to accurately classify 84% of patients as having clinically significant or not clinically significant LS risk. Our preliminary results suggest that in this diverse study population, most participants were able to rapidly, accurately, and independently complete an interactive application collecting family health history assessment that accurately assessed for Lynch syndrome risk.

Trends in smoking documentation rates in safety net clinics.

OBJECTIVE: To assess the impact of provider incentive policy on smoking status documentation. DATA SOURCES: Primary data were extracted from structured electronic medical records (EMRs) from 15 community health centers (CHCs). STUDY DESIGN: This was an observational study of data from 2006 to 2013, assessing changes in documentation of smoking status over time. DATA EXTRACTION METHODS: We extracted structured EMR data for patients age 18 and older with at least one primary care visit. PRINCIPAL FINDINGS: Rates of documented smoking status rose from 30 percent in 2006 to 90 percent in 2013; the largest increase occurred from 2011 to 2012 following policy changes (21.3% [95% CI, 8.2%, 34.4%] from the overall trend). Rates varied by clinic and across patient subgroups. CONCLUSIONS: Documentation of smoking status improved markedly after introduction of new federal standards. Further improvement in documentation is still needed, especially for males, nonwhite patients, those using opioids, and HIV + patients. More research is needed to study whether changes in documentation lead to improvements in counseling, cessation, and patient outcomes.

The effect of multiple recruitment contacts on response rates and patterns of missing data in a survey of bladder cancer survivors 6 months after cystectomy.

PURPOSE: The Bladder Cancer Quality of Life Study collected detailed and sensitive patient-reported outcomes from bladder cancer survivors in the period after bladder removal surgery, when participation in survey research may present a burden. This paper describes the study recruitment methods and examines the response rates and patterns of missing data. METHODS: Detailed surveys focusing on quality of life, healthcare decision-making, and healthcare expenses were mailed to patients 5-7 months after cystectomy. We conducted up to 10 follow-up recruitment calls. We analyzed survey completion rates following each contact in relation to demographic and clinical characteristics, and patterns of missing data across survey content areas. RESULTS: The overall response rate was 71% (n = 269/379). This was consistent across patient clinical characteristics; response rates were significantly higher among patients over age 70 and significantly lower among racial and ethnic minority patients compared to non-Hispanic white patients. Each follow-up contact resulted in marginal survey completion rates of at least 10%. Rates of missing data were low across most content areas, even for potentially sensitive questions. Rates of missing data differed significantly by sex, age, and race/ethnicity. CONCLUSIONS: Despite the effort required to participate in research, this population of cancer survivors showed willingness to share detailed information about quality of life, health care decision-making, and expenses, soon after major cancer surgery. Additional contacts were effective at increasing participation. Response patterns differed by race/ethnicity and other demographic factors. Our data collection methods show that it is feasible to gather detailed patient-reported outcomes during this challenging period.

Patient randomized trial of a targeted navigation program to improve rates of follow-up colonoscopy in community health centers.

BACKGROUND: Colorectal cancer (CRC) screening by annual fecal immunochemical test (FIT) is an accessible and cost-effective strategy to lower CRC incidence and mortality. However, this mode of screening depends on follow-up colonoscopy after a positive FIT result. Unfortunately, nearly one-half of FIT-positive patients fail to complete this essential screening component. Patient navigation may improve follow-up colonoscopy adherence. To deliver patient navigation cost-effectively, health centers could target navigation to patients who are unlikely to complete the procedure on their own. OBJECTIVES: The Predicting and Addressing Colonoscopy Non-adherence in Community Settings (PRECISE) clinical trial will validate a risk model of follow-up colonoscopy adherence and test whether patient navigation raises rates of colonoscopy adherence overall and among patients in each probability stratum (low, moderate, and high probability of adherence without intervention). METHODS: PRECISE is a collaboration with a large community health center whose patient population is 37% Latino. Eligible patients will be aged 50-75, have an abnormal FIT result in the past month, and be due for a follow-up colonoscopy. Patients will be randomized to patient navigation or usual care. Primary outcomes will be colonoscopy completion within one year of a positive FIT result, cost, and cost-effectiveness. Secondary outcomes will include time to colonoscopy receipt, adequacy of bowel prep, and communication of results to primary care providers. Primary and secondary outcomes will be reported overall and by probability stratum. DISCUSSION: This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers. TRIAL REGISTRATION: National Clinical Trial (NCT) Identifier: NCT03925883.

Lessons Learned From a Program to Reduce Diabetes Risk Among Low-Income Hispanic Women in a Community Health Clinic.

Background: The Diabetes Prevention Program (DPP) and Look AHEAD studies demonstrated that modest weight loss and increased physical activity can significantly reduce the incidence of diabetes among overweight individuals with prediabetes. However, these studies involved costly interventions, all of which are beyond the reach of most real-world settings serving high-risk, low-income populations. Our project, De Por Vida, implemented a diabetes risk-reduction intervention for Hispanic women in a Federally Qualified Health Center and assessed the program's efficacy. This report describes the methodology used to develop and implement De Por Vida, the cultural adaptations made, the community-academic partnership formed to carry out this program, and the barriers and challenges encountered through the implementation process. Methods: Our goal was to translate the DPP and Look AHEAD programs into an intervention to prevent diabetes and reduce diabetes complications among high-risk Hispanic women at a federally qualified health center in Hillsboro, Oregon, where more than half of clinic patients are Spanish-speaking, and nearly all live in poverty. This randomized clinical trial targeted overweight Spanish-speaking women at risk for, or diagnosed with, type 2 diabetes. We developed a 12-month behavioral diabetes risk-reduction intervention that was responsive to the cultural practices of the Hispanic population and that could be implemented in low-income clinical settings. Study planning and implementation involved close collaboration among the clinic leadership, a research team from the Kaiser Permanente Center for Health Research, and Arizona State University. Discussion: Creating a fully informed partnership between research and clinical institutions is the first step in successful cooperative research projects. The adoption of a bidirectional, rather than a top-down, approach to communication between researchers and health-care providers, and between clinic management and the clinic frontline staff, gave the research study team crucial information about barriers, constraints, and needs that clinic staff experienced in implementing the program. This allowed clinic management and front-line clinic staff to play an active role in study implementation, identifying problem areas, and collaborating in finding practical solutions. Clinical Trial Registration: www.clinicaltrials.gov, NCT03113916.

The ReThink study: a 3-arm parallel randomized trial of cognitive bias modification, with and without adherence promotion, for adolescent anxiety disorder: trial design and protocol.

BACKGROUND: Anxiety disorders are the most common mental health problem among youth, contribute to reduced quality of daily life, and are associated with high rates of comorbidity. However, treatment rates for anxiety are very low, causing a sizeable treatment gap. There is an immediate need to identify treatment interventions that are effective, affordable, and can be delivered easily to the youth population. Cognitive Bias Modification (CBM) is one potentially effective intervention that could reach youth on a large scale, especially when self-administered at home. Thus, we aim to assess the benefit of CBM to treat youth anxiety. Further, we aim to test whether adding an adherence promotion (AP) component to the CBM intervention can improve outcomes, and whether CBM delivered both with and without the AP component is cost effective. METHODS: This is a 12-month randomized controlled trial (RCT) conducted within an existing healthcare system. Potentially eligible youth (ages 12 to 17) will be identified by reviewing the electronic health record (EHR) for clinical anxiety diagnoses, which are then confirmed via research interview. We aim to enroll 498 participants and randomize them 1:1:1 to one of three arms: Arm 1 is a Low-Ratio version of the CBM program (nearly identical to the other CBM versions, but minimally effective); Arm 2 is a High-Ratio "active" CBM program; and Arm 3 is the High-Ratio CBM program with an added AP component. Participants will complete assessments at baseline, 1-, 3-, 6- and 12-months post-baseline. Youth in all three arms will self-administer the CBM program at home and will be asked to complete twelve intervention sessions over a four-week period. Arm 3 participants (High-Ratio CBM + AP) will also receive up to four telephone calls from phone coaches during the intervention period to provide technical assistance, encouragement, and motivational enhancement to increase adherence. The primary clinical outcome will be anxiety remission at 6-month follow-up. DISCUSSION: This study protocol describes the method and design for an RCT to test whether self-administered CBM both with and without adherence promotion can be an effective at-home treatment for anxious youth. TRIAL REGISTRATION: ClinicalTrials.gov : NCT02156531, First Posted June 5, 2014.

Assessment of willingness to pay for expanded carrier screening among women and couples undergoing preconception carrier screening.

BACKGROUND: Expanded carrier screening can provide risk information for numerous conditions. Understanding how individuals undergoing preconception expanded carrier screening value this information is important. The NextGen study evaluated the use of genome sequencing for expanded carrier screening and reporting secondary findings, and we measured participants' willingness to pay for this approach to understand how it is valued by women and couples planning a pregnancy. METHODS: We assessed 277 participants' willingness to pay for genome sequencing reporting carrier results for 728 gene/condition pairs and results for 121 secondary findings. We explored the association between attitudes and demographic factors and willingness to pay for expanded carrier screening using genome sequencing and conducted interviews with 58 of these participants to probe the reasoning behind their preferences. RESULTS: Most participants were willing to pay for expanded carrier screening using genome sequencing. Willingness to pay was associated with income level and religiosity, but not risk status for a condition in the carrier panel. Participants willing to pay nothing or a small amount cited issues around financial resources, whereas those willing to pay higher amounts were motivated by "peace of mind" from carrier results. CONCLUSION: Women and couples planning a pregnancy value genome sequencing. The potentially high out-of-pocket cost of this service could result in healthcare disparities, since maximum amounts that participants were willing to pay were higher than a typical copay and related to income.

Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) - Protocol for a pragmatic cluster randomized trial.

BACKGROUND: Chronic pain is one of the most common, disabling, and expensive public health problems in the United States. Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning. However, most patients lack access to such treatments. We are conducting a pragmatic clinical trial to test the hypothesis that patients who receive an interdisciplinary biopsychosocial intervention, the Pain Program for Active Coping and Training (PPACT), at their primary care clinic will have a greater reduction in pain impact in the year following than patients receiving usual care. METHODS/DESIGN: This is an effectiveness-implementation hybrid pragmatic clinical trial in which we randomize clusters of primary care providers and their patients with chronic pain who are on long-term opioid therapy to 1) receive an interdisciplinary behavioral intervention in conjunction with their current health care or 2) continue with current health care services. Our primary outcome is pain impact (a composite of pain intensity and pain-related interference) measured using the PEG, a validated three-item assessment. Secondary outcomes include pain-related disability, patient satisfaction, opioids dispensed and health care utilization. An economic evaluation assesses the resources and costs necessary to deliver the intervention and its cost-effectiveness compared with usual care. A formative evaluation employs mixed methods to understand the context for implementation in the participating health care systems. DISCUSSION: This trial will inform the feasibility of implementing interdisciplinary behavioral approaches to pain management in the primary care setting, potentially providing a more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment. Clinical Trials Registration Number: NCT02113592.

Time Costs for Genetic Counseling in Preconception Carrier Screening with Genome Sequencing.

Advances in technology and the promise of personalized health care are driving greater use of genome sequencing (GS) for a variety of clinical scenarios. As health systems consider adopting GS, they need to understand the impact of GS on the organization and cost of care. While research has documented a dramatic decrease in the cost of sequencing and interpreting GS, few studies have examined how GS impacts genetic counseling workloads. This study examined the time needed to provide genetic counseling for GS in the context of preconception carrier screening. Genetic counselors prospectively reported on the time spent in the results disclosure process with 107 study participants who were part of the NextGen study. We found that the median time for results disclosure was 64 min (ranged from 5 to 229 min). Preparation work was the most time-consuming activity. Qualitative data from journal entries, debrief interviews with genetic counselors, and detailed case conference notes provided information on factors influencing time for results disclosure and implications for practice. Results suggest that expanded carrier screening could require significant increases in genetic counseling time, unless we are able to generate new resources to reduce preparation work or develop other strategies such as the creation of new models to deliver this type of service.

Cost-effectiveness of Cognitive Behavioral Therapy for Depressed Youth Declining Antidepressants.

BACKGROUND AND OBJECTIVES: Adolescents with depression identified in primary care settings often have limited treatment options beyond antidepressant (AD) therapy. We assessed the cost-effectiveness of a brief cognitive behavioral therapy (CBT) program among depressed adolescents who declined or quickly stopped using ADs. METHODS: A total of 212 youth with depression were randomly assigned to treatment as usual (TAU) or TAU plus brief individual CBT. Clinical outcomes included depression-free days (DFDs) and estimated quality-adjusted life-years (QALYs). Costs were adjusted to 2008 US dollars. Incremental cost-effectiveness ratios (ICERs) comparing CBT to TAU were calculated over 12- and 24-month follow-up periods. RESULTS: Youth randomly assigned to CBT had 26.8 more DFDs (P = .044) and 0.067 more QALYs (P = .044) on average compared with TAU over 12 months. Total costs were $4976 less (P = .025) by the end of the 24-month follow-up among youth randomly assigned to CBT. Total costs per DFD were -$51 (ICER = -$51; 95% confidence interval [CI]: -$394 to $9) at 12 months and -$115 (ICER = -$115; 95% CI: -$1090 to -$6) at 24 months. Total costs per QALY were -$20 282 (ICER = -$20 282; 95% CI: -$156 741 to $3617) at 12 months and -$45 792 (ICER = -$45 792; 95% CI: -$440 991 to -$2731) at 24 months. CONCLUSIONS: Brief primary care CBT among youth declining AD therapy is cost-effective by widely accepted standards in depression treatment. CBT becomes dominant over TAU over time, as revealed by a statistically significant cost offset at the end of the 2-year follow-up.

An Economic Evaluation of a Weight Loss Intervention Program for People with Serious Mental Illnesses Taking Antipsychotic Medications.

Individuals with serious mental illnesses suffer from obesity and cardiometabolic diseases at high rates, and antipsychotic medications exacerbate these conditions. While studies have shown weight loss and lifestyle interventions can be effective in this population, few have assessed intervention cost-effectiveness. We present results from a 12-month randomized controlled trial that reduced weight, fasting glucose, and medical hospitalizations in intervention participants. Costs per participant ranged from $4365 to $5687. Costs to reduce weight by one kilogram ranged from $1623 to $2114; costs to reduce fasting glucose by 1 mg/dL ranged from $467 to $608. Medical hospitalization costs were reduced by $137,500.

Methadone maintenance and the cost and utilization of health care among individuals dependent on opioids in a commercial health plan.

BACKGROUND: Few health plans provide maintenance medication for opioid dependence. This study assessed the cost of treating opioid-dependent members in a commercial health plan and the impacts of methadone maintenance on costs of care. METHODS: Individuals with diagnoses of opioid dependence (two or more diagnoses per year) and at least 9 months of health plan eligibility each year were extracted from electronic health records for the years 2000 through 2004 (1,518 individuals and 2,523 observations across the study period-some individuals were in multiple years). Analyses examined the patterns and costs of health care for three groups of patients: (1) one or more methadone visits during the year (n=1,298; 51%); (2) no methadone visits and 0 or 1 visits in the Addiction Medicine Department (n=370; 15%); (3) no methadone visits and 2 or more visits in addiction medicine (n=855; 34%). RESULTS: Primary care (86%), emergency department (48%) and inpatient (24%) visits were common. Mean total annual costs to the health plan were $11,200 (2004 dollars) per member per year. The health plan's costs for members receiving methadone maintenance were 50% lower ($7,163) when compared to those with two or more outpatient addiction treatment visits but no methadone ($14,157) and 62% lower than those with one or zero outpatient addiction treatment visits and no methadone treatment ($18,694). CONCLUSIONS: Use of opioid maintenance services was associated with lower total costs of care for opioid-dependent members in a commercial health plan.

Development of the Patient Activation Measure for mental health.

Our objective was to adapt the physical health Patient Activation Measure (PAM) for use among people with mental health conditions (PAM-MH). Data came from three studies among people with chronic mental health conditions and were combined in Rasch analyses. The PAM-MH's psychometric properties equal those of the original 13-item PAM. Test-retest reliability and concurrent validity were good, and the PAM-MH showed sensitivity to change. The PAM-MH appears to be a reliable and valid measure of patient activation among individuals with mental health problems. It appears to have potential for use in assessing change in activation.

Service needs of families with children with ADHD.

This article describes service use, perceived helpfulness of services, and the services requested of 157 families living with a child or adolescent with attention-deficit/hyperactivity disorder (ADHD) and specifically asks if service use and service need is a function of certain social demographic factors. Whereas these data suggest that ADHD is a fairly universal experience, as indicated by the high rate of service use across ethnic groups, income status, sex, and family composition, single-mother families used the most services, Hispanic families used the fewest, and families with boys with ADHD used more services than families with girls with ADHD. Income was not a significant factor in any services used or services requested. This study lends strength to the argument that more specialized services for certain groups are needed in venues with local community services, such as schools, where the majority of these children and families are already seeking help.