"Go ahead and screen" - advice to healthcare systems for routine lynch syndrome screening from interviews with newly diagnosed colorectal cancer patients.

BACKGROUND: Lynch syndrome (LS) is the most common cause of inherited colorectal cancer (CRC). Universal tumor screening (UTS) of newly diagnosed CRC cases is recommended to aid in diagnosis of LS and reduce cancer-related morbidity and mortality. However, not all health systems have adopted UTS processes and implementation may be inconsistent due to system and patient-level complexities. METHODS: To identify barriers, facilitators, and suggestions for improvements of the UTS process from the patient perspective, we conducted in-depth, semi-structured interviews with patients recently diagnosed with CRC, but not screened for or aware of LS. Patients were recruited from eight regionally diverse US health systems. Interviews were conducted by telephone, 60-minutes, audio-recorded, and transcribed. An inductive, constant comparative analysis approach was employed.  RESULTS: We completed 75 interviews across the eight systems. Most participants were white (79%), about half (52%) were men, and the mean age was 60 years. Most self-reported either no (60%) or minimal (40%) prior awareness of LS. Overall, 96% of patients stated UTS should be a routine standard of care for CRC tumors, consistently citing four primary motivations for wanting to know their LS status and engage in the process for LS identification: "knowledge is power"; "family knowledge"; "prevention and detection"; and "treatment and surveillance." Common concerns pertaining to the process of screening for and identifying LS included: creating anticipatory worry for patients, the potential cost and the accuracy of the genetic test, and possibly having one's health insurance coverage impacted by the LS diagnosis. Patients suggested health systems communicate LS results in-person or by phone from a trained expert in LS; offer proactive verbal and written education about LS, the screening steps, and any follow-up surveillance recommendations; and support patients in communicating their LS screening to any of their blood relatives. CONCLUSION: Our qualitative findings demonstrate patients with CRC have a strong desire for healthcare systems to regularly implement and offer UTS. Patients offer key insights for health systems to guide future implementation and optimization of UTS and other LS screening programs and maximize diagnosis of individuals with LS and improve cancer-related surveillance and outcomes. TRIAL REGISTRATION: Not available: not a clinical trial.

Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial.

BACKGROUND: Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use. METHODS: As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment. DISCUSSION: This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services. TRIAL REGISTRATION: ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020.

"I really had somebody in my corner." Patient experiences with a pharmacist-led opioid tapering program.

BACKGROUND: Opioid tapering has been identified as an effective strategy to prevent the dangers associated with long-term opioid therapy for patients with chronic pain. However, many patients are resistant to tapering, and conversations about tapering can be challenging for health care providers. Pharmacists can play a role in supporting both providers and patients with the process of opioid tapering. OBJECTIVE: Qualitatively describe patient experiences with a unique phone-based and pharmacy-led opioid tapering program implemented within an integrated health care system. METHODS: In-depth telephone interviews with patients who completed the program were recorded, transcribed, and analyzed. Themes were identified through a constant comparative approach. RESULTS: We completed 25 interviews; 80% of patients were women (20), with a mean age of 58 years, and 72% (18) had been using opioids for pain management for 10 or more years. Most (60%) described a positive and satisfying experience with the tapering program. Strengths of the program reported by patients included a patient-centered and compassionate taper approach, flexible taper pace, easy access to knowledgeable pharmacist advocates, and resultant improvements in quality of life (e.g., increased energy). Challenges reported included: unhelpful or difficult-to-access nonpharmacological pain management options, negative quality of life impacts (e.g., inability to exercise), and lack of choice in the taper process. At the end of tapering, most patients (72%) described their pain as reduced or manageable rather than worse and expressed willingness to use the program in the future if a need should arise. CONCLUSIONS: Patients in a pharmacist-led opioid tapering program appreciated the program's individualized approach to care and access to pharmacist' expertise. Most interviewed patients successfully reduced their opioid use and recommended that the program should continue as an offered service. To improve the program, patients suggested increased personalization of the taper process and additional support for withdrawal symptoms and nonpharmacological pain management.

Should Health Systems Share Genetic Findings With At-Risk Relatives When the Proband Is Deceased? Interviews With Individuals Diagnosed With Lynch Syndrome.

Purpose: Genetic information has health implications for patients and their biological relatives. Death of a patient before sharing a genetic diagnosis with at-risk relatives is a missed opportunity to provide important information that could guide interventions to minimize cancer-related morbidity and mortality in relatives. Methods: We performed semi-structured interviews with individuals diagnosed with Lynch syndrome at 1 of 4 health systems to explore their perspectives on whether health systems should share genetic risk information with relatives following a patient's death. An inductive, open-coding approach was used to analyze audio-recorded content, with software-generated code reports undergoing iterative comparative analysis by a qualitative research team to identify broad themes and representative participant quotes. Results: Among 23 participating interviewees, 19 supported health systems informing relatives about their Lynch syndrome risk while the remaining 4 were conflicted about patient privacy. Most (n=22) wanted their Lynch syndrome diagnosis shared with relatives if they were unable to share and to be informed of their own risk if a diagnosed relative was unable to share. The most common issues noted regarding information-sharing with relatives included patient privacy and privacy laws (n=8), potential anxiety (n=5), and lack of contact information for relatives (n=3). Interviewee perspectives on how health systems could communicate genetic findings generated a consensus: When - a few months after but within a year of the patient's death; How - explanatory letter and follow-up phone call; and Who - a knowledgeable professional. Conclusions: Interviews demonstrated strong and consistent perspectives from individuals diagnosed with Lynch syndrome that health systems have a role and responsibility to inform relatives of genetic findings following a patient's death.

Stepped care for suicide prevention in teens and young adults: Design and methods of a randomized controlled trial.

BACKGROUND: Suicide is the second­leading cause of death among adolescents and young adults in the United States, with rates rising over much of the last decade. The design, testing, and implementation of interventions to prevent suicide in this population is a public health priority. This manuscript outlines the design and methods for a research study that compares two interventions aimed at reducing suicide and suicide attempts in youth. METHODS: We will enroll 300 youth aged 12-24 at high risk for suicide in this randomized controlled parallel group superiority trial. Participants will be randomly assigned to one of two study arms: (1) Zero Suicide Quality Improvement (ZSQI) implemented within the Kaiser Permanente Northwest (KPNW) health system, or (2) ZSQI plus a stepped care intervention for suicide prevention (SC-SP), where the services offered (including care management and dialectical behavior therapy [DBT]) increase based on risk level. Outcomes will be assessed at baseline, as well as 3-, 6-, and 12-months post randomization. The study was conceptualized and designed collaboratively by investigators at UCLA and KPNW. RESULTS: To be reported in future manuscripts. CONCLUSION: The main objective of the study is to determine whether the SC-SP intervention is superior to ZSQI with regard to lowering rates of fatal and nonfatal suicide attempts. Interventions that incorporate the latest research need to be designed and tested under controlled conditions to make progress toward the goal of achieving zero suicide. The results from this trial will directly inform those efforts. CLINICALTRIALS: gov, NCT03092271, https://clinicaltrials.gov/ct2/show/NCT03092271https://clinicaltrials.gov/ct2/show/NCT01379027.

Costs and Cost-Effectiveness of Implementing a Digital Diabetes Prevention Program in a Large, Integrated Health System.

BackgroundThe Diabetes Prevention Program (DPP) has been translated into digital formats. We report an economic evaluation of a digital DPP implemented in a large, integrated health care system. MethodsPatients (n = 4148) were invited to participate in digital DPP based on clinical characteristics (HbA1c 5.7%-6.4% and body mass index ≥ 30 kg/m2) assessed using electronic medical record data. Using a propensity score we matched (1:1) enrolled and not enrolled patients for a total of 784. We identified high-risk patients (ie, above the 50th percentile of risk; n = 202) by calculating each patient's 2-year of developing diabetes. We report the cost of the intervention and the costs of medical care over 12- and 24-month follow-up, and the incremental cost-effectiveness ratio as the cost per additional kilogram weight loss at 24 months. ResultsAt 12 months, enrolled patients had lower total costs ($6,926, 95% CI $5,681-$8,171) than not enrolled patients ($7,538, 95% CI $6,293-$8,783). This pattern attenuated slightly at 24 months (enrolled = $16,255, 95% CI $14,097-$18,412; not enrolled = $16,688, 95% CI $14,531-$18,846). We found an incremental cost-effectiveness ratio of $81.92 per additional kilogram weight loss. For high-risk patients, the digital DPP group had, on average, lower costs and greater weight loss. We found a 55% chance of the digital DPP program being cost-effective at a willingness-to-pay of $150 per additional kilogram of weight loss; at the same willingness-to-pay, there is a 60% chance in the high-risk subgroup. Limitations include the nonrandomized design and potential volunteer bias. ConclusionDigital DPP had a favorable cost-effectiveness profile compared to other lifestyle interventions.

"We Need to Taper." Interviews with Clinicians and Pharmacists About Use of a Pharmacy-Led Opioid Tapering Program.

OBJECTIVE: To identify factors that influence or interfere with referrals by primary care providers (PCPs) to a pharmacist-led telephone-based program to assist patients undergoing opioid tapering. The Support Team Onsite Resource for Management of Pain (STORM) program provides individualized patient care and supports PCPs in managing opioid tapers. DESIGN: Qualitative interviews were conducted with referring PCPs and STORM staff. Interview guides addressed concepts from the RE-AIM framework, focusing on issues affecting referral to the STORM program. SETTING: An integrated healthcare system (HCS) in the Northwest United States. SUBJECTS: Thirty-five interviews were conducted with 20 PCPs and 15 STORM staff. METHODS: Constant comparative analysis was used to identify key themes from interviews. A codebook was developed based on interview data and a qualitative software program was used for coding, iterative review, and content analysis. Representative quotes illustrate identified themes. RESULTS: Use of the STORM opioid tapering program was influenced by PCP, patient, and HCS considerations. Factors motivating use of STORM included lack of PCP time to support chronic pain patients requiring opioid tapering and the perception that STORM is a valued partner in patient care. Impediments to referral included PCP confidence in managing opioid tapering, patient resistance to tapering, forgetting about program availability, and PCP resistance to evolving guidelines regarding opioid tapering goals. CONCLUSIONS: PCPs recognized that STORM supported patient safety and reduced clinician burden. Utilization of the program could be improved through ongoing PCP education about the service and consistent co-location of STORM pharmacists within primary care clinics.

Factors associated with opioid-tapering success: A mixed methods study.

OBJECTIVE: Opioid tapering is recommended when risks of chronic opioid use outweigh benefits. Little is known about patient characteristics or factors related to tapering success. We sought to identify characteristics that predict a 50% reduction in opioid use and qualitatively characterize factors that impact tapering success. METHODS: We used multilevel hierarchical modeling to identify predictors of a 50% reduction in opioid use among Kaiser Permanente Northwest patients who underwent pharmacist-led tapering between 2012 and 2017. We conducted qualitative interviews among patients and pharmacists to identify factors influencing tapering success. RESULTS: We identified 1384 patients who, on average, were dispensed 207 milligram morphine equivalents per day at baseline. After 12 months, 56% of patients reduced their opioid use by 50%. Increased odds of 50% reduction were associated with younger age 21-49 years (Odds ratio [OR] 1.32, P = 0.004); previous surgery (OR 2.24, P < 0.001); increased number of Addiction Medicine encounters (OR 1.25, P = 0.011); substance use disorder (OR 1.62, P = 0.001); anxiety (OR 1.32, P = 0.003); non-narcotic analgesic (OR 1.22, P = 0.025) or antipsychotic medication use (OR 1.53, P = 0.006); and opioid days supplied in the previous year (OR 1.08, P < 0.001). Patients and pharmacists noted that success was influenced by patients' willingness or resistance to change opioid use, the level of patient engagement achieved through communication with their provider, aspects of the tapering process such as pace, and external factors including health issues or caregiving responsibilities. CONCLUSIONS: Over one-half of patients who underwent tapering reduced their opioid use by 50%. Patient demographic and clinical characteristics were predictive of tapering success; however, patients and pharmacists noted that patient willingness, motivation, and personal circumstances also influence tapering outcome. Opioid tapering requires an individualized approach. Both clinical factors and personal circumstances should be considered when opioid tapering is being discussed as a possible solution for a patient.

A Pharmacist-Led Program to Taper Opioid Use at Kaiser Permanente Northwest: Rationale, Design, and Evaluation.

INTRODUCTION: Primary care practitioners (PCPs) are concerned about adverse effects and poor outcomes of opioid use but may find opioid tapering difficult because of a lack of pain management training or time constraints limiting patient counseling. In 2010, Kaiser Permanente Northwest implemented a pharmacist-led opioid tapering program-Support Team Onsite Resource for Management of Pain (STORM)-to address high rates of opioid use, alleviate PCPs' workload demands, and improve patient outcomes. OBJECTIVE: To describe the rationale, structure, and delivery of this unique pharmacist-led program, which partners with PCPs and provides individualized care to help patients reduce opioid use, and the Facilitating Lower Opioid Amounts through Tapering study, which examines the program's effectiveness, cost-effectiveness, and implementation. RESULTS: The STORM program includes a pain medicine physician, a social worker or nurse, and pharmacists who have received specialized clinical and communications training. The program has a 2-fold role: 1) to provide PCP education about pain management and opioid use and 2) to offer clinician and patient support with opioid tapering and pain management. After program training, PCPs are equipped to discuss the need for tapering with a patient and to refer to the program. Program pharmacists provide a range of services, including opioid taper plans, nonopioid pain management recommendations, and taper-support outreach to patients. DISCUSSION: The STORM program provides individualized care to assist patients with opioid tapering while reducing the burden on PCPs. CONCLUSION: The STORM program may be a valuable addition to health care systems and settings seeking options to address their patients' opioid tapering needs.

Augmenting usual care SSRIs with cognitive behavioral therapy for insomnia to improve depression outcomes in youth: Design of a randomized controlled efficacy-effectiveness trial.

IMPORTANCE: Extant treatments for youth depression are only modestly effective. Alternative approaches are needed to improve health outcomes. A novel approach to improve depression outcomes is suggested by epidemiological studies finding that insomnia often predates and may contribute to depression risk. We test whether treating insomnia among youth starting a new course of SSRI antidepressants improves depression outcomes. This paper describes our study design. DESIGN: 2-arm randomized controlled efficacy-effectiveness trial. SETTING: A large non-profit health maintenance organization. PARTICIPANTS: 165 adolescents aged 12-19 with research-confirmed depression and insomnia diagnoses, starting a new episode of selective serotonin reuptake inhibitor (SSRI) antidepressant treatment prescribed by their usual care provider. INTERVENTIONS: Two sleep interventions, each 6-7 sessions, both overlaying "treatment as usual" (TAU) SSRIs: a sleep hygiene (SH) attention control condition, and cognitive-behavioral therapy for insomnia (CBTI). CONCLUSIONS AND RELEVANCE: If CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target. TRIAL REGISTRATION: clinicaltrials.gov, NCT02290496, https://clinicaltrials.gov/ct2/show/NCT02290496.

The social and economic toll of cancer survivorship: a complex web of financial sacrifice.

PURPOSE: To assess the financial outcomes and associated social and economic effects on cancer survivors and their families. METHODS: We assessed the responses of 1656 cancer survivors to a survey with both closed- and open-ended questions about cancer-related financial sacrifices they and their family experienced and evaluated differences in financial sacrifice by reported levels of cancer-related debt. RESULTS: The most commonly reported financial sacrifices included cutbacks on household budgets, challenges with health care insurance and costs, career/self-advancement constraints, reduction/depletion of assets, and inability to pay bills. Survivors who incurred $10,000 or more in debt were significantly more likely to report social and economic impacts, including housing concerns and strained relationships. CONCLUSIONS: Our analysis demonstrates both the frequency with which cancer survivors and families must make financial sacrifices as a result of their cancer, and the variety of forms that this sacrifice can take, even for individuals who have health insurance. The many types of financial hardship create challenges that are unique to each survivor and family. IMPLICATIONS FOR CANCER SURVIVORS: Interventions that allow for personalized assistance with the specific financial and social needs of cancer survivors and their families have the potential to address a critical aspect of the long-term wellbeing of this important population.

Feasibility of a pilot intervention to reduce pain and syncope during adolescent vaccination.

PURPOSE: Vaccines recommended for adolescents are considered safe and effective, however administration may occasionally result in acute pain at the injection site or syncope (fainting). These adverse effects pose a risk to patient safety and are potential barriers to adherence to future vaccinations. We assessed a novel intervention designed to help prevent acute pain and syncope associated with adolescent vaccinations. METHODS: We conducted a 3-month pilot study to assess the feasibility and acceptability of a vaccination comfort menu within two Kaiser Permanente Northwest pediatric clinics. The menu offered a variety of comfort items (e.g., cold packs, squeeze balls) that children could select prior to their vaccination. We surveyed parents of recently vaccinated adolescents and interviewed providers to assess the implementation and effectiveness of the intervention. RESULTS: Response rate for the parent survey was 33% (378/1136). Only 20% of the parents reported that their provider offered the comfort menu during the vaccination visit. Approximately 50% of the adolescents who were offered the menu selected a comfort item and most of these participants reported that the item was very (35%) or somewhat (38%) helpful in improving their vaccination experience. Per provider interviews, common barriers to implementing the intervention included lack of time and convenience, and the brevity of the pilot period. CONCLUSIONS: The comfort menu may improve the vaccination experience of youth and increase the likelihood of adherence with future vaccinations. However, only 20% of the parents reported that their provider offered the menu during the vaccination visit. Additional research is needed to determine the feasibility of implementing this intervention on a larger scale, as well as assessing whether the intervention has a significant impact on reducing adverse events.

User-Centered Design for Developing Interventions to Improve Clinician Recommendation of Human Papillomavirus Vaccination.

INTRODUCTION: Human papillomavirus (HPV) is the most common sexually transmitted infection in the US and is associated with multiple types of cancer. Although effective HPV vaccines have been available since 2006, coverage rates in the US remain much lower than with other adolescent vaccinations. Prior research has shown that a strong recommendation from a clinician is a critical determinant in HPV vaccine uptake and coverage. However, few published studies to date have specifically addressed the issue of helping clinicians communicate more effectively with their patients about the HPV vaccine. OBJECTIVE: To develop one or more novel interventions for helping clinicians make strong and effective recommendations for HPV vaccination. METHODS: Using principles of user-centered design, we conducted qualitative interviews, interviews with persons from analogous industries, and a data synthesis workshop with multiple stakeholders. RESULTS: Five potential intervention strategies targeted at health care clinicians, youth, and their parents were developed. The two most popular choices to pursue were a values-based communication strategy and a puberty education workbook. CONCLUSION: User-centered design is a useful strategy for developing potential interventions to improve the rate and success of clinicians recommending the HPV vaccine. Further research is needed to test the effectiveness and acceptability of these interventions in clinical settings.

Adapting to psychiatric disability and needs for home- and community-based care.

The objective of the study was to describe adaptation strategies and use of formal and informal support by individuals with psychiatric disabilities, to delineate remaining needs, and to determine how home- and community-based services might address those needs. Using in-depth interviews and structured questionnaires, we examined functional status, adaptation, and needs for home- and community-based care among 33 severely mentally ill members of a large health maintenance organization. Despite success in community living, participants had significant functional deficits (physical and emotional), relied heavily on only one or two key informal caregivers, and often needed significant support from mental health professionals. Limited numbers of caregivers and social isolation placed participants at risk of negative outcomes if informal support resources were to be lost. Home- and community-based care interventions that attempt to increase informal support networks and provide instrumental help (cooking, cleaning, transport) on short notice during flare-ups could augment existing (but limited) informal caregiving, help severely mentally ill individuals remain independent, and reduce the likelihood that loss of an informal caregiver would result in unwanted outcomes.