What's in This For You? What's in This For Me?: A Win-Win Perspective of Involving Study Advisory Committee Members in Palliative Care Research.

Study advisory committees (SACs) provide critical value to clinical trials by providing unique perspectives that pull from personal and professional experiences related to the trial's healthcare topic. The Emergency Medicine Palliative Care Access (EMPallA) study had the privilege of convening a 16-person SAC from the project's inception to completion. The study team wanted to understand the impact this project had on the SAC members. In this narrative, we use reflective dialogue to share SAC members' lived experiences and the impact the EMPallA study has had on members both personally and professionally. We detail the (1) benefits SAC members, specifically patients, and caregivers, have had through working on this project. (2) The importance of recruiting diverse SAC members with different lived experiences and leveraging their feedback in clinical research. (3) Value of community capacity building to ensure the common vision of the clinical trial is promoted.

Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA).

BACKGROUND: Involving patient and community stakeholders in clinical trials adds value by ensuring research prioritizes patient goals both in conduct of the study and application of the research. The use of stakeholder committees and their impact on the conduct of a multicenter clinical trial have been underreported clinically and academically. The aim of this study is to describe how Study Advisory Committee (SAC) recommendations were implemented throughout the Emergency Medicine Palliative Care Access (EMPallA) trial. EMPallA is a multi-center, pragmatic two-arm randomized controlled trial (RCT) comparing the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. METHODS: A SAC consisting of 18 individuals, including patients with palliative care experience, members of healthcare organizations, and payers was convened for the EMPallA trial. The SAC engaged in community-based participatory research and assisted in all aspects from study design to dissemination. The SAC met with the research team quarterly and annually from project inception to dissemination. Using meeting notes and recordings we completed a qualitative thematic analysis using an iterative process to develop themes and subthemes to summarize SAC recommendations throughout the project's duration. RESULTS: The SAC convened 16 times between 2017 and 2020. Over the course of the project, the SAC provided 41 unique recommendations. Twenty-six of the 41 (63%) recommendations were adapted into formal Institutional Review Board (IRB) study modifications. Recommendations were coded into four major themes: Scientific, Pragmatic, Resource and Dissemination. A majority of the recommendations were related to either the Scientific (46%) or Pragmatic (29%) themes. Recommendations were not mutually exclusive across three study phases: Preparatory, execution and translational. A vast majority (94%) of the recommendations made were related to the execution phase. Major IRB study modifications were made based on their recommendations including data collection of novel dependent variables and expanding recruitment to Spanish-speaking patients. CONCLUSIONS: Our study provides an example of successful integration of a SAC in the conduct of a pragmatic, multi-center RCT. Future trials should engage with SACs in all study phases to ensure trials are relevant, inclusive, patient-focused, and attentive to gaps between health care and patient and family needs. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT03325985, 10/30/2017.

Clinical research should involve patient and community stakeholder perspectives to make sure the study addresses questions important to the studied population. One way to do this is by creating a group of stakeholders who can advise on the conduct of a study. We assembled a Study Advisory Committee (SAC) for the Emergency Medicine Palliative Care Access (EMPallA) trial. The purpose of this clinical trial is to compare the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. This paper describes how the SACs involvement translated into direct impacts on the EMPallA trial. The trial research team held regular meetings with the SAC throughout the trial process. Their involvement led to many significant changes in the trial, such as  expanding recruitment inclusion criteria (Spanish-speaking patients), and including survey instruments to measure lonelines and caregiver burden. The SAC also devised strategies to overcome patient and caregiver recruitment and retention challenges, including the creation of patient-friendly materials and training for research coordinators. This study provides a successful example of how actively engaging patient and community stakeholders, through committee engagement, can promote patient priorities in all phases of a trial while facilitating patient recruitment and retention.

The Impact of a Primary Care Telepsychiatry Program on Outcomes of Managed Care Older Adults.

OBJECTIVE: The goal of this study was to assess the outcomes of a primary-based telepsychiatry intervention program for older managed care enrollees with depression/anxiety and with limited access to in-person psychiatric care. DESIGN: A pre-post design was used to examine service use (n = 218) and severity of depression (n = 204). Enrollment, claims, and depression and anxiety score data were obtained from the medical group. The implementation process and self-reported outcomes were examined. SETTING AND PARTICIPANTS: The program was funded by the Senior Care Action Network (SCAN) group and implemented by a large medical group serving older adults who were identified as needing outpatient psychiatric care, including those with psychiatric hospitalizations, depression/anxiety disorders, comorbid substance use disorders, or other multiple comorbidities. METHODS: Poisson regressions were used to examine changes in predicted rates of outpatient services, emergency department visits, and hospitalizations up to 24 months prior and 24 months following the first telepsychiatry visit. Changes in predicted severity of depression up to 2 quarters prior and 3 quarters following the first telepsychiatry visit were examined. RESULTS: The number of outpatient services declined significantly by 0.24 per patient per 6-month time frame following the first telepsychiatry visit. The number of emergency department visits and hospitalizations also declined after the first visit (0.07 and 0.03 per patient per 6-month time frame, respectively). Depression severity scores also declined in the quarters following the first visit (1.52). The medical group reported improvements in both wait time for appointments and no-show rates with the integration of telepsychiatry in primary care. CONCLUSIONS AND IMPLICATIONS: The telepsychiatry program lowered service use, depression severity, and increased better access to psychiatry care. The findings highlight the potential benefits of sustaining and expanding the telepsychiatry program by SCAN and other plans facing a limited supply of psychiatrists.

The Impact of Opioid Safety Edits on Opioid Utilization.

Objective To evaluate the impact of opioid safety edits on opioid utilization. Design Retrospective review. Setting Senior Care Action Network (SCAN) Health Plan, a Medicare Advantage Prescription Drug Plan. Patients, Participants The opioid safety edits reviewed included edits for the following: initial opioid fill more than 7 days' supply (DS), cumulative opioid doses 90 or greater and 240 or greater morphine milligram equivalent (MME), concurrent opioid and benzodiazepine (COB) use. Members with prescription drug claims meeting these criteria pre- and postedit implementation and those with prescription drug claim rejections resulting from the edits were included in the review. Results 15,232 members experienced claim rejections resulting from the edits. Comparison of utilization pre and postedit implementation revealed the following results (P < 0.001): 41% decrease in the proportion of members with an initial opioid fill for more than 7 DS; 18% decrease in the proportion of members on opioid doses 90 MME or more; 26% decrease in the proportion of members on opioid doses 240 MME or more; 18% decrease in the proportion of members with COB. Conclusion Opioid safety edits are an effective way to combat overuse and misuse. They serve as a means for increasing collaboration between plans, prescribers, pharmacists, and members which improves care coordination, reduces adverse risks, and helps keep members safe.

Pragmatic Considerations in Incorporating Stakeholder Engagement Into a Palliative Care Transitions Study.

BACKGROUND: Stakeholder involvement in health care research has been shown to improve research development, processes, and dissemination. The literature is developing on stakeholder engagement methods and preliminarily validated tools for evaluating stakeholder level of engagement have been proposed for specific stakeholder groups and settings. OBJECTIVES: This paper describes the methodology for engaging a Study Advisory Committee (SAC) in research and reports on the use of a stakeholder engagement survey for measuring level of engagement. METHODS: Stakeholders with previous research connections were recruited to the SAC during the planning process for a multicenter randomized control clinical trial, which is ongoing at the time of this writing. All SAC meetings undergo qualitative analysis, while the Stakeholder Engagement Survey instrument developed by the Patient-Centered Outcomes Research Institute (PCORI) is distributed annually for quantitative evaluation. RESULTS: The trial's SAC is composed of 18 members from 3 stakeholder groups: patients and their caregivers; patient advocacy organizations; and health care payers. After an initial in-person meeting, the SAC meets quarterly by telephone and annually in-person. The SAC monitors research progress and provides feedback on all study processes. The stakeholder engagement survey reveals improved engagement over time as well as continued challenges. CONCLUSIONS: Stakeholder engagement in the research process has meaningfully contributed to the study design, patient recruitment, and preliminary analysis of findings.

Community Medication Education, Data, & Safety (C-MEDS): Findings from a Pilot Project.

OBJECTIVES: Medication-related problems remain one of the largest health risks for older adults, yet there are few resources available to effectively reduce medication-related problems for community dwelling older adults. The aim of this pilot program was to determine the effectiveness of a multifaceted medication intervention on medication adherence and self-efficacy in medication use. DESIGN: A single sample, pre-post-test design. SETTING: This pilot study was conducted at Independence at Home, a Senior Care Action Network (SCAN) community service in Southern California. PARTICIPANTS: One hundred and eighty community-dwelling, diverse older adults with potential medication-related problems and their caregivers. INTERVENTION: The Community Medication Education, Data, & Safety (C-MEDS) Program identified community-dwelling older adults with potential medication-related problems and provided in-depth personalized medication safety, management and support, based on an in-home assessment and interventions delivered by trained geriatrics experts including pharmacists, nurses, a community health worker, and a pharmacy technician. MEASUREMENTS: The primary outcomes included medication use self-efficacy, measured by the MUSE, and select medication adherence measures. Adherence was measured via pill count and via the MedAdhIR tool, a scale that measures risk for medication non-adherence. RESULTS: Following participation in the C-MEDS program, community-dwelling older adult C-MEDS graduates (n = 105) had higher self-efficacy in managing medications (P < .001). Additionally, C-MEDS graduates also exhibited increased adherence to three types of medications (statins, diabetes-related, and certain hypertension drugs; P < .001). Moreover, risk of non-adherence declined significantly following C-MEDS graduation (P < .001). CONCLUSION: C-MEDS holds promise as an effective intervention among community-dwelling older adults in improving medication self-efficacy, medication adherence among select medications, and reducing risk for non-adherence. Additional studies are needed to assess replicability and impact on clinical outcomes.

Reducing Barriers to Mental Health Care: Bringing Evidence-Based Psychotherapy Home.

OBJECTIVES: Barriers to treatment for depression and anxiety are prevalent among older adults and caregivers living in the community. We designed and implemented an evidence-based psychotherapy program to reduce obstacles to care. DESIGN: A practice improvement initiative providing no-fee evidence-based mental health care at home in clients' primary languages. SETTING: Independence at Home, a community service of SCAN Health Plan in Southern California. PARTICIPANTS: Diverse older adults and adult caregivers of older people with age-related disability (mainly dementia). INTERVENTION: Redesign of an existing supportive counseling program to improve access to validated models of psychotherapy for depression and anxiety. MEASUREMENTS: We describe program content, phases of development, equity in participation from referral to program completion, clinical outcomes, and estimated direct program delivery costs. RESULTS: Insights successfully served demographically diverse clients experiencing a broad range of barriers to mental health care. A total of 211 clients completed therapy using one of three evidence-based approaches in the first 33 months of operation (2015-2018). Clinical efficacy was high and equivalent across demographic groups and therapy models. Depression, anxiety, quality of life, self-rated disability, and patient activation all improved significantly. We supported therapists' transition to the new model, modified workflows, and used clinical outcome data and therapist focus groups to improve referral, selection, and enrollment processes and simplify treatment assignment. With program maturation, treatment duration and direct costs both declined. CONCLUSION: The Insights model could add value to healthcare organizations seeking to provide effective, equitable mental health services for older adults and caregivers who have difficulty accessing care for depression, anxiety, or difficult life challenges. J Am Geriatr Soc 67:2174-2179, 2019.

2018 American Society of Consultant Pharmacists Annual Meeting & Exhibition.

Poster abstracts are evaluated based on the following criteria: significance of the problem to healthy aging or medication management; innovativeness of ideas, methods, and/or approach; methodological rigor of methods and approach; presentation of finding; implications identified for future research, practice, and/or policy; and clarity of writing. Submissions are not evaluated through the peer-reviewed process used by The Consultant Pharmacist. Industry support is indicated, where applicable. Presenting author is in italics. The poster abstract presentation is supported by the ASCP Foundation.

A Strategy for Identifying and Disseminating Best Practice Innovations in the Care of Patients with Multiple Chronic Conditions or End-of-Life Care Needs.

Patients with multiple chronic conditions and those with end-of-life care needs experience high health care costs and needs for skilled coordination and well-trained staff. Focusing on these populations presents an opportunity to improve the patient experience toward the goal of more patient-centered care and reduced costs. Although innovative programs that provide better care to these patient populations have been developed, these innovations are often localized and not actively disseminated to other settings. This paper describes a quality-improvement project aimed at developing a process to identify best practices implemented in community-based clinical settings, develop a platform to share and disseminate these best practices, and facilitate the adoption of successful practices across other similar settings. The facilitation process involved structured coaching by clinicians and researchers experienced with practice change and quality improvement. The coaching component ensured that implementation teams receive guidance in the planning and adoption process, stay on track with implementation, and have access to timely support in addressing unanticipated barriers.

Education first: reforming the first-year curriculum of the internal medicine residency.

Many opinion leaders of the academic internal medicine community have expressed concern about the adequacy of internal medicine (IM) residency training to prepare residents for their careers and to attract medical students to IM residency programs. In response to those concerns, several core organizations have prepared reports and issued significant recommendations suggesting comprehensive reform and restructuring of IM training programs.The authors discuss their approach, strategy, and efforts to restructure the first year in the IM residency training program at the University of California, Irvine. They point out that educators have often viewed the internship as a rite of passage, heavy with inpatient service commitment. However, in the authors' view, the current trend to residents' early subspecialty commitment has made it imperative that the first year of IM residency be more focused, standardized, meaningful, and effective in order to achieve core educational goals before each resident's career focus has become too narrowed and while the big picture is more apparent. The authors describe in detail their review of their first-year curriculum based on consensus goals and objectives. This process led to a restructuring of the first year that places emphasis on a defined educational model and a central core curriculum. The authors conclude that residency program leaders can restructure the first year to provide a model of education that includes appropriate educational experiences as well as meaningful time for reflection and professional growth.