An innovative approach to aligning healthcare with what matters most to patients: A hybrid type 1 trial protocol of patient priorities care for older adults with multiple chronic conditions.

BACKGROUND: Providing healthcare for older adults with multiple chronic conditions (MCC) is challenging. Polypharmacy and complex treatment plans can lead to high treatment burden and risk for adverse events. For clinicians, managing the complexities of patients with MCC leaves little room to identify what matters and align care options with patients' health priorities. New care approaches are needed to navigate these challenges. In this clinical trial, we evaluate implementation and effectiveness outcomes of an innovative, structured, patient-centered care approach (Patient Priorities Care; PPC) for reducing treatment burden and aligning health care decisions with the health priorities of older adults with MCC. METHODS: This is a multisite, assessor-blind, two-arm, parallel hybrid type 1 randomized controlled trial. We are enrolling 396 older (65+) Veterans with MCC who receive primary care at the Veterans Affairs Medical Center. Veterans are randomly assigned to either PPC or usual care. In the PPC arm, Veterans have a brief telephone call with a study facilitator to identify their personal health priorities. Then, primary care providers use this information to align healthcare with Veteran priorities during their established clinic appointments. Data are collected at baseline and 4-month follow up to assess for changes in treatment burden and use of home and community services. Formative and summative evaluations are also collected to assess for implementation outcomes according to Proctor's implementation framework. CONCLUSIONS: This work has the potential to significantly improve the standard of care by personalizing healthcare and helping patients achieve what is most important to them.

Effect of Computer-Tailored Print Feedback, Motivational Interviewing, and Motivational Enhancement Therapy on Engagement in Advance Care Planning: A Randomized Clinical Trial.

Importance: There is a tension between clinician-led approaches to engagement in advance care planning (ACP), which are effective but resource-intensive, and self-administered tools, which are more easily disseminated but rely on ability and willingness to complete. Objective: To examine the efficacy of computer-tailored print feedback (CTPF), motivational interviewing (MI), and motivational enhancement therapy (MET) on completion of a set of ACP activities, each as compared with usual care. Design, Setting, and Participants: This randomized clinical trial was conducted from October 2017 to December 2020 via telephone contact with primary care patients at a single VA facility; 483 veterans aged 55 years or older were randomly selected from a list of patients with a primary care visit in the prior 12 months, with oversampling of women and people from minoritized racial and ethnic groups. Statistical analysis was performed from January to June 2022. Interventions: Mailed CTPF generated in response to a brief telephone assessment of readiness to engage in and attitudes toward ACP; MI, an interview exploring ambivalence to change and developing a change plan; and MET, MI plus print feedback, delivered by telephone at baseline, 2, and 4 months. Main Outcome and Measures: Self-reported completion of 4 ACP activities: communicating about views on quality vs quantity of life, assignment of a health care agent, completion of a living will, and submitting documents for inclusion in the electronic health record at 6 months. Results: The study included 483 persons, mean (SD) age 68.3 (8.0) years, 18.2% women and 31.1% who were people from minoritized racial and ethnic groups. Adjusting for age, education, race, gender, and baseline stage of change for each ACP, predicted probabilities for completing the ACP activities were: usual care 5.7% (95% CI, 2.8%-11.1%) for usual care, 17.7% (95% CI, 11.8%-25.9%; P = .003) for MET, 15.8% (95% CI, 10.2%-23.6%; P = .01) for MI, P = .01, and 10.0% (95% CI, 5.9%-16.7%; P = .18) for CTPF. Conclusions and Relevance: This randomized clinical trial found that a series of 3 MI and MET counseling sessions significantly increased the proportion of middle-aged and older veterans completing a set of ACP activities, while print feedback did not. These findings suggest the importance of clinical interaction for ACP engagement. Trial Registration: ClinicalTrials.gov Identifier: NCT03103828.

Primary care clinicians' use of deprescribing recommendations: A mixed-methods study.

OBJECTIVE: to explore the effects of a deprescribing intervention on primary care clinicians' medication-related communication. METHODS: A clinical decision support tool provided clinicians in the intervention group with an individualized report regarding potentially inappropriate medications (PIMs), deintensification of diabetes and/or hypertension treatment, and poor adherence/cognition. Participants included 113 Veterans aged ≥ 65 prescribed ≥ 7 medications and their primary care clinicians. Encounters were recorded and analyzed. RESULTS: Between 36% and 38% of intervention clinicians discussed PIMs and diabetes mellitus/hypertension deintensification and 94% discussed adherence. PIMs discussions referred to the report and prompted some medication changes. The diabetes mellitus/hypertension and adherence discussions were not prompted by the report but instead arose from enhanced medication reconciliation. Changes in diabetes mellitus/hypertension medications were not made out of overtreatment concerns. There was no deprescribing for nonadherence. Enhanced medication reconciliation also led to discussions about medications not in the report. CONCLUSION: An individualized report regarding medication appropriateness prompted clinicians to perform a more thorough medication reconciliation and discuss PIMs. It did not prompt chronic care deintensification or deprescribing to enhance adherence. PRACTICE IMPLICATIONS: Feedback reports can promote robust medication reconciliation in primary care. Changing clinician practice to achieve deprescribing in chronic disease management will be more challenging.

Effect of the STAMP (Sharing and Talking About My Preferences) Intervention on Completing Multiple Advance Care Planning Activities in Ambulatory Care : A Cluster Randomized Controlled Trial.

BACKGROUND: Interventions with the potential for broad reach in ambulatory settings are necessary to achieve a life course approach to advance care planning. OBJECTIVE: To examine the effect of a computer-tailored, behavioral health model-based intervention on the engagement of adults in advance care planning recruited from ambulatory care settings. DESIGN: Cluster randomized controlled trial with participant-level analysis. (ClinicalTrials.gov: NCT03137459). SETTING: 10 pairs of primary and selected specialty care practices matched on patient sociodemographic information. PARTICIPANTS: English-speaking adults aged 55 years or older; 454 adults at practices randomly assigned to usual care and 455 at practices randomly assigned to intervention. INTERVENTION: Brief telephone or web-based assessment generating a mailed, individually tailored feedback report with a stage-matched brochure at baseline, 2 months, and 4 months. MEASUREMENTS: The primary outcome was completion of the following 4 advance care planning activities at 6 months: identifying and communicating with a trusted person about views on quality versus quantity of life, assignment of a health care agent, completion of a living will, and ensuring that the documents are in the medical record-assessed by a blinded interviewer. Secondary outcomes were completion of individual advance care planning activities. RESULTS: Participants were 64% women and 76% White. The mean age was 68.3 years (SD, 8.3). The predicted probability of completing all advance care planning activities in usual care sites was 8.2% (95% CI, 4.9% to 11.4%) versus 14.1% (CI, 11.0% to 17.2%) in intervention sites (adjusted risk difference, 5.2 percentage points [CI, 1.6 to 8.8 percentage points]). Prespecified subgroup analysis found no statistically significant interactions between the intervention and age, education, or race. LIMITATIONS: The study was done in a single region and excluded non-English speaking participants. No information was collected about nonparticipants. CONCLUSION: A brief, easily delivered, tailored print intervention increased participation in advance care planning in ambulatory care settings. PRIMARY FUNDING SOURCE: National Institute of Nursing Research and National Institute of Aging.

How Patients and Providers Weigh the Risks and Benefits of Long-Term Opioid Therapy for Cancer Pain.

PURPOSE: To understand how patients and providers weigh the risks and benefits of long-term opioid therapy (LTOT) for cancer pain. METHODS: Researchers used VA approved audio-recording devices to record interviews. ATLAS t.i., a qualitative analysis software, was used for analysis of transcribed interview data. Participants included 20 Veteran patients and 20 interdisciplinary providers from primary care- and oncology-based practice settings. We conducted semistructured interviews and analyzed transcripts used thematic qualitative methods. Interviews explored factors that affect decision making about appropriateness of LTOT for cancer related pain. We saturated themes for providers and patients separately. RESULTS: Factors affecting patient decision-making included influence from various information sources, persuasion from trusted providers, and sometimes deferral of the decision to their provider. Relative prioritization of pain management as the focal patient concern varied with some patients describing comparatively more fear of chemotherapy than opioid analgesics, comparatively more knowledge of opioids in relation to other drugs;patients expressed a preference to spend the limited time they have with their oncologist discussing cancer treatment rather than opioid use. Factors affecting provider decision making included prognosis, patient goals, patient characteristics, and provider experience and biases. Providers differed in how they weigh the relative importance of alleviating pain or avoiding opioids in the face of treating patients with cancer and histories of substance abuse. CONCLUSION: Divergent perspectives on factors need to be considered when weighing risks and benefits. Policies and interventions should be designed to reduce variation in practice to promote equal access to adequate pain management. Improved shared decision-making initiatives will take advantage of patient decision-making factors and priorities.

Signature Informed Consent for Long-Term Opioid Therapy in Patients With Cancer: Perspectives of Patients and Providers.

CONTEXT: Signature informed consent (SIC) is a part of a Veterans Health Administration ethics initiative for patient education and shared decision making with long-term opioid therapy (LTOT). Historically, patients with cancer-related pain receiving LTOT are exempt from this process. OBJECTIVES: Our objective is to understand patients' and providers' perspectives on using SIC for LTOT in patients with cancer-related pain. METHODS: Semistructured interviews with 20 opioid prescribers and 20 patients who were prescribed opioids at two large academically affiliated Veterans Health Administration Medical Centers. We used a combination of deductive and inductive approaches in content analysis to produce emergent themes. RESULTS: Potential advantages of SIC are that it can clarify and help patients comprehend LTOT risks and benefits, provide clear upfront boundaries and expectations, and involve the patient in shared decision making. Potential disadvantages of SIC include time delay to treatment, discouragement from recommended opioid use, and impaired trust in the patient-provider relationship. Providers and patients have misconceptions about the definition of SIC. Providers and patients question if SIC for LTOT is really informed consent. Providers and patients advocate for strategies to improve comprehension of SIC content. Providers had divergent perspectives on exemptions from SIC. Oncologists want SIC for LTOT to be tailored for patients with cancer. CONCLUSION: Provider and patient interviews highlight various aspects about the advantages and disadvantages of requiring SIC for LTOT in cancer-related pain. Tailoring SIC for LTOT to be specific to cancer-related concerns and to have an appropriate literacy level are important considerations.

Feasibility of Delivering a Tailored Intervention for Advance Care Planning in Primary Care Practice.

BACKGROUND/OBJECTIVES: To determine the feasibility of conducting a cluster randomized controlled trial providing individualized feedback reports to increase advance care planning (ACP) engagement in the primary care setting. DESIGN: Pilot cluster randomized controlled trial. SETTING: Two primary care practices selected for geographic colocation. PARTICIPANTS: Adults aged 55 years and older. INTERVENTION: Brief assessment of readiness to engage in (stage of change for) three ACP behaviors (healthcare agent assignment, communication with agent about quality vs quantity of life, and living will completion) generating an individualized feedback report, plus a stage-matched brochure. MEASURES: Patient recruitment and retention, intervention delivery, baseline characteristics, and stage of change movement. RESULTS: Recruitment rates differed by practice. Several baseline sociodemographic characteristics differed between the 38 intervention and 41 control participants, including employment status, education, and communication with healthcare agent. Feedback was successfully delivered to all intervention participants, and over 90% of participants completed a 2-month follow-up. More intervention participants demonstrated progression in readiness than did control participants, without testing for statistical significance. CONCLUSIONS: This pilot demonstrates opportunities and challenges of performing a clustered randomized controlled trial in primary care practices. Differences in the two practice populations highlight the challenges of matching sites. There was a signal for behavior change in the intervention group. J Am Geriatr Soc 67:1917-1921, 2019.

Increasing engagement in advance care planning using a behaviour change model: study protocol for the STAMP randomised controlled trials.

INTRODUCTION: Advance care planning (ACP) is a key component of high-quality end-of-life care but is underused. Interventions based on models of behaviour change may fill an important gap in available programmes to increase ACP engagement. Such interventions are designed for broad outreach and flexibility in delivery. The purpose of the Sharing and Talking about My Preferences study is to examine the efficacy of three behaviour change approaches to increasing ACP engagement through two related randomised controlled trials being conducted in different settings (Veterans Affairs (VA) medical centre and community). METHODS AND ANALYSIS: Eligible participants are 55 years or older. Participants in the community are being recruited in person in primary care and specialty outpatient practices and senior living sites, and participants in the VA are recruited by telephone. In the community, randomisation is at the level of the practice or site, with all persons at a given practice/site receiving either computer-tailored feedback with a behaviour stage-matched brochure (computer-tailored intervention (CTI)) or usual care. At the VA, randomisation is at the level of the participant and is stratified by the number of ACP behaviours completed at baseline. Participants are randomised to one of four groups: CTI, motivational interviewing, motivational enhancement therapy or usual care. The primary outcome is completion of four key ACP behaviours: identification of a surrogate decision maker, communication about goals, completing advance directives and ensuring documents are in the medical record. Analysis will be conducted using mixed effects models, taking into account the clustered randomisation for the community study. ETHICS AND RANDOMISATION: The studies have been approved by the appropriate Institutional Review Boards and are being overseen by a Safety Monitoring Committee. The results of these studies will be disseminated to academic audiences and leadership in in the community and VA sites. TRIAL REGISTRATION NUMBERS: NCT03137459 and NCT03103828.

Engagement in Advance Care Planning and Surrogates' Knowledge of Patients' Treatment Goals.

OBJECTIVES: A key objective of advance care planning (ACP) is improving surrogates' knowledge of patients' treatment goals. Little is known about whether ACP outside of a trial accomplishes this. The objective was to examine patient and surrogate reports of ACP engagement and associations with surrogate knowledge of goals. DESIGN: Cohort study SETTING: Primary care in a Veterans Affairs Medical Center. PARTICIPANTS: 350 community-dwelling veterans age ≥55 years and the individual they would choose to make medical decisions on their behalf, interviewed separately. MEASUREMENTS: Treatment goals were assessed by veterans' ratings of 3 health states: severe physical disability, cognitive disability, and pain, as an acceptable or unacceptable result of treatment for severe illness. Surrogates had knowledge if they correctly predicted all 3 responses. Veterans and surrogates were asked about living will and health care proxy completion and communication about life-sustaining treatment and quality versus quantity of life (QOL). RESULTS: Over 40% of dyads agreed that the veteran had not completed a living will or health care proxy and that there was no QOL communication. For each activity, sizeable proportions (18-34%) disagreed about participation. In dyads who agreed QOL communication had occurred, 30% of surrogates had knowledge, compared to 21% in dyads who agreed communication had not occurred and 15% in dyads who disagreed (P = .01). This relationship persisted in multivariable analysis. Agreement about other ACP activities was not associated with knowledge. CONCLUSION: Disagreement about ACP participation was common. Agreement about communication regarding QOL was modestly associated with surrogate knowledge of treatment goals. Eliciting surrogates' perspectives is critical to ACP. Even dyads who agree about participation may need additional support for successful engagement.

A Dyadic Perspective on Engagement in Advance Care Planning.

OBJECTIVES: To understand the perspectives of both patients and the person who would make medical decisions for them if they were unable (surrogates) on their participation in advance care planning (ACP). DESIGN: Qualitative cross-sectional study. SETTING: Community. PARTICIPANTS: Thirty-one veterans age 55 years and older and their surrogates. MEASUREMENTS: In interviews conducted with both the veteran and surrogate, they were asked to discuss their participation in four ACP activities: communication about life-sustaining treatment, communication about views on quality of life, completion of a living will, and appointment of a healthcare proxy. They were asked about barriers to and facilitators of ACP engagement. When they did not agree about engagement, they each provided their perspective on what they believed had or had not occurred. RESULTS: Many of the same barriers to and facilitators of engagement were discussed by both patients and surrogates. These included difficulty thinking about dying, differences in values, and experiences with others that demonstrated the ability of ACP to decrease burden or avoid conflict. Reasons for disagreements in perceptions about whether communication had occurred included surrogates' need for more detailed information, surrogates' lack of readiness to hear what the patient was saying, and surrogates' reliance on what they know about the patient. For some dyads, participation in the study prompted additional communication, resulting in a better shared understanding of ACP engagement. CONCLUSION: Surrogates can both impede and facilitate engagement in ACP, and they can hold different perceptions from patients regarding this engagement. Efforts to promote ACP may be most successful if they assess and address both patients' and surrogates' attitudes and help to facilitate clear communication between them.

Lower Wingate Test Power Outcomes From "All-Out" Pretest Pedaling Cadence Compared With Moderate Cadence.

The aim of the present study was to determine the effect of different pretest pedaling cadences on power outcomes obtained during the Wingate Anaerobic Test (WAnT). Vigorously exercising adult men (n = 14, 24.9 ± 1.2 years) and women (n = 14, 20.4 ± 0.6 years) participated in a randomized crossover study during which they performed the 30-second WAnT on a mechanically braked cycle ergometer (0.075 kg·kg(-1) body weight) under 2 conditions. Participants pedaled maximally with an unloaded flywheel during 5 seconds before resistance was applied and the test began (FAST). In another trial, participants maintained a moderate cadence (80 revolutions per minute [rpm]) during 5 seconds before the test began (MOD). All other components of the WAnT were identical. Peak power (PP), mean power (MP), minimum power (MinP), fatigue index (%FAT), and maximum cadence during test were recorded. Comparisons were made using a 2 × 2 factorial repeated-measures analysis of variance. Regardless of gender, the FAST condition resulted in 22.2% lower PP (612.6 ± 33.0 W vs. 788.3 ± 43.5 W), 13.3% lower MP (448.4 ± 22.2 W vs. 517.2 ± 26.4 W), 11.7% lower MinP (280.9 ± 14.8 W vs. 318.3 ± 17.2 W), and 9.0% lower %FAT (53.5 ± 1.3% vs. 58.8 ± 1.5%) than MOD condition (p < 0.01; mean ± SD). Similar outcomes were observed within gender. The authors conclude that practitioners of the WAnT should instruct participants to maintain a moderate pedal cadence (∼80 rpm) during 5 seconds before the test commences to avoid bias from software sampling and peripheral fatigue. Standardizing the pretest pedal cadence will be important to exercise testing professionals who compare data with norms or generate norms for specific populations.