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Objectives. To determine whether a community health worker (CHW) intervention improved outcomes in a low-income population with multiple chronic conditions. Methods. We conducted a single-blind, randomized clinical trial in Philadelphia, Pennsylvania (2013–2014). Participants (n = 302) were high-poverty neighborhood residents, uninsured or publicly insured, and diagnosed with 2 or more chronic diseases (diabetes, obesity, tobacco dependence, hypertension). All patients set a disease-management goal. Patients randomly assigned to CHWs also received 6 months of support tailored to their goals and preferences. Results. Support from CHWs (vs goal-setting alone) led to improvements in several chronic diseases (changes in glycosylated hemoglobin: −0.4 vs 0.0; body mass index: −0.3 vs −0.1; cigarettes per day: −5.5 vs −1.3; systolic blood pressure: −1.8 vs −11.2; overall P = .08), self-rated mental health (12-item Short Form survey; 2.3 vs −0.2; P = .008), and quality of care (Consumer Assessment of Healthcare Providers and Systems; 62.9% vs 38%; P < .001), while reducing hospitalization at 1 year by 28% (P = .11). There were no differences in patient activation or self-rated physical health. Conclusions. A standardized CHW intervention improved chronic disease control, mental health, quality of care, and hospitalizations and could be a useful population health management tool for health care systems. Trial Registration. clinicaltrials.gov identifier: NCT01900470.

My Tools 4 Care (MT4C) is a Web-based intervention that was developed based on the transitions theory. It is an interactive, self-administered, and portable toolkit containing six main sections intended to support carers of community-living persons with Alzheimer's disease and related dementia and multiple chronic conditions through their transition experiences. The objective of our study was to evaluate the effectiveness of MT4C with respect to increasing hope, self-efficacy, and health-related quality of life in carers of community-living older persons with Alzheimer's disease and related dementia and multiple chronic conditions. A multisite, pragmatic, mixed methods, longitudinal, repeated-measures, randomized controlled trial was conducted between June 2015 and April 2017. Eligible participants were randomized into either treatment (MT4C) or educational control groups. Following baseline measures, carers in the treatment group received 3 months of password-protected access to MT4C. Trained research assistants collected data from participants via phone on hope (Herth Hope Index [HHI]), self-efficacy (General Self-Efficacy Scale), and health-related quality of life (Short Form-12 item [version 2] health survey; SF-12v2) at baseline, 1, 3, and 6 months. The use and cost of health and social services (Health and Social Services Utilization Inventory) among participants were measured at baseline, 3, and 6 months. Analysis of covariance was used to identify group differences at 3 months, and generalized estimating equations were used to identify group differences over time. A total of 199 carers participated in this study, with 101 participants in the treatment group and 98 in the educational control group. Of all, 23% (45/199) participants withdrew during the study for various reasons, including institutionalization or death of the person with dementia and lack of time from the carer. In the treatment group, 73% (74/101) carers used MT4C at least once over the 3-month period. No significant differences in the primary outcome measure (mental component summary score from the SF-12v2) by group or time were noted at 3 months; however, significant differences were evident for HHI-factor 2 (P=.01), with higher hope scores in the treatment group than in the control group. General estimating equations showed no statistically significant group differences in terms of mental component summary score at all time points. Attrition and the fact that not all carers in the treatment group used MT4C may explain the absence of statistically significant results for the main outcome variable. Despite no significant differences between groups in terms of the primary outcome variable (mental component score), the significant differences in terms of one of the hope factors suggest that MT4C had a positive influence on the lives of participants. ClinicalTrials.gov NCT02428387; https://clinicaltrials.gov/ct2/show/NCT02428387 (Archived by Webcite at http://www.webcitation.org/708oFCR8h).

Background Implementation research should assess the feasibility of scale up to bridge the evidence-practice gap for integrated care programs in the prevention and management of chronic conditions. Scalability assessment is the first critical step of scale up to determine the potential suitability of a promising health program to be adopted into routine practice and the fit of the program within local contexts. The Community Partnership Program (CPP), an integrated care intervention for older adults with diabetes and multiple chronic conditions, was designed at the outset with scale up in mind, and evaluated in an implementation-effectiveness randomized controlled trial across three Canadian provinces. The final phase of this program of research was to assess scalability and determine the critical factors and next steps for the development of a scale up plan. Methods Multiple methods were used to assess the scalability of the CPP including collection and analysis of publicly available documents, synthesis of qualitative and quantitative evidence from studies of the CPP, semi-structured interviews with key informants, feedback and recommendations arising from working group meetings and knowledge exchange workshops to discuss and rate the scalability of the program. Data collection and analysis was informed by the Intervention Scalability Assessment Tool (ISAT); developed to support practitioners and policy makers in conducting systematic assessments of the suitability of health interventions for population scale-up in high-income countries. Results Overall, the CPP received high scalability ratings from participants. A phased, horizontal implementation and scale up process was recommended, facilitating local adaptations, on-going program evaluation, and accumulation of evidence. Challenges to scale up were identified, including the need for further evidence of program effectiveness in other diverse settings and populations, and designated funding and adequate health human resources. Conclusions Participants agreed the CPP meets the needs of many older adults with diabetes and multiple chronic conditions; however, they suggested further tailoring of the program to support different ethnocultural groups and targeting the CPP to older adults with higher needs. The scalability assessment process was a practical method to generate concrete strategies to facilitate the uptake of the CPP into practice. Trial registration Clinical Trials.gov Identifier NCT03664583. Registration date: September 10, 2018.

Background Although older adults with heart failure (HF) and multiple chronic conditions (MCC) frequently rely on caregivers for health management, digital health systems, such as patient portals and mobile apps, are designed for individual patients and often exclude caregivers. There is a need to develop approaches that integrate caregivers into care. This study tested the feasibility of the Social Convoy Palliative Care intervention (Convoy-Pal), a 12-week digital self-management program that includes assessment tools and resources for clinical palliative care, designed for both patients and their caregivers. Methods A randomized waitlist control feasibility trial involving patients over 65 years old with MCC who had been hospitalized two or more times for HF in the past 12 months and their caregivers. Descriptive statistics were used to evaluate recruitment, retention, missing data, self-reported social functioning, positive aspects of caregiving, and the acceptability of the intervention. Results Of 126 potentially eligible patients, 11 were ineligible and 69 were deceased. Of the 46 eligible patients, 31 enrolled in the trial. Although 48 caregivers were identified, only 15 enrolled. The average age was 76.3 years for patients and 71.6 years for caregivers, with most participants being non-Hispanic White. Notably, 4% did not have access to a personal mobile device or computer. Retention rates were 79% for intervention patients, 57% for intervention caregivers, and 60% for control participants. Only 4.6% of survey subscales were missing, aided by robust technical support. Intervention patients reported improved social functioning (SF-36: 64.6 ± 25.8 to 73.2 ± 31.3) compared to controls (64.6 ± 27.1 to 67.5 ± 24.4). Intervention caregivers also reported increased positive perceptions of caregiving (29.5 ± 5.28 to 35.0 ± 5.35) versus control caregivers (29.4 ± 8.7 to 28.0 ± 4.4). Waitlist control participants who later joined the Convoy-Pal program showed similar improvements. The intervention was well-rated for acceptability, especially regarding the information provided (3.96 ± .57 out of 5). Conclusions Recruiting informal caregivers proved challenging. Nonetheless, Convoy-Pal retained patients and collected meaningful self-reported outcomes, showing potential benefits for both patients and caregivers. Given the importance of a patient and caregiver approach in palliative care, further research is needed to design digital tools that cater to multiple simultaneous users. Trial registration ClinicalTrials.gov Identifier NCT04779931. Date of registration: March 3, 2021.

Background Person-centred care (PCC) focusing on personalised goals and care plans derived from “What matters to you?” has an impact on single disease outcomes, but studies on multi-morbid elderly are lacking. Furthermore, the combination of PCC, Integrated Care (IC) and Pro-active care are widely recognised as desirable for multi-morbid elderly, yet previous studies focus on single components only, leaving synergies unexplored. The effect of a synergistic intervention, which implements 1) Person-centred goal-oriented care driven by “What matters to you?” with 2) IC and 3) pro-active care is unknown. Methods Inspired by theoretical foundations, complexity science, previous health service research and a patient-driven evaluation of care quality, we designed the Patient-Centred Team (PACT) intervention across primary and secondary care. The PACT team collaborate with the patient to make and deliver a person-centred, integrated and proactive multi-morbidity care-plan. The control group receives conventional care. The study design is a pragmatic six months prospective, controlled clinical trial based on hospital electronic health record data of 439 multi-morbid frail elderly at risk for emergency (re) admissions referred to PACT and 779 propensity score matched controls in Norway, 2014–2016. Outcomes are emergency admissions, the sum of emergency inpatient bed days, 30-day readmissions, planned and emergency outpatient visits and mortality at three and six months follow-up. Results The Rate Ratios (RR) for emergency admissions was 0,9 (95%CI: 0,82-0,99), for sum of emergency bed days 0,68 (95%CI:0,52-0,79) and for 30-days emergency readmissions 0,72 (95%CI: 0,41-1,24). RRs were 2,3 (95%CI: 2,02-2,55) and 0,9 (95%CI: 0,68-1,20) for planned and emergency outpatient visits respectively. The RR for death at 3 months was 0,39 (95% CI: 0,22-0,70) and 0,57 (95% CI: 0,34-0,94) at 6 months. Conclusion Compared with propensity score matched controls, the care process of frail multi-morbid elderly who received the PACT intervention had a reduced risk of high-level emergency care, increased use of low-level planned care, and substantially reduced mortality risk. Further study of process differences between groups is warranted to understand the genesis of these results better. Trial registration ClinicalTrials.gov (identifier: NCT02541474 ), registered Sept 2015.

In the United States, over 60% of adults aged 65 years or older have multiple chronic health conditions, with consequences that include reduced quality of life, increasingly complex but less person-centered treatment, and higher health care costs. A previous trial of ElderTree, an eHealth intervention for older adults, found socioemotional benefits for those with high rates of primary care use. This study tested the effectiveness of an ElderTree intervention designed specifically for older patients with multiple chronic conditions to determine whether combining it with primary care improved socioemotional and physical outcomes. In a nonblinded randomized controlled trial, 346 participants recruited from primary care clinics were assigned 1:1 to the ElderTree intervention or an attention control and were followed for 12 months. All participants were aged 65 years or older and had electronic health record diagnoses of at least three of 11 chronic conditions. Primary outcomes were mental and physical quality of life, psychological well-being (feelings of competence, connectedness, meaningfulness, and optimism), and loneliness. Tested mediators of the effects of the study arm (ElderTree vs active control) on changes in primary outcomes over time were 6-month changes in health coping, motivation, feelings of relatedness, depression, and anxiety. Tested moderators were sex, scheduled health care use, and number of chronic conditions. Data sources were surveys at baseline and 6 and 12 months comprising validated scales, and continuously collected ElderTree usage. At 12 months, 76.1% (134/176) of ElderTree participants were still using the intervention. There was a significant effect of ElderTree (vs control) on improvements over 12 months in mental quality of life (arm × timepoint interaction: b=0.76, 95% CI 0.14-1.37; P=.02; 12-month ∆d=0.15) but no such effect on the other primary outcomes of physical quality of life, psychological well-being, or loneliness. Sex moderated the effects of the study arm over time on mental quality of life (b=1.33, 95% CI 0.09-2.58; P=.04) and psychological well-being (b=1.13, 95% CI 0.13-2.12; P=.03), with stronger effects for women than men. The effect of the study arm on mental quality of life was mediated by 6-month improvements in relatedness (α=1.25, P=.04; b=0.31, P<.001). Analyses of secondary and exploratory outcomes showed minimal effects of ElderTree. Consistent with the previous iteration of ElderTree, the current iteration designed for older patients with multiple chronic conditions showed signs of improving socioemotional outcomes but no impact on physical outcomes. This may reflect the choice of chronic conditions for inclusion, which need not have impinged on patients' physical quality of life. Two ongoing trials are testing more specific versions of ElderTree targeting older patients coping with (1) chronic pain and (2) greater debilitation owing to at least 5 chronic conditions. ClinicalTrials.gov NCT03387735; https://clinicaltrials.gov/study/NCT03387735. RR2-10.2196/25175.

Background Older adults ( > 65 years) with multiple chronic conditions (MCC) and depressive symptoms experience frequent transitions between hospital and home. Care transitions for this population are often poorly coordinated and fragmented, resulting in increased readmission rates, adverse medical events, decreased patient satisfaction and safety, and increased caregiver burden. There is a dearth of evidence on best practices in the provision of transitional care for older adults with MCC and depressive symptoms transitioning from hospital-to-home. This paper presents a protocol for a two-armed, multi-site pragmatic effectiveness-implementation trial of Community Assets Supporting Transitions (CAST), an evidence-informed nurse-led six-month intervention that supports older adults with MCC and depressive symptoms transitioning from hospital-to-home. The Collaborative Intervention Planning Framework is being used to engage patients and other key stakeholders in the implementation and evaluation of the intervention and planning for intervention scale-up to other communities. Methods Participants will be considered eligible if they are >  65 years, planned for discharged from hospital to the community in three Ontario locations, self-report at least two chronic conditions, and screen positive for depressive symptoms. A total of 216 eligible and consenting participants will be randomly assigned to the control (usual care) or intervention (CAST) arm. The intervention consists of tailored care delivery comprising in-home visits, telephone follow-up and system navigation support. The primary measure of effectiveness is mental health functioning of the older adult participant. Secondary outcomes include changes in physical functioning, depressive symptoms, anxiety, perceived social support, patient experience, and health and social service use and cost, from baseline to 6- and 12-months. Caregivers will be assessed for caregiver strain, depressive symptoms, anxiety, health-related quality of life, and health and social service use and costs. Descriptive and qualitative data from older adult and caregiver participants, and the nurse interventionists will be used to examine implementation of the intervention, how the intervention is adapted within each study region, and its potential for sustainability and scalability to other jurisdictions. Discussion A nurse-led transitional care strategy may provide a feasible and effective means for improving health outcomes and patient/caregiver experience and reduce service use and costs in this vulnerable population. Trial registration # NCT03157999 . Registration Date: April 4, 2017.

Smart displays and speakers offer voice interaction, which may be more accessible and appealing to older adults with chronic pain and other multimorbid conditions. Previous trials found stronger socioemotional benefits of ElderTree (vs control) among those with high primary care use and multiple chronic conditions. This study aims to test whether older adults with chronic pain and multiple other chronic conditions use and benefit more from ElderTree, an eHealth intervention targeting pain and quality of life, when delivered on a smart display. We recruited 269 participants from the University of Wisconsin-Madison health system and community organizations and randomly assigned 1:1:1 to (1) smart display with internet and ElderTree, plus usual care; (2) touchscreen laptop with internet and ElderTree, plus usual care; or (3) usual care alone. Participants were aged ≥60 years, had a chronic pain diagnosis or reported chronic pain, and at least 3 common chronic conditions. Primary outcomes were pain interference and psychosocial quality of life. Data sources were baseline, 4-month, and 8-month surveys and continuous ElderTree usage data. No significant differences were found between the laptop versus smart display groups for pain interference (b=-0.11, 95% CI -1.07 to 0.85; P=.82) or psychosocial quality (b=-0.21, 95% CI -0.96 to 0.55; P=.56), nor between the combined laptop+smart display group versus control group for either outcome (pain interference: b=-0.41, 95% CI -1.23 to 0.41; P=.33; psychosocial quality of life: b=0.04, 95% CI -0.61 to 0.69; P=.90). Mediation was not tested because effects on primary outcomes were nonsignificant. Gender did not moderate the effect of laptop versus smart display groups in pain interference (b=-1.56, 95% CI -3.56 to 0.44; P=.13). Gender did moderate the effect of the combined laptop+smart display group versus control group (b=1.91, 95% CI 0.11 to 3.71; P=.04). Women showed a significant decrease in pain interference (b=-0.69, 95% CI -1.29 to -0.10; P=.02), whereas women in the control group showed no significant change (b=0.25, 95% CI -0.53 to 1.04; P=.53). Men in the combined group showed a nonsignificant decrease (b=-0.67, 95% CI -1.47 to 0.14; P=.10), whereas men in the control group showed a significant decrease (b=-1.61, 95% CI -2.88 to -0.35; P=.01). Participants assigned to the laptop versus smart display used ElderTree more frequently and had more favorable perceptions. Analyses of secondary and exploratory outcomes showed no significant differences between groups. We found no significant differences between the combined ElderTree group and the control group for changes over time in any primary, secondary, or exploratory outcomes. Moderation analyses indicated that only gender moderated study arm effects, and only for the laptop+smart display versus control group on changes over time in the two primary outcomes. ClinicalTrials.gov NCT04798196; https://clinicaltrials.gov/ct2/show/NCT04798196. RR2-10.2196/37522.

Maintaining functional health, or the ability to live independently, is a primary goal of individuals as they age, but most older adults develop chronic conditions that threaten this goal. Physical activity is a key aspect of self-care that can improve functional health, and digital interventions offering guidance on appropriate exercise can help. However, older adults with multiple morbidities may be unable to use a laptop or smartphone-based eHealth because poor vision, dexterity, mobility, or other physical challenges make typing or touch navigation difficult. A smart display platform-comprising a smart speaker plus a small visual screen-has the potential to remove these barriers because it is voice-activated. The study aims to compare usage patterns of an eHealth intervention for older adults when delivered via a voice-based smart display versus a typing-based laptop, and assess whether the smart display outperforms the laptop in improving functional health and its specific physical and mental aspects. A minimum of 356 adults aged 60 years and older with at least 5 chronic health conditions are to be recruited from primary care clinics and community organizations. Participants will be randomized 1:1 to 12 months of access to an evidence-based intervention, ElderTree, delivered on either a smart display or a touchscreen laptop, with a postintervention follow-up at 18 months. The primary outcome is differences between groups on a comprehensive measure of physical and mental functional health. Secondary outcomes are between-group differences in the subscales of functional health (eg, physical function and depression), as well as measures of health distress, loneliness, unscheduled health care, and falls. We will also examine mediators and moderators of the effects of ElderTree on both platforms. Participants will complete surveys at baseline, 6, 12, and 18 months, and ElderTree use data will be collected continuously during the intervention period in system logs. We will use linear mixed-effect models to evaluate outcomes over time, with treatment condition and time point as between-subjects factors. Separate analyses will be conducted for each outcome. Recruitment began in July 2023 and was completed in May 2024, with 387 participants enrolled. The 12-month intervention period will end in May 2025; data collection will end in November 2025. Findings will be disseminated via peer-reviewed publications. Voice-activated digital health interventions have theoretical but untested advantages over typing-based technologies for older adults with physical limitations. As the population ages, and as multiple morbidities threaten the functional health of the majority of older adults, innovations in self-management are a matter of public health as well as individual quality of life. ClinicalTrials.gov NCT05240534; https://clinicaltrials.gov/study/NCT05240534. DERR1-10.2196/64449.

Background Many patients with poorly controlled multiple chronic conditions (MCC) also have unhealthy behaviors, mental health challenges, and unmet social needs. Medical management of MCC may have limited benefit if patients are struggling to address their basic life needs. Health systems and communities increasingly recognize the need to address these issues and are experimenting with and investing in new models for connecting patients with needed services. Yet primary care clinicians, whose regular contact with patients makes them more familiar with patients’ needs, are often not included in these systems. Methods We are starting a clinician-level cluster-randomized controlled trial to evaluate how primary care clinicians can participate in these community and hospital solutions and whether doing so is effective in controlling MCC. Sixty clinicians in the Virginia Ambulatory Care Outcomes Research Network will be matched by age and sex and randomized to usual care (control condition) or enhanced care planning with clinical-community linkage support (intervention). From the electronic health record we will identify all patients with MCC, including cardiovascular disease or risks, diabetes, obesity, or depression. A baseline assessment will be mailed to up to 50 randomly selected patients for each clinician (3000 total). Ten respondents per clinician (600 patients total) with uncontrolled MCC will be randomly selected for study inclusion, with oversampling of minorities. The intervention includes two components. First, we will use an enhanced care planning tool, My Own Health Report (MOHR) , to screen patients for health behavior, mental health, and social needs. Patients will be supported by a patient navigator, who will help patients prioritize needs, create care plans, and write a personal narrative to guide the care team. Patients will update care plans every 1 to 2 weeks. Second, we will create community-clinical linkage to help address patients’ needs. The linkage will include community resource registries, personnel to span settings (patient navigators and a community health worker), and care team coordination across team members through MOHR. Discussion This study will help inform efforts by primary care clinicians to help address unhealthy behaviors, mental health needs, and social risks as a strategy to better control MCC. Trial registration ClinicalTrials.gov: NCT03885401 . Registered on 19 September 2019.