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1.
J Palliat Care ; 38(1): 52-61, 2023 Jan.
Article in English | MEDLINE | ID: mdl-33258422

ABSTRACT

BACKGROUND: Palliative care trial recruitment of African Americans (AAs) is a formidable research challenge. OBJECTIVES: Examine AA clinical trial recruitment and enrollment in a palliative care randomized controlled trial (RCT) for heart failure (HF) patients and compare patient baseline characteristics to other HF palliative care RCTs. METHODS: This is a descriptive analysis the ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends: Comprehensive Heartcare for Patients and Caregivers) RCT using bivariate statistics to compare racial and patient characteristics and differences through recruitment stages. We then compared the baseline sample characteristics among three palliative HF trials. RESULTS: Of 785 patients screened, 566 eligible patients with NYHA classification III-IV were approached; 461 were enrolled and 415 randomized (AA = 226). African Americans were more likely to consent than Caucasians (55%; P FDR = .001), were younger (62.7 + 8; P FDR = .03), had a lower ejection fraction (39.1 + 15.4; PFDR = .03), were more likely to be single (P FDR = .001), and lack an advanced directive (16.4%; P FDR < .001). AAs reported higher goal setting (3.3 + 1.3; P FDR = .007), care coordination (2.8 + 1.3; P FDR = .001) and used more "denial" coping strategies (0.8 + 1; P FDR = .001). Compared to two recent HF RCTs, the ENABLE CHF-PC sample had a higher proportion of AAs and higher baseline KCCQ clinical summary scores. CONCLUSION: ENABLE CHF-PC has the highest reported recruitment rate and proportion of AAs in a palliative clinical trial to date. Community-based recruitment partnerships, recruiter training, ongoing communication with recruiters and clinician co-investigators, and recruiter racial concordance likely contributed to successful recruitment of AAs. These important insights provide guidance for design of future HF palliative RCTs. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02505425.


Subject(s)
Heart Failure , Hospice and Palliative Care Nursing , Humans , Palliative Care , Black or African American , Quality of Life , Heart Failure/therapy
2.
Trials ; 23(1): 452, 2022 Jun 02.
Article in English | MEDLINE | ID: mdl-35655285

ABSTRACT

BACKGROUND: Family caregivers play a vital, yet stressful role in managing the healthcare needs and optimizing the quality of life of patients with advanced cancer, from the time they are newly diagnosed until end of life. While early telehealth palliative care has been found to effectively support family caregivers, little work has focused on historically under-resourced populations, particularly African American and rural-dwelling individuals. To address this need, we developed and are currently testing Project ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone, a lay navigator-led, early palliative care coaching intervention for family caregivers of African American and rural-dwelling patients with newly diagnosed advanced cancer. METHODS: This is a 2-site, single-blind, hybrid type I implementation-effectiveness trial of the Cornerstone intervention versus usual care. Cornerstone is a multicomponent intervention based on Pearlin's Stress-Health Process Model where African American and/or rural-dwelling family caregivers of patients with newly diagnosed advanced cancer (target sample size = 294 dyads) are paired with a lay navigator coach and receive a series of six, brief 20-60-min telehealth sessions focused on stress management and coping, caregiving skills, getting help, self-care, and preparing for the future/advance care planning. Subsequent to core sessions, caregivers receive monthly follow-up indefinitely until the patient's death. Caregiver and patient outcomes are collected at baseline and every 12 weeks until the patient's death (primary outcome: caregiver distress at 24 weeks; secondary outcomes: caregiver: quality of life and burden; patient: distress, quality of life, and healthcare utilization). Implementation costs and the intervention cost effectiveness are also being evaluated. DISCUSSION: Should this intervention demonstrate efficacy, it would yield an implementation-ready model of early palliative care support for under-resourced family caregivers. A key design principle that has centrally informed the Cornerstone intervention is that every caregiving situation is unique and each caregiver faces distinct challenges that cannot be addressed using a one-size-fits all approach. Hence, Cornerstone employs culturally savvy lay navigator coaches who are trained to establish a strong, therapeutic alliance with participants and tailor their coaching to a diverse range of individual circumstances. TRIAL REGISTRATION: ClinicalTrials.gov NCT04318886 . Registered on 20 March, 2020.


Subject(s)
Mentoring , Neoplasms , Black or African American , Caregivers , Humans , Neoplasms/therapy , Palliative Care/methods , Quality of Life , Randomized Controlled Trials as Topic , Single-Blind Method
3.
J Pain Symptom Manage ; 63(1): 11-22, 2022 01.
Article in English | MEDLINE | ID: mdl-34343621

ABSTRACT

CONTEXT: Patients with advanced cancer often involve family caregivers in health-related decision-making from diagnosis to end-of-life; however, few interventions have been developed to enhance caregiver decision support skills. OBJECTIVES: Assess the feasibility, acceptability, and potential efficacy of individual intervention components of CASCADE (CAre Supporters Coached to be Adept DEcision Partners), an early telehealth, palliative care coach-led decision support training intervention for caregivers. METHODS: Pilot factorial trial using the multiphase optimization strategy (October 2019-October 2020). Family caregivers and their care recipients with newly-diagnosed advanced cancer (n = 46 dyads) were randomized to1 of 8 experimental conditions that included a combination of one of the following three CASCADE components: 1) effective decision support psychoeducation; 2) decision support communication training; and 3) Ottawa Decision Guide training. Feasibility was assessed by completion of sessions and questionnaires (predefined as ≥80%). Acceptability was determined through postintervention interviews and participants' ratings of their likelihood to recommend. Measures of effective decision support and caregiver and patient distress were collected at Twelve and Twenty four weeks. RESULTS: Caregiver participants completed 78% of intervention sessions and 81% of questionnaires; patients completed 80% of questionnaires. Across conditions, average caregiver ratings for recommending the program to others was 9.9 on a scale from 1-Not at all likely to 10-Extremely likely. Individual CASCADE components were observed to have potential benefit for effective decision support and caregiver distress. CONCLUSION: We successfully piloted a factorial trial design to examine components of a novel intervention to enhance the decision support skills of advanced cancer family caregivers. A fully-powered factorial trial is warranted. KEY MESSAGE: We pilot tested components of CASCADE, an early palliative care decision support training intervention for family caregivers of patients with advanced cancer. CASCADE components were acceptable and the trial design feasible, providing promising future directions for palliative care intervention development and testing. Pilot results will inform a fully-powered trial.


Subject(s)
Mentoring , Neoplasms , Telemedicine , Caregivers , Humans , Neoplasms/therapy , Palliative Care/methods , Pilot Projects
4.
Cancer ; 128(6): 1321-1330, 2022 Mar 15.
Article in English | MEDLINE | ID: mdl-34874061

ABSTRACT

BACKGROUND: The objective of this study was to assess the feasibility, acceptability, and potential efficacy of ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone-a lay navigator-led, early palliative care telehealth intervention for African American/Black and/or rural-dwelling family caregivers of individuals with advanced cancer (ClinicalTrials.gov identifier NCT03464188). METHODS: This was a pilot randomized trial (November 2019 to March 2021). Family caregivers of patients with newly diagnosed, stage III/IV, solid-tumor cancers were randomized to receive either an intervention or usual care. Intervention caregivers were paired with a specially trained lay navigator who delivered 6 weekly, 20-minute to 60-minute telehealth coaching sessions plus monthly follow-up for 24 weeks, reviewing skills in stress management, self-care, getting help, staying organized, and future planning. Feasibility was assessed according to the completion of sessions and questionnaires (predefined as a completion rate ≥80%). Acceptability was determined through intervention participants' ratings of their likelihood of recommending the intervention. Measures of caregiver distress and quality of life were collected at 8 and 24 weeks. RESULTS: Sixty-three family caregivers were randomized (usual care, n = 32; intervention, n = 31). Caregivers completed 65% of intervention sessions and 87% of questionnaires. Average ratings for recommending the program were 9.4, from 1 (not at all likely) to 10 (extremely likely). Over 24 weeks, the mean ± SE Hospital Anxiety and Depression Scale score improved by 0.30 ± 1.44 points in the intervention group and worsened by 1.99 ± 1.39 points in the usual care group (difference, -2.29; Cohen d, -0.32). The mean between-group difference scores in caregiver quality of life was -1.56 (usual care - intervention; d, -0.07). Similar outcome results were observed for patient participants. CONCLUSIONS: The authors piloted ENABLE Cornerstone, an intervention for African American and rural-dwelling advanced cancer family caregivers. The acceptability of the intervention and data collection rates were high, and the preliminary efficacy for caregiver distress was promising. LAY SUMMARY: To date, very few programs have been developed to support under-resourced cancer family caregivers. To address this need, the authors successfully pilot tested an early palliative care program, called Educate, Nurture, Advise, Before Life Ends (ENABLE) Cornerstone, for African American and rural family caregivers of individuals with advanced cancer. Cornerstone is led by specially trained lay people and involves a series of weekly phone sessions focused on coaching caregivers to manage stress and provide effective support to patients with cancer. The authors are now testing Cornerstone in a larger trial. If the program demonstrates benefit, it may yield a model of caregiver support that could be widely implemented.


Subject(s)
Caregivers , Neoplasms , Black or African American , Humans , Neoplasms/therapy , Palliative Care/methods , Pilot Projects , Quality of Life
5.
Support Care Cancer ; 29(11): 6913-6920, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34031751

ABSTRACT

OBJECTIVE: Resilience has been proposed as a primary factor in how many family caregivers of patients with advanced cancer are able to resist psychological strain and perform effectively in the role while bearing a high load of caregiving tasks. To evaluate this hypothesis, we examined whether self-perceived resilience is associated with distress (anxiety and depressive symptoms), caregiver preparedness, and readiness for surrogate decision-making among a racially diverse sample of family caregivers of patients with newly diagnosed advanced cancer. METHODS: Secondary analysis of baseline data from two small-scale, pilot clinical trials that both recruited family caregivers of patients with newly diagnosed advanced cancer. Using multivariable linear regression, we analyzed relationships of resilience as a predictor of mood, caregiving preparedness, and readiness for surrogate decision-making, controlling for sociodemographics. RESULTS: Caregiver participants (N = 112) were mean 56 years of age and mostly female (76%), the patient's spouse/partner (52%), and White (56%) or African-American/Black (43%). After controlling for demographics, standardized results indicated that higher resilience was relevantly associated with higher caregiver preparedness (beta = .46, p < .001), higher readiness for surrogate decision-making (beta = .20, p < .05) and lower anxiety (beta = - .19, p < .05), and depressive symptoms (beta = - .20, p < .05). CONCLUSIONS: These results suggest that resilience may be critical to caregivers' abilities to manage stress, be effective sources of support to patients, and feel ready to make future medical decisions on behalf of patients. Future work should explore and clinicians should consider whether resilience can be enhanced in cancer caregivers to optimize their well-being and ability to perform in the caregiving and surrogate decision-making roles.


Subject(s)
Caregivers , Neoplasms , Anxiety , Emotions , Family , Female , Humans , Male , Neoplasms/therapy , Stress, Psychological
6.
J Pain Symptom Manage ; 62(3): 471-481, 2021 09.
Article in English | MEDLINE | ID: mdl-33556493

ABSTRACT

CONTEXT: Research priority guidelines highlight the need for examining the "dose" components of palliative care (PC) interventions, such as intervention adherence and completion rates, that contribute to optimal outcomes. OBJECTIVES: Examine the "dose" effect of PC intervention completion vs. noncompletion on quality of life (QoL) and healthcare use in patients with advanced heart failure (HF) over 32 weeks. METHODS: Secondary analysis of the ENABLE CHF-PC intervention trial for patients with New York Heart Association (NYHA) Class III/IV HF. "Completers" defined as completing a single, in-person outpatient palliative care consultation (OPCC) plus 6 weekly, PC nurse coach-led telehealth sessions. "Non-completers" were defined as either not attending the OPCC or completing <6 telehealth sessions. Outcome variables were QoL and healthcare resource use (hospital days; emergency department visits). Mixed models were used to model dose effects for "completers" vs "noncompleters" over 32 weeks. RESULTS: Of 208 intervention group participants, 81 (38.9%) were classified as "completers" with a mean age of 64.6 years; 72.8% were urban-dwelling; 92.5% had NYHA Class III HF. 'Completers' vs. "non-completers"" groups were well-balanced at baseline; however "noncompleters" did report higher anxiety (6.0 vs 7.0, P < 0.05, d = 0.28). Moderate, clinically significant, improved QoL differences were found at 16 weeks in "completers" vs. "non-completers" (between-group difference: -9.71 (3.18), d = 0.47, P = 0.002) but not healthcare use. CONCLUSION: Higher intervention completion rates of an early PC intervention was associated with QoL improvements in patients with advanced HF. Future work should focus on identifying the most efficacious "dose" of intervention components and increasing adherence to them. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02505425.


Subject(s)
Heart Failure , Hospice and Palliative Care Nursing , Telemedicine , Heart Failure/therapy , Humans , Middle Aged , Palliative Care , Quality of Life
7.
J Palliat Med ; 24(3): 347-353, 2021 03.
Article in English | MEDLINE | ID: mdl-32721254

ABSTRACT

Background: Nearly 3 million U.S. family caregivers support someone with cancer. However, oncology clinic-based service lines that proactively screen, assess, and support cancer caregivers are nearly nonexistent. Objective: To examine first-year experiences of a nurse-led clinic-based telehealth support service (FamilyStrong) for family caregivers of patients with recently diagnosed grade IV brain tumors. Methods: This is a retrospective evaluation of operational outcomes from initial implementation of the FamilyStrong Service, developed in partnership with Caregiver and Bereavement Support Services at the University of Alabama at Birmingham (UAB) and the UAB Center for Palliative and Supportive Care. From August 2018 to December 2019, 53 family caregivers were proactively identified and enrolled by a palliative care nurse, working approximately one day/week, who performed monthly caregiver distress thermometer screenings by phone and provided emotional, educational, problem-solving, and referral support. Results: Enrolled family caregivers were a mean age of 53.5 years and mostly female (62.3%), full- or part-time employed (67.9%), and the patient's spouse/partner (79.3%). Caregivers provided support 6.7 days/week for 11.2 hours/day. The palliative care nurse performed 235 distress screenings and provided support that included 68 documented instances of emotional, problem-solving, and educational support, 41 nurse-facilitated communications with the neuro-oncology team about patient issues, and 24 referrals to UAB and community services (e.g., counseling). The most common problems caregivers wanted assistance with included: managing their relative's health condition and symptoms (51%), coordinating care/services (21%), and planning for the future/advance care planning (17%). Discussion: The FamilyStrong Program is among the first "real world" oncology clinic-based formal support services for advance cancer family caregivers.


Subject(s)
Brain Neoplasms , Telemedicine , Caregivers , Family , Female , Humans , Male , Middle Aged , Palliative Care , Retrospective Studies
8.
J Pain Symptom Manage ; 62(1): 174-182, 2021 07.
Article in English | MEDLINE | ID: mdl-33253787

ABSTRACT

Recent systematic reviews and meta-analyses have reported positive benefit of multicomponent "bundled" palliative care interventions for patients and family caregivers while highlighting limitations in determining key elements and mechanisms of improvement. Traditional research approaches, such as the randomized controlled trial (RCT), typically treat interventions as "bundled" treatment packages, making it difficult to assess definitively which aspects of an intervention can be reduced or replaced or whether there are synergistic or antagonistic interactions between intervention components. Progressing toward palliative care interventions that are effective, efficient, and scalable will require new strategies and novel approaches. One such approach is the Multiphase Optimization Strategy (MOST), a framework informed by engineering principles, that uses a systematic process to empirically identify an intervention comprised of components that positively contribute to desired outcomes under real-life constraints. This article provides a brief overview and application of MOST and factorial trial design in palliative care research, including our insights from conducting a pilot factorial trial of an early palliative care intervention to enhance the decision support skills of advanced cancer family caregivers (Project CASCADE).


Subject(s)
Hospice and Palliative Care Nursing , Palliative Care , Caregivers , Humans , Randomized Controlled Trials as Topic , Research Design
9.
JAMA Intern Med ; 180(9): 1203-1213, 2020 09 01.
Article in English | MEDLINE | ID: mdl-32730613

ABSTRACT

Importance: National guidelines recommend early palliative care for patients with advanced heart failure, which disproportionately affects rural and minority populations. Objective: To determine the effect of an early palliative care telehealth intervention over 16 weeks on the quality of life, mood, global health, pain, and resource use of patients with advanced heart failure. Design, Setting, and Participants: A single-blind, intervention vs usual care randomized clinical trial was conducted from October 1, 2015, to May 31, 2019, among 415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals. Interventions: The ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention comprises an in-person palliative care consultation and 6 weekly nurse-coach telephonic sessions (20-40 minutes) and monthly follow-up for 48 weeks. Main Outcomes and Measures: Primary outcomes were quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered "fairly good" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS]) over 16 weeks. Secondary outcomes were global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits). Results: Of 415 participants (221 men; baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n = 208) or usual care (n = 207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0). At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]). There were no relevant between-group differences in mood (HADS-anxiety, d = -0.02 [95% CI, -0.20 to 0.16]; HADS-depression, d = -0.09 [95% CI, -0.24 to 0.06]). Conclusions and Relevance: This randomized clinical trial with a majority African American sample and baseline good quality of life did not demonstrate improved quality of life or mood with a 16-week early palliative care telehealth intervention. However, pain intensity and interference (secondary outcomes) demonstrated a clinically important improvement. Trial Registration: ClinicalTrials.gov Identifier: NCT02505425.


Subject(s)
Heart Failure/therapy , Palliative Care , Telemedicine , Affect , Aged , Female , Heart Failure/complications , Heart Failure/psychology , Humans , Male , Middle Aged , Pain Measurement , Quality of Life , Single-Blind Method , Treatment Outcome
10.
JAMA Netw Open ; 3(4): e202583, 2020 04 01.
Article in English | MEDLINE | ID: mdl-32282044

ABSTRACT

Importance: Family caregivers of persons with advanced heart failure perform numerous daily tasks to assist their relatives and are at high risk for distress and poor quality of life. Objective: To determine the effect of a nurse-led palliative care telehealth intervention (Educate, Nurture, Advise, Before Life Ends Comprehensive Heart Failure for Patients and Caregivers [ENABLE CHF-PC]) on quality of life and mood of family caregivers of persons with New York Heart Association Class III/IV heart failure over 16 weeks. Design, Setting, and Participants: This single-blind randomized clinical trial enrolled caregivers aged 18 years and older who self-identified as an unpaid close friend or family member who knew the patient well and who was involved with their day-to-day medical care. Participants were recruited from outpatient heart failure clinics at a large academic tertiary care medical center and a Veterans Affairs medical center from August 2016 to October 2018. Intervention: Four weekly psychosocial and problem-solving support telephonic sessions lasting between 20 and 60 minutes facilitated by a trained nurse coach plus monthly follow-up for 48 weeks. The usual care group received no additional intervention. Main Outcomes and Measures: The primary outcomes were quality of life (measured using the Bakas Caregiver Outcomes Scale), mood (anxiety and/or depressive symptoms measured using the Hospital Anxiety and Depression Scale), and burden (measured using the Montgomery-Borgatta Caregiver Burden scales) over 16 weeks. Secondary outcomes were global health (measured using the PROMIS Global Health instrument) and positive aspects of caregiving. Results: A total of 158 family caregivers were randomized, 82 to the intervention and 76 to usual care. The mean (SD) age was 57.9 (11.6) years, 135 (85.4%) were female, 82 (51.9%) were African American, and 103 (65.2%) were the patient's spouse or partner. At week 16, the mean (SE) Bakas Caregiver Outcomes Scale score was 66.9 (2.1) in the intervention group and 63.9 (1.7) in the usual care group; over 16 weeks, the mean (SE) Bakas Caregiver Outcomes Scale score improved 0.7 (1.7) points in the intervention group and 1.1 (1.6) points in the usual care group (difference, -0.4; 95% CI, -5.1 to 4.3; Cohen d = -0.03). At week 16, no relevant between-group differences were observed between the intervention and usual care groups for the Hospital Anxiety and Depression Scale anxiety measure (mean [SE] improvement from baseline, 0.3 [0.3] vs 0.4 [0.3]; difference, -0.1 [0.5]; d = -0.02) or depression measure (mean [SE] improvement from baseline, -0.2 [0.4] vs -0.3 [0.3]; difference, 0.1 [0.5]; d = 0.03). No between-group differences were observed in the Montgomery-Borgatta Caregiver Burden scales (d range, -0.18 to 0.0). Differences in secondary outcomes were also not significant (d range, -0.22 to 0.0). Conclusions and Relevance: This 2-site randomized clinical trial of a telehealth intervention for family caregivers of patients with advanced heart failure, more than half of whom were African American and most of whom were not distressed at baseline, did not demonstrate clinically better quality of life, mood, or burden compared with usual care over 16 weeks. Future interventions should target distressed caregivers and assess caregiver effects on patient outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02505425.


Subject(s)
Caregivers/psychology , Family/psychology , Heart Failure/therapy , Palliative Care/methods , Telemedicine/methods , Aged , Female , Humans , Male , Middle Aged , Quality of Life
11.
Trials ; 19(1): 422, 2018 Aug 06.
Article in English | MEDLINE | ID: mdl-30081933

ABSTRACT

BACKGROUND: Palliative care is specialized medical care for people with serious illness that is focused on providing relief from symptoms and stress and improving the quality of life (QOL) for patients and their families. To help the 6.5 million U.S. adults and families affected by heart failure manage the high symptom burden, complex decision-making, and risk of exacerbation and death, the early integration of palliative care is critical and has been recommended by numerous professional organizations. However, few trials have tested early outpatient community-based models of palliative care for patients diagnosed with advanced heart failure and their caregivers. To address this gap, through a series of formative evaluation trials, we translated an oncology early palliative care telehealth intervention for heart failure to create ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends, Comprehensive Heartcare for Patients and Caregivers). METHODS/DESIGN: The primary objective of this multisite pragmatic randomized controlled trial is to test the efficacy of ENABLE CHF-PC plus usual heart failure care compared to usual care alone. Community-dwelling persons who are ≥50 years of age with New York Heart Association class III/IV or American Heart Association/American College of Cardiology stage C/D heart failure and their primary caregiver (if present) are being randomized to one of two study arms. The ENABLE CHF-PC intervention group receives usual heart failure care plus an in-person palliative care assessment by a board-certified palliative care provider (caregivers are invited to attend), a series of nurse coach-led, weekly psychoeducational 20 to 60 min phone sessions using a guidebook called Charting Your Course (patients: 6 sessions and caregivers: 4 sessions), and monthly check-in calls. Charting Your Course topical content includes problem-solving, coping, self-care and symptom management, communication, decision-making, advance care planning, and life review (patients only). Primary outcomes include patient QOL and mood (depressive symptoms/anxiety) and caregiver QOL, mood, and burden at 8 and 16 weeks after baseline. Outcomes will be examined using an intention-to-treat approach and mixed effects modeling for repeated measures. DISCUSSION: This trial will determine whether the ENABLE CHF-PC model of concurrent heart failure palliative care is superior to usual heart failure care alone in achieving higher patient and caregiver QOL, improving mood, and lowering burden. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02505425 . Registered on 22 July 2015.


Subject(s)
Caregivers/psychology , Health Knowledge, Attitudes, Practice , Heart Failure/mortality , Heart Failure/surgery , Palliative Care/methods , Patient Education as Topic/methods , Patients/psychology , Telemedicine/methods , Terminal Care/methods , Adaptation, Psychological , Adolescent , Adult , Affect , Aged , Aged, 80 and over , Cost of Illness , Delivery of Health Care, Integrated , Female , Heart Failure/diagnosis , Heart Failure/psychology , Humans , Male , Middle Aged , Multicenter Studies as Topic , Palliative Care/psychology , Pragmatic Clinical Trials as Topic , Quality of Life , Terminal Care/psychology , Time Factors , Treatment Outcome , United States , Young Adult
12.
Soc Work Public Health ; 33(4): 215-225, 2018.
Article in English | MEDLINE | ID: mdl-29608417

ABSTRACT

State Medicaid programs increasingly use case management to manage enrollees with chronic conditions who may become cost intensive for the program. The authors examined the impact of Alabama Department of Public Health (ADPH)'s case management on care expenditures for Medicaid enrollees with various chronic diseases, over 2011 to 2014. The authors matched case-managed enrollees with three controls per case using health conditions and sociodemographics. Thereafter, the authors used a quasi-experimental approach to estimate how per-member-per-month costs changed following case management. Case -management appeared to result in program savings, driven largely by inpatient and emergency department cost-savings. There was noticeable variation in savings for members with different chronic conditions.


Subject(s)
Case Management , Chronic Disease/economics , Chronic Disease/therapy , Health Expenditures/statistics & numerical data , Medicaid/economics , Adolescent , Adult , Aged , Alabama , Case-Control Studies , Child , Child, Preschool , Female , Humans , Infant , Infant, Newborn , Male , Middle Aged , United States , Young Adult
13.
Health Serv Res ; 51(1): 146-66, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26058985

ABSTRACT

OBJECTIVES: To estimate the effects of medical home support on the use of clinical services and Medicaid expenditures. DATA SOURCE: Medicaid claims. STUDY DESIGN: A difference-in-differences model where changes in utilization and expenditures of the intervention group are compared to changes in the nonintervention group. EXTRACTION METHODS: Using Medicaid claims from October 2010 through September 2013, service use and expenditures are measured for 12 months before and 21 months after implementation. Changes for four health status groups are examined separately. PRINCIPAL FINDINGS: The introduction of community-based support was associated with a small reduction in use and no statistically significant overall effect on expenditures. However, among those with chronic and/or mental health conditions, there were modest, statistically significant increases in use of and expenditures for a range of ambulatory and inpatient health care services, while service use for those without these conditions declined. Emergency department use increased for all groups. CONCLUSIONS: Community-based support for medical home practices is associated with a shift in the service mix provided to higher cost, more vulnerable subgroups in Medicaid. Such systems are unlikely to be associated with significant overall cost savings, at least in the short term, but may have other benefits.


Subject(s)
Health Expenditures/statistics & numerical data , Health Services/economics , Health Services/statistics & numerical data , Insurance Claim Review/statistics & numerical data , Patient-Centered Care/organization & administration , Adolescent , Adult , Age Distribution , Aged , Aged, 80 and over , Alabama , Child , Child, Preschool , Chronic Disease/economics , Emergency Service, Hospital/economics , Emergency Service, Hospital/statistics & numerical data , Female , Hospitals/statistics & numerical data , Humans , Infant , Infant, Newborn , Male , Medicaid , Mental Disorders/economics , Mental Health Services/economics , Mental Health Services/statistics & numerical data , Middle Aged , Models, Econometric , Patient-Centered Care/economics , Physicians/economics , Physicians/statistics & numerical data , Prescription Drugs/economics , Sex Distribution , Socioeconomic Factors , United States , Young Adult
14.
Am J Public Health ; 102(10): e7-e13, 2012 Oct.
Article in English | MEDLINE | ID: mdl-22897546

ABSTRACT

OBJECTIVES: We conducted a systematic review of the literature examining the relationship between built environments (e.g., parks, trails, sidewalks) and physical activity (PA) or obesity rates. METHODS: We performed a 2-step inclusion protocol to identify empirical articles examining any form of built environment and any form of PA (or obesity rate) as the outcome. We extracted data from included abstracts for analysis by using a standard code sheet developed for this study. RESULTS: Of 169 included articles, 89.2% reported beneficial relationships-but virtually all articles utilized simple observational study designs not suited for determining causality. Studies utilizing objective PA measures (e.g., pedometer) were 18% less likely to identify a beneficial relationship. Articles focusing on children in community settings (-14.2%), those examining direct measures of obesity (-6.2%), or those with an academic first author (-3.4%) were less likely to find a beneficial relationship. CONCLUSIONS: Policymakers at federal and local levels should encourage more rigorous scientific research to determine whether altered built environments will result in increased PA and decreased obesity rates.


Subject(s)
Environment Design , Motor Activity , City Planning , Humans , Obesity/epidemiology , Obesity/prevention & control , United States/epidemiology
15.
Am J Phys Med Rehabil ; 90(3): 217-25, 2011 Mar.
Article in English | MEDLINE | ID: mdl-21297398

ABSTRACT

OBJECTIVE: The objective of this study was to evaluate whether adding a pointing task would influence functional reach test performance in younger and older adults. DESIGN: While standing on a force plate, 20 older (73 ± 8 yrs) and 20 younger (23 ± 1 yrs) adults were randomly administered a modification of the functional reach test and the functional point test. Functional pointing involved reaching and pointing at the farthest possible target in a series of 1.27-cm colored craft pom-poms attached at 2.54-cm intervals on a yardstick. RESULTS: Both older adults (P = 0.001) and younger adults (P = 0.043) reached farther using the functional point test. Older adults also increased their anterior center of pressure displacement with this test (P = 0.037). CONCLUSIONS: The addition of a pointing task can make the original clinical test more functional and increase reaching distance in both older and younger adults. Further research is needed to determine whether functional pointing challenges subjects' stability limits more than the traditional test does and offers greater sensitivity in the evaluation of functional balance and fall risk.


Subject(s)
Movement/physiology , Psychomotor Performance/physiology , Upper Extremity/physiology , Aged , Aged, 80 and over , Analysis of Variance , Exercise Test , Female , Humans , Male , Middle Aged , Postural Balance/physiology , Young Adult
16.
BMC Med ; 6: 37, 2008 Dec 04.
Article in English | MEDLINE | ID: mdl-19055789

ABSTRACT

BACKGROUND: The internet has had a strong impact on how physicians access information and on the development of continuing medical education activities. Evaluation of the effectiveness of these activities has lagged behind their development. METHODS: To determine the effectiveness of a group of 48 internet continuing medical education (CME) activities, case vignette surveys were administered to US physicians immediately following participation, and to a representative control group of non-participant physicians. Responses to case vignettes were analyzed based on evidence presented in the content of CME activities. An effect size for each activity was calculated using Cohen's d to determine the amount of difference between the two groups in the likelihood of making evidence-based clinical decisions, expressed as the percentage of non-overlap, between the two groups. Two formats were compared. RESULTS: In a sample of 5621 US physicians, of the more than 100,000 physicians who participated in 48 internet CME activities, the average effect size was 0.75, an increased likelihood of 45% that participants were making choices in response to clinical case vignettes based on clinical evidence. This likelihood was higher in interactive case-based activities, 51% (effect size 0.89), than for text-based clinical updates, 40% (effect size 0.63). Effectiveness was also higher among primary care physicians than specialists. CONCLUSION: Physicians who participated in selected internet CME activities were more likely to make evidence-based clinical choices than non-participants in response to clinical case vignettes. Internet CME activities show promise in offering a searchable, credible, available on-demand, high-impact source of CME for physicians.


Subject(s)
Education, Medical, Continuing/methods , Health Knowledge, Attitudes, Practice , Internet , Physicians , Adult , Female , Humans , Male , Middle Aged
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