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1.  Discharge Hospice Referral and Lower 30-Day All-Cause Readmission in Medicare Beneficiaries Hospitalized for Heart Failure 
Circulation. Heart failure  2015;8(4):733-740.
Heart failure (HF) is the leading cause for hospital readmission. Hospice care may help palliate HF symptoms but its association with 30-day all-cause readmission remains unknown.
Methods and Results
Of the 8032 Medicare beneficiaries hospitalized for HF in 106 Alabama hospitals (1998–2001), 182 (2%) received discharge hospice referrals. Of the 7850 patients not receiving hospice referrals, 1608 (20%) died within 6 months post-discharge (the hospice-eligible group). Propensity scores for hospice referral were estimated for each of the 1790 (182+1608) patients and were used to match 179 hospice-referral patients with 179 hospice-eligible patients who were balanced on 28 baseline characteristics (mean age, 79 years, 58% women, 18% African American). Overall, 22% (1742/8032) died in 6 months, of whom 8% (134/1742) received hospice referrals. Among the 358 matched patients, 30-day all-cause readmission occurred in 5% and 41% of hospice-referral and hospice-eligible patients, respectively (hazard ratio {HR} associated with hospice referral, 0.12; 95% confidence interval {CI}, 0.06–0.24). HRs (95% CIs) for 30-day all-cause readmission associated with hospice referral among the 126 patients who died and 232 patients who survived 30-day post-discharge were 0.03 (0.04–0.21) and 0.17 (0.08–0.36), respectively. Although 30-day mortality was higher in the hospice referral group (43% vs. 27%), it was similar at 90 days (64% vs. 67% among hospice-eligible patients).
A discharge hospice referral was associated with lower 30-day all-cause readmission among hospitalized HF patients. However, most HF patients who died within 6 months of hospital discharge did not receive a discharge hospice referral.
PMCID: PMC4964848  PMID: 26019151
Medicare beneficiaries; heart failure; discharge hospice referral; 30-day all-cause readmission
2.  Predictors of Physical Restraint Use in Hospitalized Veterans at End of Life: An Analysis of Data from the BEACON Trial 
Journal of Palliative Medicine  2015;18(6):520-526.
Background: The use of physical restraints in dying patients may be a source of suffering and loss of dignity. Little is known about the prevalence or predictors for restraint use at end of life in the hospital setting.
Objective: The objective was to determine the prevalence and predictors of physical restraint use at the time of death in hospitalized adults.
Methods: Secondary analysis was performed on data from the “Best Practices for End-of-Life Care for Our Nation's Veterans” (BEACON) trial conducted between 2005 and 2011. Medical record data were abstracted from six Veterans Administration Medical Centers (VAMCs). Data on processes of care in the last seven days of life were abstracted from the medical records of 5476 who died in the six VAMCs. We prospectively identified potential risk factors for restraint use at the time of death from among the variables measured in the parent trial, including location of death, medications administered, nasogastric tube, intravenous (IV) fluids, family presence, and receipt of a palliative care consultation.
Results: Physical restraint use at time of death was documented in 890 decedents (16.3%). Restraint use varied by location of death, with patients in intensive settings being at higher risk. Restraint use was significantly more likely in patients with a nasogastric tube and those receiving IV fluids, benzodiazepines, or antipsychotics.
Conclusions: This is the first study to document that one in six hospitalized veterans were restrained at the time of death and to identify predictors of restraint use. Further research is needed to identify intervention opportunities.
PMCID: PMC4441001  PMID: 25927909
3.  Conceptualizing Surrogate Decision-Making at End of Life in the Intensive Care Unit using Cognitive Task Analysis 
Nursing outlook  2014;63(3):331-340.
Surrogate decision-makers (SDMs) face difficult decisions at end of life (EOL) for decisionally incapacitated intensive care unit (ICU) patients.
Identify and describe the underlying psychological processes of surrogate decision-making for adults at EOL in the ICU.
Qualitative case study design using a cognitive task analysis (CTA) interviewing approach. Participants were recruited from October 2012 to June 2013 from an academic tertiary medical center’s ICU located in the rural Northeastern United States. Nineteen SDMs for patients who had died in the ICU completed in-depth semi-structured CTA interviews.
The conceptual framework formulated from data analysis reveals that three underlying, iterative, psychological dimensions: gist impressions, distressing emotions, and moral intuitions impact a SDM’s judgment about the acceptability of either the patient’s medical treatments or his or her condition.
The framework offers initial insights about the underlying psychological processes of surrogate decision-making and may facilitate enhanced decision support for SDMs.
PMCID: PMC4438263  PMID: 25982772
4.  Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial 
Journal of Clinical Oncology  2015;33(13):1438-1445.
Randomized controlled trials have supported integrated oncology and palliative care (PC); however, optimal timing has not been evaluated. We investigated the effect of early versus delayed PC on quality of life (QOL), symptom impact, mood, 1-year survival, and resource use.
Patients and Methods
Between October 2010 and March 2013, 207 patients with advanced cancer at a National Cancer Institute cancer center, a Veterans Affairs Medical Center, and community outreach clinics were randomly assigned to receive an in-person PC consultation, structured PC telehealth nurse coaching sessions (once per week for six sessions), and monthly follow-up either early after enrollment or 3 months later. Outcomes were QOL, symptom impact, mood, 1-year survival, and resource use (hospital/intensive care unit days, emergency room visits, chemotherapy in last 14 days, and death location).
Overall patient-reported outcomes were not statistically significant after enrollment (QOL, P = .34; symptom impact, P = .09; mood, P = .33) or before death (QOL, P = .73; symptom impact, P = .30; mood, P = .82). Kaplan-Meier 1-year survival rates were 63% in the early group and 48% in the delayed group (difference, 15%; P = .038). Relative rates of early to delayed decedents' resource use were similar for hospital days (0.73; 95% CI, 0.41 to 1.27; P = .26), intensive care unit days (0.68; 95% CI, 0.23 to 2.02; P = .49), emergency room visits (0.73; 95% CI, 0.45 to 1.19; P = .21), chemotherapy in last 14 days (1.57; 95% CI, 0.37 to 6.7; P = .27), and home death (27 [54%] v 28 [47%]; P = .60).
Early-entry participants' patient-reported outcomes and resource use were not statistically different; however, their survival 1-year after enrollment was improved compared with those who began 3 months later. Understanding the complex mechanisms whereby PC may improve survival remains an important research priority.
PMCID: PMC4404422  PMID: 25800768
5.  Benefits of Early Versus Delayed Palliative Care to Informal Family Caregivers of Patients With Advanced Cancer: Outcomes From the ENABLE III Randomized Controlled Trial 
Journal of Clinical Oncology  2015;33(13):1446-1452.
To determine the effect of early versus delayed initiation of a palliative care intervention for family caregivers (CGs) of patients with advanced cancer.
Patients and Methods
Between October 2010 and March 2013, CGs of patients with advanced cancer were randomly assigned to receive three structured weekly telephone coaching sessions, monthly follow-up, and a bereavement call either early after enrollment or 3 months later. CGs of patients with advanced cancer were recruited from a National Cancer Institute cancer center, a Veterans Administration Medical Center, and two community outreach clinics. Outcomes were quality of life (QOL), depression, and burden (objective, stress, and demand).
A total of 122 CGs (early, n = 61; delayed, n = 61) of 207 patients participated; average age was 60 years, and most were female (78.7%) and white (92.6%). Between-group differences in depression scores from enrollment to 3 months (before delayed group started intervention) favored the early group (mean difference, −3.4; SE, 1.5; d = −.32; P = .02). There were no differences in QOL (mean difference, −2; SE, 2.3; d = −.13; P = .39) or burden (objective: mean difference, 0.3; SE, .7; d = .09; P = .64; stress: mean difference, −.5; SE, .5; d = −.2; P = .29; demand: mean difference, 0; SE, .7; d = −.01; P = .97). In decedents' CGs, a terminal decline analysis indicated between-group differences favoring the early group for depression (mean difference, −3.8; SE, 1.5; d = −.39; P = .02) and stress burden (mean difference, −1.1; SE, .4; d = −.44; P = .01) but not for QOL (mean difference, −4.9; SE, 2.6; d = −.3; P = .07), objective burden (mean difference, −.6; SE, .6; d = −.18; P = .27), or demand burden (mean difference, −.7; SE, .6; d = −.23; P = .22).
Early-group CGs had lower depression scores at 3 months and lower depression and stress burden in the terminal decline analysis. Palliative care for CGs should be initiated as early as possible to maximize benefits.
PMCID: PMC4404423  PMID: 25800762
6.  Associations between advanced cancer patients' survival and family caregiver presence and burden 
Cancer Medicine  2016;5(5):853-862.
We conducted a randomized controlled trial (RCT) of an early palliative care intervention (ENABLE: Educate, Nurture, Advise, Before Life Ends) for persons with advanced cancer and their family caregivers. Not all patient participants had a caregiver coparticipant; hence, we explored whether there were relationships between patient survival, having an enrolled caregiver, and caregiver outcomes prior to death. One hundred and twenty‐three patient‐caregiver dyads and 84 patients without a caregiver coparticipant participated in the ENABLE early versus delayed (12 weeks later) RCT. We collected caregiver quality‐of‐life (QOL), depression, and burden (objective, stress, and demand) measures every 6 weeks for 24 weeks and every 3 months thereafter until the patient's death or study completion. We conducted survival analyses using log‐rank and Cox proportional hazards models. Patients with a caregiver coparticipant had significantly shorter survival (Wald = 4.31, HR = 1.52, CI: 1.02–2.25, P = 0.04). After including caregiver status, marital status (married/unmarried), their interaction, and relevant covariates, caregiver status (Wald = 6.25, HR = 2.62, CI: 1.23–5.59, P = 0.01), being married (Wald = 8.79, HR = 2.92, CI: 1.44–5.91, P = 0.003), and their interaction (Wald = 5.18, HR = 0.35, CI: 0.14–0.87, P = 0.02) were significant predictors of lower patient survival. Lower survival in patients with a caregiver was significantly related to higher caregiver demand burden (Wald = 4.87, CI: 1.01–1.20, P = 0.03) but not caregiver QOL, depression, and objective and stress burden. Advanced cancer patients with caregivers enrolled in a clinical trial had lower survival than patients without caregivers; however, this mortality risk was mostly attributable to higher survival by unmarried patients without caregivers. Higher caregiver demand burden was also associated with decreased patient survival.
PMCID: PMC4864814  PMID: 26860217
Advanced cancer; family caregivers; patient survival
7.  Effectiveness of regionalized systems for stroke and myocardial infarction 
Brain and Behavior  2015;5(10):e00398.
Acute ischemic stroke (AIS) and ST‐segment elevation myocardial infarction (STEMI) are ischemic emergencies. Guidelines recommend care delivery within formally regionalized systems of care at designated centers, with bypass of nearby centers of lesser or no designation. We review the evidence of the effectiveness of regionalized systems in AIS and STEMI.
Literature was searched using terms corresponding to designation of AIS and STEMI systems and from 2010 to the present. Inclusion criteria included report of an outcome on any dependent variable mentioned in the rationale for regionalization in the guidelines and an independent variable comparing care to a non‐ or pre‐regionalized system. Designation was defined in the AIS case as certification by the Joint Commission as either a primary (PSC) or comprehensive (CSC) stroke center. In the STEMI case, the search was conducted linking “regionalization” and “myocardial infarction” or citation as a model system by any American Heart Association statement.
For AIS, 17 publications met these criteria and were selected for review. In the STEMI case, four publications met these criteria; the search was therefore expanded by relaxing the criteria to include any historical or anecdotal comparison to a pre‐ or nonregionalized state. The final yield was nine papers from six systems.
Although regionalized care results in enhanced process and reduced unadjusted rates of disparity in access and adverse outcomes, these differences tend to become nonsignificant when adjusted for delayed presentation and hospital arrival by means other than emergency medical services. The benefits of regionalized care occur along with a temporal trend of improvement due to uptake of quality initiatives and guideline recommendations by all systems regardless of designation. Further research is justified with a randomized registry or cluster randomized design to support or refute recommendations that regionalization should be the standard of care.
PMCID: PMC4614047  PMID: 26516616
Acute ischemic stroke; effectiveness; outcomes; ST‐segment elevation myocardial infarction
8.  Palliative Care Consultations for Heart Failure Patients: How Many, When, and Why? 
Journal of cardiac failure  2013;19(3):193-201.
In preparation for development of a palliative care intervention for patients with heart failure (HF) and their caregivers, we aimed to characterize the HF population receiving palliative care consultations (PCCs).
Reviewing charts from January 2006 to April 2011, we analyzed HF patient data including demographic and clinical characteristics, Seattle Heart Failure scores, and PCCs. Using Atlas qualitative software, we conducted a content analysis of PCC notes in order to characterize palliative care assessment and treatment recommendations.
There were 132 HF patients with PCCs, of which 37% were New York Heart Association (NYHA) Class III and 50% were Class IV. Retrospectively computed Seattle Heart Failure scores predicted 1-year mortality at 29% [IQR 19,45] and median life expectancy of 2.8 years [IQR1.6,4.2] years. Of the 132 HF patients, 115 (87%) had died by the time of the audit. In that cohort the actual median time from PCC to death was 21 [3, 125] days. Reasons documented for PCCs included: goals of care (80%), decision-making (24%), hospice referral/discussion (24%), and symptom management (8%).
Despite recommendations, PCCs are not being initiated until the last month of life. Current PCC referral mechanisms are inadequate for integrating the full range of palliative care services.
PMCID: PMC4564059  PMID: 23482081
Palliative Care; Consultation; Advanced Heart Failure
9.  Translating and Testing the ENABLE: CHF-PC Concurrent Palliative Care Model for Older Adults with Heart Failure and Their Family Caregivers 
Journal of Palliative Medicine  2014;17(9):995-1004.
Background: Heart failure (HF) and palliative care (PC) organizations recommend early PC to improve the quality of life of patients living with HF.
Objective: We conducted a two-phase formative evaluation study to translate a cancer-focused concurrent PC intervention into one that would be appropriate for rural-dwelling adults with New York Heart Association Class III-IV HF and their primary caregivers.
Methods: Phase I: We tailored the intervention for an HF population via literature review, expert consultation, and clinician (N=15) small group interviews. Phase II: We enrolled 11 patient/caregiver dyads to assess intervention feasibility and satisfaction. We assessed participants' experiences and satisfaction after session/week three and session/week six via digitally recorded interviews. Clinician and participant interviews were transcribed and content analyzed. Outcome measures were evaluated for completion rates and effect sizes.
Results: Phase I: Clinicians described barriers to initiating PC in HF, triggers for initiating PC, and suggestions for intervention improvement. Phase II: Participants were able to complete the majority of study sessions, measures, and interviews. Satisfaction interviews revealed the content to be relevant and comprehensive in addressing HF patient and caregiver primary concerns; however, participants unanimously suggested making the intervention available earlier in the illness trajectory. Efficacy measures demonstrated small to medium effect sizes.
Conclusions: We tailored and demonstrated feasibility of providing an early, concurrent palliative care intervention to patients with advanced HF and their caregivers. Based on this experience we are now conducting an efficacy trial in a racially diverse sample.
PMCID: PMC4158985  PMID: 25072240
10.  The Diverse Landscape of Palliative Care Clinics 
Journal of Palliative Medicine  2013;16(6):661-668.
Many health care organizations are interested in instituting a palliative care clinic. However, there are insufficient published data regarding existing practices to inform the development of new programs.
Our objective was to obtain in-depth information about palliative care clinics.
We conducted a cross-sectional survey of 20 outpatient palliative care practices in diverse care settings. The survey included both closed- and open-ended questions regarding practice size, utilization of services, staffing, referrals, services offered, funding, impetus for starting, and challenges.
Twenty of 21 (95%) practices responded. Practices self-identified as: hospital-based (n=7), within an oncology division/cancer center (n=5), part of an integrated health system (n=6), and hospice-based (n=2). The majority of referred patients had a cancer diagnosis. Additional common diagnoses included chronic obstructive pulmonary disease, neurologic disorders, and congestive heart failure. All practices ranked “pain management” and “determining goals of care” as the most common reasons for referrals. Twelve practices staffed fewer than 5 half-days of clinic per week, with 7 operating only one half-day per week. Practices were staffed by a mixture of physicians, advanced practice nurses or nurse practitioners, nurses, or social workers. Eighteen practices expected their practice to grow within the next year. Eleven practices noted a staffing shortage and 8 had a wait time of a week or more for a new patient appointment. Only 12 practices provide 24/7 coverage. Billing and institutional support were the most common funding sources. Most practices described starting because inpatient palliative providers perceived poor quality outpatient care in the outpatient setting. The most common challenges included: funding for staffing (11) and being overwhelmed with referrals (8).
Once established, outpatient palliative care practices anticipate rapid growth. In this context, outpatient practices must plan for increased staffing and develop a sustainable financial model.
PMCID: PMC3668622  PMID: 23662953
11.  Joint Modeling Quality of Life and Survival Using a Terminal Decline Model in Palliative Care Studies 
Statistics in medicine  2012;32(8):1394-1406.
Palliative medicine is a relatively new specialty that focuses on preventing and relieving the suffering of patients facing life-threatening illness. For cancer patients, clinical trials have been carried out to compare concurrent palliative care with usual cancer care in terms of longitudinal measurements of quality of life (QOL) until death, and overall survival is usually treated as a secondary endpoint. It is known that QOL of patients with advanced cancer decreases as death approaches; however in previous clinical trials this association has generally not been taken into account when inferences about the effect of an intervention on QOL or survival have been made. We developed a new joint modeling approach, a terminal decline model, to study the trajectory of repeated measurements and survival in a recently completed palliative care study. This approach takes the association of survival and QOL into account by modeling QOL retrospectively from death. For those patients whose death times are censored, marginal likelihood is used to incorporate them into the analysis. Our approach has two submodels: a piecewise linear random intercept model with serial correlation and measurement error for the retrospective trajectory of QOL; and a piecewise exponential model for the survival distribution. Maximum likelihood estimators of the parameters are obtained by maximizing the closed-form expression of log-likelihood function. An explicit expression of quality-adjusted life years can also be derived from our approach. A detailed data analysis of our previously reported palliative care randomized clinical trial is presented.
PMCID: PMC3623280  PMID: 23001893
end of life; joint modeling; palliative care; quality of life; survival; terminal decline
12.  Oncologists’ Perspectives on Concurrent Palliative Care in an NCI-designated Comprehensive Cancer Center 
Palliative & supportive care  2012;11(5):415-423.
To understand oncology clinicians’ perspectives about the care of advanced cancer patients following the completion of the ENABLE II (Educate, Nurture, Advise, Before Life Ends) randomized clinical trial (RCT) of a concurrent oncology palliative care model.
Qualitative interview study of 35 oncology clinicians about their approach to patients with advanced cancer and the effect of the ENABLE II RCT.
Oncologists believed that integrating palliative care at the time of an advanced cancer diagnosis enhanced patient care and complemented their practice. Self-assessment of their practice with advanced cancer patients comprised four themes: 1) treating the whole patient, 2) focusing on quality versus quantity of life, 3) “some patients just want to fight”, and 4) helping with transitions; timing is everything. Five themes comprised oncologists’ views on the complementary role of palliative care: 1) “refer early and often”, 2) referral challenges: “Palliative” equals hospice; “Heme patients are different”, 3) palliative care as consultants or co-managers, 4) palliative care “shares the load”, and 5) ENABLE II facilitated palliative care integration.
Oncologists described the RCT as holistic and complementary, and as a significant factor in adopting concurrent care as a standard of care.
PMCID: PMC3797174  PMID: 23040412
oncologist; oncology nurse practitioner; concurrent oncology palliative care; qualitative research; health care delivery
13.  Cancer Family Caregivers: A New Direction for Interventions 
Journal of Palliative Medicine  2012;15(7):775-783.
Descriptive studies of cancer family caregivers demonstrate role-related psychosocial and physical burden; however, little is known about which factors contribute to or obviate burden. Systematic reviews of caregiver intervention studies demonstrate mixed results, perhaps because some caregiver needs are still unknown and not adequately addressed. The purpose of our study was to explore the lived experience of being a caregiver for an adult with lung or colon cancer, so as to guide the development of future intervention studies.
Using phenomenologic methods, open-ended interviews were conducted at a chemotherapy clinic, New Haven, CT with 135 caregivers to adults with lung or colon cancer. Interviews were audio-recorded and transcribed. Thematic analysis was conducted with transcripts coded, reviewed, and recoded multiple times. The final 69 codes were reduced to 13 code clusters (thematic categories) distributed among 4 themes.
Four inter-related themes emerged: 1) becoming a caregiver; 2) new and altered relationships; 3) personal responses to caregiving and 4) antecedents and social context. Caregivers describe hearing the cancer diagnosis as “life-changing”. The cancer creates the context for the caregiver's relationships (with the patient, self, others, and the healthcare system), and cognitive, behavioral, affective, and spiritual responses. The caregiver's antecedent experiences and social support network form the foundation for their perceptions of the diagnosis, relationships, and personal responses.
This study implicates several intervention components to be developed and tested as favorably supporting caregivers, namely, reinforcing positive aspects of caregiving, cultivating open communication, and acknowledging the prior experiences and social foundation of the caregiver's life that can be supportive or burdensome.
PMCID: PMC3387766  PMID: 22612407
14.  The Project ENABLE II Randomized Controlled Trial to Improve Palliative Care for Rural Patients with Advanced Cancer: Baseline Findings, Methodological Challenges, and Solutions 
Palliative & supportive care  2009;7(1):75-86.
There is a paucity of randomized controlled trials (RCTs) to evaluate models of palliative care. Although interventions vary, all have faced a variety of methodological challenges including: adequate recruitment, missing data, and contamination of the control group. We describe the ENABLE II intervention, methods, and sample baseline characteristics to increase intervention and methodological transparency, and to describe our solutions to selected methodological issues.
Half of the participants recruited from our rural, US comprehensive cancer center and affiliated clinics were randomly assigned to a phone-based, nurse-led educational, care coordination palliative care intervention model. Intervention services were provided to half of the participants weekly for the first month and then monthly until death, including a bereavement follow-up call to the caregiver. The other half of the participants were assigned to care as usual. Symptoms, QOL, mood, and functional status were assessed every 3 months until death.
Baseline data of 279 participants were similar to normative samples. Solutions to methodological challenges of recruitment, missing data, and "usual care" control group contamination are described.
It is feasible to overcome many of the methodological challenges to conducting a rigorous palliative care RCT.
PMCID: PMC3685415  PMID: 19619377
Palliative Care; Randomized Controlled Trial; Advanced Cancer; Methodological Issues; Intervention Study; Rural
15.  The Project ENABLE II Randomized Controlled Trial to Improve Palliative Care for Patients with Advanced Cancer 
There are few randomized controlled trials of the effectiveness of palliative care.
To determine the effect of a palliative care intervention on quality of life (QOL), symptom intensity, mood, and resource utilization.
Design, Setting, and Participants
Randomized controlled trial (November 2003-May 2008) of 322 patients with advanced cancer and an identified caregiver in a rural, NCI-designated comprehensive cancer center (the Norris Cotton Cancer Center, Lebanon, NH) and affiliated outreach clinics and Veteran’s Affairs Medical Center (White River Junction, VT).
A multi-component, psycho-educational, palliative care intervention (Project ENABLE) conducted by an advanced practice nurse consisting of 4 weekly educational sessions and monthly follow-up until death or study completion.
Main Outcome Measures
(1) The Functional Assessment of Chronic Illness Therapy-Palliative (range: 0 to 184; higher scores indicate better QOL), (2) Edmonton Symptom Assessment Scale (range: 0 to 900; higher scores indicate greater symptom intensity), (3) Center for Epidemiological Studies-Depression (range: 0 to 60; higher scores indicate more depressive symptoms), completed at baseline, 1 month and every 3 months until death or study completion, (4) days in hospital, intensive care unit (ICU), and emergency department visits recorded in the medical record.
322 participants with gastrointestinal (41%), lung (36%), genitourinary (12%), and breast (10%) cancer were randomized. Estimated treatment effects (intervention minus usual care) for all subjects were 4.6 (P = .02) for QOL, −27.8 (P = .06) for symptom intensity, and −1.8 (P = .02) for depressed mood. Estimated average treatment effects in the sample of participants who died during the study were 8.6 (P = .02) for QOL, −24.2 (P = .24) for symptom intensity, and −2.7 (P = .03) for depressed mood. Days in hospital, intensive care unit, and emergency department visits were not different between groups.
Compared to participants receiving usual oncology care, participants receiving a palliative care intervention addressing physical, psychosocial, and care coordination provided concurrently with oncology care had higher QOL and mood; comparisons of symptom intensity and days in hospital, ICU, and emergency department visits were not statistically significant.
Trial Registration Identifier: NCT00253383
PMCID: PMC3657724  PMID: 19690306
16.  Patient Perspectives on Participation in the ENABLE II Randomized Controlled Trial of a Concurrent Oncology Palliative Care Intervention: Benefits and Burdens 
Palliative medicine  2012;27(4):375-383.
ENABLE (Educate, Nurture, Advise Before Life Ends) II was one of the first randomized controlled trials (RCTs) examining the effects of a concurrent oncology palliative care intervention on quality of life, mood, and symptom control for advanced cancer patients and their caregivers. However, little is known about how participants experience early palliative care and the benefits and burdens of participating in a palliative care clinical trial.
To gain a deeper understanding of participants’ perspectives about the intervention and palliative care trial participation.
A qualitative descriptive study using thematic analysis to determine benefits and burdens of a new palliative care intervention and trial participation.
Of the 72 participants who were alive when the study commenced, 53 agreed to complete an in-depth, semi-structured interview regarding the ENABLE II intervention and clinical trial participation.
Participants’ perceptions of intervention benefits were represented by four themes: enhanced problem-solving skills, better coping, feeling empowered, and feeling supported or reassured. Three themes related to trial participation: helping future patients and contributing to science, gaining insight through completion of questionnaires, and trial/intervention aspects to improve.
The benefits of the intervention and the positive aspects of trial participation outweighed trial “burdens”. This study raises additional important questions relevant to future trial design and intervention development: when should a palliative care intervention be initiated and what aspects of self-care and healthy living should be offered in addition to palliative content for advanced cancer patients when they are feeling well?
PMCID: PMC3657725  PMID: 22573470
Qualitative Study; Randomized Controlled Trial; Palliative Care; Intervention study
17.  Palliative Medicine and Decision Science: The Critical Need for a Shared Agenda To Foster Informed Patient Choice in Serious Illness 
Journal of Palliative Medicine  2011;14(10):1109-1116.
Assisting patients and their families in complex decision making is a foundational skill in palliative care; however, palliative care clinicians and scientists have just begun to establish an evidence base for best practice in assisting patients and families in complex decision making. Decision scientists aim to understand and clarify the concepts and techniques of shared decision making (SDM), decision support, and informed patient choice in order to ensure that patient and family perspectives shape their health care experience. Patients with serious illness and their families are faced with myriad complex decisions over the course of illness and as death approaches. If patients lose capacity, then surrogate decision makers are cast into the decision-making role. The fields of palliative care and decision science have grown in parallel. There is much to be gained in advancing the practices of complex decision making in serious illness through increased collaboration. The purpose of this article is to use a case study to highlight the broad range of difficult decisions, issues, and opportunities imposed by a life-limiting illness in order to illustrate how collaboration and a joint research agenda between palliative care and decision science researchers, theorists, and clinicians might guide best practices for patients and their families.
PMCID: PMC3236099  PMID: 21895453
18.  Impact on Caregiver Burden of a Patient-Focused Palliative Care Intervention for Patients with Advanced Cancer 
Palliative & supportive care  2010;8(4):395-404.
Caregivers of patients with advanced cancer experience physical and emotional strain that can raise their own risk for morbidity and mortality. This analysis was performed to determine whether ENABLE II, a patient-focused palliative care intervention that increased patients’ quality of life, reduced symptom intensity, and lowered depressed mood compared to usual care, would affect caregiver burden.
Caregivers of patients with advanced cancer from the parent study completed a caregiver burden scale and patients completed quality of life, symptom intensity, and depressed mood measures. Data were collected at baseline, 1 month, and every 3 months thereafter until patient death or the study ended. Decedents’ caregivers were asked to complete an after death interview regarding the quality of care that the patient received.
There were no significant differences in caregiver burden between intervention and usual care conditions. Follow-up analyses showed that higher caregiver objective burden and stress burden were related to lower patient quality of life, higher symptom intensity, and higher depressed mood. Caregivers who perceived that patients had unmet needs at end-of-life reported higher objective burden, and those who perceived that patients were not treated with respect reported higher demand burden.
Significance of results
The results indicate that a successful patient-focused intervention did not have a similar beneficial effect on caregiver burden. Future interventions should focus on caregivers as well as patients, with particular attention to caregivers’ perceptions of patient care, and seek to change both negative and positive effects of informal caregiving.
PMCID: PMC3063059  PMID: 20875202
caregiver burden; intervention; palliative care; cancer
19.  Developing Successful Models of Cancer Palliative Care Services 
Seminars in oncology nursing  2010;26(4):266-284.
This article describes successful institutionally-based programs for providing high quality palliative care to people with cancer and their family members. Challenges and opportunities for program development are also described.
Data Sources
Published literature from 2000 to present describing concurrent oncology palliative care clinical trials, standards and guidelines were reviewed.
Clinical trials have demonstrated feasibility and positive outcomes and formed the basis for consensus guidelines that support concurrent oncology palliative care models.
Implications for nursing practice
Oncology nurses should advocate for all patients with advanced cancer and their families to have access to concurrent oncology palliative oncology care from the time of diagnosis with a life-limiting cancer.
PMCID: PMC2976669  PMID: 20971407
Cancer palliative care models; review; palliative care standards
20.  Reliability and Validity of the Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal) Scale 
The Functional Assessment of Chronic Illness Therapy (FACIT) system provides a general, multidimensional measure of health-related quality of life (FACT-G) that can be augmented with disease or symptom-specific subscales. The 19-item palliative care subscale of the FACIT system has undergone little psychometric evaluation to date. The aim of this paper is to report the internal consistency, factor structure, and construct validity of the instrument using the palliative care subscale (FACIT-Pal). Two hundred fifty-six persons with advanced cancer in a randomized trial testing a palliative care psychoeducational intervention completed the 46-item FACIT-Pal at baseline. Internal consistency was greater than 0.74 for all subscales and the total score. Seventeen of the 19 palliative care subscale items loaded onto the four factor solution of the established core measure (FACT-G). As hypothesized, total scores were correlated with measures of symptom intensity (r = −0.73, P < 0.001) and depression (r = −0.75, P < 0.001). The FACIT-Pal was able to discriminate between participants who died within three months of completing the baseline and participants who lived for at least one year after completing the baseline assessment (t = −4.05, P <0.001). The functional well-being subscale discriminated between participants who had a Karnofsky performance score (KPS) of 70 and below and participants with a KPS score of 80 and above (t = 3.40, P <0.001). The findings support the internal consistency reliability and validity of the FACIT-Pal as a measure of health-related quality of life for persons with advanced cancer.
PMCID: PMC2746408  PMID: 18504093
Palliative care; quality of life; psychometrics
21.  Quality of Life of Long-Term Survivors of Breast Cancer and Lymphoma Treated With Standard-Dose Chemotherapy or Local Therapy 
This study compared the quality of life (QOL) of long-term survivors of breast cancer and lymphoma who had been treated with standard-dose systemic chemotherapy or local therapy only.
Patients and Methods
Long-term survivors (mean, 10.0 ± 5.3 years after treatment) of breast cancer or lymphoma who had been treated with systemic chemotherapy (breast, n = 141, age = 57.0 ± 10.1 years; lymphoma, n = 66, age = 55.8 ± 13.5 years) or local therapy only (breast, n = 294, age = 65.8 ± 9.1 years; lymphoma, n = 37, age = 50.4 ± 12.8 years) were interviewed by phone using the Quality of Life–Cancer Survivors Tool.
Multivariate analysis of covariance, controlling for sex, age, education, stage of disease, and time since last treatment, revealed that survivors who had been treated with systemic chemotherapy scored significantly lower on overall QOL compared with survivors treated with local therapy only (P = .04). Analysis of covariance on the subscale scores revealed that, compared with survivors who received local therapy, survivors treated with chemotherapy scored significantly lower on the Social subscale (P < .0001), but no differences emerged on the Psychological or Spiritual subscales. There was a statistically significant interaction between treatment and diagnosis (P = .01), as measured by the Physical subscale, indicating that lymphoma survivors treated with chemotherapy scored worse than all other groups.
Important QOL differences emerged between the chemotherapy and local therapy groups, suggesting that long-term QOL may vary depending on the type of treatment and diagnosis.
PMCID: PMC1237110  PMID: 15994149

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