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Abstract

Introduction:

Studies show that home-based palliative care (HBPC) improves participant outcomes and satisfaction with care while also decreasing hospitalizations and emergency department visits. U.S. health care payment reforms create financial opportunities to offer HBPC. Consequently, more HBPC programs are emerging, heightening the need to evaluate their effectiveness.

Methods:

This randomized, controlled trial is comparing the effectiveness of an evidence-based model of HBPC and enhanced usual primary care for participants who receive primary care from medical groups and clinics organized under an accountable care organization or Medicare Advantage plan. Palliative care services are reimbursed by our partnering health plan provider. The five-year trial will enroll 1155 seriously ill participants (and ∼884 of their caregivers) with heart failure, chronic obstructive pulmonary disease, or advanced cancer. We are collecting data via telephone surveys with participants at baseline and one and two months postenrollment and with caregivers at baseline, one and two months postenrollments, and following the death of a loved one. We are collecting participant-reported outcome measures of pain, symptoms, anxiety, depression, participant-provider communication, and hope. Caregiver outcome measures include caregiver burden, communication with providers, anxiety, and depression. Additional outcomes are participant survival time and participants' emergency department visits and hospitalizations.

Study Implementation: Challenges and Contributions:

Our research team has encountered several significant challenges in early study implementation. These include engaging primary care providers in the study and coordinating logistics with a health plan. Both challenges have contributed to a lag in participant enrollment. Despite these challenges, our study holds tremendous promise to accelerate adoption and spread of an evidence-based HBPC model across the country.

Introduction

Background

Despite significant evidence demonstrating the effectiveness of home-based palliative care (HBPC) in improving patient outcomes while reducing medical service use,^1-3 widespread replication of HBPC in the United States has been stymied by lack of a payment stream for such services.⁴ Recent policy developments, however, have created incentives for insurers and health care providers to expand access to these programs. Among the developments that now make it financially advantageous to offer HBPC are expansion of Medicare Advantage (MA) plans and accountable care organizations (ACOs).

MA plans and ACOs

MAs plans are administered by private insurers who contract with Medicare to cover all of an enrolled patient's Medicare benefits.⁵ From a patient perspective, MA plans are appealing because they limit out-of-pocket costs and offer programs and services standard for Medicare recipients. The trade-off is that patients usually must receive care from the plan's network of doctors and hospitals. Since 2015, MA enrollment has increased 32%, with 22.4 million people enrolled for 2019 coverage.⁶

MA plans generate revenue when their total cost of providing care is less than the total amount they receive from the Medicare Trust Fund, plus any premiums paid by their enrollees,⁷ and when they demonstrate that their network provides high-quality care for beneficiaries. The Centers for Medicare and Medicaid Services continuously monitors care quality to ensure that MA plans deliver proper care.

ACOs are similar to MA plans in that hospitals, physicians, and other health care providers, working together as a network, share financial and medical responsibility for providing coordinated care to patients in hopes of limiting unnecessary spending⁸ and improving care coordination.

As a result of incentives introduced in 2012 under the Affordable Care Act, ACOs have been spreading rapidly. From 2012 to early 2018, the number of ACOs increased from 168 to 1011. During that same period, the number of persons served by ACOs increased from just under 5 to 32.7 million.⁹

Similar to MA plans, ACOs provide a financial incentive for the network's health care providers to cooperate and reduce spending by avoiding unnecessary health care utilization.¹⁰ Networks that save money while also meeting predetermined quality targets typically retain part of the savings.¹⁰

Incentive to implement HBPC programs

HBPC programs have been shown to improve care quality while reducing cost³; a growing number of payers and providers are recognizing this value proposition.

With payment models established and aligned incentives created, HBPC is now poised to roll-out across the country. The focus now must be on the structure, process, and outcome measures that matter to patients—identifying what services work for which patients. No prior controlled trials of HPBC have been conducted within the alternative payment models that are spreading.¹¹ The trial described here is designed to fill this gap.

Objectives

Primary objectives and hypotheses

The primary objective for this study is to test the comparative effectiveness of an evidence-based model of HBPC integrated within primary care clinics and enhanced usual primary care (EUC) on patient-reported symptoms, including pain, depression, and anxiety. Our study team includes university-based researchers, some of them practicing clinicians, and a senior manager of advanced illness and palliative care for Blue Shield of California, the insurance company partnering with this study. We hypothesize that patients receiving HBPC will report greater reductions in pain and symptoms, depression, and anxiety than those receiving EUC.

Secondary objectives and hypotheses

Secondary trial outcomes include patient-reported measures of hope, patient-physician communication, survival, and hospital use. We hypothesize that patients receiving HBPC will report greater increase in hope, more improved communication with physicians, survive longer, and have fewer emergency department visits and hospital episodes than those receiving EUC.

Secondary caregiver outcomes include depression, anxiety, physician communication, burden, and experience of death. We hypothesize that caregivers of patients receiving HBPC will report greater reductions in depression and anxiety, more improved communication with physicians, greater reduction in burden, and lower postdeath distress than caregivers of patients receiving EUC.

Methods

Study design

Subjects and setting

This is a randomized comparative effectiveness trial with randomization at the participant level. We will enroll 1155 seriously ill participants with cancer, chronic obstructive pulmonary disease (COPD), and heart failure (HF) and ∼884 of their caregivers. We are recruiting Blue Shield of California patients who are referred to 1 of 10 HBPC programs that serve individuals covered by a Blue Shield of California ACO contract or MA plan.

Interventions/arms

Home-based palliative care

This trial evaluates an evidence-based model of HBPC that consists of home visits by a trained, interdisciplinary palliative care team composed of a physician, nurse, social worker, and spiritual counselor.¹² This core team may be housed in an independent hospice or home health agency or may be convened in-house by the ACO contract or MA plan. The insurance provider contracts with the core team, using a per member per month payment for patients enrolled in HBPC. The core team will provide pain and symptom management, psychosocial support, advanced care planning, disease management education, spiritual counseling, grief counseling, and other services in response to patient and caregiver needs. HBPC patients and their caregivers also will have access to a 24/7 helpline.

Training

Each HBPC team will receive training in the study aims, participant eligibility criteria, core intervention elements, and team roles.

Fidelity

A coinvestigator (R.B.), the originator of the HBPC model, will oversee the HBPC teams to ensure fidelity with the HBPC model. He also will participate in HBPC teams' case conference meetings and provide clinical direction to each team as needed.

Enhanced usual care

Within the medical groups, usual primary care consists of appointment-based access to primary care physicians as well as access to specialist care. In addition, each medical group offers telephonic disease case management as well as pain and symptom management. These usual care services will be enhanced in several ways. First, all participants randomized to EUC will be assigned a case manager who has added training in palliative care (Table 1).

Table 1.

Online Training Course Curriculum for Case Managers (Courses Created by the Center to Advance Palliative Care)

Course title	Continuing medical education credit hours	Nursing contact hours
An In-Depth Look at Palliative Care and its Services	0.75	1.25
Advance Care Planning Conversations	0.50	1.00
Delivering Serious News	0.50	0.75
Discussing Prognosis	0.50	0.75
Clarifying Goals of Care	0.50	0.80
Care Coordination	0.75	1.00
Pain Management	0.75	2.00

In addition, a second coinvestigator (M.R.), a specialist palliative care physician, will provide treatment recommendations to the participants' case manager and primary care physician or specialist physician using the baseline assessment of pain, dyspnea, nausea, and depression. General treatment recommendations will be provided along with a related Palliative Care Fast Facts and Concepts, a one- to two-page brief on a specific palliative care topic (e.g., diarrhea management or family meetings), which summarizes best practices related to the topic.¹³ Clinicians will be encouraged to contact the palliative care physician for additional email or telephonic consultation as needed.

Finally, all primary care physicians at the participating ACOs, irrespective of their patients' study arm assignment, will have access to, and be able to earn continuing education credits from, the Center to Advance Palliative Care's online palliative care training courses.¹⁴ We asked primary care physician to complete 6 of the ∼50 available courses, each lasting from 30 to 60 minutes. These six courses include the following: an overview of palliative care services with the evidence that supports their effectiveness in improving patient and caregiver outcomes; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.

Fidelity

The palliative care physician (M.R.) will oversee and provide clinical recommendations and consultation to primary care physicians for participants randomized to the EUC study arm.

Core components of each intervention are presented in Table 2. It should be noted that primary care physicians do not receive additional compensation beyond their standard ACO contract for caring for patients enrolled in EUC.

Table 2.

Comparison of Trial Groups

Care component	Trial group provision of service
Care component	EUC	HBPC
Advance care planning/goal setting/POLST discussion	When MDs determine necessary	Every participant enrolled in HBPC
Pain and symptom management	During regular office visits	HBPC team members assess at each home visit
Psychosocial support	Via telephone for one-month period following hospitalization	Social worker home visits
Spiritual support	Not available	Home visits by the spiritual counselor
Home visits	Home health as medically necessary and hospice on referral	At least every other week and as needed
Communicating prognosis	When PCPs determine necessary	Ongoing discussions with HBPC team members
Referral to hospice	When PCPs determine necessary	Assessed for eligibility and acceptance weekly
Caregiver support	Not available	At least weekly
24/7 Support	Not available	Telephone support for every participant enrolled in HBPC
Team conference case review	Not available	Weekly
Medication review/reconciliation	With high cost claims only	Every participant enrolled in HBPC

EUC, enhanced usual primary care; HBPC, home-based palliative care; MD, medical doctor; PCP, primary care physician; POLST, Physician Orders for Life-Sustaining Treatment.

Eligibility criteria

Patient inclusion criteria include the following:

18 years of age or older

Diagnosis of HF, COPD, or advanced cancer

One or more hospitalizations or emergency department visits in the previous year

An Australia-modified Karnofsky Performance Scale score of ≤70%¹⁵ or a palliative performance score of ≤70%

English or Spanish speaking

Patient exclusion criteria include the following:

Receiving hospice or HBPC

Diagnosis of end-stage renal disease requiring long-term dialysis or a kidney transplant to maintain life (these patients typically qualify for Medicare benefits that cover all their health-care needs.)

Lives in a nursing home

Caregiver inclusion criteria include the following:

English or Spanish speaking

18 years of age or older

Able to provide consent

The participant for whom the caregiver provides care has consented to participate in the trial

Caregivers are excluded if they are professional, paid caregivers (i.e., hired by an agency, nonfamily member, or friend).

Recruitment and study procedures

Recruitment and informed consent

Adult participants who have a primary diagnosis of cancer, COPD, or HF are recruited from several sources over a planned three-year period. Participants are referred to the HBPC trial by our insurance partner and medical group case managers, hospital discharge planners, primary care physicians, and specialist physicians. Research assistants (RAs) then mail to each potential participant an information letter describing the trial along with study consent forms. Three days after sending these documents, RAs telephone participants to confirm additional eligibility criteria. If eligibility is confirmed, RAs obtain verbal consent. If the participant does not have capacity to consent, the RA uses a standardized script to identify the most appropriate proxy for the participant. RAs ask the potential proxy for verbal consent and the participant for assent.

RAs also ask participants to identify their primary caregiver, and telephone each caregiver to present the trial and ask for the caregiver's consent to participate. If the caregiver agrees to participate, verbal consent is obtained. If either participants or caregivers do not agree to participate in the trial, the RA queries and documents the reason for refusal. Written informed consent was waived for this trial.

Randomization

Eligible participants are randomized to HBPC or EUC in a 1:1 allocation ratio, with a random blocking factor and stratification on ACO or MA plan. Randomization is completed by the trial data coordinating staff upon verification of trial eligibility. Randomization assignments are communicated to the participants' primary care physicians and HBPC team as appropriate. RAs who collect trial outcomes are blinded to participants' intervention assignment throughout trial follow-up.

Data collection: surveys, medical records, and administrative data

All participant and caregiver outcomes were reviewed by participant and caregiver advisors to this study and identified as meaningful and important. All outcome and data collection measures are presented in Table 3.

Table 3.

Outcomes, Measures, and Data Collection Points

Outcome	Participant	Measure description	Frequency
Demographics	PT, CG	Self-reported telephone survey of demographics includes: medical conditions (PT), age, ethnicity, gender, marital status, and for CGs: employment status, relationship to participant, income level, living arrangement (e.g., together with or separate from the participant), average hours spent caregiving each day, and additional availability of caregiving support.	BL
Patient-physician communication	PT, CG	Consultation Care Measure includes communication, approach to the problem, and interest in the patient's life.²⁸	BL, 30, 60
Hope	PT	The Herth Hope Index assesses hope as it relates to a person's ability to cope with medical illness, loss, and related psychosocial stressors.²⁹	BL, 30, 60
Pain and symptoms	PT	The revised Edmonton Symptom Assessment System (ESAS) measures severity of pain, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sense of well-being, and activity.^30,31	BL, 30, 60
Anxiety and depression	PT, CG	The Hospital Anxiety and Depression Scale³² and the PHQ-9 (PT only), a 9-item scale based on the nine DSM-IV criteria for depression, will be used.³³	BL, 30, 60, two months postdeath (CG)
Caregiver burden	CG	The Zarit Burden Interview, a 12-item instrument that has been used with caregivers for a wide range of patients.^34,35	BL, 30, 60
Caregiver global health	CG	The PROMIS Global Health instrument assesses physical and mental health, with higher scores indicating better functioning.³⁶	BL, 30, 60, two months postdeath
Survival time	PT	Calculated by subtracting the date of death from the trial enrollment date.	EOS
Emergency department visits and hospital admissions	PT	Insurance claims databases will provide count emergency department visits, hospital admissions, and hospital days for each patient from the time of trial enrollment until death or the end of the trial period.	EOS
Family experience of death	CG	This survey will be conducted with caregivers whose family member dies during the study period. The Bereaved Family Survey assesses well-being and dignity, information and communication, respect for treatment preferences, emotional and spiritual support, and symptom management.³⁷	Two months postdeath
HBPC service use	PT in HBPC arm only	HBPC records will provide frequency and duration of all home visits by HBPC team members, frequency of calls to the 24/7 helpline, and days on HBPC service.	EOS

30, 30-day follow-up; 60, 60-day follow-up; BL, baseline; CG, caregiver; EOS, end of study; PHQ-9, Patient Health Questionnaire,Question 9; PT, patient.

For participants enrolled in HBPC, the following are additionally tracked:

Frequency and duration of all home visits by HBPC team members

Frequency of calls to the 24/7 helpline

Days on HBPC service

Outcome measures

Primary and secondary outcome data are collected for participants and caregivers based on the schedule presented in Table 3. All survey measures for both participants and caregivers are collected at baseline and at one and two months + seven days following enrollment.

Survival, emergency department visits, and hospital admissions are collected following participant's death or at the end of the study. Caregiver's experience of participant's death is collected two months following participant's death.

Adverse events

An adverse event (AE) is defined as any unfavorable and unintended diagnosis or symptom, that is beyond or more extreme than expected of the patient's medical condition, which either occurs during the study, having been absent at baseline, or if present at baseline, appears to worsen. Because the study population is seriously ill with an expected limited prognosis, the AEs for these study participants are all expected.

For participants, an AE is defined as:

(1)

Patient-reported extreme pain (9 or 10 on pain scale)

(2)

Death

(3)

Suicidality (triggered by a response of several days or more from Patient Health Questionnaire, Question 9 [PHQ-9])

(4)

Emergency department visit for hospital admission

Caregiver AEs are defined as:

(1)

Death

(2)

Suicidality

(3)

Emergency department visit or hospital admission

Data management and security

Participant referrals are transmitted to the study's data team via a secure, double-encrypted email account. All participant information is stored on a secured computer that is not connected to the Internet. Only specified trial data team members have access to this computer. RAs enter de-identified survey responses from participants and caregivers electronically using REDCap, an online software program that is hosted and supported by this study's lead research organization at a physically secure 24/7 data hosting facility. Data are backed up nightly with offsite disaster recovery. The online surveys do not document identifying information about the respondents. Only trial data team members have access to the randomization feature and viewing of randomized intervention.

Statistical analysis plan

Sample size estimation

Anticipated intervention effect sizes were based on prior randomized controlled trials, as well as our own studies.^12,16-19 Given the variety of outcomes, trial design, and populations, effect sizes varied from 0.18 to 0.69, with a median of 0.41. To be conservative, and because the EUC group may show stronger effects than the standard of care comparators that were used in most of these studies, an effect size of 0.25 (which is around the first quartile of effect sizes reported in these studies) was used. Given three specified coprimary outcomes (i.e., symptoms, depression, and anxiety), a Bonferroni-corrected two-sided alpha level of 0.017 (0.05/3) was used. With power of 90% and two-sided alpha of 0.017, 433 participants per group (866 total) were determined to be required to detect the effect size of 0.25. One thousand one hundred and fifty-five participants will be randomized to incorporate an estimated 25% loss to follow-up.

From our experience¹² and others,²⁰ an estimated 12% of participants will not have a caregiver; however, a lower attrition rate among caregivers than participants is expected. Given an estimated 1016 trial participants with caregivers and an estimated 13% refusal rate, we expect to enroll 884 caregivers. With an estimated 15% attrition rate, our power is adequate for all analyses with a complete sample of 796 caregivers.

Analysis plan

Descriptive statistics of the two intervention arms will be performed to characterize covariates and outcome measures at baseline and each follow-up assessment. To evaluate baseline comparability, preliminary analyses will compare demographic and clinical characteristics, as well as outcome measures, at baseline between the treatment groups. The main effects of treatment group at each follow-up and then on the longitudinal trend will be investigated. Repeated measures analyses with mixed effects models will be used to examine the effects of program conditions on continuous participant and caregiver outcome measures. Given the participant population, missing primary outcome data are expected and will be represented by informative missingness, arising from death and illness. Analysis of longitudinally collected outcome data will therefore use joint modeling of the longitudinal and survival (right censored) outcome data with shared parameter models that model the dependence between longitudinal and survival outcomes through a shared random effect.^21-23 For any continuous variable measured ideally at baseline and one and two months, a linear mixed effects model will be used as the longitudinal submodel to compare treatment groups. Conditional on the random effects, the longitudinal and censoring processes are assumed independent, and the full joint likelihood will be used to estimate and test model parameters; most importantly, the HBPC treatment effect will be estimated and tested with consideration of differential censoring at the subject level. The treatment effect will first be tested jointly at months one and two; if the treatment effect is significant, estimation and testing for treatment effects will be conducted at each follow-up time with the addition of a treatment-by-time covariate.

Treatment group differences in survival will be evaluated with a proportional hazards model; the primary independent variable is randomized intervention, and covariates will include randomization stratification factor, medical condition (HF, cancer, COPD), as well as baseline prognostic factors that differ between treatment groups. Kaplan-Meier survival curves by treatment group will be displayed, and proportional hazards assumptions will be evaluated. Numbers of emergency department visits, hospitalizations, and length of stays will be compared between treatment groups using Poisson (or negative binomial, if Poisson overdispersion is present) regression, with independent variables as listed in the survival model. An offset of time on-trial will be specified.

Although the use of specialty palliative care by both groups will be tracked, an intent-to-treat analysis, by which subjects will be analyzed according to randomized intervention, will be performed. Variables differentiating treatment groups at baseline will be included as model covariates; the randomization stratification factor of ACO will also be included as a model covariate. Each of the three primary outcomes will be tested at a Bonferroni-corrected p-value of 0.017; the sample size calculations incorporated this adjusted alpha level. Evaluation of secondary outcomes and all subgroup analyses will control for the false discovery rate.²³

Subgroup analysis

As treatment effects are expected to operate differently on participants with different attributes, three subgroup analyses on both participant and caregiver variables will be conducted by primary medical condition (HF, COPD, and cancer), white versus nonwhite ethnicity, and age (<65 vs. >65 and older). Outcomes will be examined by primary medical condition to determine differences in outcomes by disease. Ethnicity will be examined as a preliminary step in determining equivalent outcomes for nonwhite participants and caregivers, and age will be examined to understand whether outcomes vary by age group.

Potential limitations

The HBPC trial is subject to certain potential limitations. First, participants are randomized at the participant level, as opposed to randomizing at the regional ACO, or another organizational level. Although this study design increases potential risk of contamination, it reduces potential variation in outcomes due to differences in clinical sites, for which there are many, or between the “clusters” we would create by randomizing at the ACO level. The study reduces potential for contamination because our intervention model, HBPC, combines HBPC and usual care. That is, participants receiving this intervention may also seek and receive all forms of usual care.

Second, through our funder, we are restricted in our ability to collect cost-effectiveness or cost-benefit data. We will seek additional funding for these analyses.

Ethics determination

The trial will be conducted according to good clinical practice guidelines, US 21 CFR part 50 and part 56, 21 CFR 312, and ICH E6. The University of Southern California Institutional Review Board (IRB) approved the trial protocol. All changes to the protocol will be submitted to the IRB, as needed. A Data and Safety Monitoring Board (DSMB) comprising experts in palliative care medicine, research, and caregiving reviews the study protocol and oversees participant safety and trial conduct.

Study Implementation

Challenges and contributions

As might be expected any time, a pragmatic trial is implemented within a complex health care system and targets seriously ill participants, we have encountered numerous challenges. They can be discussed within the context of two overarching, although related, themes: provider engagement and participant recruitment.

Engaging coordinating payers and providers

A health care innovator recently noted, “…coming up with…transformative technologies (or palliative care innovations) is just the first step, and a step that historically has rarely resulted in the sort of instant transformation we've naively anticipated…It's the long and complex path towards implementation that we should have anticipated….”²⁴ We knew at the start of our trial that it would be challenging to integrate a new service program into a complex health care system that is often described as fragmented and broken, but we underestimated how challenging.

Interest in participating in the trial was initially strong among the ACO leadership and HBPC providers we had approached during the application phase; afterward, however, it was harder—and took longer—to formalize the partnerships needed. Some of the partnership tasks required were independent of our trial; they related solely to implementing a new program. These tasks required our Blue Shield insurance partner to introduce palliative care and the program to each participating ACO (initially, we anticipated 10 ACO partners) while simultaneously negotiating a contract with the HBPC agency that was to work in partnership with the ACO. Our Blue Shield coinvestigator was tasked with identifying appropriate and willing ACO, MA, and HBPC partners and shepherding them through the contract process with her employer. The contracts stipulated who would get paid what and when for which services. Each contract negotiation presented unique challenges because each was conducted with different partners working in settings whose cultures varied widely.

For the large majority of our HBPC partners, these contracts entailed opening a new line of business: palliative care. All our HBPC partners originally operated primarily, if not solely, as hospice organizations. After securing the contract with our insurance partner, these HBPC sites then needed to hire and train a team of HBPC providers. With a limited palliative care workforce,²⁵ the hiring process extended into many months for some of our HBPC sites.

Our negotiations were made even more complicated by the fact that ACO/MA and HBPC partners had to be willing to participate in a research trial, which imposed a new set of conditions and obligations among partners. Organizations that agreed to participate had to assign staff to work with the research team to integrate research protocols into their work flows. Some HBPC partners had to expand their staff so that they could add this new service line.

We quickly learned that we could not bring 10 ACO/MA-HBPC pairs on board within months of the trial's start, largely for two reasons: (1) negotiations between Blue Shield and the ACO-HBPC pairs took more time than anticipated, and (2) some of the pairs approached for study inclusion ultimately declined to participate in the research. We settled for bringing each on as the payer contracts were signed. In the trial's first year, our insurance partner executed contracts with one ACO with four ACO sites and their associated HBPC providers, all the while attempting to initiate contract discussions with additional ACOs and HBPC providers. More than two years into the trial, we are still working to engage more ACOs and HBPC providers.

Recruiting and enrolling participants

We had reason to believe that primary care physicians would be a good and perhaps sufficient source of participant referrals to our study. Given ACOs' financial and medical responsibility for providing coordinated care to participants with the goal of increasing quality of care and reducing spending, primary care physicians serve as a “linchpin” in ACOs.²⁶ Our insurance partner sought to solidify the coordination role of primary care physicians (and therefore accountability to patients) by encouraging primary care physicians to identify patients in need of palliative care and thus potentially eligible for the study. In addition, health care leaders increasingly have recognized that there are too few palliative care specialists to meet the needs of an aging population. Many are now calling for frontline providers to help deliver palliative care to their seriously ill patients. Also, Medicare recently has begun reimbursing primary care physicians for advance care planning discussions with patients, giving rise to new primary care physician-directed education programs. We anticipated that these in turn might trigger greater awareness of the need for palliative care services. We also planned to facilitate patient referrals by giving primary care physicians a prescreened list of patients—patients who, according to our insurance partner's administrative data, met the trial's criteria for health service use and diagnosis. Finally, we offered incentives for primary care physicians to engage with the trial, including access to online palliative care training approved for continuing medical education units and telephonic access to a nationally recognized palliative care specialist for questions and consultation.

We modified our outreach efforts to primary care physicians in numerous ways over considerable time before we had to conclude that primary care physicians were not a reliable referral source for our trial. Other experts with experience recruiting patients for palliative care have reported to us this same conclusion. The reasons, largely anecdotal at this point, are various. Some physicians did not want to refer their patients to a research study. Many, under the mistaken assumption that palliative care is end-of-life care, reported that none or very few of their patients needed palliative care. Others were uncomfortable sharing care for their patients with new service providers. Our efforts to address these barriers—through education about the trial, about palliative care, and about the HBPC partners—ultimately proved futile. Consequently, we have widened our referral net to include hospital discharge planners, case managers, in-patient and clinic-based palliative care providers, and physician specialists.

Conclusion

Although HBPC models administered by fully integrated health maintenance organizations and V.A. Medical Centers have been evaluated,¹¹ none has been tested across multiple ACOs or nonintegrated systems featuring contracts with alternative reimbursement models. If payers and providers working within these newer models respond to emerging needs for HBPC by launching untested programs—as some seem poised to do—a promising opportunity to improve care for seriously ill patients may evolve into an array of home-grown programs of questionable benefit to patients and caregivers.²⁷ Our trial aims to address this critical gap in evidence by determining and comparing the extent to which two different palliative care models are beneficial to patients and caregivers. Findings are expected to accelerate adoption of evidence-based HBPC.

Acknowledgment

Research reported in this presentation was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award IHS-1602-34070.

The trial is registered at clinicaltrials.gov (NCT03128060).

Footnotes

Author Disclosure Statement

The opinions presented in this presentation are solely the responsibility of the authors and do not necessarily represent the views of the PCORI, its Board of Governors, or Methodology Committee. Authors have no conflict of interest to report.

This is a study protocol and thus does not contain or report any primary data.

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Expanding Access to Home-Based Palliative Care: A Randomized Controlled Trial Protocol

Abstract

Abstract

Introduction:

Methods:

Study Implementation: Challenges and Contributions:

Introduction

Background

MA plans and ACOs

Incentive to implement HBPC programs

Objectives

Primary objectives and hypotheses

Secondary objectives and hypotheses

Methods

Study design

Subjects and setting

Interventions/arms

Home-based palliative care

Training

Fidelity

Enhanced usual care

Fidelity

Eligibility criteria

Recruitment and study procedures

Recruitment and informed consent

Randomization

Data collection: surveys, medical records, and administrative data

Outcome measures

Adverse events

Data management and security

Statistical analysis plan

Sample size estimation

Analysis plan

Subgroup analysis

Potential limitations

Ethics determination

Study Implementation

Challenges and contributions

Engaging coordinating payers and providers

Recruiting and enrolling participants

Conclusion

Acknowledgment

Footnotes

Author Disclosure Statement

References