The Promoting Effective Advance Care for Elders (PEACE) Randomized Pilot Study: Theoretical Framework and Study Design

Abstract

Practice guidelines are available for hospice and palliative medicine specialists and geriatricians. However, these guidelines do not adequately address the needs of patients who straddle the 2 specialties: homebound chronically ill patients. The purpose of this article is to describe the theoretical basis for the Promoting Effective Advance Care for Elders (PEACE) randomized pilot study. PEACE is an ongoing 2-group randomized pilot study (n = 80) to test an in-home interdisciplinary care management intervention that combines palliative care approaches to symptom management, psychosocial and emotional support, and advance care planning with geriatric medicine approaches to optimizing function and addressing polypharmacy. The population comprises new enrollees into PASSPORT, Ohio's community-based, long-term care Medicaid waiver program. All PASSPORT enrollees have geriatric/palliative care crossover needs because they are nursing home eligible. The intervention is based on Wagner's Chronic Care Model and includes comprehensive interdisciplinary care management for these low-income frail elders with chronic illnesses, uses evidence-based protocols, emphasizes patient activation, and integrates with community-based long-term care and other community agencies. Our model, with its standardized, evidence-based medical and psychosocial intervention protocols, will transport easily to other sites that are interested in optimizing outcomes for community-based, chronically ill older adults. (Population Health Management 2012;15:71–77)

Introduction

T here is evidence that millions of people with chronic illnesses who live in the community suffer from unrelieved pain, uncontrolled physical symptoms, and unresolved psychosocial or spiritual problems.¹ Much of this suffering could be avoided through the appropriate application of both palliative care and geriatric medicine concepts. The goals of palliative care are to prevent and treat the suffering caused by pain and other physical symptoms as well as unresolved psychosocial, cultural, and spiritual issues.^2,3 The palliative care model encompasses many diagnoses and is appropriate early in the course of life-threatening or debilitating illnesses that are persistent or recurring and adversely affect daily functioning or can be predicted to reduce life expectancy.²

Though geriatric medicine will apply palliative care principles, the goals of geriatric medicine are focused more on optimizing patients' health and well-being as well as their complex chronic conditions, while attempting to achieve the highest level of functioning so that they may live in the setting of their choice for as long as possible. Although these medical specialties are 2 distinct disciplines, the populations they serve often overlap, especially homebound patients with chronic life-threatening or debilitating illness.

Purpose

The purpose of this report is to describe the theoretical basis for the Promoting Effective Advance Care for Elders (PEACE) trial, a randomized pilot study being conducted to determine the feasibility of a fully-powered study to test the effectiveness of an in-home interdisciplinary care management intervention. The intervention combines concepts from palliative care and geriatric medicine to improve a global measure of quality care for new enrollees into PASSPORT, Ohio's community-based, long-term care Medicaid waiver program.

Theoretical Framework

In modern disease-oriented medicine, holistic care, which addresses all aspects of a patient's suffering, is often lacking for populations with chronic illness.¹ Real changes are needed in the health care delivery system to enable adherence to evidence-based guidelines to ensure the highest quality of life for all patients. Wagner et al.⁴ theorize that optimal care for patients with chronic illness is not possible in a traditional health care system that heavily emphasizes disease treatment. In these traditional systems, primary care providers have limited time and lack ready access to the evidence-based guidelines necessary to provide the systematic assessments, preventive interventions, patient education, and psychosocial follow-up required to provide effective care to patients with chronic conditions.^5

–8 Furthermore, patients pass from one care setting to another (eg, from acute care hospital to ambulatory care) with little or no communication between providers or follow-up to ensure that patient needs are addressed. According to Wagner's model, improvement in the care of patients with chronic conditions can occur only when specific changes occur in the health care delivery system, including changes in organizational structure, establishing community linkages, providing effective self-management support, delivery system redesign, evidence-based decision support, and improved information systems. Implementation of these changes should result in more productive interactions between patients and providers that assure the delivery of services that promote optimal function, health, and patient activation.

The PEACE intervention incorporates these elements of Wagner's theoretical framework to create a care model that is integrated into the patient's total health care and is responsive to patient and family needs. The core of our model involves regular meetings with an interdisciplinary team that is comprised of palliative care, geriatrics, nursing, social work, pastoral care, counseling, and pharmacy specialists from both Summa Health System and the local Area Agency on Aging 10B, Inc. (AAA). This allows for effective communication across disciplines and agencies and provides support for those who are implementing the intervention. With this interdisciplinary team model, the PEACE trial is able to integrate acute and long-term care entities and cut across traditional silos that have been created by Medicare and Medicaid health care payment policy.

Setting

The PEACE trial is being conducted jointly between Summa Health System in Akron, Ohio and the AAA. A working relationship between this health system and this community agency had already been established in a previous project called SAGE (Summa Health System/Area Agency on Aging 10B/Geriatric Evaluation Project). Summa is an integrated health delivery system with 2060 licensed beds on 6 campuses. In addition to these acute care hospitals, this integrated system is comprised of a multispecialty physician group, loosely aligned independent physician practices, a health insurance arm, an acute rehabilitation hospital, home care, a physician house call program, palliative care and hospice services, multiple service lines including postacute and senior services, and the Summa Foundation.

Ohio's AAA 10B Inc. is an independent, private, nonprofit corporation that serves more than 20,000 elderly consumers in northeastern Ohio. The AAA is designated by the Ohio Department of Aging to develop a network of services to assist older adults and their families. Its mission is to provide older adults and their caregivers with long-term care choices, consumer protection, and education so that they can achieve the highest quality of life. In addition to its community care coordination programs and its elder rights division, the AAA administers the state's Medicaid waiver program, PASSPORT, which is a home- and community-based social model of care delivery that addresses the functional/social/psychological/behavioral needs of low-income, chronically ill older adults whose functional status qualifies them for nursing home placement. A primary goal of PASSPORT is to delay or prevent nursing home placement. The population served by AAA extends across 4 counties and several not-for-profit health systems/hospitals including Summa Health System.

Target Population

Most people with chronic life-limiting or debilitating illnesses live at home⁹; therefore, community-based interventions should reach the greatest number of people in need of a palliative care/geriatrics hybrid intervention. There are 27,000 PASSPORT clients in the state of Ohio (16% of Ohio's elderly population), and the local AAA 10B has approximately 3200 clients in a surrounding 4-county area. All PASSPORT enrollees must have Medicaid and be >60 years of age; most also have Medicare. They must have life-limiting illnesses, be nursing home eligible, and have at least 2 deficits in Activities of Daily Living, all of which makes them appropriate for palliative care interventions. Despite this, advanced care planning is not a standard intervention for PASSPORT care managers and is rarely undertaken. Enrollment into PASSPORT represents an important care transition that is a natural place to introduce advanced care planning and individual goal setting to a large number of clients.¹ It also is ideal because it occurs in the patient's home while the patient is not dealing with an acute illness. The PEACE study will recruit and randomize clients at the time of their enrollment into PASSPORT, taking palliative care and geriatric medicine expertise from a hospital-based setting to the home setting and promoting early advanced care planning and integration of medical and psychosocial care.

Overview of the Intervention

The intervention incorporates the 6 elements of Wagner's Chronic Care Model to create a comprehensive, patient-centered intervention that redesigns health care delivery for chronically ill, low-income, frail elderly patients. A brief description of the intervention will explain how the elements of the model have been used to build this comprehensive care management intervention (Table 1).

Table 1.

Implementation of Wagner's Model

Requirement of Wagner's Model	Elements of the Intervention that Fit the Model
Organizational structure, leadership, incentives, and resources	Interdisciplinary team coordinates care with Area Agency on Aging and other community agencies
	Team provides support to PCPs
	Reimburse PCPs for a care management interface
	PCP receives academic detailing from team
	Improves PCP office efficiency, productivity and patient outcomes
Establishing community linkages	Collaboration between a large integrated health system and a local Area Agency on Aging
	Area Agency on Aging care managers provide patients with referrals to community-based disease-specific education, prevention programs, and physical activity
Providing effective self-management support	Care manager and patient work collaboratively to set goals, devise care plans, and problem solve
	Patient education
	Frequent follow-up for assistance, skills training, coaching, and help with problem solving
	Provide patient with written summary of care plans
	Provide appropriate referrals
	Accompany patient to PCP visit to model communication skills
	Role-play problem solving
	Assure adequate psychosocial support
	Advance care planning
	2^nd 6 months of intervention more supervised self-management
Delivery system redesign	Use of interdisciplinary team
	PASSPORT care managers who work with patient, medical professionals, and PCP
	Frequent follow-up by care manager to encourage adherence and to identify problems at an early stage
	Care manager reassesses patients if they are rehospitalized
Evidence-based decision support	Use of evidence-based protocols based on ACOVE, NCP and IAHPC
	Team advises PCP
	Academic detailing provided to PCPs
	Detailed pharmacology review by geriatrics-certified pharmacist
Improved information systems	Electronic protocol templates
	Team assessment findings and care plans are communicated to the PCP by fax, phone, and during a dedicated office visit

ACOVE, Assessing Care for Vulnerable Elders; IAHPC, International Association of Hospice and Palliative Care; NCP, National Consensus Project; PCP, primary care physician.

After randomization, specially trained PASSPORT care managers, to whom the intervention group clients were assigned, send a fax to each client's primary care physician (PCP) and any named specialists to describe the study, inform him or her of the client's enrollment in the study, and elicit his or her opinion of appropriate goals for the patient. For simplicity, physicians are asked to rate the patient's status from “many treatment options still available” to “few treatment options still available.” (Because of common misconceptions associated with the term palliative care, we used the phrase advanced illness management when communicating with physicians and clients.)

Within 3 weeks of enrollment into PASSPORT, clients in the intervention group receive the first of 2 in-home palliative care needs assessments. The second visit occurs within approximately 2 weeks of the first. These standardized assessments are performed by one of the PASSPORT care managers, who assess client (and family when available) needs and goals under the following topics: connections, comfort, ethics, client and family well-being, and grief.

If the care manager finds that the client's goals are vastly different from those indicated by the client's physician(s), then the care manager or the palliative care physician from the interdisciplinary team calls the physician(s) between the first and second visit to clarify discrepancies. This information is used during the second home visit to help inform realistic goal setting.

Within approximately 2 weeks of the second home visit there is an interdisciplinary team meeting to review the findings of the care manager's assessment. The core team includes a hospice and palliative medicine specialist, a geriatrician, the PASSPORT care manager, a palliative care nurse specialist, a social worker, a spiritual advisor, and a pharmacist. Extended team members include physical and occupational therapists, a dietitian, a geriatric advance practice nurse, and a psychologist, who are consulted as needed. The team develops individualized evidence-based care plans based on standardized protocols that were developed for this study and were derived from an extensive literature review, the Assessing Care for Vulnerable Elders (ACOVE) project,¹⁰ the National Consensus Project (NCP) for Quality Palliative Care,² and the International Association of Hospice and Palliative Care (IAHPC)¹ Manual of Palliative Care. This team process empowers care managers to implement the interventions. A copy of this care plan is sent to the client's PCP.

The PASSPORT care manager discusses the care plan with the client (and family when available, which often is not the case for this population) to ensure that it accurately reflects the patient's goals. Once the client and family are in agreement, the PASSPORT care manager accompanies the client to a paid PCP visit to review the plan with the PCP and to provide “academic detailing.”¹¹

Once the care plan is agreed upon by all, the PASSPORT care manager makes another home visit to implement the plan and activate/coach the patient. Standardized protocols guide implementation of the plan. These include teaching disease and symptom management, identifying symptom management needs, developing an emergency response plan, addressing functional needs, teaching caregivers about disease/symptom management, assisting with access to community resources, referring to a counselor for psychological support as needed, assessing/assisting with spiritual needs, determining unmet medical needs, reviewing medications, and facilitating client/PCP/family communication. This process also involves completing appropriate legal documents recognized by the State of Ohio (ie, state DNR [Do Not Resuscitate] and living will forms). Although Ohio does not yet recognize the Physician Orders for Life-Sustaining Treatment as legally binding (legislation is pending), we complete a revised form of it for clients, as appropriate, because of its superior information content and value in guiding advance care planning discussions. We include it in the information clients are asked to communicate with all health care providers. Clients are provided with written self-management materials. Caregiver needs also are assessed, when appropriate, using informal open-ended questions, and community supports are mobilized to meet their needs. Clients have access to either the care manager or a hospital-based team member 24 hours/day because acute exacerbations might otherwise prompt clients to seek help in the emergency department.¹²

The PASSPORT care manager follows up with the client as needed, but at least monthly by phone for 12 months to determine whether the goals of care have changed. If the client is rehospitalized or if there is another inflection point in the trajectory of their chronic illness, the team assessment is updated and the goals of care reevaluated.

Usual Care

Clients randomized to the control group receive usual PASSPORT care, which follows a more psychosocial than biopsychosocial model. A letter is sent to the PCP informing him or her that the client was enrolled in the study. Clients also receive mailed palliative care educational information every month in an attempt to mask group assignment. At the end of the study the palliative care nurse specialist performs a single home visit to outline goals of care and refers the client to their PCP for follow-up on those goals.

Outcomes

Study outcomes, measured at 3, 6, 9, and 12 months, include:

1. Symptom management (measured using the Memorial Symptom Assessment Scale)¹³;

2. Quality of life/death (measured using the QUAL-E)^14,15;

3. Relationships (measured using the Meaning in Life Scale)¹⁶;

4. Decision making/care planning/continuity/communication (measured using the Patient Activation Measure)¹⁷;

5. Depession and anxiety (measured using the Hospital Anxiety and Depression Scale)¹⁸

To compare the 2 groups on these multiple end points, we will use a global hypothesis testing strategy that strongly controls Type I error while optimizing power for consistent intervention effects.^19

–22

How the PEACE Intervention Is Consistent with Wagner's Chronic Care Model

1. Organizational structure, leadership, incentives, and resources

The PEACE intervention would not have been possible without the cooperation between our health system's Senior Services leadership and high-level administrators at the AAA. Leadership from both organizations realized that optimal outcomes for clients with chronic conditions could not be obtained as long as professional silos were not breached. It was agreed that only through a collaborative team process, involving professionals who represent the complete biopsychosocial sphere, could the goals of both health care and social service providers be met. This resulted in the team meetings held at the AAA once per week.

2. Establishing community linkages

To our knowledge, this is the first care management model of this nature, wherein a health care system and an AAA act as full partners. AAA personnel ensure that psychosocial needs are addressed and assist with gaining access to those services, while members of the medical team assure optimal medical, palliative care, and geriatric syndrome management. From a medical perspective, it has become apparent that polypharmacy is a major issue for this population, potentially contributing to morbidity, unnecessary hospitalizations, and inadequate care. An AAA care manager typically does not have direct access to pharmacists or knowledge resources regarding medications or polypharmacy. By having a pharmacist as an integral member of the PEACE trial team, this problem can be addressed. The care manager also provides patients with information on community-based disease-specific education, prevention programs, and physical activity.

3. Providing effective self-management support

The first step in effective care management is having the patient state his or her goals of care. Care plans are then devised to help the patient achieve those goals. The first 6 months of the PEACE intervention provides for frequent follow-up so that the care manager can provide assistance, skills training, coaching, and help with problem solving. Typically, this population with complex chronic illnesses and health literacy issues has little knowledge of their conditions or prognosis. Conversations and education regarding these topics typically are lacking during PCP and specialty office encounters, which normally focus on disease-specific medical interventions. Therefore, the care manager promotes self-directed care by providing the client with a written summary of the care plans devised by the team as well as with educational resources. He or she also accompanies patients to PCP visits as needed to provide role modeling, advocacy, and coaching. In addition, the care manager maximizes clients' psychosocial support to optimize their ability to self-manage. Advance care planning also is incorporated into the intervention to ensure that clients maintain as much control over their care as they desire and to improve communication with the PCP. The first 6 months of the intervention involves intensive care management; during the second 6 months the care manager allows the client to practice self-management.

4. Delivery system redesign

Interdisciplinary care management is advocated to optimize the care of patients with a variety of chronic illnesses and is central to operationalizing Wagner's model. The redesign implemented in the PEACE trial integrates the medical and social models of care by creating an interdisciplinary interagency collaborative care management team that meets at the AAA, utilizes social worker and nurse care managers as well as hospital-based palliative care and geriatric medicine experts, and coordinates care with the PCP. The presence of this care manager ensures coordination of care across all providers and settings while enhancing adherence to evidence-based protocols in a way that generally is not possible for a single PCP.

The interdisciplinary team provides the leadership, incentives, and resources for PCPs who manage chronically ill patients. In addition, the PCP is provided with added resources via the academic detailing that accompanies all team recommendations, and is paid to specifically review the care plan and work with the nurse/social worker care manager.

Another important aspect of delivery system redesign is the regular and frequent follow-up by the care managers in the client's home. The in-home visits improve health care delivery by allowing the care managers a firsthand look at the client's environment and potential barriers to the client's goals. The frequent follow-up also allows the care managers to identify potential problems at an early stage so that interventions can be initiated promptly.

5. Evidence-based decision support

Evidence-based recommendations for effective management of many chronic conditions are numerous and continually changing. The ACOVE¹⁰ project was undertaken to provide an objective measure of the quality of care that health systems provide to community-dwelling elderly patients who are at risk for functional decline or death. Clinical practice guidelines to optimize palliative care delivery also have been published by the NCP for Quality Palliative Care,² the National Quality Forum's (NQF's) Preferred Practices for Palliative and Hospice Care Quality,³ and the IAHPC.¹ However, it has been shown that vulnerable older adults with chronic illnesses receive recommended care less than 30% of the time.¹⁰ In the PEACE trial, all of these best-practice guidelines have been incorporated into our intervention to guide the team recommendations. We provide PCPs with a copy of the guidelines along with pertinent references as well as short paragraphs containing academic detailing to enhance decision support. A detailed pharmacological review that takes into account the patient's goals as well as pertinent guidelines is performed by a geriatrics or palliative care specialist pharmacist after the team meeting. This review also is provided to the PCP to promote optimal prescribing.

6. Improved information systems

Team assessment findings and computerized care plans are communicated to the PCP by fax, telephone, and during a dedicated office visit. For a larger trial we hope to devise an electronic system for consistent transfer of advance care documents across care settings during transitions in care.

7. Integration across the 3 “galaxies”

Wagner's Chronic Care Model illustrates that health care for those with chronic illness occurs through 3 galaxies:

• Community

• Health care system and payment structure

• Provider organization; clinic, integrated delivery system, loose network of providers

The PEACE trial is organized to adapt and change care delivery in these 3 galaxies by applying the essential features discussed. This trial is built upon partnerships between agencies that have 2 different funding streams (ie, Medicare and Medicaid). It attempts to bridge these silos by strategic community partnership and collaboration. Integrating care manager resources and providing support to the PCP are other examples of bridging and integrating in situations where such integration or partnering typically does not exist. A recent analysis done at the Hilltop Institute compared and measured the utilization of Medicare and Medicaid resources for those with and without home- and community-based support and concluded that integrating Medicare and Medicaid could be a cost-effective way to reduce total expenditures for this population. Further, if their care actually were managed, these low-income populations that have social as well as chronic complex medical issues could achieve improved outcomes (eg, access, quality). The PEACE pilot study has the potential to demonstrate these principles.

Discussion

Randomized trials are needed across a broad range of diagnostic categories to test the effectiveness of interventions meant to incorporate geriatric medicine and palliative care principles in the community and earlier in the chronic disease process. Therefore, we designed the PEACE trial as a randomized trial to test an intervention that will target an array of progressive chronic conditions with community-dwelling elderly clients who are symptomatic with their illnesses. We developed standardized protocols from IAHPC, NQF, and NCP recommendations to make this model evidence based and easily generalizable. We use an interdisciplinary team, which is recommended for the complex issues encountered in geriatrics and palliative care,^2,3,24 and we take the team into the home to promote early advance care and goal-setting discussions before a crisis occurs. Because the NCP and NQF recommend case management for coordination of services across settings, we use PASSPORT care managers to implement the intervention in consultation with a palliative care nurse specialist, making the model more generalizable. The NCP states that all clients should have access to PCPs who are knowledgeable about basic palliative care practices; therefore, we provide all PCPs with academic detailing derived from evidence-based guidelines.¹¹ We collaborate with each client's PCP, including a paid PCP visit during which the PASSPORT care manager, client, and family (where appropriate) discuss the recommendations made by the interdisciplinary team to keep the PCP in control of the client's care, rather than a palliative care or geriatrics specialist. This is an efficient way to reach larger numbers of clients with fewer specialists, promotes continuity of care, and increases the palliative care and geriatric medicine skill set of community PCPs. We will be using outcomes recommended by the Outcomes Workgroup of the US Cancer Pain Relief Committee²⁵ to promote ease of interpretation and aid in comparison of outcomes between studies. We will analyze the data using multiple end point analysis, a novel application for a statistical technique that allows evaluation across multiple domains while protecting against Type I error.^19

–22 In a future, fully-powered trial, we will track costs through the state's Medicare and Medicaid databases because declining health care resources make it imperative to create a cost-effective model to integrate palliative care into the general health care system, as well as to overcome many of the barriers to continuity of care created by lack of integration of Medicare and Medicaid programs for the chronically ill. A cost-effectiveness analysis will be done in collaboration with health economists at Scripps Gerontology Center and the Department of Statistics at Miami University in Ohio, who have experience, knowledge, and familiarity with Ohio Medicare and Medicaid databases. The cost-effectiveness analysis also will include the costs of providing the intervention.

If the results of the PEACE trial show the superiority of the intervention, then this data will be important for health care policy makers who are concerned with finding effective ways to integrate acute and long-term care, specifically those involved with the emerging Patient-Centered Medical Home and Accountable Care Organization models. These models are based on the premise that, to successfully reengineer the health care system, we must eliminate silos (eg, insurance companies, physicians, hospitals, patients, community caregivers) and improve care coordination, quality, and satisfaction. The PEACE trial has accomplished this by successfully integrating providers not only across disciplines, but also across institutions with the explicit purpose of improving their coordination of care. Accountable care also requires that patients and providers have the knowledge and tools to effectively manage chronic illness care, including effective self-management. In the PEACE trial, we provide PCPs with the results of a thorough in-home medication review, a comprehensive biopsychosocial assessment, and academic detailing so that they have pertinent information to effectively address the patient's chronic illness. Patient goal setting and self-management coaching also are integral to the PEACE intervention. Finally, accountable care ultimately must reduce the total cost of health care. Although we do not yet have cost data for this study, we know anecdotally that only 1 of the intervention patients was admitted to a nursing facility, a number of patients died at home, and we made major medication changes for some patients that significantly improved their lives. It is the results of such trials, including cost analyses, that will help inform appropriate payment methods for multiple providers and stakeholders involved across the continuum. This includes community and social agencies, which are necessary but too often not considered in the “total care” of the patient. Our model, with its standardized, evidence-based medical and psychosocial intervention protocols, will transport easily to other sites that are interested in optimizing outcomes for chronically ill older adults.

Footnotes

Acknowledgments

The authors would like to thank Kent Westerfield, LSW, Judy Gabric, RN, Brenda Weaver, LSW, Dottie Geiselman, RN, Adrianne Hailey, RN, and Sandra Poorman, RN for serving as care managers for this study, all AAA assessment nurses for their assistance with client recruitment, Susan Sikora, RN and Michele Gareri, RN for patient recruitment and outcome measurement, and Kim Peterson for her assistance with study protocols and manuscript preparation. We would also like to thank the Area Agency on Aging 10B Inc., especially Sandee Ferguson, RN, MS

Author Disclosure Statement

Drs. Allen, Radwany, and Moore, and Ms. Hazelett, Ms. Ertle, and Ms. Fosnight disclosed no financial or personal conflicts of interest related to this study.

This study was funded by the National Palliative Care Research Center and the Summa Foundation. The sponsors of this study were not involved in its design or implementation.

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