|The causes of unsuccessful post-hospitalization transitions
for chronically-ill patients
|Between 20% and 30% of hospitalized medical patients are
readmitted within the first 30 days post-discharge [1-4]. Adverse
outcomes often result from patients' difficulty managing their complex
self-care regimens [5,6]. Problems include inadequate clinician
monitoring post discharge [2,7,8], and caregivers often are left out of
the communication loop further contributing to preventable
rehospitalization, emergency care visits, and higher healthcare costs
[9-11]. Care management can reduce rehospitalization rates and
mortality risk [12-14], but resources required to provide these services
are often unavailable . Nurse telephone calls post-discharge are
labor intensive [16,17], and evidence is still weak that post-discharge
clinician follow-up alone improves outcomes [18-24]. Comprehensive discharge planning is a key feature of transition support programs
[25,26], but is frequently impossible to provide during brief hospital
stays and also has variable evidence as a stand-alone intervention .
Patients often do not understand their medications or chief diagnosis
at discharge , and few systems are in place to ensure that key
information is transferred to the clinicians who will follow the patient
in ambulatory care [29-31].
|The importance of strengthening informal care post
|Informal caregivers often play an important role in supporting
chronically-ill patients’ efforts to: follow self-management plans,
identify early warning signs of acute illness, absorb the extensive selfcare
information patients need to stay well [32-35], use formal health
systems effectively, and cope emotionally with their ongoing illness
[36-38]. Unfortunately, social networks of potential caregivers are often
fragmented , and patients frequently are unwilling to ask loved ones to play a more active role . Although adult children typically
feel involved in their ill parents’ care regardless of geographic distance
, there typically is no internal mechanism within the patient’s
social context for these potential caregivers to assume clearly defined
|Interactive voice response (IVR) telephonic communication
to improve transitions
|In this trial, we use IVR calls as a primary tool for increasing
communication between patients, informal caregivers, and clinicians.
IVR communication has low marginal cost and is accessible to patients
regardless of their location or computer literacy [44,45]. Automated
calls can identify important health concerns arising post-discharge
[7,46], and studies show that most patients are very satisfied with such
services; some even preferring automated calls to “live” calls from a
clinician [47-51] .Chronic disease management models that include
IVR calls are feasible [48,52,53] and provide valid and reliable data
about patients' status between visits . In prior trials we have shown that disease management programs including automated telephone
assessments can improve outcomes for outpatients with diabetes or
with heart failure [54-58].
|The current trial uses IVR-based caregiver involvement to support
the goals of transition support as defined in project “BOOST” (better
outcomes for older adults through safe transitions; Table 1) . In
brief, this model includes pre- and post-discharge components
supported by specific recommendations and structured clinical forms
for managing key patient-centered information, e.g., a patient
discharge preparation list, Personal Health Record, and forms for
reconciling medications. A quasi-experimental trial of the BOOST
service showed a 50% reduction in 30-day rehospitalization rates and a
57% reduction at 90 days ; results were similar in a subsequent
randomized trial . Several recent studies have demonstrated that
feedback to informal caregivers may increase the effectiveness of IVRbased
interventions supporting self-management while simultaneously
decreasing caregiver distress [58,60-62].
|Intervention and conceptual framework
|The intervention evaluated in the current trial is designed to
improve outcomes through three separate mechanisms of action
(Figure 1): tailored and timely education provided directly to the
patient via IVR, improved clinical follow-up based on monitoring
reports and fax alerts, and more active and empowered caregivers. To
our knowledge this is the first model to improve the quality and
quantity of informal care for discharged patients by: (a) increasing
informal caregivers’ knowledge of patients’ health status and
behavioral needs, (b) educating caregivers about the key goals of
successful community transitions, and (c) giving caregivers targeted
advice about how to address problems and communicate effectively.
|Patients are identified at the time of an acute-care medical
admission to: the University of Michigan Health System, the VA Ann
Arbor Healthcare System, and a third non-profit private healthcare system in Michigan. Patients are eligible if they are at least 50 years of
age and have a common chronic illness frequently associated with an
increased risk of rehospitalization due to inadequate transition support
, i.e., chronic heart failure, stroke, coronary artery disease
requiring hospitalization, arrhythmia, chronic obstructive pulmonary
disease, peripheral vascular disease, deep vein thrombosis, pulmonary
embolism, pneumonia, type 2 diabetes, urinary tract infection,
gastroenteritis, Clostridium difficile infection, or asthma. Patients are
excluded if they: have a serious mental illness such as schizophrenia,
are in hospice care, do not speak English, are unable to use a telephone,
have a non-health system-affiliated primary care provider, are unable
to nominate a potentially eligible “CarePartner” (see criteria below), or
are cognitively impaired during hospitalization as determined by a
validated screener . Recruitment nurses use specially designed
algorithms to conduct queries of admission data to identify potentially
eligible patients' diagnoses and possible exclusionary criteria.
Additional patients are identified based on reviews of charts for newly
admitted patients. The recruiter meets with potential recruits in the
hospital to describe the study, screen for eligibility, and obtain
|Patients in both study arms are asked to nominate an informal
caregiver or CarePartner (CP) living outside of their household who is
willing to play a structured role in their transition care. We use the
norbeck social support questionnaire (NSSQ)  to identify the
people with whom the patient has the most frequent contact and who
provide the most instrumental and emotional support. Based on NSSQ
scores, research assistants assist the patient in identifying the most
suitable person to serve as their CP. Potential CPs are contacted by the
recruitment nurse in person or by phone during the hospital stay or
when absolutely necessary, during the first 7 days post discharge. CPs
are ineligible if they have a serious mental illness, do not speak English,
are less than 21 years of age, or do not have access to email.
|After patients complete their informed consent and baseline
assessment, they and their CP are randomized to the intervention
group or usual care. The randomization procedure is concealed to
recruiters by means of pre-sealed envelopes. Group assignment is not
disclosed to patients until after they have completed baseline surveys.
|Usual care: All study participants continue to receive usual care in
which discharge instructions and a written list of medications are presented by a member of the nursing staff. CPs randomized to the
usual care group receive written information about how to successfully
support the patient’s transition from hospital to home, including
information provided by the national caregiver alliance
(www.caregiver.org). They also receive self-care information specific to
their patient-partner’s discharge diagnoses.
|CarePartner program intervention: (Table 2) Intervention patients
review with the recruitment nurse materials based on the BOOST
transition program, such as the Personal Health Record and structured
discharge preparation checklist. We use information from the inpatient
record along with any specific instructions from the practice to identify
each patient’s “care manager,” i.e., primary contact for post-discharge
follow-up, prior to discharge. Also prior to discharge, patients have
post-discharge primary care visits scheduled by the inpatient team
with support from the recruitment nurse. Visit information is recorded
in the patient’s Personal Health Record, and the recruitment nurse
enters the dates/times into the IVR follow-up system so that patients
and their CPs can receive reminder calls.
|At the time of enrollment, intervention-group patients indicate the
times and phone numbers with which they would like to receive their
IVR assessment and self-care support calls. During the initial two
weeks post discharge, patients receive daily assessment calls with up to
three attempts made at 30-minute intervals. The system re-calls the
patient if a busy signal is received, and if someone other than the
patient answers the call, the service instructs the person to bring the
patient to the phone or can call back at a later time. After the initial
post-discharge period, patients receive IVR assessments three times
per week for two weeks, and then weekly for the remainder of the 90
days. Calls to patients include statements and queries recorded in a
human voice. Patients respond to requests for information using the
touch-tone keypad on their telephone. Reminder messages to patients
(via automated calls) and to their CPs (via email and automated
reminder calls) reinforce dates of follow-up appointments and possible
ways to address barriers such as transportation problems.
|During IVR calls, patients receive recorded feedback about
problems they report. Feedback messages are designed to: reinforce the
importance of medication adherence, remind patients to use the
information from their patient-centered record to schedule and attend
appointments; remind patients about primary care and specialist
follow-up; and teach patients various “red-flags,” i.e., indicators of
worsening health status and how those should be addressed. Although
most of the call content focuses on general self-care issues such as
medication adherence, key disease-specific issues also are addressed.
For example, for patients diagnosed with heart failure, the calling
system asks patients about possible changes in weight and provides
information about the connections between fluid retention and
medication adherence, salt intake and fluid intake . Action
suggestions specify whether the patient should contact their CP and/or
care manager and the suggested timeframe for responding. During
each call, patients are instructed to call 911 if they are experiencing
urgent problems such as chest discomfort. At the end of each call,
patients have the option of hearing the name and phone number of
their care manager.
|Urgent problems such as breathing difficulties generate a fax alert.
The thresholds for these alerts were negotiated with representatives of
the primary care leadership in the participating health systems, and in
some cases care managers are able to tailor those thresholds across
patients and over time for a given patient. Care managers have access to a website that includes panel-level data based on patients’ most
recent assessments that identifies patients with urgent and non-urgent
problems. Care managers also are able to review patients’ complete
calling history, including preferred calling times, rates of completing
assessments, and what patients reported in each assessment call.
|CPs can access feedback about the patient’s status via the Internet or
a specially designed voicemail system. CPs receives e-mail reports
summarizing the results of patients’ automated assessment and
behavior change calls. Email feedback about urgent issues is
accompanied by a brief automated call, alerting the CP to check their
e-mail for a detailed report. CPs can call in to the system using a tollfree
number, identify themselves based on a PIN, and receive
information about the patient’s most recent IVR assessment.
|CPs and any in-home caregivers in the intervention arm receive
informational support for their interactions with each other (Table 3),
including materials designed to encourage effective communication
regarding the patient’s post-discharge care via principals of
motivational interviewing . The CP is asked to initiate 10
minute-15 minute conversations at least weekly with the patient to
review the patient's upcoming post-discharge appointments, selfmanagement
goals, and most recent automated assessment reports.
During those conversations, CPs are asked to address each of the four
pillars of effective transitions within the Coleman model [65,67,68].
CPs and other caregivers can opt to receive a supplemental study
training DVD that reiterates and extends the content provided in
written materials regarding issues such as role expectations for patients
and caregivers, and the suggested structure for the CP-patient followup
conversations. CPs are encouraged to speak regularly with any inhome
caregivers. Effective communication among all caregivers is
promoted through communication of “core values” for the program,
including: equal access to information and strategies for assigning
tasks and resolving potential disagreements. Email summaries
following patients’ assessment calls also are sent to patients and other
caregivers at their request. CPs and in-home caregivers have access to a
toll-free number that they can call to hear automated information
including the recommendations from the patient’s most recent
assessment. Informational messages in the emails to CPs and study
material provided at enrollment emphasize the importance of keeping
all caregivers informed.
|Individual patient assessment calls include reminders to patients
regarding the importance of contacting their care manager if their
health deteriorates, and patients can access contact information for
their primary provider during each call. CPs are instructed to
encourage their patient-partner to contact their clinicians directly,
rather than having the CP serve as a communication intermediary.
|Description of measures
|Patients complete a telephone interview with a trained research
assistant at baseline, 30 days and 90 days post-discharge (Table 4). The
goals of the survey are to measure patients’ health service use, healthrelated
quality of life, self-care behaviors, understanding of the transition process, interaction with CPs, and socioeconomic
vulnerabilities. At follow-up, patients are asked whether they attended
post-discharge appointments and the reasons for any missed
appointments. Patients report their pattern of CP telephone and inperson
contact. Patients also report information about discussions
with their CP regarding their self-care, whether they are comfortable
disclosing information to the CP, and whether the CP is too burdened
by other life issues to be of much help . Finally, patients report the
extent to which they discuss with their CP self-care issues that are the
focus of the intervention, including medication use, appointment
adherence, and behavioral goal setting. Patients in the intervention
group also complete a brief survey of their intervention satisfaction.
|CP surveys are conducted at baseline and 90 days via email with
follow-up postal mailings. CPs report their pattern of patient contact
and the extent to which they discuss with the patient self-care issues
that are the focus of the intervention, including use of positive
feedback, overcoming barriers to self-care, and reminders about
medication refills. CPs’ perceptions of the quality of their relationship
with the patient are measured using items similar to those described
above for the patient survey . We use second-person adapted
versions of the patient measures of adherence and HRQL to assess
caregiver’s perceptions of the patient’s status. We use these data to test
the hypothesis that the gap between patient and CP perceptions will
decrease in the intervention arm of the study, while remaining the
same (or even growing) in the control arm.
|Semi-structured interviews are conducted with a purposive sample
of patients, CPs, in-home caregivers, and clinicians involved in these
patients’ transition care. Interviewees are selected so that the sample is
diverse in terms of patients’ race, gender, age, and the patient’s baseline
health-related quality of life scores. Topics covered during the patient
interviews include: patients’ self-efficacy for managing their self-care,
the perceived role of their CPs in their transition care, and (for patients
in the intervention arm) strengths and weaknesses of the intervention
and suggestions for improvement. Similar topics are explored in the CP
and clinician interviews, with an added emphasis on possible changes
in caregiving strain, and communication with their patient-partner
and other caregivers.
|Information on patients’ inpatient admissions and outpatient visits
to primary care and specialty care is obtained from electronic clinical
and billing records. At enrollment, patients are asked to approve
retrieval of discharge information from non-affiliated hospitals. Vital
status of patients who cannot be contacted at follow-up is determined
using requests for information from the health systems, informal
caregivers, and a National Death Index search. The IVR calling system
automatically captures information on: the time, date, and outcome of
all patient call attempts; all patient reported information from the
assessments; copies of all CP and care manager e-mails; copies of all
care manager faxes, and a record of all CP and care manager log-ins.
|Data management and analysis plan
|Patients are the unit of randomization and analysis. Potential
variation in outcomes across care managers will be treated as fixed
effects. Our primary outcome is 30-day rehospitalization [86,87].
Power for the trial was calculated assuming 22% of usual care patients
will experience a rehospitalization within 30 days post-discharge, a rate
consistent with prior studies and our own hospital tracking systems
[17,88,89]. We calculated the sample size of 760 subjects to provide
80% power to detect a 35% reduction in this rate, assuming a twotailed
alpha of 0.05. To conservatively allow for up to 10% attrition, we
will recruit a total of 846 patients. A sample of this size also will be
sufficient to detect a medium/small effect on SF-12 scores (i.e., the
effect observed in the Sisk  trial) and other continuous outcomes.
|We will examine differences across treatment groups in baseline
measures of study endpoints as well as other potential prognostic
indicators, such as patients’ age, race, and gender. As in our prior
studies [52,53] we will monitor the completion rates for automated
assessment calls and the correlates of system use. Intervention
satisfaction ratings will be correlated with system use, patients’
baseline characteristics, and changes in patients’ status between
baseline and follow-up.
|All outcome analyses will be conducted based on intention to treat.
We will use Kaplan-Meier survival curves to assess differences in
event-free survival during the 30 and 90 days post-discharge period.
Survival curves will be compared using log-rank tests. If chance
differences occur between baseline characteristics of CarePartner and
usual care groups, we will use Cox proportional hazards models to
control for these differences. We will use t-tests to evaluate differences
across groups in HRQL change scores between baseline versus 30 days
and 90 days. Differences with p<0.05 will be considered statistically
significant. In the event that groups are found to be different on
important baseline characteristics, we will use MANCOVA models
comparing change scores controlling for unbalanced covariates. We
expect that most continuous endpoints for the trial such as adherence
scores and patients’ satisfaction with the quality of the transition
process will be normally distributed. All of these analyses will be based
on similar models, with scores at 30 days and 90 days as dependent
variables, scores on the same variable at baseline as a covariate, and
treatment group as the independent variable.
|We will use standard techniques  to evaluate changes in the
magnitude of the relationship between experimental condition and the
outcome before and after potential mediators (e.g., changes in CPpatient
communication) are introduced. Analyses of effect moderation
will focus on patients’ baseline need for social support, baseline health
status, characteristics of their CP (e.g., competing demands), and the
presence of an in-home caregiver . We will examine potential
intervention effects within subgroups of patients who do and do-not
report an in-home caregiver. We then will create multivariate models
that include a main intervention effect along with a term for the
interaction between intervention group and in-home caregiver
availability. We will examine both positive and negative impacts of the
intervention on caregiving stress, how CPs and other caregivers
distribute responsibilities, and the role of CPs in supporting patients’
interaction with their healthcare team.
|Results and Discussion
|The intervention protocol was approved by the University of
Michigan Institutional Review Board, the Ann Arbor VA Human
Subjects Committee, and the MidMichigan Health System Institutional
Review Board. The trial has been registered in clinicaltrials.gov
(ID#NCT01672385). All patients provide written informed consent. A
total of 352 patients have been recruited as of August 1st, 2015.
Recruitment and data collection are ongoing.
|Patients with complex chronic conditions experience frequent and
costly hospitalizations , and many have unsuccessful transitions
back to the community post-discharge . Proactive, post-discharge
follow-up can reduce patients’ rehospitalization risk [14,93], but most
health systems lack the staffing and information infrastructure to
provide these services effectively. New models of transition support
articulate the characteristics of effective services , but clinicians
often cannot provide the intensive self-care assistance that these
programs prescribe . Informal caregivers represent a low-cost and
effective adjunct to care management [95,96], but caregivers lack: the
tools they need to monitor patients’ status, the education necessary to
understand patients’ self-care needs, and the skills to know how to
respond when issues arise during a transition from hospital to home.
Increasingly, high-risk patients live alone; and when spousal caregivers
are available, they often are overwhelmed by competing demands,
including their own healthcare needs [97,98]. The challenge for
improving post-discharge outcomes is to identify services that can
support patients, their clinical teams, as well as informal caregivers to
improve transition quality while preventing caregiver strain.
|In this trial, we are evaluating a unique combination of accessible
health technologies and coordinated communication among patients’
informal caregivers and their clinical teams to fill the growing gap
between what discharged patients' need and available resources. A
unique advance in the intervention is the explicit provision of
transition support not only for patients but also for an informal
caregiver or CarePartner. Unlike prior efforts that require additional
staffing, the proposed program is designed to enhance care and
outcomes using resources that can be easily integrated with available
discharge planning procedures. To our knowledge, this is the only
study of its kind to challenge the paradigm of clinician-centered postdischarge
care by explicitly providing informal caregivers with a
structured role and the tools they need to be integral members of the
care-support team. Unlike most transition programs that focus on problems related to a single disease, this intervention recognizes that
patients frequently are readmitted for any number of health issues
other than a given index condition, and therefore the intervention is
designed to accommodate patients with a wide range of admitting and
|One potential disadvantage of this intervention is that it
theoretically could generate unnecessary health service use among
patients by increasing their overall sensitivity to relatively benign/selflimiting
symptoms. However, data from our prior studies [54-57] have
not shown increased outpatient visit rates. The weekly calls, which
begin after two weeks of daily calls and two weeks of 3x/week calls,
may be insufficient to promptly identify some rapid medical
deteriorations. No hard evidence has established the most appropriate
frequency of assessments for patients after a hospitalization, and we
believe that the proposed plan provides a balance between sensitivity
to developing problems and potential false-positives from self-limiting
conditions. Patients in the intervention have established access to a
care manager and their CP should their symptoms deteriorate between
assessment calls. Study participants receive follow-up from a limited
number of care managers, which may both limit generalizability and
make it impossible to evaluate variation associated with care manager
practice style. Finally, baseline surveys with CPs are conducted after
patients are randomized. While this is not ideal, we believe that it is
more important to initiate patients’ IVR assessments immediately after
their discharge so that the first few days following discharge are closely
monitored for short-term complications.
|In closing, we are testing a unique combination of accessible health
technologies and coordinated communication for patients, their
informal caregivers, and their clinical teams. A unique advance in this
intervention is that-by giving caregivers greater information,
education, and support-the program may decrease the burden, stress,
and frustration that caregivers frequently experience. We hope that
this and similar interventions will address the substantial gap between
what discharged patients need and the resources that are realistically
|John Piette is a VA Senior Research Career Scientist. The study was
funded by the National Institute of Aging (NIH grant: R01AG039474).
Additional financial support came from grant number P30DK092926
from the National Institute of Diabetes and Digestive and Kidney
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