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PROTOCOL
Effectiveness of advanced practice nurse-led telehealth on
readmissions and health-related outcomes among patients with postacute myocardial infarction: ALTRA Study Protocol
Karen Wei Ling Koh, Wenru Wang, A. Mark Richards, Mark Y. Chan & Karis Kin Fong Cheng
Accepted for publication 17 December 2015
Correspondence to W. Wang:
e-mail: [email protected]
Karen Wei Ling Koh MSN RN APN
Assistant Director of Nursing/PhD
Candidate
National University Heart Centre
Singapore, National University Health
System and Alice Lee Centre for Nursing
Studies, Yong Loo Lin School of Medicine,
National University of Singapore, Singapore
Wenru Wang PhD RN
Assistant Professor
Alice Lee Centre for Nursing Studies, Yong
Loo Lin School of Medicine, National
University of Singapore, Singapore
A. Mark Richards MD PhD FRACP
Professor/Director
Department of Medicine, University of
Otago, Christchurch, New Zealand and
Cardiovascular Research Institute, National
University Health System, Singapore
Mark Y. Chan MBBS MHS
Associate Professor
Yong Loo Lin School of Medicine, National
University of Singapore, Singapore
Karis Kin Fong Cheng PhD RN
Professor
Alice Lee Centre for Nursing Studies, Yong
Loo Lin School of Medicine, National
University of Singapore, Singapore
KOH K.W.L., WANG W., RICHARDS A.M., CHAN M.Y. & CHENG K.K.F.
Effectiveness of advanced practice nurse-led telehealth on readmissions and
health-related outcomes among patients with post-acute myocardial infarction:
ALTRA study protocol. Journal of Advanced Nursing 72(6), 1357–1367.
doi: 10.1111/jan.12933
(2016)
Abstract
Aim. To develop and examine the effectiveness of an advanced practice nurse-led
telehealth rehabilitative programme as a transitional nursing therapeutic on
readmission rates and health-related outcomes among patients with acute
myocardial infarction postdischarge.
Background. Patients suffering from acute myocardial infarction are experiencing
an increasing trend of frequent readmissions. This implicates both the effectiveness
of healthcare services and patient’s quality of life. Advanced Practice Nurse-led
telehealth rehabilitative programme has yet to be explored as a strategy to
minimize preventable readmissions and improve patient’s self-efficacy so as to
enhance quality of life after a heart attack.
Design. Randomized controlled trial with repeated measures.
Methodology. A consecutive sampling of 172 patients with acute myocardial
infarction will be recruited from a tertiary acute hospital in Singapore. Participants
will be randomized into two groups. The experimental group (ALTRA) will receive
Advanced Practice Nurse-led telehealth rehabilitative programme on discharge. The
control group will receive only standard follow-up care. The outcome measures
include readmissions, cardiac self-efficacy, cardiovascular risk factors, quality of life,
anxiety and depression. The data will be collected at the baseline, 1 and 6 month
postdischarge. A postprogramme evaluation will be conducted among the
participants to assess its acceptability, strengths and weakness.
Discussion. ALTRA aims to engage and support patients with acute myocardial
infarction by increasing self-care management through education and telehealth
contacts with Advanced Practices Nurses. This provides a smoother transition of
illness to health and ultimately, reduces preventable costly readmissions.
Trial registration. The study has been registered with clinicaltrials.gov. The trial
registration number is NCT02483494.
Keywords: advanced practice nurse, cardiac rehabilitation,
outcomes, postacute myocardial infarction, readmissions, telehealth
© 2016 John Wiley & Sons Ltd
health-related
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K.W.L. Koh et al.
Why is this study needed?
Readmission after an acute myocardial infarction is a rising concern. The recovery and coping strategy after a traumatic life-threatening event can be very challenging for the
patients.
Most patients do not attend the cardiac rehabilitation programme which aims to enhance quality of life and have
shown to reduce readmissions. As such, newer nursing care
strategies need to be developed and researched on to
encourage self-care management while optimizing the right
siting of care provision by the healthcare industry.
Introduction
Cardiovascular disease is the global leading cause of death
with 7 3 million deaths attributed by coronary artery disease
(CAD) in 2008 (World Health Organisation 2013). Ischaemic heart disease is the third leading cause of both death and
illness for hospitalization in Singapore (Ministry of Health
2014a,b). Epidemiological data show that the incidence of
acute myocardial infarction (AMI) in 2013 is 9463 in Singapore (Ministry of Health 2015). While advanced medical
technologies have tremendously improved the in-hospital survival after an AMI, more patients are now at risk of readmission after being discharged into the community. In the USA,
nearly 20% of patients with AMI are readmitted within
30 days of discharge costing its government a hefty USD 17
billion annually (Bradley et al. 2012, Centers for Medicare
and Medicaid Services 2013). In National University Heart
Centre, Singapore (NUHCS), approximately 10 8% of its
patients (N = 743) with AMI were readmitted between
August 2011–July 2012. Although NUHCS data maybe significantly lower, frequent readmissions inclusive of emergency department (ED) visits pose operational, resource and
financial constraint on healthcare system. As of date, little is
known in Singapore context as to an effective intervention to
reduce such costly readmissions. The purpose of this paper
was to present a research study protocol to examine the
effectiveness of advanced practice nurse (APN)-led telehealth
on readmission rates and health-related outcomes among
patients with AMI. Current literature on interventions to
reduce readmissions will be explored and the theoretical
framework underpinning the research will be discussed.
Background
Readmissions have been shown to be associated with lower
patient satisfaction and poorer healthcare quality and efficiency (Boulding et al. 2011). This certainly reflects the gap
in the current clinical practice for postdischarge care of AMI
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patients. As such, the Centres for Medicare and Medicaid
(CMS) in States have started to publish to publicly 30 days
rehospitalization rates for heart failure, pneumonia and AMI
in as part of a federal strategy in attempts to improve quality
of care and reduce preventable readmission (CMS 2013).
This stresses the urgency to ensure that health care is effective in meeting the needs of patients during the transition
period from hospital to home and to keep them healthy in
the community.
The recovery and coping strategy after a traumatic lifechanging event can be daunting for both the patients and
families. They often feel vulnerable especially when there is a
lag time of a minimum one month’s wait in the follow-up
appointment. During the stressful acute phase of hospitalization, educating self-care to patients pose to be challenging
given that the lack of physical and psychological readiness
due to their acuity of illness, fatigue and anxiety
(Commodore-Mensah & Himmelfarb 2012). These do not
only impacts the patient’s confidence level to perform certain
lifestyle modifications for a healthy heart but also on psychosocial aspects of well-being as 15% to 20% of AMI
patients subsequently develop anxiety or depression (Sarkar
et al. 2007). It was also demonstrated in a prospective
cohort study (N = 1024) that lower self-efficacy among CAD
patients had statistically significant lower overall health and
quality of life and higher physical limitation and symptoms
burden (Sarkar et al. 2007). Such factors could have interplayed and resulted in patients seeking for medical attention
via readmissions as a maladaptive coping strategy.
Cardiac rehabilitation (CR), a structured programme comprises medical reviews, exercises, didactic education and personalized counselling, has been highly recommended as
national guideline to provide effective secondary cardiovascular disease prevention to reduce risk factors profile, readmissions and enhancing the quality of life (Scottish
Intercollegiate Guidelines Network 2002). In a meta-analysis
(N = 63), secondary prevention programmes demonstrated a
positive effect on risk factors, quality of life and even
reduced recurrent AMI by 17% over a median of 12 months
among CAD patients (Clark et al. 2005). The different
strategies of: (1) education only; (2) education and supervised exercise; or (3) structured supervised exercise did not
show superiority in terms of benefits (Clark et al. 2005).
Despite its proven outcomes, participation rates of CR
remain poor (Beswick et al. 2004). There is a multitude of
factors that poses as a barrier for attending CR. For example, demographical factors such as age and transportation
access, medical history such as severe myocardial infarction
or multiple co-morbidities, or health belief such as nonattendee not wanting to be reminded of their heart
conditions played a role in the low participation rates
(O’Connell 2014).
© 2016 John Wiley & Sons Ltd
JAN: PROTOCOL
It is imperative to seek for alternative strategies to engage
and support patients during this transition of illness without
the physical needs of travelling. A review of seven randomized controlled trials of patients with AMI demonstrated
increasing evidence that home care with elements of education, exercise and nursing support postdischarge via home
visits or telephone calls reduces readmission rates (Koh
2014). Reduction in readmissions will ultimately lead to
decrease emotional and economic impact on the patient’s
end.
Studies, using the Master’s prepared APNs, have demonstrated reduced readmissions, lengthened time between readmissions and decreased healthcare cost. An example of
beneficiary includes APNs rendering comprehensive discharge planning and home follow-up interventions in high
risk of rehospitalizing older patients (Naylor et al. 2004,
McCauley et al. 2006). Further rigorous research engaging
APNs as part of the nursing therapeutics would serve to
establish their effectiveness in optimizing healthcare services
and reducing costly readmissions. In a systematic review
(N = 9), telehealth was demonstrated to reduce both allcause and heart failure readmissions among chronic heart
failure patients in two thirds of the trials (Chaudhry et al.
2007). Telemonitoring or telehealth is defined as the use of
communication technologies to monitor patient’s clinical
status remotely and is gaining attention as an intervention to
facilitate and improve self-care of patients with chronic
diseases (Chaudhry et al. 2007, Anker et al. 2011). A
qualitative study showed that heart failure patients on telemonitoring for 6 months developed self-care skills in decision-making and ability to monitor their own conditions
(Riley et al. 2013).
The combination of increasing readmissions and low
participation rates of secondary prevention programme like
cardiac rehabilitation hold major implications for nursing
practice in the delivery of care for post-AMI patients. Newer
strategies need to be developed and researched on to cater to
changing demands of healthcare consumers especially in
encouraging self-care management while optimizing the right
siting of care provision by the healthcare industry. The
review on the seven randomized controlled trials showed limited but increasing evidence that home-based post-AMI programme implemented immediately postdischarge can assist
the early recovery phase resulting in reduction in healthcare
cost due to inappropriate use of health services such as hospitalization or ED visit (Koh 2014). With increasing complexities due to multiple co-morbidities and psychological
issues in patients post-AMI, a home-based follow-up strategy
using innovative remote monitoring via telehealth and APNs
to provide patient’s rehabilitative care is a potential area of
research to evaluate its effectiveness to reduce readmissions
and improve health-related outcomes.
© 2016 John Wiley & Sons Ltd
ALTRA study
Theoretical framework
Meleis’ middle-range theory of transitions has been selected
as a guiding framework for conceptualizing the transitional
nursing care therapeutics and its relevant study variables in
relations to transiting from hospital to home after a lifechanging event such as AMI (Meleis et al. 2000). This
change in health status places an individual into a transition
process and a period of vulnerability to risks that may in
turn affect their health (Meleis et al. 2000). The development
of nursing therapeutics should be focused on preventing
unhealthy transitions while health and well-being is the
outcome of the process (Meleis & Trangenstein 1994). The
four main components of the transition theory that will be
explored in this study include:
(1) nature of the transition – AMI as health and illness event
requiring hospitalization;
(2) transition conditions – patient’s demographics;
(3) nursing therapeutics – APN-led telehealth with care mon-
itoring and education; and
(4) patterns of response – readmissions, confidence level, sub-
jective and objective well-being.
Figure 1 illustrates the proposed theoretical framework
with its variable for this study. The theory proposes that the
first three dimensions will affect the individual’s patterns of
response during the transition. The three time frames of transition flow in this study are: (1) hospitalization during which
discharge preparation occurs; (2) transitional phase postdischarge supported with nursing interventions and (3) home at
community.
The study
Aims
The aim of the study is to develop and examine the effectiveness of an APN-led telehealth rehabilitative programme
as a transitional nursing therapeutic on readmissions and
health-related outcomes among patients with AMI postdischarge.
Research questions
The research questions are as follows:
(1) What is the effectiveness of APN-led telehealth programme (ALTRA) in:
•
•
reducing readmission days per 1000 follow up days,
improving health-related outcomes including cardiac
self-efficacy, cardiovascular risk factors, quality of
life, anxiety and depression?
1359
K.W.L. Koh et al.
Unhealthy
Hospital
Home @
Community
Transition
Support
Healthy
Patterns of Response
Nature of Transition
Health/Illness Related
Process Indicators
Developing Confidence
and Coping with New
Lifestyle
– Acute Myocardial
Infarction & Status
– Admission Status
– Length of Stay
Transition Conditions
Patient Characteristics
–
Nursing
Therapeutics
APN-led Telehealth
– Care monitoring
– Education
Age/Gender/Race
Socioeconomic Status
Lives Alone
Risk Factors
– Cardiac Self Efficacy
– CV Risk Factors
– Quality of Life
– Anxiety/Depression
Outcome Indicators
Mastery for Healthy
Transition
– Readmission
– Emergency Visit
Figure 1 Theoretical framework.
(2) What are the participant’s perceptions and experiences
using ALTRA?
either to the experimental or control group using pre-sealed
envelopes.
Research hypotheses
Participants
It is hypothesized that compared with those in the control
group, participants in the ALTRA group will:
(1) have significantly lower readmission days per 1000 follow up days;
(2) have significantly higher levels of cardiac self-efficacy;
(3) have significantly better control of cardiovascular risk
factors;
(4) report significantly higher levels of quality of life;
(5) report significantly lower levels of anxiety and depression.
Sampling method
The target population will be high-risk patients admitted to
a tertiary acute hospital in Singapore with an episode of
AMI. A consecutive sampling of patients admitted to Coronary Care Unit (CCU) or cardiac wards of the acute hospital
will be adopted over an 18 months interval. Inclusion criteria
are: (1) age above 21 and below 85; (2) clinical diagnosed
and documented AMI as primary diagnosis managed by
NUHCS including pre-discharge N-Terminal –pro Brain
Natriuretic Peptide (NT-proBNP) ≥400 pg/mL for STEMI
and ≥600 pg/mL for NSTEMI; (3) Undergone PCI for the
index event; (4) able to read and speak English and Chinese;
and (5) has access to telecommunications. Exclusion criteria
are: (1) patients discharge to institutionalized care; (2) coexisting terminal illness such as cancer; (3) psychiatric or
cognitive disorders; (4) impaired bilateral hearing or vision
and (5) patients requiring vascularization via coronary artery
bypass graft surgery.
The use of NT-proBNP as a prognostic predictor of cardiovascular death and stroke was clearly demonstrated in a
Design/methodology
Design
The research is designed as a single-centre randomized twoarmed parallel controlled trial to examine the effectiveness
of APN-led telehealth in reducing readmission days in high
risk AMI patients. After obtaining written consent and
baseline measurements, the study participants identified as
high-risk will be stratified and then randomly assigned
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© 2016 John Wiley & Sons Ltd
JAN: PROTOCOL
longitudinal study (N = 3761) and this would help clinicians
to better identify patients who were of a higher risk resulting
in a need for hospitalization (Omland et al. 2007). Based on
cardiologists’ expert opinions on analysis of local data, the
cut-offs for the NT-proBNP levels have been recommended
for Asian population to be of a higher risk of all subsequent
post-AMI deaths and heart failure events.
Sample size determination
A conventional medium effect size, according to Cohen’s recommendation and a previous study with 50 per cent reduction in readmission days per 1000 follow up days, will be
used to determine the sample size required (Cohen 1992,
Young et al. 2003). A minimum sample size of 63 in each
arm and a total of 126 would be required to detect a minimally important difference in reducing relative readmission
days of 50 per cent between the two groups at 80% power
and 5% error. An attrition rate of 35% is estimated for this
study based on a previous study that examined the effect of
telephonic follow-up of AMI patients postdischarge on
health-related quality of life (Hanssen et al. 2009). It is
planned to recruit a minimum of 172 participants in this
study with 86 patients in each group.
Randomization
Patients who are admitted to CCU or cardiac wards will be
screened for eligibility. Once eligible, patients will be invited
to participate in the trial and an informed consent will be
taken by the principal investigator. Thereafter, a blood sample will be taken to measure the NTproBNP level. After
meeting the required levels of NTproBNP, participants will
first undergo stratified randomization according to the Acute
Coronary Syndrome subgroup: ST-Elevation Myocardial
Infarction (STEMI) and Non ST-Elevation Myocardial
Infarction (NSTEMI). Thereafter, they will be randomized
into the TELEHEALTH vs. CONTROL group in 1:1 sequential block randomization (blocks of 4-6). This is to achieve
treatment groups of equal sizes (Schulz & Grimes 2002).
Randomization will be done manually with sequentially
numbered, opaque pre-sealed envelopes at the research site.
The envelope will be drawn for each successfully recruited
participant without replacement. A new bag of envelopes
will be created for subsequent varying blocks until the
sample size has been achieved.
Study intervention
APN-Led teleheath rehabilitative programme
The experimental arm will receive APN-led telehealth management for: (1) 2 months of intensive telehealth follow-up;
and (2) continuous monitoring with calls for the subsequent
© 2016 John Wiley & Sons Ltd
ALTRA study
4 months. Both groups will receive usual follow-up care
which comprises inpatient education by cardiac care nurses,
cardiologist, or APN follow up at first and fifth month
postdischarge and option to enrol into outpatient structured
cardiac rehabilitation programme.
Initial …
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