A Nurse-coordinated Integrated Care Model to Support Decision-making and Self-care in Patients With Atrial Fibrillation: A Randomized Controlled Trial
Phase: NA
Conditions: Atrial Fibrillation
Sponsor: The University of Hong Kong

Study Protocol and Analysis Plan (English version, version 2, 11 Dec 2019) 
 
 
Study Protocol and Analysis Plan 
Study Official Title: A nurse-coordinated integrated care model to support decision-making and self-care in 
patients with atrial fibrillation: A randomized controlled trial   
Principal Investigator:   
Prof. Li Wai-chi, Polly, Assistant Professor, The School of Nursing, HKU   
Co-Investigators:   
Prof. Yu Sau-fung, Doris, Professor, The School of Nursing, HKU   
Prof. Yan Ping-yen, Bryan, Associate Professor, Department of Medicine and Therapeutics, CUHK   
Background of research   
Health implications in patients with atrial fibrillation   
Atrial fibrillation (AF) is a common abnormal cardiac rhythm characterized by an irregular and rapid heartbeat.   
In this condition, uncoordinated electrical activity causes ineffective atrial contractions and variable ventricular  
activation. Sluggish atrial blood flow increases the risk of blood clot formation, which itself independently increases  
the risk of cardio-embolic stroke by five-fold in AF patients, compared to people with a normal sinus rhythm.[1] In  
addition, AF is associated with tachycardia-induced cardiomyopathy in patients with a poorly controlled ventricular  
rate.[2] AF also predisposes patients to increased risks of myocardial infarction,[3, 4] heart failure,[5] dementia,[6]  
and death.[7] Indeed, the healthcare burden associated with AF-related hospitalization has largely surpassed that  
associated with heart failure.[8] Given these detrimental health consequences, international practice guidelines[9]  
have highlighted stroke prevention and arrhythmia control as the major focuses of AF management, whereas the  
management of modifiable risk factors is equally important to improving the their health outcomes of AF patients.[10,  
11]   
Challenges associated with stroke prevention   
To minimize the AF-associated risk of stroke, international guidelines[9, 12] recommend providing oral   
anticoagulants (OACs), either vitamin K antagonist (VKA) or non-vitamin K antagonist oral anticoagulants  
(NOACs), to male patients with ≥1 and female patients with ≥2 of the following risk factors: congestive heart failure;  
hypertension; age ≥75 years; diabetes mellitus; prior stroke or transient ischemic stroke or thromboembolism;  
vascular disease; age 65 to 74 years and female sex (i.e., CHA2DS2-VASc score). Despite compelling evidence  
supporting the strong efficacy of OACs in preventing stroke in AF patients, the use of these agents is limited by three  
major factors: under-prescription, non-adherence, and a suboptimal therapeutic range for VKA treatment. A  
systematic review of 54 studies found that 50% of high-thromboembolic-risk AF patients did not receive appropriate  
OAC therapy.[13] Likewise, a recent study[14] of 9,727 patients with AF in Hong Kong reported that nearly 40%  did 
not receive OAC therapy and another 40% received only conservative aspirin therapy, which has proven  
ineffective for AF-related stroke prevention. OAC under-prescription is mainly attributable to physicians’ concerns  
regarding the side effect of an increased bleeding tendency,[15] as patients are more willing to bear this risk, given  
the benefit of preventing a stroke episode.[16] However, physicians inaccurately perceive that patients fear the risk  of 
bleeding more than the risk of stroke.[17] The investigation team revealed similar findings in another local  
study,[18] where physicians reported the perception that patients were at a high risk of developing adverse events as  
the most common barrier to OAC prescription. The physicians reported moderately high levels of decisional conflict,  
as they did not fully understand patients’ views regarding the risks and benefits of OAC use.[18] Such studies have  
shown that the inability of patients to effectively convey their values and preferences to physicians has contributed  to 
the low OAC utilization rate among AF patients.   
Even among patients receiving OAC therapy, the effectiveness is limited by poor adherence and suboptimal  
anticoagulation control quality. The efficacy of VKA depends strongly on the anticoagulation intensity, a parameter  
measured using the international normalized ratio (INR), for which the ideal therapeutic range lies between 2.0 and  
3.0 for AF. Suboptimal anticoagulation control quality refers to a proportion of time in the therapeutic range of  
<70%.[9] Not only does the narrow therapeutic index of a traditional VKA increase the challenge of maintaining an  
optimal dose, but the requirements for frequent laboratory monitoring, dose adjustment, and strict lifestyle  
modifications to reduce drug–food interactions also reduce patient adherence. Although the newer NOACs provide  
improved anticoagulation predictability, which enables fixed dosing without requiring routine laboratory monitoring,  
the shorter plasma half-lives of these agents require perfect medication adherence to achieve the targeted therapeutic  
effects. Recent large-scale observational studies have reported that <50% of patients remain adherent to OAC therapy  
at 1- to 2-year follow-up time points,[19, 20] and up to 25–38% of patients fail to achieve optimal anticoagulation  
control.[21] The lack of knowledge surrounding AF, treatment options, and the consequences of non-adherence  
comprise 
the 
major 
determinants 
of 
non-adherence 
and 
suboptimal 
anticoagulation 
control.[22]    

Study Protocol and Analysis Plan (English version, version 2, 11 Dec 2019) 
 
 
 
Challenges associated with arrhythmia and risk factor control   
Both pharmacological and non-pharmacological strategies are equally important for arrhythmia control.   
Although pharmacological management is relatively less challenging than stroke prevention, non-pharmacological  
measures rely heavily on patients’ self-care actions, including good adherence to therapeutic regimens, self- 
monitoring and management of signs and symptoms, management of crises related to disease deterioration and  
treatment complications, and lifestyle modifications.[9] Among these self-care actions, patients’ efforts to accurately  
monitor their heart rates and detect irregularities comprise the most crucial factor informing treatment efficacy and,  
consequently, the need for treatment adjustment. This is especially true because symptom reporting does not truly  
reflect patients’ responses to AF treatment.[23] Nevertheless, AF patients seldom perform self-monitoring in the  
form of pulse checks.[24] In addition, compelling evidence indicates that aggressive control of risk factors, such as  
hypertension, obesity, smoking, excessive alcohol intake, diabetes mellitus, and obstructive sleep apnea, is crucial to  
reducing the burden of AF and disease deterioration.[25] Moreover, risk factor control is pivotal to reducing the  
bleeding risk associated with OAC prescription.[9] The control of these risk factors relies considerably on the success  
of patients’ behavioral modifications and treatment adherence. Yet, substantial evidence suggests poor self-care  
among AF patients in this regard,[26] as well as an association of suboptimal self-care with increases in AF-related  
hospitalizations and mortality.[9, 26]    
 
The aforementioned complex challenges facing AF management suggest an imminent need to develop a model  of 
care for optimizing OAC prescriptions and related therapeutic effects, improving arrhythmia and risk factor control,  and 
enhancing patients’ self-care regarding disease monitoring, maintenance, and crisis management. Therefore, a  
structured and multifaceted model of care is needed to meet all these challenges in this vulnerable group. Nurse- 
coordinated care with an emphasis on OAC optimization and self-care enhancement has emerged as a method for  
addressing these complicated care requirements of AF patients.   
Empirical effects of nurse-coordinated care   
The increasing recognition of the complicated care needs of AF patients has led more researchers to investigate   
the effects of nurse-coordinated care models. Gillis et al.[27] and Carter et al.[28] used a pre- and post-test study  
design to examine the effects of a nurse-led clinic for newly diagnosed AF patients referred by their family physicians  
or an emergency department. Patients underwent a stroke risk and symptom assessment conducted by the nurse,  
while the clinic physician developed an OAC and antiarrhythmic agent treatment plan based on the patients’ risk and  
symptom profiles. This plan was then communicated to each patient’s family physician to guide drug prescription.  
The nurse also provided a brief face-to-face group education session on AF management to patients. The preliminary  
study by Gillis et al. demonstrated reductions of 82% and 56% in AF-related emergency department visits and  
hospitalizations, respectively, among 68 patients,[27] whereas the study by Carter et al. reported a significant increase  
in OAC prescriptions but no significant differences in all-cause deaths, cardiovascular hospitalizations, and AF- 
related emergency visits at 12 months.[28]   
Hendriks et al. adopted a more robust randomized controlled trial (RCT) design to examine the effects of an  
integrated nurse-led AF clinic in Europe (N = 712).[29-31] In that trial, the nurse determined the most appropriate  
treatment based on the patients’ symptoms, AF type, and stroke risk with the support of guideline-based software.  
Following an endorsement by a cardiologist, the nurse communicated the treatment plans to the patients along with  an 
education regarding AF, treatment, and symptom monitoring. Compared with the conventional care offered by  
cardiologists in the outpatient clinic, the nurse-led intervention significantly reduced cardiovascular-related deaths  
and hospitalizations,[29] and a cost-effectiveness analysis demonstrated that this intervention effectively reduced  
costs.[31] However, the nurse-led intervention failed to yield significant improvements in the patients’ psychosocial  
outcomes, including the health-related quality of life (HRQoL), anxiety, and depression,[30] possibly because the  
included patients were relatively healthy and had low CHADS2 scores. In addition, up to 25% of the patients had  
incomplete baseline data from the HRQoL analysis.   
Whereas the above studies focused on stroke risk assessment and OAC optimization, Stewart et al. conducted  an 
RCT to evaluate the effects of a home-based, nurse-led, transitional care intervention on patients admitted  
primarily because of AF.[32] This intervention focused mainly on optimizing patients’ self-care. A pre-discharge  
assessment of self-care ability was conducted, and after discharge, a nurse provided clinical assessments and  
education about AF and its symptoms, reduced barriers to medical follow-up and optimum self-care, and made  
referrals to relevant health services according to patients’ clinical statuses and needs through home visits. Despite the  
lack of a care component for optimizing OAC prescriptions, the nurse-led transitional care intervention significantly  
extended the number of non-hospitalized days and the survival duration, but did not reduce all-cause mortality or  
hospitalizations.[32] A comparison of these findings with the aforementioned study by Hendriks et al. suggests that  an 
effective model of care should include components of self-care enhancement as well as OAC prescription  
optimization.   
Even though previous studies demonstrated some positive effects of the nurse-coordinated care model for AF  
patients, they were strongly limited by the consideration of patients as passive care recipients. Indeed, this approach  is 
contradictory to the philosophy of chronic disease management proposed by the World Health Organization   

Study Protocol and Analysis Plan (English version, version 2, 11 Dec 2019) 
 
 
(WHO).[33] In response to the burgeoning population of patients affected by chronic diseases worldwide, the WHO  
proposed the Innovative Care for Chronic Conditions (ICCC) framework as a strategy for chronic disease  
management. The ICCC framework highlights the importance of empowering patients to become active care  
agents.[33] To address the complex needs of AF patients, the model of care must shift from a traditional paternalistic  
to a patient-participatory approach. Currently, the literature also lacks reports of a comprehensive model  
encompassing all important care components, including stroke risk-guided OAC prescription, self-care enhancement  
for arrhythmia optimization, and risk factor control. Despite the complexity of AF self-care, previous studies mainly  
used a didactic approach to self-care education. This method has been widely criticized as unable to internally  
motivate patients to make decisions and solve problems, and for ineffectively facilitating sustainable behavioral  
changes.[34] As patients with AF are their own major caregivers, successful management relies heavily on their  
efforts to engage in day-to-day self-care actions. For instance, decisions regarding OAC use require individuals to  
analyze the values of potential outcomes in a process requiring self-determination. In such cases, the active  
engagement of AF patients in various stages of disease management, from initial therapeutic planning to long-term  
self-care, is crucial to equipping and motivating patients to participate in self-care.   
Enhancing AF self-care through an empowerment-based approach   
Patient empowerment has recently emerged as an effective paradigm for improving health outcomes by   
promoting patient participation.[35] Empowerment is a philosophy of care in which interactive teaching strategies  and 
experiential learning are used to develop patients’ inherent capacities to gain control over the required behavioral  
changes and make decisions about their health problems.[36, 37] This patient-centered collaborative approach  
requires a goal-setting process to increase patients’ motivation and autonomy,[36] and a subsequent process to assist  
patients with developing an action plan for goal attainment.[36] To the best of our knowledge, such an empowerment- 
based educational approach has not yet been used to promote self-care among AF patients. Nevertheless, extensive  
empirical evidence supports the beneficial effects of such an approach on the self-care of other chronic diseases,  
particularly diabetes and asthma.[34, 38, 39] Other studies have consistently reported that this approach effectively  
enhances patients’ abilities to manage their chronic health conditions by fostering behavioral modifications and  
improving coping and problem-solving skills, as well as various disease-specific outcomes.[38, 40] Given the  
inadequacy of the current model of care to address the complex needs of AF patients, this project hypothesizes that  a 
nurse-coordinated integrated care model featuring a patient-empowerment approach can improve the health  
outcomes of AF patients.   
Work done by us   
The proposed study will address the findings of research conducted by the investigation team. We previously   
investigated physicians’ attitudes and beliefs regarding OAC prescription for AF patients and found that the  
physicians experienced moderately high levels of decisional conflict because they did not know their patients’ views  
regarding the risks and benefits of OAC use.[18] In addition, an ongoing GRF project conducted by one of the Co-I  
(BY) has shown that the approach of using a single-lead ECG device for rapid AF screening is feasible, up to 1.7%  of 
patients who attended medical outpatient clinics were newly diagnosed with AF. These patients are prone to  
developing disabling strokes if their conditions remain undetected and untreated. The preliminary data of this on- 
going GRF study also show that the use of didactic patient education is not effective in increasing OAC use in these  
patients. In this connection, this team of investigators, which has a strong track record in cardiac care, interventions  to 
empower patients and caregivers, self-care enhancement using a patient empowerment model, and psychosocial  
interventions, intensify the model of care by adopting an evidence-based nurse-coordinated empowerment-based  
approach to improve the health outcomes of patients with AF.    
Research plan and methodology    
The proposed study will have two aims: i) to evaluate the effects of a nurse-coordinated integrated care model   
with a patient empowerment approach on the compatibility of patients’ and physicians’ decisions regarding OAC  
use, medication adherence, anxiety, depression, and HRQoL and ii) to explore how and why the intervention affects  
health outcomes from the patients’ perspectives. The first aim is based on a research hypothesis in which AF patients  
exposed to the nurse-coordinated integrated care model will be more likely to report achieving compatible patient  and 
physician decisions regarding OAC use, better changes in medication adherence, anxiety, depression, and  
HRQoL, compared to patients who receive conventional care.   
Study design    
This will be a sequential mixed-methods study with two phases. Phase 1 will comprise a prospective, single-  
blinded RCT to investigate the effects of the nurse-coordinated integrated care model on various health outcomes  
among patients with AF. Phase 2 will comprise an exploratory qualitative study to determine how and why the  
intervention works. Figure 1 outlines the Phase 1 study implementation protocol. After collecting baseline data, the  
research nurse (RA1) will randomly allocate patients into the intervention or control group. Block randomization  
(block size: 8, 10, or 12) will be used to ensure even participant distribution between the two groups. The block size   

Study Protocol and Analysis Plan (English version, version 2, 11 Dec 2019) 
 
 
and respective study group allocation sequence will be determined using a computer-generated sequence.  
Chronologically recruited patients will be allocated to the study groups by RA1 according to this computer-generated  
sequence. Participants allocated to receive the nurse-coordinated integrated care model will be provided with an  
appointment 1–2 weeks before their next scheduled medical appointment to initiate the intervention. The participants  
allocated to the control group will continue to receive conventional care as arranged by the hospital. An independent  
research assistant (RA2) who is blinded to the study group allocations will collect post-intervention data through  
medical record reviews and telephone interviews upon completion of the intervention and 6 months thereafter.   
Figure 1. Study implementation protocol   
 
Subject screening and recruitment by RA1   
 
Baseline data collection (T0) by RA1   
 
Block randomization    
 Risk profile assessment and shared decision- 
making on OAC utilization (face-to-face) by RA1   
 Five weekly empowerment-based group   
educational module (face-to face) by RA1   
 Nurse-initiated telephone support by RA1   
 Patient-initiated telephone calls by RA1   
Standard care provided by  
the hospital   
 
 
Qualitative interview for a subsample of 30   
subjects   
2nd post-intervention data collection (T2) by RA2   
 
 
Study participants   
The proposed study will be conducted at six medical out-patient clinics of the study hospital. We plan to use   
two approaches to recruit patients: 1) screening patients at the specialist out-patient clinics; and 2) identifying  
potential subjects from the Clinical Management System of the study hospital. All patients ≥65 years of age who  
attend the clinics will be invited to undergo rapid, single-lead ECG device-based screening for AF performed by  
trained student helpers. The study will arrange for patients with positive screening results to undergo a 12-lead ECG  
analysis onsite to confirm the diagnosis. The RA1 will check consecutive patients identified through this screening  
process against the following eligibility criteria for study participation: (1) age ≥65 years, (2) community-dwelling,  (3) 
confirmed diagnosis of AF, (4) a CHA2DS2-VASc score of ≥1 in men and ≥2 in women, and (5) no use of OAC  
therapy. Patients with impaired communication or cognitive abilities (i.e., an Abbreviated Mental Test score ≤6) or  
severe co-existing medical conditions (e.g., terminal illness) that would hinder participation in research activities will  be 
excluded. For the first approach, one of the co-investigators of this project (B Yan) had adopted the same approach,  
which indicated that the newly identified AF was found in 1.5% on a single time-point screening, and additional  
1.2% was detected in those screened on multiple time-points.[41] As such, approximately 25,000 patients need to be  
screened to achieve the target sample size. To safeguard an adequate sample is recruited, a second approach to screen  
patients who have already established the diagnosis will be identified from the Clinical Management System (CMS).  
The RA1 will  identify potential participants who are under the care of specialist out-patient clinics of the study  
hospital from the CMS. Patients with documented AF who met the aforementioned criteria and are not receiving  
appropriate OACs for stroke prevention will be approached for further screening according to the selection criteria.  
This approach is supported by a study [14] which indicated a serious gap between empirical evidence and practice in  
the local setting: among 9,727 patients with AF in Hong Kong: nearly 40% did not receive any OAC and another  40% 
were conservatively put on aspirin.   
The proposed sample size was estimated based on the primary outcome of HRQoL. To our best knowledge, no   
previous study examined the effect of a nurse-coordinated empowerment-based care model on AF patients. However,  
we have identified a few similar interventional studies targeting patients with different diseases, including diabetes[42,   
1st post-intervention data collection (T1) by RA2   

Study Protocol and Analysis Plan (English version, version 2, 11 Dec 2019) 
 
 
43] and hemodialysis recipients.[44] Of these studies, the effect sizes of the empowerment interventions on HRQoL  
ranged from 0.09 to 1.17, depending on the HRQoL domains. In general, an experimental design involving a larger  
sample size can enable researchers to detect a smaller effect size on an outcome at a specific statistical power and  
significance level. However, a small effect size may not be clinically important. Therefore, after considering both the  
clinical relevance and previous study findings, the sample size of this study was determined to yield adequate power  
for the detection of at least a small to medium effect size[45] on the primary outcome. Using power analysis software  
package PASS 13 (NCSS, Kaysville, USA), we estimated a sample size of 176 per study arm to yield 80% power at  a 
5% significance level for the detection of an effect size as small as 0.3 on our primary outcome when comparing  the 
two study arms at the post-intervention time points. After allowing for a potential dropout rate of 10%, 392  
participants (196 per arm) will be recruited.   
For Phase 2 of the study, a purposive sample of 30 participants from the intervention group will be invited to  
participate in a qualitative interview. Participants with different treatment responses to the nurse-coordinated  
integrated AF care model will be recruited according to changes in their post-intervention HRQoL scores. Ten  
participants will be selected from each range of HRQoL changes: 0–34th percentile, 35th–68th percentile, and >68th  
percentile.    
Study interventions   
Intervention group: Nurse-coordinated integrated care model for AF   
Participants in the intervention group will participate in a 13-week, nurse-coordinated integrated care model  
comprising the following care components intended to comprehensively address the needs of AF patients: 1) a risk  
profile assessment and shared decision-making regarding OAC use; 2) an empowerment-based educational module  on 
AF self-care; 3) nurse-initiated telephone support; and 4) patient-initiated contact for professional advice. The  
details of each care component of the intervention (Figure 2) are described below.   
Figure 2. Nurse-coordinated integrated care model   

Study Protocol and Analysis Plan (English version, version 2, 11 Dec 2019) 
 
 
 
1. 
Risk profile assessment and shared decision-making regarding OAC use   
A pre-consultation session will be provided 1–2 weeks before the patient’s next medical clinic consultation. This   
session will comprise two components: an individualized assessment and a group-based session to enhance patients’  
participation in shared decision-making. First, RA1 will conduct a comprehensive, individualized risk assessment of  
patients. The risk assessment will address multiple aspects, including i) the stroke risk based on the CHA2DS2-VASc  
score, ii) bleeding risk based on the HAS-BLED score, and iii) quality of VKA anticoagulation therapy based on the  
SAMe-TT2R2 score. Details of the CHA2DS2-VASc score were elaborated in a previous section of this proposal. The  
HAS-BLED score predicts the bleeding risk according to the following risk factors: hypertension, abnormal  
renal/liver function, stroke, bleeding history or predisposition, labile INR, age >65 years, and concomitant  
drug/alcohol use. The SAMe-TT2R2 score assesses the likelihood of poor INR control among patients with AF on  
VKA therapy according to sex, age, medical history, treatment, tobacco use, and race. These risk stratification scores  
provide information crucial to determining the optimal treatment options for each patient.    
 
After the risk assessment, the nurse will conduct a face-to-face session in a small-group (6–8 patients/group)  
format to empower patients regarding decision-making and communication with physicians. This face-to-face  
approach was selected in accordance with literature suggesting it to be more effective than a written format.[46]  
Additionally, group teaching can promote peer learning and modeling. The session will begin with a structured  
educational session on AF and its complications, with emphasis placed on understanding the link between AF and  
ischemic stroke and the deleterious effects of rapid ventricular rates on cardiac function. The currently available and  
suitable OAC options (warfarin and NOACs) and their pros and cons (including the self-financed nature of novel  
OAC) as well as the rationales for rate and rhythm control will also be discussed. To assist patients with decision- 
making regarding OAC use, a patient decision aid developed by the National Institute of Health and Care  
Excellence[47] will be used. This aid organizes treatment options in an Option Grids format, wherein 10 frequently  
asked questions are presented vertically downwards with the options presented horizontally across the table. This  
format facilitates comparison and clarifies the options. Numeric and graphic formats with pictograms will be used to  
help patients understand the absolute and relative risks of a stroke when not using OACs or a major bleeding episode  
while using OACs. Patients’ individual risk profiles will be used to illustrate their stroke risks with and without OAC  
and their bleeding risk with OAC in a graphical format. The nurse will present the risk and benefit information in a  
fair and balanced manner.   
 
Another care component will engage patients in shared decision-making regarding OAC use by empowering  
them to better communicate their decisions to physicians during upcoming medical consultations. This component  
will highlight the key points of assertive communication, including asking questions, expressing concerns, and stating  
opinions and preferences regarding OACs for stroke prevention. The patients will be encouraged to generate a list of  
questions and concerns to propose to their physicians. To enhance patients’ confidence in their ability to maintain  
assertive communication in stressful situations, a series of scenario-based patient models in video format will be used  
to optimize the acquisition of skills for handling challenging encounters. A role-play-based rehearsal will be  
conducted to allow patients to practice their new skills and observe others’ behavior. The nurse will debrief patients  to 
discuss their performance and provide feedback. Throughout the session, the nurse will adopt a supportive and  non-
judgmental attitude.   
2. 
Empowerment-based group educational module   
The same group of patients will attend an empowerment-based educational module beginning 1 week after their   
medical appointments. The module will comprise five weekly educational sessions covering the following major  
topics related to AF self-care: i) medication management, ii) symptom monitoring, iii) crisis management, iv)  
activities and exercise, and v) risk factor management to reduce risks of stroke and bleeding. The educational content  
of each session will comply with the recommendations of major practice guidelines for AF managment.[9, 12]   
 
During each session, the nurse will implement the empowerment process (Table 1) to enhance patients’  
knowledge, skill acquisition, and confidence in AF self-care. The empowerment approach emphasizes the use of  
interactive teaching strategies, experiential learning, and self-reflection during the educational process to optimize  
learning.[37] First, the nurse will deliver a structured educational session about the topic of the week. Emphasis will  
be placed on assisting patients with understanding the links between their self-care behaviors and health  
consequences to ensure that they appreciate the importance of their own efforts in managing AF. The nurse will  
encourage patients to share their current practices, and facilitate them to identify discrepancies between the suggested  
self-care and their current practices. The nurse will also highlight possible health consequences of these discrepancies  
and assist patients with setting self-directed goals related to those areas. After goal-setting, a subsequent interactive  
skill-building session will ensure that patients acquire the skills required to perform specific self-care behaviors. For  
example, to enhance patients’ confidence regarding crisis management, a series of scenario-based patient models in  
video format will be used to optimize the acquisition of skills needed to handle challenging encounters related to  
possible crises, such as a major bleeding event or suspected stroke episode. A role-play-based rehearsal will be  
conducted, and the nurse will discuss the patients’ performances and provide feedback. The nurse will make use of  
group dynamics by encouraging peer discussions of successful self-care actions, feelings, concerns, and perceived   

Study Protocol and Analysis Plan (English version, version 2, 11 Dec 2019) 
 
 
barriers to goal achievement. The nurse will also work with the patients to mutually develop action plans for achieving  
goals set during each weekly educational session. Each subsequent session will begin with a discussion of progress  in 
goal attainment. Challenges and barriers faced while implementing the action plans set during the previous week  will 
also be discussed.   
 
Table 1. The empowerment process.    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3. 
Nurse-initiated telephone support   
The nurse will provide continued support by telephone after the face-to-face sessions have been completed (two   
weekly and two bi-weekly calls). A telephone record containing patients’ clinical profiles, AF-related treatments,  
self-management goals, and action plans will be used to facilitate the process. The nurse will monitor patients’  
adherence, symptom profiles, treatment efficacies, adverse effects, and goal attainment progress; identify barriers in  
the self-care process; and provide resolutions and continued support via the telephone. Health counseling and advice  
given will be documented to guide subsequent telephone correspondence.    
4. 
Patient-initiated contact for professional advice   
All participants from the intervention group will be provided with telephone access to the nurse for inquiries   
regarding disease management during office hours. The nurse will provide health advice and counseling accordingly.  
For severe undesirable symptoms and adverse reactions to medications, the nurse will attempt to advance patients’  
follow-up appointments or advise patients to seek emergency medical care if necessary. All correspondence and  
advice given will be documented in patients’ profiles.   
Control group: Conventional care   
The control group will receive the conventional care provided by the study hospital.    
Fidelity monitoring of the study intervention   
Multiple methods will be used to monitor the fidelity of the study interventions. Assessment and record forms   
will be used to document the care activities provided to patients during the sessions, telephone calls, and patient- 
initiated contacts. The nurse will file these assessment records to facilitate care coordination. Care activities will be  
coded, tracked, and checked against the intervention protocol. A standardized manual will be developed to guide the  
delivery of each group-based education session. Moreover, the PI will randomly select five groups in the intervention  
arm for monitoring. Face-to-face sessions will be videotaped after obtaining the participants’ consent. Two research   
5-step empowerment process    
Intervener’s counseling techniques for the   
empowerment process   
   
 Be supportive to assist patients to identify their   
inadequacy in self-care   
 Avoid judgmental attitudes   
 Be patient-centered in identifying the barriers to self-  
care   
 Use active listening to identify concerns, fears and   
beliefs that may hinder effective self-care    
 Be collaborative with the patients to work through   
ambivalence to set patient-directed goals   
 Use reflection and paraphrasing to validate patients’   
feelings and their capacities to solve problems   
 Be respectful to the expertise of patients    
 Genuinely believe in patients’ ability to make the   
changes   
 Acknowledge patients’ right and responsibility to   
make self-care choices and to be the primary decision   
makers   
Structured  
education    
Peer sharing  
& address   
concerns   
Self-  
reflection &   
Skill building  
goal setting     
Action   
planning     

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fellows will review the tapes and complete a performance checklist after a briefing session by the PI. In addition, the  
nurse will document reflective notes after each session and hold monthly discussions with the investigation team.  
Participants’ attendance will be recorded. All these data will be submitted for interpretation.   
Outcome measures    
The following instruments will be administered at baseline, upon completion of the intervention, and 6 months   
thereafter.   
Compatibility between patient and physician decisions   
Patients will be asked to indicate whether a decision regarding the choice of OAC was made before the consultation  
and, if yes, details of the choice.[48] The physician’s prescription of any OACs will be monitored after the  
consultation. The nurse will confirm prescriptions with the patients and trace prescription record information in the  
Hospital Authority’s Clinical Management System. The patients’ choices and physicians’ prescription decisions will  
be examined to determine compatibility.   
8-item Morisky Medication Adherence Scale (MMAS-8)   
The MMAS-8 will be used to assess self-reported medication adherence.[49] Each item measures a specific  
medication-taking behavior using a dichotomous (yes/no) response (Items 1–7) or a 5-point Likert scale (Item 8).  The 
scores range from 0 to 8, with higher scores indicating better adherence. The Chinese version yields acceptable  
internal consistency (Cronbach’s α = 0.77), good test-retest reliability (r = 0.88), and construct validity.[49]   
Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire   
The 20-item AFEQT[50] measures disease-specific HRQoL in AF patients using 4 subscales: symptoms, daily  
activities, treatment concerns, and treatment satisfaction. All subscales are rated on a 7-point Likert scale, with higher  
scores indicating a poorer HRQoL. The subscales’ Cronbach’s alphas ranged from 0.88 to 0.95, the test-retest  
reliability and construct validity are satisfactory, and the instrument is responsive to treatment.[50] This investigation  
team developed the Chinese version of the AFEQT, which is currently undergoing psychometric validation.    
Hospital Anxiety and Depression Scale (HADS, Chinese-Cantonese version)   
The 14-item Chinese-Cantonese version of the HADS[51] will be used to measure anxiety and depression. This  
instrument is rated on a 4-point Likert scale, with higher scores indicating more intense anxiety and depression. The  
HADS is reported to have good internal consistency (Cronbach’s alpha = 0.86) and satisfactory factorial, concurrent,  
and criterion validity.[51]    
Data analysis   
The statistical analysis of the outcome comparisons will be performed based on the intention-to-treat principle.   
Variables with skewed data will be transformed appropriately prior to analysis. Baseline characteristics between the  
two study arms will be compared using the t-test or chi-square test where appropriate. A mixed-effects model will be  
used to compare differential changes in the outcome variables over time and between the two arms. The mixed-effects  
model can account for intra-correlated repeated-measures data and produce unbiased estimates even if some data are  
missing, as long as the data are missing at random. All statistical analyses will be performed using SAS version 9.4  
(SAS Institute, Cary, NC). All statistical tests will be 2-sided, with a significance level of 0.05.   
For the qualitative study, qualitative audiotape data will be transcribed verbatim, and the PI will ensure the  
accuracy of the transcripts. These data will be subjected to a content analysis, following an open coding session. The  
coded units will then be organized to create categories.[52] Particularly, the qualitative data will be analyzed to seek  a 
better understanding of why and how the nurse-coordinated integrated care model affects the health outcomes of  AF 
patients. The trustworthiness of the qualitative phase of the study will be enhanced by audiotaping all interviews,  
conducting an audit trail involving two investigators (PI and DY) who independently code the qualitative data, and  
comparing the coded data, with a discussion-based resolution of discrepancies. Themes emerging from the qualitative  
data will be used to explain the quantitative findings of the RCT study.   
 
Ethical Consideration   
This study followed the Declaration of Helsinki on medical protocol and ethics. Ethics approval will be obtained   
from both the Joint Clinical Research Ethics Committee of the Chinese University of Hong Kong and New   
Territory East Cluster. Patients are voluntary participants in the study. A written informed consent, which will   
include the research title, purpose, explanation of the research, and the procedures of the study, will be obtained   
from each eligible participant. Risks and benefits are also explained clearly to the participants. Participants have the  
right to withdraw from the study at any time. They will be protected from discomfort and harm during the study.   
Further, anonymity and confidentiality of the participants will be strictly protected. Their decision of participating   
in the study will not affect the quality of present or future care they receive in the hospital.   

Study Protocol and Analysis Plan (English version, version 2, 11 Dec 2019) 
 
 
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