Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03924739 |
| Other study ID # |
RGC14604418 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 3, 2018 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
June 2023 |
| Source |
The University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to evaluate the effects of a nurse-coordinated, empowerment-based integrated
care model on self-care behaviors and psychosocial outcomes in patients with atrial
fibrillation (AF), and to explore how this intervention affects the self-care behaviors and
quality of life from the patients' perspective.
Stroke prevention by oral anticoagulants (OAC) and control of arrhythmia and risk factors
remain the cornerstones of AF management. However, under-prescription, non-adherence to
treatment, and suboptimal anticoagulation control limit the efficacy of OACs. The poor
abilities of patients regarding the self-control of arrhythmia and risk factors further
contributes to worse outcomes. According to the World Health Organization, the best approach
to chronic disease management involves the empowerment of patients to become active self-care
agents. The literature indicates that a multifaceted, nurse-coordinated care model
integrating all important care components with an empowerment approach could most effectively
and actively engage patients in self-care.
This mixed-methods study comprises a randomized controlled trial and an exploratory
qualitative study. A total of 392 community-dwelling patients aged ≥65 years with a confirmed
diagnosis of AF, a high stroke risk, and no OAC treatment will be recruited from the medical
outpatient clinics of a university-affiliated teaching hospital. The patients will be
randomly allocated to intervention or control groups, which will receive treatment via the
nurse-coordinated integrated care model or standard care, respectively. We hypothesize that
compared to patients receiving standard care, AF patients exposed to the nurse-coordinated
care model will be more likely to achieve compatible patient and physician decisions
regarding the use of OAC, as well as better changes in medication adherence, anxiety,
depression and health-related quality of life both immediately and 6 months post
intervention.
This study will uniquely adopt an empowerment-based approach to equip patients as active
agents in AF management through a nurse-coordinated integrated care model that
comprehensively addresses their needs. The findings will advance our knowledge of patients'
self-care behaviors in the context of AF and will provide a new model of care to improve
health outcomes in this population.
Description:
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 oral anticoagulants (OAC) use, medication adherence,
anxiety, depression, and health-related quality of life (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 randomized controlled trial (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. 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 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.
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 are described below.
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
vitamin K antagonist (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 International normalized ratio (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. 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 Non-vitamin-K oral anticoagulants (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 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 management.
During each session, the nurse will implement the empowerment process 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. 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 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.
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.
