A Nurse-coordinated Integrated Care Model to Support Decision-making and Self-care in Patients With Atrial Fibrillation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire
研究概览
简要总结
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.
详细描述
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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥65 years
- •community-dwelling
- •confirmed diagnosis of AF
- •a CHA2DS2-VASc score of ≥1 in men and ≥2 in women
- •no use of OAC therapy
排除标准
- •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
结局指标
主要结局
Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire
时间窗: Change from Baseline AFEQT at the 13th week (after the intervention) and 6 months (follow up)
The 20-item AFEQT 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.
次要结局
- Use of oral anticoagulants(At 6 months (follow up))
- Morisky, Green and Levine Adherence Scale (MGLS)(Change from Baseline MGLS at the 13th week (after the intervention) and 6 months (follow up))
- Decision concordance on oral anticoagulant between patients and physicians(At 6 months (follow up))
- Hospital Anxiety and Depression Scale (HADS)(Change from Baseline HADS at the 13th week (after the intervention) and 6 months (follow up))
研究者
Dr. Polly Wai-Chi Li
Assistant Professor
The University of Hong Kong