Cardiac Rehabilitation: From Hospital to Municipal Setting.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 514
- 试验地点
- 2
- 主要终点
- Adherence
研究概览
简要总结
In recent decades, local healthcare services have undergone dramatic changes. The World Health Organization (WHO) refers to a shift from specialized hospital to local healthcare services to meet the growing expectations for better performance and outcomes in health care and better value for money. It is unique that Central Denmark Region has assigned phase II cardiac rehabilitation (CR) as a local healthcare task. However, there is sparse knowledge about how this reform may influence processes of care and outcomes in CR. This association is important to investigate when dramatic organisational changes in settings of evidence based interventions is implemented, as well as in relation to helping people with heart disease return to an active and satisfying everyday life.
详细描述
Background In recent decades, local healthcare services have undergone dramatic changes. The World Health Organization (WHO) refers to a shift from specialized hospital to local healthcare services to meet the growing expectations for better performance and outcomes in health care and better value for money. In line with the WHO statements a structural reform reorganised the entire public sector in Denmark in 2007. The local healthcare services were given the responsibility for the more generalised rehabilitation of patients with chronic diseases, and hospitals were to carry out more specialised rehabilitation for patients with chronic diseases admitted to a hospital. Today, several local healthcare services provide non-pharmacological phase II cardiac rehabilitation (CR); this phase encompasses the immediate post discharged period. Central Denmark Region has - as the only region in Denmark - assigned phase II CR as a local healthcare task. This unique reform became effective on 1 January, 2017. However, there is sparse knowledge about how this reform may influence processes of care and outcomes in CR.
CR programmes do not meet the required evidence-based standard Several countries have developed clinical practice guidelines for CR, including Denmark in 2013. The guidelines incorporate the best available evidence for the management of CR to assist health professionals and patient decisions about appropriate rehabilitation. However, it is unclear to what extent local healthcare services CR is performed in accordance with the clinical practice guidelines for CR. Doherty P et al. studied the extent to which programmes meet national minimum standards for the delivery of CR as prescribed by the National Certification Programme for CR in UK. The authors found that 31% out of 170 unique CR programmes were delivered with high performance, 46% as mid-level performance, 18% were lower-level, while 5% failed to meet any of the minimum criteria. We have not been able to find other similar studies for performance of CR programmes in Denmark or elsewhere. Therefore, it is unclear whether the performance varies in local healthcare services CR programmes in Denmark, and whether there is a need for improvement to provide all patients a high-quality evidence-based service.
Patient education using learning and coping improves adherence Patient education is recommended in the clinical practice guidelines for CR and is defined as: "The process by which health professionals and others impact information to patients who will change their health behaviors or improve their health status". In the guidelines several educational topics are listed as important for patient education. However, the rationale for the specific areas is not completely explained in the guidelines. Furthermore, the guidelines only advice on what to teach, not how it should be done e.g. educational models, material, provider and setting. A systematic review shows that the delivery of patient education programmes can vary substantially, but common topics include nutrition, exercise, risk factor modification, psychosocial well-being and medications. Also duration, frequency and ongoing maintenance or re-inforcement vary between programmes. However, the Danish Health Authority recommend using evidence-based methods in patient education including Learning and Coping, Motivational interview.
In Central Denmark Region, six out of 19 local healthcare services have decided to use Learning and Coping in CR while remaining local healthcare services use different approaches. Learning and Coping is a health pedagogical strategy that builds on inductive teaching with high involvement of the participants. Characteristics of Learning and Coping are that 'experienced patients' plan, teach and evaluate, in cooperation with health professionals. In a hospital setting, Learning and Coping has shown an increase inpatient adherence in CR including training and patient education, especially for those with low socioeconomic status. However, it is unclear whether using Learning and Coping in local healthcare services performs similar results. These results are needed because low socioeconomic status is a common barrier to attending CR programmes.
Patient education using Learning and Coping to overcome barriers to CR System-, physical- and personal-level barriers in CR are well-described in the literature. Studies show that 13% to 20% of eligible patients are not referred to CR, and 19% to 45% do not attend CR. Also, long wait time to CR after referral entail low attendance. Health-related factors such as anxiety, depression, pain, or other illnesses are reported curtail the uptake. Like exercise-limiting comorbidities predict fewer sessions. Older adults, women, people who belong to ethnic minority groups, are young, have low socioeconomic status, live alone and receive limited social support are low attenders. Other studies show that family obligations and the distance from home to the programme setting entail low attendance. Few studies found that self-payment is a barrier to attend CR. This may not be an issue in Denmark as the Danish healthcare system provides tax-funded healthcare to the country's 5.7 million residents, including free access to hospital care, general practitioners and primary healthcare services including CR. Patients should be encouraged to attend patient education as literature reviews show that educational interventions with cardiac care increase patients' knowledge and facilitate behavior change. Furthermore, education interventions increase physical activity and lead to healthier dietary habits, smoking cessation and a higher quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Included municipalities are expected to receive 2,310 patients with IHD per year (figures from 2017) to attend a CR program. Statistical power; These figures were used to address "the difference in patient outcome in intervention CR and usual CR". Using the minimally important difference available for HeartQoL (mean difference of 2.0, standard deviation 2.0)(1) and the HADS (mean difference of 2.0 and standard deviation of 3.8)(2) and within site clustering ( intra-cluster correlation of 0.01 and an average cluster size of 185 patients - design effect of 2.84) we would need to recruit at least 312 patients per group at 90% power and 5%.
References
- Smid DE, et al. Responsiveness and MCID Estimates for CAT... J Am Med Dir Assoc 2017 Jan;18(1):53-58.
- Oldridge N, et al. The HeartQoL: Part II. Validation of a new core health-related quality of life questionnaire... Eur J Prev Cardiolog 2014 01/01; 2017/09;21(1):98-106.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •We include all adult patients ( >18 years old) discharged from hospital with in Central Denmark Region between September 1, 2018 and July 31,
- •Ischaemic Heart Disease will be defined according to the International Classification of Diseases version 10 (ICD-10): DI210, DI210A, DI210B, DI211, DI211A, DI211B, DI213, DI214, DI219, DI248, DI249, DI240, DI209, DI251, DI251B, and DI
- •In 2016, this population represented approx. 2,700 patients.
排除标准
- •People survive cardiac arrest
结局指标
主要结局
Adherence
时间窗: During a 12 week programme
Adherence to CR, defined as percentage of total prescribed sessions.
次要结局
- Health-related quality of life(4 times during 12 months after engaging Cardia Rehabilitation)
- Anxiety and depression(4 times during 12 months after engaging Cardia Rehabilitation)
- Coping(4 times during 12 months after engaging Cardia Rehabilitation)
- Return to work(12 months after ended Cardiac Rehabilitation)
- Cost-effectiveness(When patients enter intervention CR or usual CR and again 12 months after ended CR)
- Completion(At the end of a 12 week rehabilitation program)
