Clinical trial NCT03734185: Cardiac Rehabilitation: From Hospital to Municipal Setting.
Official title: Cardiac Rehabilitation: From Hospital to Municipal Setting.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Rehabilitation
Keywords: Cardiac Rehabilitation
Lead sponsor: Defactum, Central Denmark Region
Sponsor class: OTHER_GOV
First posted: 2018-11-07
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

It is unique that Central Denmark Region has assigned phase II CR as a local healthcare services. Thus, it is crucial to know more about performance in local healthcare services CR and whether all patients receive high-quality evidence-based services regardless of where they live. To our knowledge, no studies have examined the association between performance in different health pedagogical strategies and outcomes. 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. This study is unique and may inform and affect the way CR is organised and performed on a national and an international level to improve quality of care.

Eligibility criteria: Inclusion criteria:

We include all adult patients ( \>18 years old) discharged from hospital with in Central Denmark Region between September 1, 2018 and July 31, 2019. 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 DI251. In 2016, this population represented approx. 2,700 patients.

Exclusion criteria:

People survive cardiac arrest

Primary outcomes:
measure: Adherence
timeFrame: During a 12 week programme
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 4 times during 12 months after engaging Cardia Rehabilitation
measure: Anxiety and depression
timeFrame: 4 times during 12 months after engaging Cardia Rehabilitation
measure: Coping
timeFrame: 4 times during 12 months after engaging Cardia Rehabilitation
measure: Return to work
timeFrame: 12 months after ended Cardiac Rehabilitation
measure: Cost-effectiveness
timeFrame: When patients enter intervention CR or usual CR and again 12 months after ended CR
measure: Completion
timeFrame: At the end of a 12 week rehabilitation program
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Charlotte Gjørup Pedersen
Study officials:
affiliation: Defactum, Central Denmark Region
name: Charlotte Gjørup Pedersen, PhD
role: PRINCIPAL_INVESTIGATOR
References: