Clinical trial NCT05972031: EMBOSS A Person-centred Integrated-care for Chronic Diseases in Patients of Low Socio Economic Status
Official title: EMBOSS: Reach and Effect of a Person-centred Integrated-care Approach for Chronic Diseases and MultimorBidity in Patients of Low sOcio- Economic StatuS in General Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Condition
Chronic Conditions, Multiple
Keywords: Primary care
Person-centered
Integrated-care
Health literacy
Health disparities
Socio-economic status
General practice
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: TREATMENT

Brief summary: People of low socio economic status (SES) more often than others suffer from chronic diseases like diabetes mellitus, chronic obstructive pulmonary disease (COPD), or coronary diseases. Compared to others People of low SES more often have to deal with multiple diseases (multimorbidity) and experience worse health outcomes. The health literacy of people of low SES is often low. Current chronic disease management programs focus on reducing the burden of a single disease by prescribing medication, protocoled monitoring routines, or lifestyle advice.

However, the effectiveness of these interventions is low in people with low SES, as the interventions insufficiently take into account the specific problems and needs of this (multimorbid) population. A person-centered and integrated-care approach, that puts the patient at the center of care instead of the disease and in which care is tailored to the individual patient with chronic disease(s), seems to be more appropriate, but only when low SES people are closely involved in the development, testing, and evaluation of such an approach. Also, certain preconditions should be met, such as training of specific knowledge and skills of the healthcare professionals involved.

In the EMBOSS project, the investigators will develop, test, evaluate, and implement a person-centered integrated-care approach for and in close collaboration with people with low SES who have one or more chronic diseases. Thus, the EMBOSS study will have the potential to reducing health disparities in this group, to broadening the action perspectives of general practitioners and practice nurses for an increasing diverse patient population and to a better fit of lifestyle interventions in people of low SES.

Detailed description: In the Netherlands, 28% of the population is lowly educated, i.e. the level of education is MBO1 (secondary vocational education) or lower, which is the main indicator of low socioeconomic status. Low-educated people suffer 2-4 times more often than high-educated people from diabetes mellitus, COPD, coronary disease (often in combination) and of the risk factors contributing to these diseases. The healthy life-expectancy for low educated people is 14 years shorter, the health outcomes are worse (more complications of cardiovascular diseases and diabetes), because of high levels of chronic stress due to challenging living circumstances, negatively influencing self-confidence and executive functions, limited health and digital literacy - all determinants of effective self-management. Most people with chronic diseases are being cared for in general practice (GP). However, professionals in GP often struggle with the care for low-educated patients, experiencing difficulties in recognizing patients with low (health) literacy, and in adapting communication and advice to the needs of this group. Low-educated patients more often visit the GP, and are more often referred to costly secondary care.

Many interventions for chronic diseases fail to show effectiveness in low-SES groups. The reasons are multiple:

1. materials and procedures used are too complicated,
2. daily survival sets different priorities,
3. communication and approach by healthcare professionals don't suit the needs and skills of this population, actions or materials are too expensive.

Effectiveness of interventions can be improved by involving low-SES patients in the development and by training healthcare professionals. Low-educated patients should be explicitly recruited in intervention evaluation studies as this population is underrepresented in clinical studies, which impedes generalizability of results. Chronic care for patients with diabetes mellitus type 2 (DM2), COPD and/or cardiovascular diseases (CVD) in GP is carried out through disease management programmes. However, major limitations of these programmes are that it focused on a single disease, while half of the patients suffers from multimorbidity. Also, the programmes do not truly reflect the needs of patients who experience this disease management as fragmented with too little attention for the partienst personal context. Therefore, a more generic disease management (GDM) programme including a person-centred and integrated-care (PC-IC) approach seems to be a promising strategy. Such an approach puts the patient at the centre of care, tailoring chronic care to the individual's needs and addressing all the issues important to him. It starts with a comprehensive biopsychosocial assessment of all relevant problems. Subsequently, a personalised treatment plan is made with individualised goals, actions and professionals involved. The programme responds to the needs and context of the 'whole' patient to provide the right care in the right place at the right time. It supposes to stimulate patient's self-management.

Currently, in the Netherlands, some regional projects with GDM programmes and PC-IC approaches are running, of which 'OPTIMA FORMA' may be the best known. This project started in 2018 and consists of three stages in which a GDM programme including a PC-IC approach is developed, tested and evaluated in three large Dutch primary care cooperatives, i.e Nijmegen, Arnhem, and Doetinchem. However, in 'OPTIMA FORMA' as in other ongoing projects, there is no specific attention for or involvement of people with low SES. This will obviously reduce the effectiveness of this approach in low SES patients, as one third of the population with chronic diseases consists of patients with low SES. The investigators there is an urgent need for PC-IC interventions that specifically address the needs of low SES population in order to be effective. Therefore, the investigators supported the three primary care cooperatives who participate in OPTIMA FORMA with the development of a GDM programme specifically for low SES patients. With help from patients with low SES and the healthcare professionals of the low SES patient, the investigators collected information on experiences, facilitators, and barriers from the previously conducted pilot study of OPTIMA FORMA PHASE2 (CMO 2021-8106).

The investigators used this information in co-creation sessions with patients with low SES and healthcare professionals to adjust the OPTIMA FORMA programme to a GDM programme that better suits the needs of low SES patients (EMBOSS programme).

The hypothesise off the EMBOSS programme will not only result in better outcomes of care in this group (and thus decreasing socio-economic health disparities), but also to a more effective role of GPs and practice nurses with more work satisfaction and less workload. In the current study our primary research question is:

What is the effectiveness of the EMBOSS intervention, i.e. a GDM programme including a PC-IC approach developed with and for low SES people with one or more chronic diseases compared to care as usual, i.e. SDM programmes for DM2, COPD and/or CVD in general practice? The investigators will perform a cluster randomized controlled trial with a follow-up time of 12 months.

Eligibility criteria: Inclusion Criteria:

* Currently enrolled in any of the single disease management programmes (usual care) for DM2, COPD, asthma or CVD

Exclusion Criteria:

* Limited life expectancy (less than 3 months)
* Patients with high level of SES (or educational level \> MBO2)

Primary outcomes:
measure: patient-reported health-related quality of life Physical Health
timeFrame: 12 months
measure: patient-reported health-related quality of life Mental health
timeFrame: 12 months
measure: Patient-experienced quality of care
timeFrame: 12 months
Secondary outcomes:
measure: Patient activation as measured by PAM
timeFrame: Baseline, 6 months, 12 months
measure: Health-related quality of life as measured by the EQ-5D-5L instrument
timeFrame: Baseline, 6 months, 12 months
measure: BMI
timeFrame: Baseline, 6 months, 12 months
measure: HbA1c
timeFrame: Baseline, 6 months, 12 months
measure: Blood glucose
timeFrame: Baseline, 6 months, 12 months
measure: Blood LDL-cholesterol
timeFrame: Baseline, 6 months, 12 months
measure: Systolic and diastolic blood pressure
timeFrame: Baseline, 6 months, 12 months
measure: Positive affect of healthcare providers
timeFrame: Baseline, 6 months, 12 months
measure: Experience of healthcare providers
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: RadboudUMC
Study officials:
References: