EMBOSS A Person-centred Integrated-care for Chronic Diseases in Patients of Low Socio Economic Status

Sponsor

Radboud University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05972031

Collaborator

(none)

540

Enrollment

Location

Arms

18.1

Anticipated Duration (Months)

29.9

Patients Per Site Per Month

Study Details

Study Description

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 they more often have to deal with multiple diseases (multimorbidity) and they experience worse health outcomes. Their health literacy 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 they 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, we 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Condition Chronic Conditions, Multiple	Behavioral: Person-centred integrated care intervention	N/A

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. Their healthy life-expectancy is 14 years shorter. Their 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 their communication and advice to the needs of this group. These patients more often visit their 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:

materials and procedures used are too complicated,
daily survival sets different priorities,
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 they focus on a single disease, while half of the patients suffers from multimorbidity. Also, they do not truly reflect the needs of patients who experience this disease management as fragmented with too little attention for their 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. We think there is an urgent need for PC-IC interventions that specifically address the needs of low SES population in order to be effective. Therefore, we 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 their healthcare professionals we collected information on experiences, facilitators, and barriers from the previously conducted pilot study of OPTIMA FORMA PHASE2 (CMO 2021-8106).

We 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). We hypothesise that 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? We will perform a cluster randomized controlled trial with a follow-up time of 12 months.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

540 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cluster randomized controlled trialCluster randomized controlled trial

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 29, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Person-centred integrated care intervention The core of the person-centered approach is a cyclical process and for EMBOSS developed for patients with low SES. The practice nurse in the GP will act as case manager and can consult other health providers. The first step in the intervention is assessing the integral health status of the patient (health across multiple domains), using a visual conversation tool. The second step is discussing the results with the patient. Personal goals are formulated in the third step. In the fourth step, the healthcare professional and patient will choose through shared-decision making the most appropriate interventions and support to achieve these goals, which are documented in a personal plan. Next, referrals are made if necessary and the treatment is started. An evaluation is planned and carried out. All practices in the EMBOSS intervention group will be trained by Pharos on how to recognize and provide GDM to low SES patients using appropriate communication skills and the specific tools.	Behavioral: Person-centred integrated care intervention See arm description. Other Names: Usual care
No Intervention: Usual care Practices in the control group provide care as usual, which consists of the SDM programmes according to the national care standards and General Practice guidelines (NHG) for DM2, COPD and CVD. According to these protocolised programmes, patients with COPD, CVD or DM2 visit their general practice at a standard frequency per year (1 - 4 times) and standard monitoring measurements and topics are discussed. The practices that are randomised to the control group will not receive any additional training related to this study.

Arm

Intervention/Treatment

Experimental: Person-centred integrated care intervention

The core of the person-centered approach is a cyclical process and for EMBOSS developed for patients with low SES. The practice nurse in the GP will act as case manager and can consult other health providers. The first step in the intervention is assessing the integral health status of the patient (health across multiple domains), using a visual conversation tool. The second step is discussing the results with the patient. Personal goals are formulated in the third step. In the fourth step, the healthcare professional and patient will choose through shared-decision making the most appropriate interventions and support to achieve these goals, which are documented in a personal plan. Next, referrals are made if necessary and the treatment is started. An evaluation is planned and carried out. All practices in the EMBOSS intervention group will be trained by Pharos on how to recognize and provide GDM to low SES patients using appropriate communication skills and the specific tools.

Behavioral: Person-centred integrated care intervention

See arm description.

Other Names:

Usual care

No Intervention: Usual care

Practices in the control group provide care as usual, which consists of the SDM programmes according to the national care standards and General Practice guidelines (NHG) for DM2, COPD and CVD. According to these protocolised programmes, patients with COPD, CVD or DM2 visit their general practice at a standard frequency per year (1 - 4 times) and standard monitoring measurements and topics are discussed. The practices that are randomised to the control group will not receive any additional training related to this study.

Outcome Measures

Primary Outcome Measures

patient-reported health-related quality of life Physical Health [12 months]
Global Physical Health [Time Frame: Baseline, 6 months, 12 months] Physical aspect of health-related quality of life as measured by the PROMIS-Global 10 instrument (T-scores; higher T-score indicates better physical aspect of HrQoL) Promis 10 is a patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales.
patient-reported health-related quality of life Mental health [12 months]
Global Mental Health [Time Frame: Baseline, 6 months, 12 months] Mental aspect of health-related quality of life as measured by the PROMIS-Global 10 instrument (T-scores; higher T-score indicates better mental aspect of HrQoL) Promis 10 is a patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales.
Patient-experienced quality of care [12 months]
atient-experienced quality of care [Time Frame: Baseline, 6 months, 12 months] Person-centredness of care as measured by the Person Centred Coordinated Care Experience Questionnaire (P3CEQ) instrument; minimum score 0, maximum score 30, higher score equals better P3CE.

Secondary Outcome Measures

Patient activation as measured by PAM [Baseline, 6 months, 12 months]
Patient activation as measured by the Patient Activation Measure instrument; minimum 0, maximum 100, higher score equals better patient activation.
Health-related quality of life as measured by the EQ-5D-5L instrument [Baseline, 6 months, 12 months]
Health-related quality of life as measured by the EQ-5D-5L instrument; minimum 0, maximum 1, higher score equals better HrQoL
BMI [Baseline, 6 months, 12 months]
Combined length and weight according to general practice data (registered for normal care)
HbA1c [Baseline, 6 months, 12 months]
according to general practice data
Blood glucose [Baseline, 6 months, 12 months]
according to general practice data
Blood LDL-cholesterol [Baseline, 6 months, 12 months]
according to general practice data
Systolic and diastolic blood pressure [Baseline, 6 months, 12 months]
according to general practice data
Positive affect of healthcare providers [Baseline, 6 months, 12 months]
Satisfaction with job according to selection of MAS-GZ instrument (minimum 8, maximum 40, higher score indicates higher positive affect)
Experience of healthcare providers [Baseline, 6 months, 12 months]
Satisfaction with job according to selection of CO-PILOT instrument (minimum 1, maximum 10, higher score is better experience of healthcare providers)