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

NCT05972031 | Unknown

• 1 other identifier: 2022-15786
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Condition; Chronic Conditions, Multiple

Keywords

Primary care; Person-centered; Integrated-care; Health literacy; Health disparities; Socio-economic status; General practice

Outcome Measures

Primary Outcomes (3)

• patient-reported health-related quality of life Physical Health

  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.

  12 months

• patient-reported health-related quality of life Mental health

  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.

  12 months

• Patient-experienced quality of care

  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.

  12 months

Secondary Outcomes (9)

• Patient activation as measured by PAM

  Baseline, 6 months, 12 months

• Health-related quality of life as measured by the EQ-5D-5L instrument

  Baseline, 6 months, 12 months

• BMI

  Baseline, 6 months, 12 months

• HbA1c

  Baseline, 6 months, 12 months

• Blood glucose

  Baseline, 6 months, 12 months

Study Arms (2)

Person-centred integrated care intervention

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

Person-centred integrated care intervention BEHAVIORAL

See arm description.

Also known as: Usual care

Person-centred integrated care intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

RadboudUMC

Nijmegen, Netherlands

RECRUITING

MeSH Terms

Conditions

Chronic Disease; Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hester Van Bommel, MSc

CONTACT

+31302349800; hester.vanbommel@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized controlled trial

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: August 2, 2023
• Study Start: January 29, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-02

Locations

NL (1)