OPTIMA FORMA Phase 3

NCT05495230 | Completed

• 1 other identifier: 2022-15788
• Study Type: interventional
• Target: 842
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic diseases and multimorbidity are increasingly prevalent. However, over the last decades, attempts at improving primary care for chronic diseases have been focussed on the management of individual chronic diseases and single disease management (SDM) programs have been implemented in Dutch primary care. This causes multiple problems for patients with one or more chronic diseases, such as negative interaction between treatment of single diseases, high treatment burden, negative patient experiences, lack of attention for problems in other domains of life that may interact with the chronic disease, and difficulties in shared decision making by the use of strict protocols in SDM programs. A person-centred and holistic approach is widely recognized as the solution to the problems observed in chronic disease care. Therefore, we guided three large Dutch primary care cooperatives, who have been organizing SDM programmes on diabetes mellitus type 2 (DM2), COPD, and cardiovascular diseases (CVD) in primary care for the last decades, with the development of a new generic disease management (GDM) programme including a person-centered and holistic approach (CMO 2019-5756). The three primary care cooperatives have recently conducted a pilot study in which we evaluated the feasibility of the programme (CMO 2021-8106) to further optimise its content and procedures. In the coming years, all three primary care cooperatives will gradually implement the optimised programme in all general practices in their regions. In the current study, our aim is to evaluate the effectiveness of the GDM programme on Quadruple Aim outcomes, i.e. patient experiences, population health, health care provider experiences, and cost effectiveness. We will conduct a cluster randomized controlled trial in the three primary care cooperatives with a follow-up of 12 months. Fifteen practices will be randomised to either care as usual according to the current SDM programmes, or to the GDM programme including a person-centered and holistic care approach. Approximately 40 patients per practice with DM2, COPD and/or CVD will be recruited.

Conditions

Chronic Condition; Chronic Conditions, Multiple

Keywords

Primary care; General practice; Person-centred integrated care

Outcome Measures

Primary Outcomes (1)

• Composite score HRQoL & patient-experienced quality of healthcare

  % difference between intervention group and control group of dichotomous composite score ( yes / no MCID improvement in health-related quality of life or quality of healthcare), which is based on the scores of PROMIS dimensions (GPH, GPM) and the P3CEQ-score.

  12 months

Secondary Outcomes (13)

• Global Physical Health

  Baseline, 6 months, 12 months

• Global Mental Health

  Baseline, 6 months, 12 months

• Patient-experienced quality of care

  Baseline, 6 months, 12 months

• 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

Study Arms (2)

Usual care

OTHER

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.

Other: Usual care

Person-centred integrated care intervention

EXPERIMENTAL

The core of the person-centered and holistic approach is a cyclical process. The practice nurse in the general practice will act as case manager and can consult the general practitioner or other health providers when necessary. The first step in the intervention is assessing the integral health status of the patient (health across multiple domains, including physiological measurements and symptoms of disease), using a (preferably digital) questionnaire at home and physical measurements. The second step is discussing the results with the patient in a semi-structured way. 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 healthcare plan. Next, referrals are made if necessary and the treatment is started. An evaluation is planned and carried out, if necessary multiple times.

Behavioral: Person-centred integrated care intervention

Interventions

Person-centred integrated care intervention BEHAVIORAL

See arm description.

Person-centred integrated care intervention

Usual care OTHER

See arm description.

Usual care

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)
• Unable to speak or read the Dutch language

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Chronic Disease; Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

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

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: August 2, 2022
• First Posted: August 10, 2022
• Study Start: January 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 18, 2024

Record last verified: 2023-11

Locations

NL (1)