tOwards a Patient Centred mulTIMorbidity Approach FOR Chronic Disease MAnagement in Primary Care (OPTIMA FORMA) PHASE 3: Cluster Randomized Controlled Evaluation Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 842
- Locations
- 1
- Primary Endpoint
- Composite score HRQoL & patient-experienced quality of healthcare
Study Overview
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.
Detailed Description
Rationale: 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.
Objective: 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.
Study design: 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.
Study population: all patients with DM2, COPD and/or CVD who currently receive SDM according to the SDM programmes of the participating primary care cooperatives are eligible to participate.
Intervention: a GDM programme including person-centered and holistic care. This programme will replace the SDM programmes for DM2, COPD and CVD that are currently used in the participating primary care cooperatives.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •Unable to speak or read the Dutch language
Arms & Interventions
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.
Intervention: Usual care (Other)
Person-centred integrated care intervention
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.
Intervention: Person-centred integrated care intervention (Behavioral)
Outcomes
Primary Outcomes
Composite score HRQoL & patient-experienced quality of healthcare
Time Frame: 12 months
% 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.
Secondary Outcomes
- Global Physical Health(Baseline, 6 months, 12 months)
- Global Mental Health(Baseline, 6 months, 12 months)
- Patient activation as measured by PAM(Baseline, 6 months, 12 months)
- Blood glucose(Baseline, 6 months, 12 months)
- Experience of healthcare providers(Baseline, 6 months, 12 months)
- Health-related quality of life as measured by the EQ-5D-5L instrument(Baseline, 6 months, 12 months)
- Health care use according to patient(Baseline, 3 months, 6 months, 9 months, 12 months)
- BMI(Baseline, 6 months, 12 months)
- HbA1c(Baseline, 6 months, 12 months)
- Blood LDL-cholesterol(Baseline, 6 months, 12 months)
- Systolic and diastolic blood pressure(Baseline, 6 months, 12 months)
- Patient-experienced quality of care(Baseline, 6 months, 12 months)
- Positive affect of healthcare providers(Baseline, 6 months, 12 months)