Clinical trial NCT05495230: OPTIMA FORMA Phase 3
Official title: tOwards a Patient Centred mulTIMorbidity Approach FOR Chronic Disease MAnagement in Primary Care (OPTIMA FORMA) PHASE 3: Cluster Randomized Controlled Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Condition
Chronic Conditions, Multiple
Keywords: Primary care
General practice
Person-centred integrated care
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 842
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: 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.

Main study parameters/endpoints: effectiveness will be evaluated by Quadruple Aim outcomes at baseline, at 6 months, and at 12 months follow-up by comparing changes in the intervention group with the comparator group. Patient experiences will be measured with the P3CEQ questionnaire. Population health will be measured with the PROMIS Global-10 questionnaire. Self-management will be measured with the Patient Activation Measure (PAM) score. Healthcare professional experiences will be measured with the MASGZ and the COPILOT questionnaire. Data for calculating costs and conducting a cost-effectiveness analyses will be measured by the Medical Consumption questionnaire and the EQ-5D questionnaire and by process outcomes such as the number and type of consultations and referrals, and duration of consultations from the Electronical Medical Files. At 12 months, a purposive sample of patients and professionals will participate in focus group interviews to collect information on experiences and facilitators and barriers for further implementation. Also, the competences needed by the healthcare professionals to provide personalised and integrated chronic care will be explored.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

* The intervention has been developed by the three primary care cooperatives in close collaboration with their healthcare professionals and their patient panels and with the guidance of our research group. Also, input from the Dutch College of General Practitioners (NHG) and from InEen, the branch organisation for primary care cooperatives, has been obtained to ensure that the intervention will suit their vision and future plans for reorganising Dutch primary care chronic disease management. The intervention is also in line with current movements in healthcare, such as the Positive Health concept.
* All three primary care cooperatives are intending to gradually implement the intervention throughout their regions in the upcoming years. Thus, the GDM programme will be implemented and will replace current SDM, even without the current cluster RCT as proposed in this study protocol.
* The burden and risks associated with the intervention are negligible and comparable with the usual care, i.e. the current SDM programmes.
* Patients in the control group will continue with their care as usual, i.e. single chronic disease management according to the protocols of the SMD programmes that have been used in the participating cooperatives since the last decade.
* The additional burden or risk associated with participation in this study is negligible. After written informed consent, patients in both groups will fill in a digital or paper questionnaire at baseline, 6 months, and 12 months. Estimated time to fill in the questionnaire is 20 minutes. A purposive sample of approximately 15 patients will participate in focus-groups interviews at the end of follow-up.

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)
* Unable to speak or read the Dutch language

Primary outcomes:
measure: Composite score HRQoL & patient-experienced quality of healthcare
timeFrame: 12 months
Secondary outcomes:
measure: Global Physical Health
timeFrame: Baseline, 6 months, 12 months
measure: Global Mental Health
timeFrame: Baseline, 6 months, 12 months
measure: Patient-experienced quality of care
timeFrame: Baseline, 6 months, 12 months
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: Health care use according to patient
timeFrame: Baseline, 3 months, 6 months, 9 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: