Clinical trial NCT05406193: A New Care Model for Patients With Complicated Multimorbidity
Official title: A New Care Model for Patients With Complicated Multimorbidity A Cluster-randomised Pilot Study in General Practice, Municipalities, and Hospitals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multimorbidity
Keywords: General practice
Integrated care
Multimorbidity
Lead sponsor: Slagelse Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2022-06-06
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients with complex multimorbidity experience a high treatment burden, fragmentation of care and poor clinical outcomes. General practice is the key organizational setting in terms of offering these patients integrated, longitudinal, and patient-centered care. Therefore, we propose a new general practice based model to improve overview, patient involvement and integration of care. The new care model consist of a teaching session on multimorbidity for the health care professionals, a prolonged overview consultation for patients with complex multimorbidity with the general practitioner, resulting in an individual care plan shared with the municipalities and secondary care, access to cross-sectoral video conferences with secondary care specialists and. Control practices provide health care as usual. We evaluate the care model in a cluster-randomized non-blinded, parallel-group trial in general practice. Fourteen general practices are allocated 1:1 to either intervention or control. We evaluate the effectiveness of the intervention with patient-reported questionnaire at baseline, 6-month follow-up, and 12-month follow-up. Primary outcome measure is the Patient Assessment of Chronic Illness Care (PACIC). Secondary outcome measure includes patient-reported quality of life and the treatment burden for the patients with multimorbidity. Furthermore, the project include a process evaluation of the complex intervention with the objective to assess how the intervention is delivered and to identify important facilitators and barriers for implementing the intervention. The new model is integrated into the existing health care system structures and has the potential for a sustainable improvement in care for patients with complex multimorbidity.


Eligibility criteria: Inclusion Criteria:

1. Has more than one of the 3 common chronic diseases (diabetes, chronic obstructive pulmonary, chronic heart conditions)
2. Has been hospitalised, or visited an outpatient clinic due to their chronic diseases during the previous year
3. Take at least five different prescription drugs assessed from the Shared Medicine Card recording in the general practice
4. The general practitioner or the nurse in the practice recognise the patient as a "demanding" patient with complicated multimorbidity that will benefit from an overview consultation.

Exclusion Criteria:

* Patients who cannot speak Danish,
* Patients who cannot give informed consent,
* Patients who have a life expectancy of less than 12 months

Primary outcomes:
measure: Change from baseline Patient Assessment of Chronic Illness Care (PACIC) at 12 months
timeFrame: From baseline to 12-month follow-up
Secondary outcomes:
measure: Change from baseline Patient Assessment of Chronic Illness Care (PACIC) at 6 months
timeFrame: From baseline to 6-month follow-up
measure: Change from baseline EuroQol-5 Domain (EQ-5D-5L) at 6 months
timeFrame: From baseline to 6-month follow-up
measure: Change from baseline EuroQol-5 Domain (EQ-5D-5L) at 12 months
timeFrame: From baseline to 12-month follow-up
measure: Change from baseline Multimorbidity Treatment Burden Questionnaire (MTBQ) at 6 months
timeFrame: From baseline to 6-month follow-up
measure: Change from baseline Multimorbidity Treatment Burden Questionnaire (MTBQ) at 12 months
timeFrame: From baseline to 12-month follow-up
Other outcomes:
Locations:
city: Albertslund
country: Denmark
facility: Lægerne Kanaltorvet
city: Albertslund
country: Denmark
facility: Thorkil Christensen
city: Brøndby
country: Denmark
facility: Brøndbyøster Torv
city: Ishøj
country: Denmark
facility: Lægerne i Brohuset
city: Korsør
country: Denmark
facility: Lægecenter Korsør
city: Slagelse
country: Denmark
facility: Læge Depenau vej-Hansen
city: Slagelse
country: Denmark
facility: Læge Jørgen Larsen
city: Slagelse
country: Denmark
facility: Læge Lene Stiggaard
city: Slagelse
country: Denmark
facility: Lægerne Reventlow, Wolfhagen og Bendtsen
city: Slagelse
country: Denmark
facility: Lægerne ved Lystskoven
city: Vallensbæk
country: Denmark
facility: Lægerne Vallensbæk Nord
Study officials:
affiliation: Innovation and Research Centre for Multimorbidity, Slagelse hospital, Region Zealand
name: Anne Frølich, Professor
role: STUDY_CHAIR
References: