Clinical trial NCT03362983: Integrated, Multidisciplinary, Person-centered Care for Patients With Complex Comorbidities: Heart, Kidney and Diabetes
Official title: Integrated, Multidisciplinary, Person-centered Care for Patients With Complex Comorbidities: Heart, Kidney and Diabetes - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Chronic Kidney Diseases
Cardiovascular Diseases
Chronic Disease
Multimorbidity
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: University of British Columbia
First posted: 2017-12-05
Enrollment: 131
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patient with complex comorbidities present a growing challenge for health-care providers, that the current system is poorly designed to handle. Concomitant cardiovascular disease, renal dysfunction and diabetes represent almost half of all patients attending cardiac, kidney and diabetes clinics. Patients with all three of these will be randomized to standard care or to a combined, integrated, person-centered, intensified chronic disease management.

Detailed description: Patients with concomitant cardiovascular disease, renal dysfunction and diabetes represent almost half of all patients attending cardiac, kidney and diabetes clinics, and about 15 % suffer all three. This proportion of patients with multiple chronic conditions increase markedly by age. These complicated diseases interact, and treatment of one affect the others. Despite this have a progressive subspecialisation caused cardiologist to treat "only" the heart, nephrologists "only" the kidneys and endocrinologists' "only" diabetes. Studies and guidelines follow the same pattern. At best this require patients to visit specialists in each field; at worst result in redundant examinations, under-diagnosis and under-treatment of comorbidities. From the patient perspective, there is a great need for coordination and improvement of the care, not only to reduce disease progression but also to optimise quality of life.

We aim to study if the treatment and outcome for patients with concomitant cardiovascular disease, renal dysfunction and diabetes can be improved through a new model to deliver healthcare. We have designed an integrated clinic to handle all three conditions at the same visit, with a person-centered team-based approach between patients, nurses and physicians, with bi-weekly therapy conferences by dedicated and educated cardiologists, nephrologists and endocrinologists. At these, optimised care-plans are developed, and at following team-visits and phone contacts, these are implemented.

The intervention will be studied in a randomised controlled trial (CareHND) at HND-centrum, a novel integrated outpatient clinic in Stockholm.

Our main hypothesis is that HND-centra results in better care, from several aspects, at lower overall burden on the health care system.

The CareHND study will randomise an estimated 260 patients to HND-centrum or standard care.

The sample size is based on a power calculation for the combined outcome (Project 1): readmissions for heart failure, death, myocardial infarction, end-stage renal disease or TIA / stroke with 2 years follow up.

For Project 2, 3 and 4 detailed below the sample size will be 131. At 131 patients randomized an interim analysis will also be performed for the main outcome, after which the sample size will be adjusted if needed.

Inclusion criteria - CareHND:

1. - Established cardiovascular disease, and:
2. - Diabetes mellitus type 1 or 2, and:
3. - Established kidney disease (eGFR \<60 mL/min/m2 or macroalbuminuria).

Intervention:

Combined (nurses, physicians and paramedics), integrated (nephrology, diabetology and cardiology), person-centered, intensified chronic disease management at an integrated clinic for up to 12 months.

Outcome measures:

Project 1: traditional outcome measures including disease progression. Project 2: perceived quality of care. Project 3: value-based analysis of integrated clinic and health management. Project 4: Comparison between Sweden and Canada.

Eligibility criteria: Inclusion Criteria:

1. - Established cardiovascular disease (such as history of myocardial infarction, angina, or heart failure requiring hospitalization, previous stroke or TIA with certain diagnosis, and peripheral vascular disease), as well as:
2. - Diabetes mellitus type 1 or 2 (treated diabetes, or new onset diabetes according to WHO criteria or HbA1C \> 48, and symptoms, as well as:
3. - Established kidney disease (eGFR \<60 mL/min/m2 calculated with the CKD-EPI formula, or an average of the CKD -EPI and Cystatin-C eGFR, or borderline GFR but concomitant microalbuminuria, or macroalbuminuria, or kidney transplant).

Exclusion Criteria:

1 - Inability to provide consent

Primary outcomes:
measure: Disease progression (n=260)
timeFrame: 2 years
measure: Patient centered outcome measures (n=131)
timeFrame: 1 year
measure: Quality-of-care outcome measures (n=131)
timeFrame: 1 year
Secondary outcomes:
measure: Organ damage (n=131)
timeFrame: 1 year
measure: System biology (n=131)
timeFrame: 1 year
measure: Health care structure and utilization (n=131)
timeFrame: 1 year.
measure: Patient safety (n=131)
timeFrame: 1 year
measure: Interdisciplinary learning (n=20)
timeFrame: 1 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: HND centrum, Danderyd University Hospital
state: Stockholms LAN
Study officials:
affiliation: Danderyd University Hospital and Karolinska Institutet
name: Jonas Spaak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: