Integrated, Multidisciplinary, Person-centered Care for Patients With Complex Comorbidities: Heart, Kidney and Diabetes (CareHND)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03362983|
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Chronic Kidney Diseases Cardiovascular Diseases Chronic Disease Multimorbidity||Other: CareHND||Not Applicable|
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:
- - Established cardiovascular disease, and:
- - Diabetes mellitus type 1 or 2, and:
- - Established kidney disease (eGFR <60 mL/min/m2 or macroalbuminuria).
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Integrated, Multidisciplinary, Person-centered Care for Patients With Complex Comorbidities: Heart, Kidney and Diabetes - a Randomized Trial|
|Actual Study Start Date :||January 1, 2016|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||March 1, 2019|
Experimental: Care HND Intervention
Integrated, multidisciplinary, person centered care at HND-centrum.
Multidisciplinary, integrated, person-centered care at the integrated HND-clinic
No Intervention: Standard care
Standard care at separate specialty clinics and primary care as needed.
- Disease progression (n=260) [ Time Frame: 2 years ]Combined death or readmission due to heart failure, myocardial infarction, PCI/CABG, end stage renal failure, acute renal failure or TIA / stroke.
- Patient centered outcome measures (n=131) [ Time Frame: 1 year ]Perceived quality of care and patient empowerment assessed by a PROMs (Patient Reported Outcome Measure) questionaire with a sum score.
- Quality-of-care outcome measures (n=131) [ Time Frame: 1 year ]Combined score of achieved target blood pressure, target HbA1C and target LDL.
- Organ damage (n=131) [ Time Frame: 1 year ]Decline in eGFR
- System biology (n=131) [ Time Frame: 1 year ]Changes in markers of disease progression in transcriptomics, proteomics and metabolomics.
- Health care structure and utilization (n=131) [ Time Frame: 1 year. ]Health care utilization measured by number of outpatient and inpatient contacts
- Patient safety (n=131) [ Time Frame: 1 year ]Using logged patient safety reports.
- Interdisciplinary learning (n=20) [ Time Frame: 1 year ]Qualitative analysis of interdisciplinary learning between personnel.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362983
|Contact: Jonas Spaak, MD, PhDemail@example.com|
|HND centrum, Danderyd University Hospital||Recruiting|
|Stockholm, Stockholms LAN, Sweden, 18261|
|Contact: Jonas Spaak, MD, PhD +46 76 2014178 firstname.lastname@example.org|
|Principal Investigator:||Jonas Spaak, MD, PhD||Danderyd University Hospital and Karolinska Institutet|