Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04258176 |
| Other study ID # |
634802 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2018 |
| Est. completion date |
March 31, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Central Jutland Regional Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Patients with complex chronic multiple illnesses constitute an increasing challenge and more
evidence-based knowledge of effective practice is required. In Denmark and the rest of the
world, improved health care, public health, and increased focus on early diagnosis have led
to increases in life expectancy resulting in a growing population of older people living with
multiple long-term conditions (multimorbidity). Today, every fourth Dane suffers from more
than one concomitant chronic or severe disease, estimated to rise to 60% for those over 65
years.
National and international health care is organised and targeted as specialised,
mono-diagnostic efforts for single diseases leading to lack of coordination and failure to
integrate multidisciplinary patient trajectories. Danish research shows that general practice
is challenged by insufficient collaboration between professionals involved in the treatment.
Despite this, there exists limited evidence of initiatives aiming to improve care for
multimorbid patients.
This study aims to:
1. identify chronic multimorbid patients and to analyse their use of two or more outpatient
clinics, their general use of health care utilisations and their disease pattern and
characteristics (Cross-sectional study using national registers).
2. develop an innovative organisational structure around a multidisciplinary outpatient
pathway for multimorbid patients and to pilot-test it (feasibility study)
3. phase-III test a multidisciplinary outpatient pathway and to preliminarily evaluate the
effects in patients and health professionals and on resource utilisations (effect study)
Description:
Background Patients with complex chronic multiple illnesses constitute an increasing
challenge and more evidence-based knowledge of effective practice is required. In Denmark and
the rest of the world, improved health care, public health, and increased focus on early
diagnosis have led to increases in life expectancy resulting in a growing population of older
people living with multiple long-term conditions (multimorbidity). Today, every fourth Dane
suffers from more than one concomitant chronic or severe disease, estimated to rise to 60%
for those over 65 years. Multimorbidity is more prevalent in women, rises with declining
social status and is associated with poorer quality-of-life. With an increasing proportion of
multimorbid patients, the prevalence of polypharmacy will increase. A multisymptomatic and
complicated disease pattern applies to both physical and mental illness, multiplicative
effects can create a need for people within different specialities working together. Earlier
studies show, that the most common chronic diseases are diabetes, cardiovascular disease,
cancer, chronic obstructive pulmonary disease and asthma. Comorbid diseases tend to compound
and interact, for example, COPD and diabetes are often seen in combination with
cardiovascular disease.
Everyday-life of multimorbid patients is influenced by drug consumption, frequent visits to
general practice, hospitalisations and outpatient clinics. A recent study showed that
patients with three chronic conditions visit health professionals five times a month and
spend 50-71 hours per month on health-related activities. However, studies on derivative
effects of multimorbidity are scarce and research focus is primarily placed on mainly health
services. Multimorbid patients experience and are in reality exposed to lack of coordination,
lack of inter-disciplinary communication and overall poor care management. Individual
resources and priorities in everyday life play a dominant role in navigating the tension
between everyday life and the health care system. This is often extremely demanding for
patients to navigate in.
National and international health care is organised and targeted as specialised,
mono-diagnostic efforts for single diseases leading to lack of coordination and failure to
integrate multidisciplinary patient trajectories. Danish research shows that general practice
is challenged by insufficient collaboration between professionals involved in the treatment.
Despite this, there exists limited evidence of initiatives aiming to improve care for
multimorbid patients. Previous initiatives involve getting patients to take more active part
in their disease, creating disease insight, involving case managers, patient-shared medical
appointments, collaborative models and communication technology. Present on-going studies
focusing on interventions for multimorbid patients are also few.
In conclusion, the evidence is sparse on collaborative approaches directed at multimorbid
patients and on organising health care systems to accommodate this.
Objectives and hypotheses Hypothesis 1 Multimorbid patients have numerous contacts to
outpatient clinics and are characterised as being older patients with common chronic
diseases, a complicated disease pattern and frequent users of health care utilisations.
Objective 1: To identify chronic multimorbid patients and to analyse their use of two or more
outpatient clinics, their general use of health care utilisations and their disease pattern
and characteristics.
Hypothesis 2: It is feasible to convert several outpatient clinic pathways to one
multidisciplinary outpatient pathway and to structure an organisation around it.
Objective 2: To develop an innovative organisational structure around a multidisciplinary
outpatient pathway for multimorbid patients and to pilot-test it.
Hypothesis 3: Patients and health care professionals find it advantageous to convert
outpatient visits for multimorbid patients to a multidisciplinary outpatient pathway, and the
use of resources will lower.
Objective 3: To phase-III test a multidisciplinary outpatient pathway and to preliminarily
evaluate the effects in patients and health professionals and on resource utilisations.
Materials and Methods
Objective 1:
In a national cross-sectional study, data on multimorbid patients is obtained using validated
Danish registries, processed with remote access to Statistics Denmark.
Inclusion criteria:
- Patients who are diagnosed with more than one chronic disease
- Seen in more than one outpatient clinic (within 18 months, 12 months, 6 months, 3
months)
- ≥18 years of age.
Exposure and outcomes: Primary exposure constitutes chronic diseases occurring in multimorbid
patients with classification a priori. Based on diagnoses (selected diagnoses chosen from
previous studies), clinical, socio-demographic characteristics and the need for health care
are investigated. We wish to demonstrate how these exposures are distributed by the number of
concomitant outpatient visits within different time intervals of 18 months, 12 months, 6
months, 3 months.
Objective 2:
In a feasibility-design efforts will be devoted to setting up an innovative multidisciplinary
outpatient pathway based on recommendations for complex interventions in the health system.
It involves the process of going from a conceptual to an operational setup.
Procedure: A multidisciplinary outpatient pathway will be established at the University
Research Clinic for Innovative Patient Pathways. Through literature review and specialist
opinions, interviews, the intervention will consist of two or more disciplines collaborating
in establishing a treatment plan for the patient. A process manual of the individual phases
and a participatory cooperative approach will be used. A steering group will involve plastic
organic groups (health care professionals, patients, general practitioners), which will
contribute along with the hospital's task force team (center management, senior health care
professionals, representatives of quality development) through process support.
Exposure and outcomes: In the multidisciplinary outpatient pathway, health care professionals
will collaborate between medical specialties and examinations gathered for one joint
encounter with the patient. An integrated discharge summary is sent to general practice. The
exact structure and composition of the multidisciplinary outpatient pathway is part of the
feasibility study. Interviews are conducted on patients and healthcare professionals to
assess their experience with the pathway. Also a process evaluation is made.
Study 3: To phase-III test a multidisciplinary outpatient pathway and to preliminary evaluate
the effects in patients and healthcare professionals and on resource utilisations.
In a prospective study with difference-in-difference analysis, a cohort of multimorbid
patients seen in outpatient clinics is included based on the composition from the feasibility
study.
Exposure: The newly established multidisciplinary outpatient pathway. Outcomes: In paired
measurements, Patient Reported Experience Measures (PREM) are recorded in questionnaires
before and after trajectories in conventional mono-disciplinary outpatient clinics are
converted to trajectories in the multidisciplinary outpatient pathway. Questionnaires are
compiled according to the literature of existing, validated questionnaires and supplemented
by ad hoc questions when no existing questionnaire exists). Questionnaires are set up in the
processing program, REDCap and sent through "e-boks" merged with doc2mail where replies are
entered directly in REDCap through a link. Questionnaires will also be sent by letter.
The cohort will be followed for one year for data collection on health care utilisations
(e.g. admissions, visits to outpatient clinics, redeemed prescriptions, contacts to general
practice or emergency medical services, hospital activity/examinations). A control group of
patients from other hospitals with trajectories in outpatient clinics are matched by gender,
age, disease, comorbidity, and length of disease. Difference-in-difference comparisons are
made on healthcare utilizations one year prior to the index date (first consultation with the
new pathway). Data is retrieved from national registers.
