Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02541474 |
| Other study ID # |
2014/1707 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2016 |
| Est. completion date |
December 31, 2018 |
Study information
| Verified date |
May 2018 |
| Source |
University Hospital of North Norway |
| Contact |
Gro K Berntsen, MD, Dr Med |
| Phone |
90518895 |
| Email |
gro.berntsen[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
There is an urgent need to develop new care models for patients with long-term and complex
needs. Our goal is services that are seamless, pro-active and person-oriented.
Intervention:
The Patient-centered health care team (PACT) is a service model for frail elderly patients
with multiple long term conditions. PACT is a seamless and proactive health service model
that aims to ensure safe early discharge and prevent hospital admissions for elderly frail
patients. The four pivotal elements are are supported by theoretical and empirical
underpinnings: 1) Goal-oriented person centered approach 2) Inter-disciplinary comprehensive
geriatric team: 3) Pro-active care plan.
Study Objective:
1) To investigate whether the PACT model improves health-related quality of life and patient
generated goals 2) carry out a health economic evaluation of PACT.
Design:
The evaluation model for complex interventions is our guiding evaluation framework. This is a
non-randomized, matched control, before after study. The intervention unit, is the care
organization, including four hospitals - municipality dyads. Two intervention dyads and two
control dyads. Index patients from intervention hospitals will be matched age, sex and number
of chronic conditions.
Intervention group: Patients with emergency admission to the UNN internal medicine department
in Tromsø and Harstad who are age > 65, have three or more long-term conditions, an emergency
admission within the last year, and an informed consent is given by patient or next of kin.
(Approved by ethics board 07.05.2015). The exclusion criteria are: Language barriers, and
less than 3 months life expectancy.
Controls: Recruited from the Nordlanssykehuset (Bodø) and UNN-Narvik internal medicine
departments, matched to the index patient's sex, age, number of long-term conditions. Control
patients will be subject to the same data-collection as intervention patients.
Data collections: All patient data will be collected at baseline, 6 and 12 months. Outcomes:
The primary outcome is the adjusted differences in the change of Quality of Life, measured by
Short Form-36 (SF-36), physical health dimension between intervention and control groups at 6
months after inclusion in study.
Description:
Paradoxically, the very success of our health care system causes the number of patients with
multiple are on the rise. Studies of European populations above 75 years of age show
LTC-prevalences of more than 70%, and rates of multimorbidity around 40-50%(8-10). Patients
with LTC-conditions accounted for 3/4ths of health care spending in an early US report, and
patients with 4 or more co-morbidities consumed 5 times as much health services as those with
no LTC in a recent Irish report. The current care system is designed to deliver disease
specific, urgent/ episodic care, and is poorly suited to the needs this growing patient group
Best practice models for patients with Long Term conditions (LTCs) and complex needs have
been developed. In medicine, the underlying models are often implicit, which can cause the
misunderstanding that medical research is practical, factual and not theory driven. In
complex interventions, underpinning theoretical models are considered essential for study
design.. In the planning and design of this intervention, the investigators have chosen to
use the Chronic Care Model (CCM). Other models of chronic care are either slightly
overlapping or in alignment with the CCM, but none of them cover all the areas of the CCM. It
is the only model with both a systems- a clinical- and a patient perspective. Furthermore it
has a growing evidence base for its effects on both care-processes, health outcomes and
cost-effectiveness. It continues to inspire care reform both in large international care
organizations, and in our local northern Norwegian context. The CCM builds on two pillars:
"The informed active patient" and "The pro-active prepared health care team", which are equal
partners engaging in "productive interactions" for "health and functional outcomes". Evidence
Based Medicine (EBM) is the basis for identification of appropriate actions. Integrated team
care delivery is then tailored to the patients' needs, values and preferences. Both health
management support and use of clinical information systems are included in the model as key
supporting factors(33).
A recent report documents that the health care delivery in Helse Nord is far from the ideal
CCM-care. The main challenges were a lack of attention to the patient's personal context and
priorities, and a fragmented care delivery. A large-scale CCM inspired project which answers
these challenges, is under development at the university Hospital of North Norway (UNN). Its
dual focus is coordination of care through two core components: 1) the proactive, prepared
interdisciplinary teams with personnel from both hospitals and the municipalities to address
the current fragmented care delivery and 2) the informed active patient approach to care
planning. The initiative, which will be funded by redeploying existing staff to work in the
teams. The team will facilitate patient centered and integrated care by conducting a
structured person centered need assessments, develop individual evidence based care plans,
and provide service integration across levels of care.
Research questions, hypotheses and methods The CCM is currently established as best practice
for LTC-care delivery. Yet, the evidence of effectiveness of the CCM in terms of health and
functional outcomes in several systematic reviews remain inconsistent. All CCM interventions,
must tailor the CCM to local historical, cultural and regulatory context. Thus the
heterogeneity of CCM-interventions is large, which may explain the observed inconsistencies.
In our review, the investigators noted that many CCM-interventions seemed to lose the link to
the underlying theory in the operationalization process. Active two-way patient-provider
dialogues and practical skills development in self-management are central for better
outcomes. However "the informed active patient" and "self-management support" were often
translated into passive one-way educational interventions. Furthermore, the content of many
of the CCM-interventions was often inadequately described, making it difficult to ascertain
their fidelity to the underlying theory.
Our research questions are: What is the effect of a theory driven CCM-implementation on:
- Patient health and functional outcomes?
- System outcomes: Length of stay and emergency admissions in primary and/ or secondary
care institutions?
Material and methods:
Design: The evaluation model for complex interventions is our guiding evaluation framework .
This is a non-randomized, matched control, before after study(46). The investigators
recognize that randomization is the most robust method of avoiding systematic bias between
comparison groups. However, our intervention aims to change usual geriatric care, in terms of
both structures and routines at the organizational level of two municipal-hospital dyads. A
patient level randomization will require the organization to switch between old "usual care"
and a new team-based pro-active routines on a patient-by-patient basis, is unlikely to be
successful. As there are only four hospitals involved in the study, randomization at the
organizational level would not really control for bias either. The chosen design improves
comparability between the comparison groups by matching them on factors known to be important
for outcomes (age, sex and number of chronic conditions), to adjust for baseline differences
between the populations with a before-after design, and to adjust for known confounders by
the propensity score method(47, 48). The design is approved by Cochrane to be included in
systematic reviews of interventions (46).
Setting: Trials are often performed on selected patients without comorbidities making studies
suffer from limited external validity. Van Royen et al (2014) argue that there is a driving
demand for real-word clinical practice data. In this project, the team members will develop
the intervention as part of the daily activity at the hospitals including "normal" medical
patients > 67, making the trial setting naturalistic. The real-world setting and normal
patient caseload makes the design resemble usual care, thus increasing the generalizability
from the trial to other patients in regular practice. A naturalistic setting is viewed to be
the gold standard for economic evaluations, which is also an objective for the project.
The intervention: PACT is a seamless and proactive health service model that aims to ensure
safe early discharge and prevent hospital admissions for elderly frail patients. The four
pivotal elements are all part of the CCM-model, and are supported both by theoretical and
empirical underpinnings: 1) Inter-disciplinary comprehensive geriatric team: Frail elderly
patients are often multi-morbid, and in need of multiple simultaneous competencies. The team
will push for early discharge to minimize the deconditioning and iatrogenic risks associated
with hospitalization(. The team will identify eligible patient's, make an integrated
assessment of needs upon admission, marshal the necessary resources to resolve current
clinical issues, and prepare for early discharge supported by home based services such as
home -monitoring, and -care. The team will develop and use different intervention options
such as case management, discharge- and follow-up protocols, an array of telehealth options
(telephone support, telemedicine, telemonitoring and smart home solutions) combined with
in-person home visits when needed. Patients will remain a team responsibility for a period of
3-5 days after discharge 2) Involving patients in care and self-management: When the clinical
situation is stable, the patient will be invited to make a systematic assessment of needs,
values and preferences with a care-team member. The patient's wishes are then translated into
realistic care goals in a shared decision making process. Most importantly, the team can
avoid undesired care, which is especially important in a palliative phase. The teams should
also provide opportunities for patient education, social- and physical adaptions, and/or
skills training to improve self-management. Patient involvement and engagement in care has
been shown to improve health and functional outcomes. 3) Pro-active care plan: CCM promotes a
systematic early identification of functional decline. The team should discuss the most
probable scenarios of clinical deterioration, and provide action plans for them, which are
available to both patients and team. An example is to provide patients with Chronic
Obstructive Pulmonary Disease with a drug kit, which the patient can use under guidance from
care personnel. The pro-active care plan should also include a road map towards the health
goals identified together with the patient. 4) One point of contact: To avoid unnecessary
delays and prompt action to early signs of clinical problems, patients should not have to
"hunt" down the right professional. A 24/ 7 call-center will be their one-point- of contact.
The call center will have the resources to mobilize the necessary clinical responses,
including single members of- or the completely comprehensive geriatric team.
