Collaborative Care for patients with a bipolar disorder: an effectstudy.

Background.
A bipolar disorder is a severe mental illness with often many consequences on
daily life for patients as well as caregivers/family/friends. Treatment
currently exists of pharmacotherapy, sometimes combined with psychotherapy,
psycho education and teaching selfmanagement skills. A proportion of patients
shows satisfying responses to this treatment, and the illness remains
relatively stabile over time. Another subgroup of patients however does not
respond adequately to the treatment offered. They show a rather low response to
therapeutic efforts and suffer from frequent manic or depressive episodes and
cognitive impairments. Often they have little social support and show low
social functioning. Frequently co-morbid psychiatric and somatic disorders are
present which complicate the course of the bipolair disorder. For this subgroup
of patients a specialised multidisciplinary approach is required, with optimal
integration of the efforts of the different professionals who are involved in
treatment and care. It is also important that the patient is actively involved
in treatment, e.g. in the definition of goals of treatment and their
priority. In literature such a treatment is referred to as 'Collaborative
Care'. Little research has been performed on the effects of such an integrated
treatment program for patients with a bipolar disorder. Bauer et al. (2006),
Simon et al. (2005, 2006) en Suppes et al. (2003) researched the effects of
multidisciplinary treatment methods for people with a bipolar disorder and the
results are promising.

We expect Collaborative Care to have a positive effect on functioning, amount
and severity of symptoms, quality of life, costs, mastery, attitude to
pharmacotherapy, and satisfaction with care. If effect of this intervention
can be demonstrated we have an evidence based intervention at our disposal in
which the coordinating nurse performs an important coordinating role. This
intervention can be included in the existing (multidisciplinary) guidelines for
treatment of bipolar disorders.

Methods
This study is a two-armed clusterrandomized clinical trial. The aim is to
evaluate the collaborative care program in specialized ambulatory mental health
care in the Netherlands. Collaborative Care (CC) will be evaluated against
treatment as usual. CC includes tailored care, aimed at individualised goals
set collaboratively by the patient, his caregiver, the nurse and the
psychiatrist, who all are members of the Collaborative Team; contracting and
shared decision making are core elements of CC, as well as psycho education,
Problem Solving Treatment, systematic relapse prevention, monitoring of
outcomes, pharmacotherapy and somatic care. Specialist nurses coordinate care
and execute parts of the treatment program. Nurses and psychiatrists in the
intervention group will be trained in the intervention. The intervention period
is one year. Measurements will take place in the experimental and control
groups at baseline, at six and at twelve month. Outcomes are symptomatology,
quality of life, costs, psychosocial functioning, mastery, attitudes towards
medication and satisfaction with care. Caregiver outcomes are burden and
satisfaction with care.

Research questions:
1 What are the effects of a CC program performed by nurses (compared to Care as
Usual) for patients with a bipolar disorder on their functioning,
symptomatology, quality of life, mastery, attitude towards pharmacotherapy and
satisfaction with care?

2 What are the effects of CC (compared to Care as Usual) for
caregivers/family/friends of patients with a bipolar disorder on their
perceived burden and satisfaction with care?

3 What is the cost effectivity of CC compared to CaU?

The Collaborative Care Program (CCP) will be implemented in several ambulatory
mental health care facilities in the Netherlands. Nurses and psychiatrist will
be trained, which means that *Collaborative Care' will be provided, tailored
to the needs of the patient. Core elements of CC are:
* Forming of a Collaborative Care Team. This team consists at least of the
patient, (and preferably a family member or friend), the nurse and the
psychiatrist. The team meets every three months. The primary nurse coordinates
care and is responsible for continuity of care. The patient has an active role
in his / her own treatment. If the patient agrees, then family members, friends
or caregivers are invited to participate in treatment.
* Contracting. The patient is an active member of the CC-team. One important
aim is to agree on the most important problems to be worked on, the related
goals, and which care is needed to achieve these goals . A contract is being
made, in which the problems, goals, content of treatment and care, and outcomes
are elaborated.
* Psycho education (based on the Dutch Psycho education course, based on Hofman
et al., 1992; Honig et al., 1997) adapted to the needs of patient and family.
* Problem Solving Treatment (Schreuders et al., 2005/2007).
* Monitoring and relapse prevention, by using the Life Chart Method (Leverich &
Post, 1998; Kupka et al., 1996) and an emergency plan (LithiumPlusWerkgroep,
2001).
* Pharmacotherapy and somatic care, with continuous monitoring of the effects,
* Support on developping a healthy lifestyle.
If indicated some extra interventions will be provided:
* Activity Scheduling, if patients are prolonged depressed.
* Rehabilitation modules, if patients have low quality of life and minimal
social participation.

We expect no negative side effects of this study.