To examine the cost-effectiveness of a treatment protocol focused on self management rehabilitation followed by replacement in primary care for patients with chronic depression and/or anxiety who are currently being treated in secondary care.
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure will be global quality of life as measured with the
World Health Organization Quality of Life instrument, Brief version
(WHOQOL-BREF).
Secondary outcome
Secondary outcome measure will be cost-effectiveness. Costs will be measured
using the Trimbos/iMTA questionnaire for psychiatric disorders, according to a
societal perspective, thus involving medical costs and productivity costs.
Furthermore, depressive and anxiety symptoms will be measured with the Patient
Health Questionnaire- 9 (PHQ-9) and the Beck Anxiety Inventory (BAI)
respectively. Since empowerment of patients is also an aim of this
intervention, this will be assessed using the Empowermentlist.
Background summary
A significant group of patients treated in secondary care is considered to
suffer from chronic depression and/or anxiety. These patients have not
responded to several evidence based treatments and are currently being treated
by a psychiatric nurse in "supporting contacts". This form of care is expensive
and not evidence based. Treatment focused on self management rehabilitation and
eventually replacement in primary care with specialty back up (collaborative
care) might improve patients quality of life and be more efficient and (cost-)
effective.
Study objective
To examine the cost-effectiveness of a treatment protocol focused on self
management rehabilitation followed by replacement in primary care for patients
with chronic depression and/or anxiety who are currently being treated in
secondary care.
Study design
A randomized controlled trial. Patients will be asked to participate by their
care giver (psychiatric nurse) and fully informed about the nature of the
study. If they are willing to participate they will be randomized to the
intervention group (self management protocol, provided by a trained psychiatric
nurse, followed by replacement with specialty back-up in primary care) or the
control group (continuation of usual care, with the possibility of following
the self management protocol after the end of the study period).
Intervention
A self management protocol provided by a trained psychiatric nurse in secondary
care. During 13 sessions in 26 weeks patients form an action plan to
re-establish social contacts, improve their daily living activities, patients
and their families are educated about the nature of their chronic disorder,
suicidality, crises and they learn how to cope with these issues. At the end of
this protocol, patients are guided in their replacement in primary care.
Professionals working in primary care who will be taking over care for
participating patients, will be educated about a model of collaborative care
for patients with chronic depression or anxiety. Every primary care practice
has to select a mental health professional (psychiatric nurse, social worker or
psychologist) who functions as a care manager. This care manager works in close
collaboration with the general practitioner and actively monitors functioning
of the patient. The general practitioner will be responsible for prescription
of medication. Both care manager and general practitioner have easy access to
the advice of a consultant psychiatrist who is already familiar with the
patient and are provided with a protocol for crisis situations. The process of
replacement to primary care will be guided by the psychiatric nurse from
secondary care. A qualitative study alongside this randomized controlled trial
will be conducted to examine experiences of professionals and patients with the
intervention in greater detail.
Study burden and risks
Considering care provided to the patients, no burden or risk is associated with
participation. All patients receive at least usual care. For patients in the
intervention group, transfer to primary care is closely monitored and if
necessary, patients may return to secondary care. The burden associated with
participation in this study consists solely of the conduction of a diagnostic
interview (45 minutes) and completing the baseline and two follow-up
questionnaires. It takes about 30 minutes to complete this questionnaire. A
small subsample of participants (approximately 15) will be invited for a
qualitative interview, lasting one hour.
Da Costakade 45
3521 VS Utrecht
NL
Da Costakade 45
3521 VS Utrecht
NL
Listed location countries
Age
Inclusion criteria
Chronic anxiety or chronic depression (> 2 years)
Have not responded to at least 1 evidence based psychological therapy and and at least 3 evidence based medication steps (checklist)
Currently receiving "supporting contacts" from a psychiatric nurse
Exclusion criteria
Bipolar disorder
Psychosis
Insufficient knowledge of the dutch language
Cognitive problems / low IQ (<80)
Dementia
Terminal disease
Alcohol or drugs addiction
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL33674.097.10 |
OMON | NL-OMON27623 |