Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03989765 |
| Other study ID # |
298907 |
| Secondary ID |
273546 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 25, 2019 |
| Est. completion date |
September 30, 2022 |
Study information
| Verified date |
June 2024 |
| Source |
University Hospital, Akershus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
There is considerable geographical variation in the rates of compulsion in psychiatric
services within as well as between countries. Reducing the use of compulsion of patients with
severe mental illness is an expressed policy aim, and also a demand from service user
organisations. In Norway, municipalities hold responsibility for primary care and are
therefore central to the delivery of services to people with severe mental illness. This
indicates a potential for intervening at the municipal level to reduce the use of compulsion
where it is high. The Reducing Coercion in Norway study (RECON) will, in collaboration with
municipalities with high compulsion rates, develop a municipal-level intervention (Stage 1)
that will be implemented in a cluster-RCT (Stage 2) to test if it has effect on compulsion
rates.pulsion rates.
Description:
BACKGROUND:
In Norway, as in other parts of the Western world, there have been concerns about increase in
the use of compulsory mental health care for patients with severe mental illness. There is
growing public concern, however, despite the explicit instruction from the Norwegian
government that health services should reduce the use of compulsion, rates have not
decreased. The Reducing Coercion in Norway study (RECON) is designed to develop and test an
intervention, at the municipal level, to reduce the use of compulsion.
Most referrals to compulsory treatment come from primary care. In Norway, it is the 400+
municipalities who hold responsibility for primary care. This includes multi-disciplinary
municipal mental health teams, substance abuse services, social care and GP services. At the
Specialist level, four Regional Health Authorities Commission a number of Health Trusts to
deliver specialist mental health care through acute hospitals and District Psychiatric
Centres. These centres often collaborate, in different ways, with municipal services.
Municipal service providers are often those in most frequent contact with patients with
severe mental illness, and will commonly be those detecting early signs of relapse.
Importantly, municipal services (usually GPs or out of hours emergency services) will serve
as gatekeepers for involuntary admissions, as they refer to specialist services who then may
invoke the Mental Health Act that sanctions compulsion. This suggests a potential for
developing strategies within municipal services to intervene early and possibly prevent some
episodes of compulsion. Very little research has investigated the role municipal services
play in the compulsion or on relevant cross-sectoral collaborations. There is also limited
research on out-patient interventions designed to reduce compulsion. A systematic review
could only include 15 experimental studies internationally. Joint crisis plans, risk
assessments and counselling of staff were identified as promising interventions. However,
most studies had insufficient samples or were of too poor quality to draw conclusions.
Moreover, all included studies were based in specialist out-patient services.
The 'Six Core Strategies' intervention, developed to reduce seclusion and restraint in
psychiatric hospitals, has shown positive effects. The six strategies involved are:
structured efforts to improve leadership and organisational change; use of data to inform
practice; workforce development; use of seclusion and restraint reduction tools; involvement
of peers, and; rigorous debriefing techniques. It has been implemented in six countries, with
positive results. No equivalent has been developed for municipal services. Service users and
clinicians in Norway have, however, suggested potential strategies for municipal services to
impact on compulsion rates. These include crisis plans; structured meetings of patients'
networks, spaces for informal contact; key contact persons for patients; improved skills for
early detection of relapse and; improved local collaboration. Given the potential role of
municipalities for reducing the use of compulsion, it seems clear that further research is
needed. RECON takes the Six Core Strategies model as a starting point for developing and
testing a municipality-based intervention for reducing the use of compulsion.
AIM To develop, implement and test the effectiveness of a municipality-based intervention to
reduce the use of compulsion in mental health services, in municipalities with rates of
involuntary treatment episodes above the national average.
The aim will be reached through a two-staged approach.
OBJECTIVES AND METHODS STAGE 1:
In order to facilitate stakeholder input and to ground the research in a thorough
understanding of the structures and processes of municipal service delivery, much of the data
to address Objectives 1-3 will be collected through a mix of qualitative methods.
1. To identify and secure the participation of mid-sized municipalities with above average
levels of involuntary treatment episodes Mid-sized municipalities (20-50K inhabitants),
with above average rates of compulsion and motivated to change service delivery to
tackle compulsion, will be recruited to take part in the study. This will take place in
the period June- September 2019.
2. To map the mechanics of current practice together with local health and social services,
service users, family caregivers and other stakeholders Local current practice will be
mapped regarding what services are available in the intervention sites and how they work
individually and collaboratively with patients with severe mental illness. Particular
focus will be on the processes in municipal services that lead to involvement of GPs and
possible referral for assessment for compulsion, and how patients are cared for after
discharge (some of them subject to outpatient compulsion). Across the five sites
semi-structured interviews and/or focus groups will be conducted with service leads in
municipal mental health and addiction services (outpatient and housing services), GPs,
social services and corresponding services in the local DPCs and focus groups with
service users and family caregivers. These data will be subject to thematic analysis.
Content analyses will be conducted of relevant service plans and other documents
outlining leadership and workforce development, service collaboration, and any relevant
guidelines. This will take place in the period July- December 2019.
3. To develop a municipality-based intervention for reducing compulsion in collaboration
with municipalities and service users.
The data collected will be used in the development of the intervention through mediated
dialogue seminars with services in the intervention sites. Based on the Six Core
Strategies it is likely that themes will include: leadership and organizational change;
using data to inform practice; workforce development; use of seclusion and restraint
reduction tools (in the municipal setting this might include crisis plans, risk
assessment and de-escalation tools); involve peers, and; rigorous debriefing techniques
(most likely after a referral for assessment for detention and/or after discharge from
hospital). This will take place in the period January- March 2020.
OBJECTIVES AND METHODS, STAGE 2:
4. To implement and study the intervention in five municipalities The intervention
developed in Stage 1 will be implemented by services in five municipalities, supported
by the research team. Regular site visits and contacts will be conducted to monitor
progress and fidelity to the intervention in the intervention sites. This will feed into
a process evaluation that will identify potential facilitating factors and barriers for
successful implementation. This will take place in the period April 2020- April 2021.
5. To test the effect of the intervention in a cluster-randomised controlled trial The
effectiveness of the intervention will be measured by comparing the change in outcomes
between the intervention and the control group (difference in difference). Outcome data
will be obtained aggregated at municipality level, from the National Patient Registry
and be measured over three time periods.
The main hypotheses are that:
- There will be a larger reduction in prevalence rate of involuntary treatment episodes in
the intervention arm as compared with the control arm during the intervention period
(i.e., Index vs T1) (primary analysis)
- There will be a larger reduction in prevalence rate of involuntary treatment episodes in
the intervention arm as compared with the control arm in the longer term (i.e., Index vs
T2).
The investigators similarly hypothesise that the change in secondary outcomes will be larger
in the intervention arm than the control arm during the intervention period (i.e., Index vs
T1) and in the longer term (i.e., Index vs T2)
SAMPLE SIZE CONSIDERATIONS Asking municipalities to take part in a research programme by
which they are required to change current practices is likely to be experienced as demanding.
As explained above, research staff will be supporting the municipalities throughout. It is
therefore necessary to keep the number of clusters at a manageable size.
Because outcome data will be aggregated at municipality level, power calculation at patient
level is precluded. Based on current statistics, a mid-sized municipality has 40-100
involuntary admissions and 12-30 episodes of outpatient compulsion each year. Municipalities
with above average rates of compulsory treatment per 10K population will be targeted, with
the aim to include five municipalities in the intervention arm and five in the control arm.
This should be sufficient to give stable estimates of the primary and secondary outcome
measures.
STATISTICAL ANALYSES Prevalence rates in the intervention and the control arms during the
Index, T1 and T2 periods will be calculated and presented together with 95% confidence
intervals. Differences between the intervention and the control arm in the change in
prevalence rate from the Index to the T1 period (as primary analysis) and the Index to the T2
period will be assessed by z-test for proportions. Change in overall duration of involuntary
treatment episodes will be compared between the intervention and the control arm by
Independent samples t-test. Even though the available data will be aggregated at municipality
level, knowing the size of each municipality, the number of episodes, mean length of episodes
and standard deviation for those length of episodes will enable the use of the aforementioned
tests. Exploratory analyses comparing outcomes between T1 and T2 periods will be considered.
CONSENT
- In each cluster, consent to participate will be obtained from the person in charge of
municipal mental health services
- All professionals, patients and family carers who participate in qualitative research
activities in Stage 1will provide individual informed consent prior to enrolment
- All primary and secondary outcome measures will be collected from the Norwegian Patient
Records and will be aggregated at municipal level. As no research activity will take
place in control sites, no consent will be sought.
RANDOMISATION:
Randomisation of eligible municipalities took place prior to inviting interventions
municipalities to take part as follows. All municipalities that met the inclusion criteria
(n=28) were ranked in descending order of the rates of involuntary admission per 10K
population. In the cases where two or more neighbouring municipalities were on that list
(n=7), the ones with the lowest rate were excluded. This left a list of 21municipalities.
Paired stratification was applied by which paired the first and second municipality on the
list were paired, number 3 and 4, number 5 and 6 etc. Within each pair, one municipality was
drawn at random to take part in the intervention arm and the other was allocated to the
control arm. If a municipality allocated to the intervention arm declines to take part, the
control municipality will not be included. It was important to avoid a large spread in terms
of the rate of involuntary admissions. Therefore, if a municipality allocated to the
intervention arm declines participation and their neighbouring municipality had been
excluded, that neighbour municipality will no longer be ineligible and will be included in
the intervention arm, if willing to participate.
