Clinical trial NCT03950388: Trial of a Ward-Based Intervention to Improve Access to Psychologically-Informed Care and Psychological Therapy for Mental Health In-Patients
Official title: A Cluster Randomised Controlled Trial of a Ward-Based Intervention to Improve Access to Psychologically-Informed Care and Psychological Therapy for Mental Health In-Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Clinical Trials Unit, Manchester
First posted: 2019-05-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Care Quality Commission (2017) concludes that too often care for people with severe mental health problems on mental health inpatient wards institutionalises people, rather than helping them to have an independent life in the community. There is good evidence that psychological interventions improve patient well-being and independent living, but patients on acute mental health wards often do not have access to evidence-based psychological therapies which are strongly advised by NICE guidance for severe mental health problems (e.g. NICE, 2011). The overall aim of this programme of work is to increase patient access to psychological therapies on acute mental health inpatient wards. Stage one of the programme aimed to identify barriers and facilitators to delivering therapy in these settings through a large qualitative study. The key output of stage one was an intervention protocol that is designed to be delivered on acute wards to increase patient access to psychologically-informed care and therapy. Stage two of the programme aims to test the effects of the intervention on patient wellbeing and serious incidents on the ward which are routinely collated by wards and patient and staff contact is not required (primary outcomes), patient social functioning and symptoms, staff burnout, ward atmosphere from staff and patient perspectives and cost effectiveness of the intervention (secondary outcomes). The study is a single blind, pragmatic, cluster randomised controlled trial and will recruit thirty-four wards across England that will be randomised to receive the new intervention plus treatment as usual, or treatment as usual only. Primary and secondary outcomes will be assessed at baseline and 6-month and 9-month follow-ups, with serious incidents on the ward collected at an additional 3-month follow-up. A process evaluation will be nested within the trial to understand factors that influence the effects of the intervention and implementation in real world settings.


Eligibility criteria: Inclusion Criteria:

Ward:

1) Generic, working-age, adult acute mental health wards.

Staff (RCT Outcome Measures):

1. Consent to complete self-report measures.
2. Based on the ward for at least 75% of their working week.

Patient (RCT Outcome Measures):

1. Capacity to consent to complete the self-report measures
2. Sufficient levels of concentration to complete the required battery of self-report measures with breaks if needed. This will be determined by the researcher when meeting the participant and in collaboration with the clinical team.
3. Sufficient English language proficiency to take part in qualitative interviews or agreement to the use of an interpreter. This will be determined by the researcher when meeting the participant and in collaboration with the clinical team.

Staff (Semi-structured interviews):

1. Consent to have interviews digitally audio recorded.
2. Direct experience of working with patients with severe mental health problems on an acute inpatient ward that has taken part in the RCT.

Patients (Semi-structured interviews):

1. Capacity to provide informed consent for interviews.
2. Consent to have interviews recorded.
3. At least one week's experience of being an in-patient on an acute in-patient ward that has taken part in the RCT.
4. Sufficient English language proficiency to take part in qualitative interviews or agreement to the use of an interpreter.

Exclusion Criteria:

Ward:

1. Wards that have a specialist function, such as older people, intensive care or rehabilitation.
2. Wards that already have more than 1 session of dedicated psychological therapy input per week. This is because we need to ensure treatment as usual does not include significant elements of the intervention we are aiming to test.

Staff (RCT Outcome Measures):

1. Non-permanent staff, such as bank or agency workers.
2. Staff who are planning to leave the ward before the intervention period starts.

Patient (RCT Outcome Measures):

1. Patients whose discharge is planned for before the start of the intervention period.
2. Unable to complete self-report measures due to difficulties with concentration or high levels of distress. This will be determined by the researcher when meeting the participant and in collaboration with the clinical team.
3. Unable or unwilling to provide informed consent.

Staff (Semi-structured interviews):

1. Non-permanent staff, such as bank or agency workers.
2. Working on the ward for less than 2 weeks at the time of the interview.
3. Unwilling to consent to having interviews audio recorded.

Patient (Semi-structured interviews):

1. Less than one week's experience of in-patient care at the time of the interview.
2. Unable or unwilling to provide informed consent for interviews.
3. Unable or unwilling to have interviews audio recorded.
4. Insufficient English language proficiency to take part in the interview and does not consent to the use of an interpreter.
5. Insufficient English language proficiency to complete the self-report measures and does not consent to the use of an interpreter.

Primary outcomes:
measure: Patient wellbeing
timeFrame: Baseline, 6 months and 9 months
measure: Serious incidents on ward
timeFrame: Baseline, 3 months, 6 months and 9 months
Secondary outcomes:
measure: Whether the intervention improves patients' symptoms
timeFrame: Baseline, 6 months and 9 months
measure: Whether the intervention improves staff perceptions of ward atmosphere.
timeFrame: 6 months
measure: Whether the intervention improves patient perceptions of ward atmosphere.
timeFrame: 6 months
measure: Whether the intervention reduces staff burnout.
timeFrame: Baseline, 6 months and 9 months
measure: Cost-effectiveness of the psychological service model using health economic measures.
timeFrame: Baseline, 6 months and 9 months
measure: Identify contextual factors that promote/inhibit implementation and routine incorporation of psychologically-informed care and therapies into everyday practice.
timeFrame: 6 months
measure: Identify contextual factors that promote/inhibit implementation and routine incorporation of psychologically-informed care and therapies into everyday practice.
timeFrame: 6 months
measure: Identify contextual factors that promote/inhibit implementation and routine incorporation of psychologically-informed care and therapies into everyday practice.
timeFrame: 6 months
measure: Whether the intervention improves social functioning.
timeFrame: Baseline, 6 months and 9 months
measure: Improves quality of life
timeFrame: Baseline, 6 months and 9 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Greater Manchester Mental Health NHS Foundation Trust
state: Greater Manchester
city: Leeds
country: United Kingdom
facility: Leed & York Partnership NHS Foundation Trust
Study officials:
References:
citation: Berry K, Raphael J, Wilson H, Bucci S, Drake RJ, Edge D, Emsley R, Gilworth G, Lovell K, Odebiyi B, Price O, Sutton M, Winter R, Haddock G. A cluster randomised controlled trial of a ward-based intervention to improve access to psychologically-informed care and psychological therapy for mental health in-patients. BMC Psychiatry. 2022 Feb 3;22(1):82. doi: 10.1186/s12888-022-03696-7.