Trial of a Ward-Based Intervention to Improve Access to Psychologically-Informed Care and Psychological Therapy for Mental Health In-Patients

Mental Health Clinical Trial

— TULIPS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03950388
• Other study ID #: R122297
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: June 2022

Study information

• Verified date: September 2021
• Source: University of Manchester
• Contact: Katherine Berry
• Phone: 0161 306 0400
• Email: katherine.berry[@]manchester.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health

Intervention

Behavioral:
• Intervention
Wards randomly assigned to receive the intervention will have a Band 8a Psychologist based on the ward for 0.5FTE for 7 months. During this time, all patients will be involved with the proposed stepped model of care intervention at one of three levels. The level the patient receives will be decided by the multidisciplinary ward team. At Step one, all patients will have a psychological formulation developed by the psychologist in conjunction with the patient or members of the ward team. At Step 2, all qualified nurses will be trained and supervised to deliver guided self-help material of psychological interventions targeting key problem areas for patients. At Step 3, patients will be offered up to 16, one-to-one therapy sessions with the psychologist.

Locations

Country	Name	City	State
United Kingdom	Leed & York Partnership NHS Foundation Trust	Leeds
United Kingdom	Greater Manchester Mental Health NHS Foundation Trust	Manchester	Greater Manchester

Sponsors (2)

Lead Sponsor	Collaborator
University of Manchester	Manchester Clinical Trials Unit

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient wellbeing	Patient well being using the Warwick-Edinburgh Mental Well-being Questionnaire. WEMWBS: Scale: 1= None of the time, 2 = Rarely, 3 = Some of the time, 4 = Often, 5 = All of the time. Participants are asked to select an option considering the statement over the past 2 weeks. WEMWBS is a 14 item scale with 5 response categories, summed to provide a single score ranging from 14-70. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing, thereby making the concept more accessible.	Baseline, 6 months and 9 months
Primary	Serious incidents on ward	Report taken from each Trust about the number of different serious incidents reported on a ward across a 3 month time period. Serious Incidents: Taken from current reports pulled by each trust to monitor the number of incidents which occur within a ward. Categorised by each Trust using a levelling system of 1-5 with 5 being the most serious level. The incidents are also categorised by event type which varies at each Trust and again is the responsibility of each data entry personnel to assign a category. Data to be taken at baseline for the 3 months prior, at 3 months for the 3 months prior, at 6 months for the 3 months prior and at 9 months for the 3 months prior	Baseline, 3 months, 6 months and 9 months
Secondary	Whether the intervention improves patients' symptoms	Using Brief Symptom Inventory questionnaire. Scale: 0= Not at all; 1 = a little bit, 2 = moderately, 3= quite a bit, 4 = extremely, R= refused Duration: answers based on past 7 days including day of completion Score: The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing.Respondents rank each feeling item (e.g., "your feelings being easily hurt") on a 5-point scale ranging from 0 (not at all) to 4 (extremely). Rankings characterize the intensity of distress during the past seven days.; The items comprising each of the 9 primary symptom dimensions are as follows: Somatization: Items 2, 7, 23, 29, 30, 33, and 37; Obsession-Compulsion: Items 5, 15, 26, 27, 32, and 36; Interpersonal Sensitivity: Items 20, 21, 22, and 42; Depression: Items 9, 16, 17, 18, 35, and 50; Anxiety: Items 1, 12, 19, 38, 45, and 49; Hostility: Items 6, 13, 40, 41, and 46; Phobic Anxiety: Items 8, 28, 31, 43, and 47; Paranoid Ideation: Items	Baseline, 6 months and 9 months
Secondary	Whether the intervention improves staff perceptions of ward atmosphere.	Using the VOTE Scale: Strongly agree, agree, slightly agree, slightly disagree, disagree, strongly disagree	6 months
Secondary	Whether the intervention improves patient perceptions of ward atmosphere.	Using the VOICE Scale: Strongly agree, agree, slightly agree, slightly disagree, disagree, strongly disagree	6 months
Secondary	Whether the intervention reduces staff burnout.	Using Maslach Burnout Inventory questionnaire; MBI: Scale:0 = Never, 1 = a few times a year or less, 2 = once a more or less, 3= a few times a month, 4 = once a week, 5 = a few times a week, 6 = every day.; Duration: Based on 22 statements the participant is to note from 0-6 next to the statement that bests describes how frequently they feel that way.; Score: The participants receive an emotional exhaustion score (EE) (Qs 1,2,3,6,8,13,14,16,20). A depersonalization score (Dep) (Qs 5,10,11,15,22) A professional accomplishment score (PA) (Qs 4,7,9,12,17,18,19,21). EE score is High (27 or over), Moderate (17-26) and low (0-16). Dep score is high (13 or over), Moderate (7-12) or Low (0-6). PA score is high (39 or over), moderate (32-38) or low (0-31).	Baseline, 6 months and 9 months
Secondary	Cost-effectiveness of the psychological service model using health economic measures.	Using Health Economics measures (using service use questionnaires) Service use inventory developed from CSRI.	Baseline, 6 months and 9 months
Secondary	Identify contextual factors that promote/inhibit implementation and routine incorporation of psychologically-informed care and therapies into everyday practice.	Using implementation fidelity data from the psychologist and ward nurses	6 months
Secondary	Identify contextual factors that promote/inhibit implementation and routine incorporation of psychologically-informed care and therapies into everyday practice.	Using observation data - observe 6 chosen intervention wards	6 months
Secondary	Identify contextual factors that promote/inhibit implementation and routine incorporation of psychologically-informed care and therapies into everyday practice.	Using interview data - interviews with patients and staff on intervention wards	6 months
Secondary	Whether the intervention improves social functioning.	Using Personal and Social Performance Scale. One for the a-c areas and one specific to the d area.; Degrees of severity areas a-c. Degrees of severity area d. Absent, Mild, Manifest, Marked, Severe, Very Severe. Overall score of between 0-100 to be given based on the scores for each of the areas (a-d)	Baseline, 6 months and 9 months
Secondary	Improves quality of life	EQ-5D-5L: Each of the 5 dimensions comprising the EQ-5D descriptive system is divided into 5 levels of perceived problems: Level 1: indicating no problem Level 2: indicating slight problems Level 3: indicating moderate problems Level 4: indicating severe problems Level 5: indicating extreme problems A unique health state is defined by combining 1 level from each of the 5 dimensions.; Scoring: level 1 is coded as 1, level 2 as 2, level 3 as 3, level 4 as 4 and level 5 as 5. There should be only ONE response for each dimension NB: Missing values can be coded as '9'.NB: Ambiguous values (e.g. 2 boxes are ticked for a single dimension) should be treated as missing values. The EQ VAS should be coded as per where the X is placed on a scale of 0-100 with 100= the best health and 0= the worst health. Missing values should be coded as '999'.	Baseline, 6 months and 9 months