Cluster Randomised Controlled Trial of the Serious Mental Illness Health Improvement Profile [HIP]

Not Applicable

Completed

• Conditions: Topic: Mental Health Research Network; Subtopic: Bipolar affective disorder, Schizophrenia; Disease: Schizophrenia, Bipolar affective disorder, Schizoaffective disorder; Mental and Behavioural Disorders; Mental illness

• Registration Number: ISRCTN41137900
• Lead Sponsor: orfolk and Waveney Mental Health NHS Foundation Trust (UK)

Brief Summary

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21726440 2. 2014 results in https://www.ncbi.nlm.nih.gov/pubmed/25324028 3. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29540122 (added 27/09/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-04
• Study Completion: 2014-04-07
• Last Update Posted: 29 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1.Registered mental health nurse (MHN) working in a community mental health setting
2. Registered with the Nursing and Midwifery Council [NMC] for at least 6 months
3. Employed at Agenda for Change band 5-7
4. Working in one of the community mental health teamsacross the study sites
5. Has at least 5 patients on their caseload with a primary diagnosis of serious mental illness (SMI) (as confirmed by the Team Leader)

Patients:
1. Aged over 18
2. On the caseload of the MHN participant at the start of the project
3. Has a primary diagnosis of SMI (as confirmed by the last recorded diagnosis in the patient record either being schizophrenia, schizoaffective or bipolar disorder as confirmed by the Team Leader).; Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified

Exclusion Criteria

Following screening by the Research Assistant, MHNs will not be included if they:

1. Are still in preceptorship following recent Nursing and Midwifery Council [NMC] registration as a MHN
2. Are about to go on maternity leave
3. Are pregnant or up to 6 months post partum

Following screening by the Trial Coordinator and the Team Leader patients with SMI will not be included if they:

1. Currently lack the capacity to consent to treatment as documented by a heath professional on Form 4 in their case notes (NWMHFT, 2005) as they would also be considered unable to consent to participation in research.
2. Have a serious or unstable medical condition (e.g. advanced/incurable cancer; severe co-morbidity such as people on renal haemodialysis, end-stage Chronic obstructive pulmonary disease (COPD) and New York Heart Association (NYHA) classification grade 3 or 4 heart failure; severe unpredictable pain)
3. Where the Team Leader considers participation in the trial will put the patient, nurse or research assistant at increased risk or increased cost to the service to manage risk

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PCS SF-36v2; Timepoint(s): 1 year follow-up

Secondary Outcome Measures

Name	Time	Method
<br> 1. MCS SF-36v2<br> 2. EQ-5D<br> 3. Levels of health care resource use<br> 4. PHASe (adapted)<br> 5. QRISK®2<br> 6. HIP Audit Form<br> 7. Patient Semi-structured Interview Schedule, Nurse Focus Group Interview<br> 8. Schedule and Psychiatrist/GP Telephone Interview Schedule<br>