A cluster randomised controlled trial and process evaluation of a training programme for mental health professionals to enhance user involvement in care planning in service users with severe mental health issues (EQUIP): study protocol for a randomised controlled trial.
BACKGROUND
Involving service users in planning their care is at the centre of policy initiatives to improve mental health care quality in England. Whilst users value care planning and want to be more involved in their own care, there is substantial empirical evidence that the majority of users are not fully involved in the care planning process. Our aim is to evaluate the effectiveness and cost-effectiveness of training for mental health professionals in improving user involvement with the care planning processes.


METHODS
This is a cluster randomised controlled trial of community mental health teams in NHS Trusts in England allocated either to a training intervention to improve user and carer involvement in care planning or control (no training and care planning as usual). We will evaluate the effectiveness of the training intervention using a mixed design, including a 'cluster cohort' sample, a 'cluster cross-sectional' sample and process evaluation. Service users will be recruited from the caseloads of care co-ordinators. The primary outcome will be change in self-reported involvement in care planning as measured by the validated Health Care Climate Questionnaire. Secondary outcomes include involvement in care planning, satisfaction with services, medication side-effects, recovery and hope, mental health symptoms, alliance/engagement, well-being and quality of life. Cost- effectiveness will also be measured. A process evaluation informed by implementation theory will be undertaken to assess the extent to which the training was implemented and to gauge sustainability beyond the time-frame of the trial.


CONCLUSIONS
It is hoped that the trial will generate data to inform mental health care policy and practice on care planning.


BACKGROUND
ISRCTN16488358 (14 May 2014).
NIHR School for Primary Care Research, Manchester Academic Health Science Centre, University of Manchester, Williamson Building, Oxford Road, Manchester, M13 9PL, England. peter.bower@manchester.ac.uk.
Peter
P
Bower
Centre for Biostatistics, Institute of Population Health, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, England. chris.roberts@manchester.ac.uk.
Chris
C
Roberts
Centre for Biostatistics, Institute of Population Health, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, England. neil.oleary@manchester.ac.uk.
Neil
N
O'Leary
School of Health Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2HA, England. patrick.callaghan@nottingham.ac.uk.
Patrick
P
Callaghan
School of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, England. penny.bee@manchester.ac.uk.
Penny
P
Bee
School of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, England. claire.fraser@manchester.ac.uk.
Claire
C
Fraser
School of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, England. chris.gibbons@manchester.ac.uk.
Chris
C
Gibbons
School of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, England. Nicola.Olleveant@manchester.ac.uk.
Nicola
N
Olleveant
Faculty of Health Sciences, University of Southampton, Highfield, Southampton, SO17 1BJ, England. a.e.rogers@soton.ac.uk.
Anne
A
Rogers
Centre for Health Economics, Institute of Population Health, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, England. linda.davies@manchester.ac.uk.
Linda
L
Davies
School of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, England. richard.drake@manchester.ac.uk.|Manchester Mental Health and Social Care Trust, Chorlton House, 70 Manchester Road, Chorlton-cum-Hardy, Manchester, M21 9UN, England. richard.drake@manchester.ac.uk.
Richard
R
Drake
NIHR School for Primary Care Research, Manchester Academic Health Science Centre, University of Manchester, Williamson Building, Oxford Road, Manchester, M13 9PL, England. caroline.sanders@manchester.ac.uk.
Caroline
C
Sanders
School of Health Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2HA, England. oonagh.meade@nottingham.ac.uk.
Oonagh
O
Meade
School of Health Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2HA, England. andrew.grundy@nottingham.ac.uk.
Andrew
A
Grundy
School of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, England. lauren.walker-2@manchester.ac.uk.
Lauren
L
Walker
School of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, England. lindsey.cree@manchester.ac.uk.
Lindsey
L
Cree
School of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, England. kathryn.berzins@manchester.ac.uk.
Kathryn
K
Berzins
School of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, England. Helen.brooks@manchester.ac.uk.
Helen
H
Brooks
School of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, England. susan.beatty@manchester.ac.uk.
Susan
S
Beatty
Manchester Mental Health and Social Care Trust, Chorlton House, 70 Manchester Road, Chorlton-cum-Hardy, Manchester, M21 9UN, England. patrick.cahoon@mhsc.nhs.uk.
Patrick
P
Cahoon
Manchester Mental Health and Social Care Trust, Chorlton House, 70 Manchester Road, Chorlton-cum-Hardy, Manchester, M21 9UN, England. Anita.rolfe@mhsc.nhs.uk.
Anita
A
Rolfe
School of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, England. karina.lovell@manchester.ac.uk.
Karina
K
Lovell
D003153:Community Health Services / Q000191:economics / Q000706:statistics & numerical data*; D003362:Cost-Benefit Analysis; D017048:Health Care Costs; D006282:Health Personnel / Q000191:economics / Q000193:education*; D006295:Health Resources / Q000191:economics / Q000706:statistics & numerical data*; D006801:Humans; D007318:Inservice Training / Q000191:economics; D001523:Mental Disorders / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D008603:Mental Health; D008605:Mental Health Services / Q000191:economics / Q000706:statistics & numerical data*; D010347:Patient Care Planning / Q000191:economics; D010349:Patient Compliance; D010358:Patient Participation / Q000191:economics; D017060:Patient Satisfaction; D015397:Program Evaluation; D011788:Quality of Life; D012107:Research Design; D057566:Self Report; D012720:Severity of Illness Index; D013222:State Medicine / Q000706:statistics & numerical data; D006113:United Kingdom