The impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial

BACKGROUND Patient and public involvement in research (PPIR) may improve trial recruitment rates, but it is unclear how. Where trials use PPIR to improve design and conduct, many do not communicate that clearly to potential participants. Better communication of PPIR might encourage patient enrolment, as trials may be perceived as more socially valid, relevant, and trustworthy. We aimed to evaluate the impact on recruitment of directly advertising PPIR to potential trial participants. METHODS A cluster trial, embedded within a host trial ('EQUIP') recruiting service users diagnosed with severe mental illness. The intervention was informed by a systematic review, a qualitative study, social comparison theory and a stakeholder workshop including service users and carers. Adopting Participatory Design approaches, we co-designed the recruitment intervention with PPIR partners using a leaflet to advertise the PPIR in EQUIP and sent potential participants invitations with the leaflet (intervention group) or not (control group). Primary outcome was the proportion of patients enrolled in EQUIP. Secondary outcomes included the proportions of patients who positively responded to the trial invitation. RESULTS 34 community mental health teams were randomised and 8182 service users invited. For the primary outcome, 4% of patients in the PPIR group were enrolled versus 5.3% of the control group. The intervention was ineffective for improving recruitment rates (adjusted OR= 0.75, 95% CI= 0.53 to 1.07, p=0.113). For the secondary outcome of positive response, the intervention was not effective, with 7.3% of potential participants in the intervention group responding positively versus 7.9% of the control group (adjusted OR=0.74, 95% CI= 0.53 to 1.04, p=0.082). We did not find a positive impact of directly advertising PPIR on any other outcomes. CONCLUSION To our knowledge, this is the largest ever embedded trial to evaluate a recruitment or PPIR intervention. Advertising PPIR did not improve enrolment rates, or any other outcome. It is possible that rather than advertising PPIR being the means to improve recruitment, PPIR may have an alternative impact on trials by making them more attractive, acceptable and patient-centred. We discuss potential reasons for our findings and implications for recruitment practice and research

Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis

Supported by F. Hoffmann–La Roche

Carers' experiences of involvement in care planning: a qualitative exploration of the facilitators and barriers to engagement with mental health services.

BACKGROUND: Formal recognition and involvement of carers in mental health services has been the focus of recent policy and practice initiatives as well as being supported by carers themselves. However, carers still report feeling marginalised and distanced from services. A prominent theme is that that they are not listened to and their concerns are not taken seriously. Compared to service user views, the reasons underpinning carers’ dissatisfaction with care-planning procedures have been relatively neglected in the research literature, despite the substantial and significant contribution that they make to mental health services. The aim of the study was to explore carers’ experiences of the care planning process for people with severe mental illness. METHODS: Qualitative interviews and focus groups were undertaken with carers. Data were combined and analysed using framework analysis. RESULTS: Whilst identifying a shared desire for involvement and confirming a potential role for carers within services, our data highlighted that many carers perceive a lack of involvement in care planning and a lack of recognition and appreciation of their role from health professionals. Barriers to involvement included structural barriers, such as the timing and location of meetings, cultural barriers relating to power imbalances within the system and specific barriers relating to confidentiality. CONCLUSIONS: This qualitative study led by a researcher who was a carer herself has developed the understanding of the potential role of carers within the care planning process within mental health services, along with the facilitators and barriers to achieving optimal involvement

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

BackgroundInvolving 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/DesignThis 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. DiscussionIt is hoped that the trial will generate data to inform mental health care policy and practice on care planning. Trial Registration NumberISRCTN16488358 (14 May 2014) <br/

The impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial

Background: Patient and public involvement in research (PPIR) may improve trial recruitment rates, but it is unclear how. Where trials use PPIR to improve design and conduct, many do not communicate this clearly to potential participants. Better communication of PPIR might encourage patient enrolment, as trials may be perceived as more socially valid, relevant and trustworthy. We aimed to evaluate the impact on recruitment of directly advertising PPIR to potential trial participants. Methods: This is a cluster trial, embedded within a host trial (\u27EQUIP\u27) recruiting service users diagnosed with severe mental illness. The intervention was informed by a systematic review, a qualitative study, social comparison theory and a stakeholder workshop including service users and carers. Adopting Participatory Design approaches, we co-designed the recruitment intervention with PPIR partners using a leaflet to advertise the PPIR in EQUIP and sent potential participants invitations with the leaflet (intervention group) or not (control group). Primary outcome was the proportion of patients enrolled in EQUIP. Secondary outcomes included the proportions of patients who positively responded to the trial invitation. Results: Thirty-four community mental health teams were randomised and 8182 service users invited. For the primary outcome, 4% of patients in the PPIR group were enrolled versus 5.3% of the control group. The intervention was not effective for improving recruitment rates (adjusted OR = 0.75, 95% CI = 0.53 to 1.07, p = 0.113). For the secondary outcome of positive response, the intervention was not effective, with 7.3% of potential participants in the intervention group responding positively versus 7.9% of the control group (adjusted OR = 0.74, 95% CI = 0.53 to 1.04, p = 0.082). We did not find a positive impact of directly advertising PPIR on any other outcomes. Conclusion: To our knowledge, this is the largest ever embedded trial to evaluate a recruitment or PPIR intervention. Advertising PPIR did not improve enrolment rates or any other outcome. It is possible that rather than advertising PPIR being the means to improve recruitment, PPIR may have an alternative impact on trials by making them more attractive, acceptable and patient-centred. We discuss potential reasons for our findings and implications for recruitment practice and research

The impact of advertising patient and public involvement on trial recruitment:embedded cluster randomisedrecruitment trial

Background Patient and public involvement in research (PPIR) may improve trial recruitment rates, but it is unclear how. Where trials use PPIR to improve design and conduct, many do not communicate this clearly to potential participants. Better communication of PPIR might encourage patient enrolment, as trials may be perceived as more socially valid, relevant and trustworthy. We aimed to evaluate the impact on recruitment of directly advertising PPIR to potential trial participants. Methods This is a cluster trial, embedded within a host trial (‘EQUIP’) recruiting service users diagnosed with severe mental illness. The intervention was informed by a systematic review, a qualitative study, social comparison theory and a stakeholder workshop including service users and carers. Adopting Participatory Design approaches, we co-designed the recruitment intervention with PPIR partners using a leaflet to advertise the PPIR in EQUIP and sent potential participants invitations with the leaflet (intervention group) or not (control group). Primary outcome was the proportion of patients enrolled in EQUIP. Secondary outcomes included the proportions of patients who positively responded to the trial invitation. Results Thirty-four community mental health teams were randomised and 8182 service users invited. For the primary outcome, 4% of patients in the PPIR group were enrolled versus 5.3% of the control group. The intervention was not effective for improving recruitment rates (adjusted OR = 0.75, 95% CI = 0.53 to 1.07, p = 0.113). For the secondary outcome of positive response, the intervention was not effective, with 7.3% of potential participants in the intervention group responding positively versus 7.9% of the control group (adjusted OR = 0.74, 95% CI = 0.53 to 1.04, p = 0.082). We did not find a positive impact of directly advertising PPIR on any other outcomes. Conclusion To our knowledge, this is the largest ever embedded trial to evaluate a recruitment or PPIR intervention. Advertising PPIR did not improve enrolment rates or any other outcome. It is possible that rather than advertising PPIR being the means to improve recruitment, PPIR may have an alternative impact on trials by making them more attractive, acceptable and patient-centred. We discuss potential reasons for our findings and implications for recruitment practice and research

Embedding shared decision-making in the care of patients with severe and enduring mental health problems: The EQUIP pragmatic cluster randomised trial

Background Severe mental illness is a major driver of worldwide disease burden. Shared decision-making is critical for high quality care, and can enhance patient satisfaction and outcomes. However, it has not been translated into routine practice. This reflects a lack of evidence on the best way to implement shared decision-making, and the challenges of implementation in routine settings with limited resources. Our aim was to test whether we could deliver a practical and feasible intervention in routine community mental health services to embed shared decision-making for patients with severe mental illness, by improving patient and carer involvement in care planning. Methods We cluster randomised community mental health teams to the training intervention or usual care, to avoid contamination. Training was co-delivered to a total of 350 staff in 18 teams by clinical academics, working alongside patients and carers. The primary outcome was the Health Care Climate Questionnaire, a self-report measure of ‘autonomy support’. Primary and secondary outcomes were collected by self-report, six months after allocation. Findings In total, 604 patients and 90 carers were recruited to main trial cohort. Retention at six months was 82% (n = 497). In the main analysis, results showed no statistically significant difference in the primary outcome between the intervention and usual care at 6 months (adjusted mean difference -0.064, 95% CI -0.343 to 0.215, p = 0.654). We found significant effects on only 1 secondary outcome. Conclusions An intervention to embed shared decision-making in routine practice by improving involvement in care planning was well attended and acceptable to staff, but had no significant effects on patient outcomes. Enhancing shared decision-making may require considerably greater investment of resources and effects may only be apparent over the longer term