Non-randomised Feasibility Study Research Articles

The CO-produced Psychosocial INtervention delivered by GPs to young people after self-harm (COPING): protocol for a feasibility study

Background Self-harm in young people is a growing concern and reducing rates a global priority. General practitioners (GPs) can intervene early after self-harm but there are no effective treatments presently available. We developed the GP-led COPING intervention, in partnership with young people with lived experience and GPs, to be delivered to young people 16–25 years across two consultations. This study aims to examine the feasibility and acceptability of conducting a fully powered effectiveness trial of the COPING intervention in NHS general practice. Methods This will be a mixed-methods external non-randomised before-after single arm feasibility study in NHS general practices in the West Midlands, England. Patients aged 16–25 years who have self-harmed in the last 12 months will be eligible to receive COPING. Feasibility outcomes will be recruitment rates, intervention delivery, retention rates, and completion of follow-up outcome measures. All participants will receive COPING with a target sample of 31 with final follow-up data collection at six months from baseline. Clinical data such as self-harm repetition will be collected. A nested qualitative study and national survey of GPs will explore COPING acceptability, deliverability, implementation, and likelihood of contamination. Discussion Brief GP-led interventions for young people after self-harm are needed and address national guideline and policy recommendations. This study of the COPING intervention will assess whether a main trial is feasible. Registration ISRCTN (ISRCTN16572400; 28.11.2023).

Implementing a shared decision-making intervention to support treatment decisions for patients following an anterior cruciate ligament rupture — a protocol for the POP-ACLR feasibility study

BackgroundTreatment for anterior cruciate ligament (ACL) rupture may follow a surgical or nonsurgical pathway. At present, there is uncertainty around treatment choice. Two shared decision-making tools have been codesigned to support patients to make a decision about treatment following an ACL rupture. The shared decision-making tools include a patient information leaflet and an option grid. We report the protocol for a mixed-methods feasibility study, with nested qualitative interviews, to understand feasibility, acceptability, indicators of effectiveness and implementation factors of these shared decision-making tools (combined to form one shared decision-making intervention).MethodsA single-centre non-randomised feasibility study will be conducted with 20 patients. Patients diagnosed with an ACL rupture following magnetic resonance imaging will be identified from an orthopaedic clinic. The shared decision-making intervention will be delivered during a clinical consultation with a physiotherapist. The primary feasibility outcomes include the following: recruitment rate, fidelity, acceptability and follow-up questionnaire completion. The secondary outcome is the satisfaction with decision scale. The nested qualitative interview will explore experience of using the shared decision-making intervention to understand acceptability, implementation factors and areas for further refinement.DiscussionThis study will determine the feasibility of using a newly developed shared decision-making intervention designed to support patients to make a decision about treatment of their ACL rupture. The acceptability and indicators of effectiveness will also be explored. In the long term, the shared decision-making intervention may improve service and patient outcomes and ensure cost-effectiveness for the NHS; ensuring those most likely to benefit from surgical treatment proceed along this pathway.Trial registrationPending registration on ISRCTN.

Effectiveness of patient reminders on influenza vaccination coverage among adults with chronic conditions: A feasibility study in Australian general practices

BackgroundInfluenza vaccination is recommended for Australians 18+ years old with medical risk factors, but coverage is suboptimal. We aimed to examine whether automatic, opportunistic patient reminders (SMS and/or printed) before appointments with a general practitioner increased influenza vaccination uptake. MethodsThis clustered non-randomised feasibility study in Australian general practice included patients aged 18–64 years with at least one medical risk factor attending participating practices between May and September 2021. Software installed at intervention practices identified unvaccinated eligible patients when they booked an appointment, sent vaccination reminders (SMS on booking and 1 h before appointments), and printed automatic reminders on arrival. Control practices provided usual care. Clustered analyses adjusted for sociodemographic differences among practices were performed using logistic regression. ResultsA total of 12,786 at-risk adults attended 16 intervention practices (received reminders = 4066; ‘internal control’ receiving usual care = 8720), and 5082 individuals attended eight control practices. Baseline influenza vaccination uptake (2020) was similar in intervention and control practices (~34%). After the intervention, uptake was similar in all groups (control practices = 29.3%; internal control = 30.0%; intervention = 31.6% (p-value = 0.203). However, SMS 1 h before appointments increased vaccination coverage (39.3%, adjusted OR = 1.65; 95%CI 1.20;2.27; number necessary to treat = 13), especially when combined with other reminder forms. That effect was more evident among adults with chronic respiratory, rheumatologic, or inflammatory bowel disease. ConclusionThese findings indicate that automated SMS reminders delivered at proximate times to appointments are a low-cost strategy to increase influenza vaccination among adults at higher risk of severe disease attending Australian general practices.

Improving diagnostics using extended point-of-care testing during in-home assessments of older adults with signs of emerging acute disease: a prospective observational non-randomised pilot and feasibility study

BackgroundDelayed recognition of acute disease among older adults hinders timely management and increases the risk of hospital admission. Point-of-Care testing, including Focused Lung Ultrasound (FLUS) and in-home analysis of biological material, may support clinical decision-making in suspected acute respiratory disease. The aim of this study was to pilot test the study design for a planned randomised trial, investigate whether in-home extended use of point-of-care testing is feasible, and explore its’ potential clinical impact.MethodsA non-randomised pilot and feasibility study was conducted during September–November 2021 in Kolding Municipality, Denmark. A FLUS-trained physician accompanied an acute community nurse on home-visits to citizens aged 65 + y with signs of acute respiratory disease. The acute community nurses did a clinical assessment (vital signs, capillary C-reactive protein and haemoglobin) and gave a presumptive diagnosis. Subsequently, the physician performed FLUS, venipuncture with bedside analysis (electrolytes, creatinine, white blood cell differential count), nasopharyngeal swab (PCR for upper respiratory pathogens), and urine samples (flow-cytometry). Primary outcomes were feasibility of study design and extended point-of-care testing; secondary outcome was the potential clinical impact of extended point-of-care testing.ResultsOne hundred consecutive individuals were included. Average age was 81.6 (SD ± 8.4). Feasibility of study design was acceptable, FLUS 100%, blood-analyses 81%, PCR for upper respiratory pathogens 79%, and urine flow-cytometry 4%. In addition to the acute community nurse’s presumptive diagnosis, extended point-of-care testing identified 34 individuals with a condition in need of further evaluation by a physician.ConclusionOverall, in-home assessments with extended point-of-care testing are feasible and may aid to identify and handle acute diseases in older adults.

Empowering School Staff to Support Pupil Mental Health Through a Brief, Interactive Web-Based Training Program: Mixed Methods Study.

Schools in the United Kingdom and elsewhere are expected to protect and promote pupil mental health. However, many school staff members do not feel confident in identifying and responding to pupil mental health difficulties and report wanting additional training in this area. We aimed to explore the feasibility of Kognito's At-Risk for Elementary School Educators, a brief, interactive web-based training program that uses a simulation-based approach to improve school staff's knowledge and skills in supporting pupil mental health. We conducted a mixed methods, nonrandomized feasibility study of At-Risk for Elementary School Educators in 6 UK primary schools. Our outcomes were (1) school staff's self-efficacy and preparedness to identify and respond to pupil mental health difficulties, (2) school staff's identification of mental health difficulties and increased risk of mental health difficulties, (3) mental health support for identified pupils (including conversations about concerns, documentation of concerns, in-class and in-school support, and referral and access to specialist mental health services), and (4) the acceptability and practicality of the training. We assessed these outcomes using a series of questionnaires completed at baseline (T1), 1 week after the training (T2), and 3 months after the training (T3), as well as semistructured qualitative interviews. Following guidance for feasibility studies, we assessed quantitative outcomes across time points by comparing medians and IQRs and analyzed qualitative data using reflexive thematic analysis. A total of 108 teachers and teaching assistants (TAs) completed T1 questionnaires, 89 (82.4%) completed T2 questionnaires, and 70 (64.8%) completed T3 questionnaires; 54 (50%) completed all 3. Eight school staff members, including teachers, TAs, mental health leads, and senior leaders, participated in the interviews. School staff reported greater confidence and preparedness in identifying and responding to mental health difficulties after completing the training. The proportion of pupils whom they identified as having mental health difficulties or increased risk declined slightly over time (medianT1=10%; medianT2=10%; medianT3=7.4%), but findings suggested a slight increase in accuracy compared with a validated screening measure (the Strengths and Difficulties Questionnaire). In-school mental health support outcomes for identified pupils improved after the training, with increases in formal documentation and communication of concerns as well as provision of in-class and in-school support. Referrals and access to external mental health services remained constant. The qualitative findings indicated that school staff perceived the training as useful, practical, and acceptable. The findings suggest that brief, interactive web-based training programs such as At-Risk for Elementary School Educators are a feasible means to improve the identification of and response to mental health difficulties in UK primary schools. Such training may help address the high prevalence of mental health difficulties in this age group by helping facilitate access to care and support.

Acceptability and experience of a smartphone symptom monitoring app for people with psychosis in China (YouXin): a qualitative study

BackgroundAccess to high-quality mental healthcare remains challenging for people with psychosis globally, including China. Smartphone-based symptom monitoring has the potential to support scalable mental healthcare. However, no such tool, until now, has been developed and evaluated for people with psychosis in China. This study investigated the acceptability and the experience of using a symptom self-monitoring smartphone app (YouXin) specifically developed for people with psychosis in China.MethodsSemi-structured interviews were conducted with 10 participants with psychosis to explore the acceptability of YouXin. Participants were recruited from the non-randomised feasibility study that tested the validity, feasibility, acceptability and safety of the YouXin app. Data analysis was guided by the theoretical framework of acceptability.ResultsMost participants felt the app was acceptable and easy to use, and no unbearable burdens or opportunity costs were reported. Participants found completing the self-monitoring app rewarding and experienced a sense of achievement. Privacy and data security were not major concerns for participants, largely due to trust in their treating hospital around data protection. Participants found the app easy to use and attributed this to the training provided at the beginning of the study. A few participants said they had built some form of relationship with the app and would miss the app when the study finished.ConclusionsThe YouXin app is acceptable for symptom self-monitoring in people with experience of psychosis in China. Participants gained greater insights about their symptoms by using the YouXin app. As we only collected retrospective acceptability in this study, future studies are warranted to assess hypothetical acceptability before the commencement of study to provide a more comprehensive understanding of implementation.

Partnering Early to Provide for Infants At Risk of Cerebral Palsy (PĒPI ARC): protocol for a feasibility study of a regional hub for early detection of cerebral palsy in Aotearoa New Zealand.

Cerebral palsy (CP) can now be diagnosed in infants with identified CP risk factors as early as three months of age; however, many barriers prevent equitable access to early detection pathways. The "Partnering Early to Provide for Infants At Risk of Cerebral Palsy" feasibility study (PĒPI ARC) seeks to trial a new approach to decrease inequitable health service in Aotearoa New Zealand for high-risk infants and their families. PĒPI ARC incorporates face-to-face clinics, an in-person and virtual Hub, and the use of telehealth to enable flexible access to CP assessments and support for health professionals in early CP detection. A non-randomised feasibility study was conducted from a tertiary Neonatal Intensive Care Unit (NICU) in Wellington and included seven regional referral centres, servicing nearly 30% of the total population in New Zealand (NZ). The families of infants with a high risk of neurodevelopmental impairment and health professionals interacting with the Hub were invited to participate. Mixed methods were used to evaluate the (i) equitable implementation of an early detection pathway, (ii) acceptability, (iii) demand among families and health professionals, (iv) efficacy in relation to reducing the age of receipt of CP diagnosis, and (v) the experiences around communication and information sharing. The NZ Health and Disability Ethics Committee approved this study (HDEC: 2022 FULL 13434). The findings will be disseminated in peer-reviewed journals, in conference presentations, and via professional networks. Australian New Zealand Clinical Trials Registry: ACTRN12623000600640.

Watch Me Play!: protocol for a feasibility study of a remotely delivered intervention to promote mental health resilience for children (ages 0–8) across UK early years and children’s services

BackgroundHalf of mental health problems are established by the age of 14 years and 75% by 24 years. Early intervention and prevention of mental ill health are therefore vitally important. However, increased demand over recent years has meant that access to child mental health services is often restricted to those in severest need. Watch Me Play! (WMP) is an early intervention designed to support caregiver attunement and attention to the child to promote social-emotional well-being and thereby mental health resilience. Originally developed in the context of a local authority mental health service for children in care, it is now also delivered online as a low intensity, scalable, preventative intervention. Although WMP shows promise and is already used in some services, we do not yet know whether it is effective.MethodsA non-randomised single group feasibility study with embedded process evaluation. We propose to recruit up to 40 parents/carers of children aged 0–8 years who have been referred to early years and children’s services in the UK. WMP involves a parent watching the child play and talking to their child about their play (or for babies, observing and following signals) for up to 20 min per session. Some sessions are facilitated by a trained practitioner who provides prompts where necessary, gives feedback, and discusses the child’s play with the caregiver. Services will offer five facilitated sessions, and parents will be asked to do at least 10 additional sessions on their own with their child in a 5-week period. Feasibility outcomes examined are as follows: (i) recruitment, (ii) retention, (iii) adherence, (iv) fidelity of delivery, (v) barriers and facilitators of participation, (vi) intervention acceptability, (vii) description of usual care, and (viii) data collection procedures. Intervention mechanisms will be examined through qualitative interview data. Economic evaluation will be conducted estimating cost of the intervention and cost of service use for child and parents/carers quality-adjusted life years.DiscussionThis study will address feasibility questions associated with progression to a future randomised trial of WMP.Trial registrationISRCTN13644899. Registered on 14th April 2023.

Skin-to-skin stabilisation and uninterrupted respiratory support for preterm infants after birth: feasibility of a new and simplified rPAP system

BackgroundThe rPAP respiratory support system, used for delivery room stabilisation with nasal prongs, has been shown to reduce the need for intubation in extremely preterm infants. A simplified version of...

Appropriate Prescribing for older adults with Multimorbidity (Pro-M): protocol for a feasibility study

BackgroundPotentially inappropriate prescribing is common among older adults with multimorbidity due to various reasons, from concurrent application of multiple single-disease clinical guidelines to fragmentation of care. Interventions such as medication review have been implemented worldwide to reduce inappropriate prescribing for older adults. However, the implementability of such interventions are underexplored in the outpatient clinics in Singapore’s public hospitals. Hence, the Pro-M study aims to assess the feasibility of implementing a physician-pharmacist collaborative care intervention in geriatric medicine outpatient clinics to facilitate appropriate prescribing for older adults in Singapore.MethodsThis is a single-arm, non-randomised feasibility study using a pre-post evaluation design. This study consists of two parts: (1) implementation phase of the intervention (6 months) and an (2) evaluation phase (3 months). Eligible patients will be recruited from geriatric medicine outpatient clinics at two public hospitals in Singapore through convenience sampling. The main components of the Pro-M intervention are: (1) pharmacist-facilitated medication reviews with feedback on any medication issues and potential recommendations to physicians, and (2) physicians communicating changes to other relevant prescribers. The evaluation phase will involve surveying and interviewing physicians and pharmacists involved in the implementation of the intervention. A mixed-method approach will be employed for data collection and analysis. The quantitative and qualitative findings will be triangulated and reported using Proctor’s implementation outcomes: appropriateness, penetration, acceptability, fidelity, feasibility, and sustainability. A basic cost analysis will be conducted alongside the study.DiscussionThis is a phase 2 study to test the feasibility of implementing an intervention that was co-created with stakeholders during phase 1 development of an intervention to optimise prescribing for older adults with multimorbidity. The implementation will be assessed using Proctor’s implementation outcomes to provide insights on the process and the feasibility of implementing medication reviews for older adults with multimorbidity as a routine practice in outpatient clinics. Data collected from this study will inform a subsequent scale-up study.Trial registrationClinicalTrials.gov Identifier: NCT05756478. Registered on 06 March 2023.

Structured, Creative Dance Classes for Children with Developmental Disabilities: A Pilot Study of Feasibility and Preliminary Effect on Motor Function.

Promoting physical wellness for preschool-aged children with developmental disorders (DD) is a known challenge. Interventions are more likely to succeed when physical activity opportunities are available to children within the context of their typical environments. We evaluated the feasibility and preliminary effect of 1 potential solution: structured creative dance classes delivered within a preschool environment. Using a non-randomized feasibility study design, we offered physical activity in the form of creative dance classes for children with and without DD within an inclusive preschool. Classes lasted 30 minutes and were held once a week or 7 weeks. We measured attendance (primary), observed active participation (% of class duration), and balance (Pediatric Balance Scale). Non-parametric descriptive statistics are expressed as median (interquartile range). Balance was evaluated regarding (a) difference between groups at baseline (Mann-Whitney statistic) and (b) intervention effect for children with DD (1-tailed, paired t-test). Twelve preschoolers (age range = 3-5 years) participated: 4 with DD and 8 with neurotypical development. Attendance was 93% (79%-100%) for children with and 100% for children without DD. Per class, rate of active participation in dance activity was 33% (28%-45%) for children with and 80% (71%-82%) for children without DD. Starting balance scores were lower (P = .014) for children with DD (42 (39-45)) compared to those without (51 (50-52)). Post-intervention, balance scores improved for the children with DD to 50 (50-51) (df = 3, p = .014, t-statistic = 2.35); each child with DD surpassed minimal detectable change for balance. Creative dance classes, delivered within an inclusive preschool environment, are feasible for some preschool-aged children with DD to participate in and efficacious as a physical training challenge at low activity doses. More study is warranted of this potential solution to meet the need for physical wellness promotion among young children with DD.

Brief cognitive behavioural therapy for eating disorders symptomatology among a mixed sample of adolescents and young adults in primary care: A non-randomised feasibility and pilot study.

Brief and accessible therapies for people with an eating disorder is an important health target. Ten-session cognitive behavioural therapy (CBT-T) is a brief treatment evaluated in people with a non-underweight eating disorder. This study aimed to evaluate the feasibility and preliminary effectiveness of CBT-T for young people in primary care. This cohort pilot study used group (adolescents vs. young adults) by time (over four time points) Generalised Linear Mixed Model analysis. Participants included 13-25-year-olds attending an early intervention mental health service, receiving 10 sessions of CBT-T. Feasibility was assessed using recruitment, retention and satisfaction. Eating and other pathology measures were administered at baseline, weeks four and 10, and 12-week follow-up. Of the 63 commencing treatment, 38 completed 10 CBT-T sessions (60%). Most (94%) reported high treatment satisfaction. Significant reductions in eating pathology, depression and stress were found. Age group did not yield differences in CBT-T outcome, with large to very large effect sizes across outcome variables. Anxiety was associated with attrition. This study provides preliminary support for the use of CBT-T in primary care, across adolescence and early adulthood. Findings require replication in other clinical settings and comparison to other clinical approaches and control populations.

Group, Blended and Individual, Unguided Online Delivery of Mindfulness-Based Cognitive Therapy for People With Cancer: Feasibility Uncontrolled Trial.

Online mindfulness based cognitive therapy (eMBCT) has been shown to reduce psychological distress in people with cancer. However, this population has reported lack of support and asynchronous communication as barriers to eMBCT, resulting in higher nonadherence rates than with face-to-face MBCT. Using a co-creation process, we developed 2 formats of eMBCT: group, blended (combination of therapist-guided group and individual online sessions) and individual, unguided (individual, unguided online sessions only). Group, blended eMBCT offers peer support and guidance, whereas individual, unguided eMBCT offers flexibility and the possibility of large-scale implementation. The objective of this nonrandomized feasibility study was to assess aspects of feasibility of the group, blended and individual, unguided eMBCT interventions. Participants were people with cancer who chose between group, blended and individual, unguided eMBCT. Both intervention conditions followed the same 8-week eMBCT program, including an introductory session and a silent day (10 sessions total). All sessions for individual, unguided eMBCT occurred via the platform Minddistrict, whereas group, blended eMBCT consisted of 3 online videoconference sessions guided by a mindfulness teacher and 5 sessions via Minddistrict. We assessed the feasibility of the intervention quantitatively and qualitatively by evaluating its acceptability among participants. Additionally, we assessed limited efficacy by looking at the number of questionnaires participants completed pre- and postintervention. We included 12 participants for each eMBCT condition. Participants in group, blended eMBCT completed, on average, 9.7 of 10 sessions, compared with an average 8.3 sessions for individual, unguided eMBCT (excluding dropouts). Of the 24 participants, 13 (54%) agreed to be interviewed (5 unguided and 8 blended). Participants in both conditions reported positive experiences, including the convenience of not having to travel and the flexibility to choose when and where to participate. However, among the barriers for participation, participants in the group, blended condition reported a preference for more group sessions, and participants in the individual, unguided condition reported a lack of guidance. Additionally, for the group, blended condition, the effect sizes were small for all outcome measures (Hedges g range=0.01-0.36), except for fatigue, which had a moderate effect size (Hedges g=0.57). For the individual, unguided condition, the effect sizes were small for all outcome measures (Hedges g range=0.24-0.46), except for mindfulness skills (Hedges g=0.52) and engagement with the intervention (Hedges g=1.53). Participants in this study had a positive experience with group, blended and individual, unguided eMBCT. Based on the results from this study, we will adjust the intervention prior to conducting a full-scale randomized controlled trial to evaluate effectiveness; we will add 1 group session to the group, blended eMBCT using Zoom as the platform for the group sessions; and we will send reminders to participants to complete questionnaires. ClinicalTrials.gov NCT05336916; https://clinicaltrials.gov/ct2/show/NCT05336916.

Intervention for a correct medication list and medication use in older adults: a non-randomised feasibility study among inpatients and residents during care transitions

Abstract Background Medication discrepancies in care transitions and medication non-adherence are problematic. Few interventions consider the entire process, from the hospital to the patient’s medication use at home. Aim In preparation for randomised controlled trials (RCTs), this study aimed (1) to investigate the feasibility of recruitment and retention of patients, and data collection to reduce medication discrepancies at discharge and improve medication adherence, and (2) to explore the outcomes of the interventions. Method Participants were recruited from a hospital and a residential area. Hospital patients participated in a pharmacist-led intervention to establish a correct medication list upon discharge and a follow-up interview two weeks post-discharge. All participants received a person-centred adherence intervention for three to six months. Discrepancies in the medication lists, the Beliefs about Medicines Questionnaire (BMQ-S), and the Medication Adherence Report Scale (MARS-5) were assessed. Results Of 87 asked to participate, 35 were included, and 12 completed the study. Identifying discrepancies, discussing discrepancies with physicians, and performing follow-up interviews were possible. Conducting the adherence intervention was also possible using individual health plans for medication use. Among the seven hospital patients, 24 discrepancies were found. Discharging physicians agreed that all discrepancies were errors, but only ten were corrected in the discharge information. Ten participants decreased their total BMQ-S concern scores, and seven increased their total MARS-5 scores. Conclusion Based on this study, conducting the two RCTs separately may increase the inclusion rate. Data collection was feasible. Both interventions were feasible in many aspects but need to be optimised in upcoming RCTs.

Adapting the ADVANCE group program for digitally-supported delivery to reduce intimate partner violence by men in substance use treatment: a feasibility study.

COVID-19 restrictions created barriers to "business as usual" in healthcare but also opened the door to innovation driven by necessity. This manuscript (1) describes how ADVANCE, an in-person group perpetrator program to reduce intimate partner violence (IPV) against female (ex)partners by men in substance use treatment, was adapted for digitally-supported delivery (ADVANCE-D), and (2) explores the feasibility and acceptability of delivering ADVANCE-D to men receiving substance use treatment. Firstly, the person-based approach and mHealth development framework were used to iteratively adapt ADVANCE for digitally-supported delivery including conceptualization, formative research, and pre-testing. Then, a non-randomized feasibility study was conducted to assess male participants' eligibility, recruitment, and attendance rates and uptake of support offered to their (ex)partners. Exploratory analyses on reductions in IPV perpetration (assessed using the Abusive Behavior Inventory; ABI) and victimization (using the revised ABI; ABI-R) at the end of the program were performed. Longitudinal qualitative interviews with participants, their (ex)partners, and staff provided an understanding of the program's implementation, acceptability, and outcomes. The adapted ADVANCE-D program includes one goal-setting session, seven online groups, 12 self-directed website sessions, and 12 coaching calls. ADVANCE-D includes enhanced risk management and support for (ex)partners. Forty-five participants who had perpetrated IPV in the past 12 months were recruited, forty of whom were offered ADVANCE-D, attending 11.4 (SD 9.1) sessions on average. Twenty-one (ex)partners were recruited, 13 of whom accepted specialist support. Reductions in some IPV perpetration and victimization outcome measures were reported by the 25 participants and 11 (ex)partners interviewed pre and post-program, respectively. Twenty-two participants, 11 (ex)partners, 12 facilitators, and 7 integrated support service workers were interviewed at least once about their experiences of participation. Overall, the program content was well-received. Some participants and facilitators believed digital sessions offered increased accessibility. The digitally-supported delivery of ADVANCE-D was feasible and acceptable. Remote delivery has applicability post-pandemic, providing greater flexibility and access. Given the small sample size and study design, we do not know if reductions in IPV were due to ADVANCE-D, time, participant factors, or chance. More research is needed before conclusions can be made about the efficacy of ADVANCE-D.

Development and implementation of sexual and gender minority curriculum for advanced practice nursing: A feasibility study.

To explore the feasibility of development and implementation of an educational intervention addressing sexual and gender minority healthcare issues; examine recruitment processes and instrument appropriateness. Non-randomized feasibility study. The educational intervention was developed and implemented in family nurse practitioner courses with data collection from August through December 2022. Clinical preparedness, attitudinal awareness and basic knowledge were measured using the lesbian, gay, bisexual and transgender Development of Clinical Skills Scale. Development and implementation of the intervention was feasible but will require amendment before progressing to the pilot study. Clinical preparedness and basic knowledge increased post-intervention, but attitudinal awareness did not improve. Recruitment did not achieve the desired sample size. Instrument internal consistency reliability was confirmed. Feasibility was established but will require amendment prior to the pilot study. To prepare nurses and nurse practitioners to care for sexual and gender minority patients. This study addressed the feasibility of developing and implementing a sexual and gender minority healthcare education using an e-Learning platform. Findings confirm that the intervention was feasible but will require amendment. The intervention increased knowledge and clinical preparedness in caring for this population, but recruitment was challenging. This research will impact nurses, nurse practitioners and nurse educators. The authors adhered to the relevant EQUATOR guidelines. The Consolidated Standards of Reporting Trials guideline extension for reporting randomized and feasibility guidelines were used. Sexual and gender minority community members contributed to the intervention development. WHAT DOES THIS PAPER CONTRIBUTE TO THE WIDER GLOBAL CLINICAL COMMUNITY?: The feasibility of using interactive e-learning educational resources to provide sexual and gender minority healthcare curriculum. Evidence to support the use of the Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale to measure learning outcomes. This study was not prospectively registered because it was an educational intervention involving graduate student nurses and did not assess clinical outcomes of patients.

Participation in an Online Prenatal Mindfulness- Relationship-Based (PMRB) Program: Outcomes for Maternal Mindfulness, Mental Health, Interoception, and Mother-Infant Relationship during Pregnancy and Post-Partum

This feasibility study sought to investigate the impact of an online 9-session Prenatal Mindfulness Relationship-Based (PMRB) group treatment program upon maternal mental health (depression, anxiety, and stress), interoception, and mother-infant relationship during pregnancy and post-partum. The study was designed in two parts 1) a quantitative examination of pre, post-treatment and 10-12 weeks post-partum measures targeting 13 pregnant women from a non-clinical population and 2) a qualitative exploration of the same pregnant women’s experiences of the PMRB program reported during the sessions, including their birth stories. Responses to an open-ended question about how the program had supported them during pregnancy, labor/birth and the first post-partum trimester were summarised using thematic analysis. Women (N = 36) were recruited to the non-randomised feasibility study and 13 were allocated to the PMRB program. Women were excluded due to the online recruitment timeframe, missing baseline gestational age and unavailability for the proposed time. All the allocated women completed the program during pregnancy and the baseline and post-treatment surveys. There were 12 women who completed the post-partum follow-up. Only one participant was lost to the follow up for unknown reasons. Results revealed an improvement in mindfulness, depression, interoception and mother-infant relationship post-treatment and at postpartum follow-up. The qualitative analysis led to the identification of 16 themes, which were organized in four categories describing the experience of participants.<em> </em>Findings provide preliminary support for the feasibility of the PMRB program to improve maternal mindfulness, interoception, mental wellbeing and mother-infant relationship during pregnancy and post-partum. The qualitative evaluation suggested the PMRB program may help women cope with emotional challenges and be more connected to their bodies and infant. The program may also help women become more aware of their unborn infant as a sentient being and the influence of their health and mental wellbeing on the infant development and health. Furthermore, it may be a facilitator of the mother-infant relationship during pregnancy and post-partum, promoting infant’s healthy development.

Evaluating a smartphone-based symptom self-monitoring app for psychosis in China (YouXin): A non-randomised validity and feasibility study with a mixed-methods design.

Psychosis causes a significant burden globally, including in China, where limited mental health resources hinder access to care. Smartphone-based remote monitoring offers a promising solution. This study aimed to assess the validity, feasibility, acceptability, and safety of a symptom self-monitoring smartphone app, YouXin, for people with psychosis in China. A pre-registered non-randomised validity and feasibility study with a mixed-methods design. Participants with psychosis were recruited from a major tertiary psychiatric hospital in Beijing, China. Participants utilised the YouXin app to self-monitor psychosis and mood symptoms for four weeks. Feasibility outcomes were recruitment, retention and outcome measures completeness. Active symptom monitoring (ASM) validity was tested against corresponding clinical assessments (PANSS and CDS) using Spearman correlation. Ten participants completed qualitative interviews at study end to explore acceptability of the app and trial procedures. Feasibility parameters were met. The target recruitment sample of 40 participants was met, with 82.5% completing outcome measures, 60% achieving acceptable ASM engagement (completing >33% of all prompts), and 33% recording sufficient passive monitoring data to extract mobility indicators. Five ASM domains (hallucinations, suspiciousness, guilt feelings, delusions, grandiosity) achieved moderate correlation with clinical assessment. Both quantitative and qualitative evaluation showed high acceptability of YouXin. Clinical measurements indicated no symptom and functional deterioration. No adverse events were reported, suggesting YouXin is safe to use in this clinical population. The trial feasibility, acceptability and safety parameters were met and a powered efficacy study is indicated. However, refinements are needed to improve ASM validity and increase passive monitoring data completeness.

Acceptability of a proposed practice pharmacist-led review for opioid-treated patients with persistent pain: A qualitative study to inform intervention development

Introduction Regular review of patients prescribed opioids for persistent non-cancer pain (PCNP) is recommended but not routinely undertaken. The PROMPPT (Proactive clinical Review of patients taking Opioid Medicines long-term for persistent Pain led by clinical Pharmacists in primary care Teams) research programme aims to develop and test a pharmacist-led pain review (PROMPPT) to reduce inappropriate opioid use for persistent pain in primary care. This study explored the acceptability of the proposed PROMPPT review to inform early intervention development. Methods Interviews ( n = 15) and an online discussion forum ( n = 31) with patients prescribed opioids for PCNP and interviews with pharmacists ( n = 13), explored acceptability of a proposed PROMPPT review. A prototype PROMPPT review was then tested and refined through 3 iterative cycles of in-practice testing (IPT) ( n = 3 practices, n = 3 practice pharmacists, n = 13 patients). Drawing on the Theoretical Framework of Acceptability (TFA), a framework was generated (including a priori TFA constructs) allowing for deductive and inductive thematic analysis to identify aspects of prospective and experienced acceptability. Results Patients felt uncertain about practice pharmacists delivering the proposed PROMPPT review leading to development of content for the invitation letter for IPT (introducing the pharmacist and outlining the aim of the review). After IPT, patients felt that pharmacists were suited to the role as they were knowledgeable and qualified. Pharmacists felt that the proposed reviews would be challenging. Although challenges were experienced during delivery of PROMPPT reviews, pharmacists found that they became easier to deliver with time, practise and experience. Recommendations for optimisations after IPT included development of the training to include examples of challenging consultations. Conclusions Uptake of new healthcare interventions is influenced by perceptions of acceptability. Exploring prospective and experienced acceptability at multiple time points during early intervention development, led to mini-optimisations of the prototype PROMPPT review ahead of a non-randomised feasibility study.

Novel Multidimensional Pain Assessment Tool Is a Feasible, Valid, and Enjoyable Approach to Communication of Pain Symptoms in Pediatric Sickle Cell Disease

Background: Pain is the most common symptom of sickle cell disease (SCD) and is especially difficult to assess in the pediatric population. Children have varied developmental stages and cognitive abilities making the communication of this subjective experience hard to operationalize. Both the assessment of pain and validation of these assessments is challenging. No pediatric pain assessment tool has been deemed valid and reliable across all ages and types of pain. Commonly used pediatric tools include the Wong-Baker Faces scale, the numeric rating scale, and the visual analog scale (VAS), which combines the visuals of faces and numeric rating. These are unidimensional - only assessing the severity of pain, and in the case of faces, can cause confusion between pain severity and patient affect. In children with SCD, accurate pain assessment is crucial to current and lifelong management. “Painimation” is a technology-based pain assessment tool that incorporates conceptual animations, rather than numbers or words, to characterize pain. These animations are intended to help clinicians better understand pain from the patient's perspective. They are dynamic and transcend language. For example, animations are designed to communicate dull pulsating pain, sharp electric pain, or anything in between. “Painimation” does not rely on verbal communication skills, making it ideal for use in the pediatric population. “Painimation” has been validated in adults with SCD and is currently in implementation trials. Our study aims to determine the feasibility and validity of “Painimation” in pediatric SCD. Methods: This is a single site non-randomized cross-sectional feasibility and validity study. Participants were 10 - 21 years old with SCD who presented to clinic in baseline health. Participants completed the Painimation application, which consists of a numeric pain rating scale (1-10), a front and back 2-dimensional body image that can be shaded to indicate areas affected by pain, and eight abstract animations intended to represent different pain qualities (tingling, shooting, stabbing, throbbing, pounding, cramping, electrifying, and burning). The patient chose up to three animations and the intensity of each chosen animation was adjusted using a sliding bar without numeric labels. The animations were presented to the patient without labeling the intended quality. The patients then completed a survey consisting of questions regarding the usability of Painimation, clinical questions regarding their disease, Lansky Play-Performance Scale, and validated patient reported outcomes questions (PedsQL, Ped-PRO-CTCAE, PROMIS). Results: We enrolled 30 participants between April 1 and July 31, 2023, with recruitment ongoing. Five records were incomplete and were not analyzed at this time. The mean ratings when asked whether 1) Painimation was easy to use, 2) the patient enjoyed using Painimation, and 3) the patient would use Painimation to communicate pain with their provider were respectively 3.28±.74 (SD), 3.08±.95, and 3.12±1.17 (scale 0-4), indicating a generally favorable result for feasibility. The median VAS score was 5.10 (IQR = 0.25, 8.25). Pain was most reported in the back lower chest (60%), front stomach (48%), and front chest (44%). The stabbing animation was the most chosen at 56% followed by the cramping animation at 20%. Electrifying and Cramping animations had the highest agreement with their intended McGill descriptors at 40%. VAS scores and Painimation severity scores demonstrated excellent positive correlation (Pearson r=.74). Conclusion: Painimation is a feasible pain assessment tool in pediatric SCD with high user satisfaction. Severity scores on Painimation correlate strongly with VAS scores. The pain characteristic conveyed by each animation adds unique dimensions to this measure and will be further analyzed. Painimation is a novel pediatric pain assessment that holds the promise of greatly improving the communication of pain and transforming care in Pediatric SCD.