Can Healthcare Assistant Training (CHAT) improve the relational care of older people? A developmental and feasibility study of a complex intervention

Background: Older people account for an increasing proportion of those receiving NHS acute care. The quality of healthcare delivered to older people has come under increased scrutiny. Healthcare assistants (HCAs) provide much of the direct care of older people in hospital. Patients’ experience of care tends to be based on the relational aspects of that care including dignity, empathy and emotional support. Objective(s): We aimed to: understand the relational care training needs of HCAs caring for older people; design a relational care training intervention for HCAs; and assess the feasibility of a cluster-randomised controlled trial to test the new intervention against HCA training as usual. Design: (1) Telephone survey of all NHS hospital Trusts in England to assess current HCA training provision; (2) focus groups of older people and carers and (3) semi-structured interviews with HCAs and other care staff to establish training needs and inform intervention development; (4) feasibility cluster-randomised controlled trial. Setting: (1) All acute NHS hospital Trusts in England; (2,3,4) Three acute NHS hospital Trusts in England and the populations they serve. Participants: (1) 113 of 161 (70.2%) Trusts took part in the telephone survey; (2) 29 older people or carer participants of three focus groups; (3) 30 HCA and 24 ‘other staff’ interviewees; (4) 12 wards (four per Trust); 112 HCAs; 92 patients during the pre-randomisation period and 67 patients during the post-randomisation period. Interventions: For the feasibility trial a training intervention (Older People’s Shoes) for HCAs developed as part of the study was compared with HCA training as usual. Main outcome measures: Patient level outcomes were the experience of emotional care and quality of life during their hospital stay as measured by the Patient Evaluation of Emotional Care during Hospitalisation (PEECH) and the European Quality of Life (EQ-5D) questionnaires. HCA outcomes were empathy measured by the Toronto Empathy Questionnaire (TEQ) and attitudes towards older people measured by the Age Group Evaluation and Description (AGED) Inventory. Ward level outcomes were the quality of HCA/patient interaction measured by the Quality of Interaction Scale (QUIS). Results: (1) A third of Trust telephone survey participants reported HCA training content that we considered to be ‘relational care’. Training for HCAs is variable across Trusts and focused on new recruits. The biggest challenge for HCA training is getting HCAs released from ward duties. (2) Older people and carers are aware of the pressures ward staff are under but good relationships with care staff determines whether the experience of hospital is positive. (3) HCAs have training needs related to ‘difficult conversations’ with patients and relatives; they have particular preferences for learning styles that are not always reflected in available training. (4) In the feasibility trial 187 of the 192 planned ward observation sessions were completed; response to HCA questionnaires at baseline, eight and 12 weeks post-randomisation was 64.2%, 46.4% and 35.7% respectively; 57.2% of eligible patients returned completed questionnaires. Limitations: This was an intervention development and feasibility study so no conclusions can be drawn about the effectiveness of the intervention. Conclusions: The intervention had high acceptability among nurse trainers and HCA learners. Viability of a definitive trial is conditional on overcoming specific methodological (patient recruitment processes) and contextual (involvement of wider ward team) challenges. Future work: Methods to ease the burden of questionnaire completion without compromising ethics or methodological rigour need to be explored. Study registration: ISRCTN1038579

The feasibility of determining the effectiveness and cost-effectiveness of medication organisation devices compared with usual care for older people in a community setting: systematic review, stakeholder focus groups and feasibility randomised controlled trial

Background: Medication organisation devices (MODs) provide compartments for a patient’s medication to be organised into the days of the week and the recommended times the medication should be taken. Aim: To define the optimal trial design for testing the clinical effectiveness and cost-effectiveness of MODs. Design: The feasibility study comprised a systematic review and focus groups to inform a randomised controlled trial (RCT) design. The resulting features were tested on a small scale, using a 2 × 2 factorial design to compare MODs with usual packaging and to compare weekly with monthly supply. The study design was then evaluated. Setting: Potential participants were identified by medical practices. Participants: Aged over 75 years, prescribed at least three solid oral dosage form medications, unintentionally non-adherent and self-medicating. Participants were excluded if deemed by their health-care team to be unsuitable. Interventions: One of three MODs widely used in routine clinical practice supplied either weekly or monthly. Objectives: To identify the most effective method of participant recruitment, to estimate the prevalence of intentional and unintentional non-adherence in an older population, to provide a point estimate of the effect size of MODs relative to usual care and to determine the feasibility and acceptability of trial participation. Methods: The systematic review included MOD studies of any design reporting medication adherence, health and social outcomes, resource utilisation or dispensing or administration errors. Focus groups with patients, carers and health-care professionals supplemented the systematic review to inform the RCT design. The resulting design was implemented and then evaluated through questionnaires and group discussions with participants and health-care professionals involved in trial delivery. Results: Studies on MODs are largely of poor quality. The relationship between adherence and health outcomes is unclear. Of the limited studies reporting health outcomes, some reported a positive relationship while some reported increased hospitalisations associated with MODs. The pre-trial focus groups endorsed the planned study design, but suggested a minimum recruitment age of 50–60 years. A total of 35.4% of patients completing the baseline questionnaire were excluded because they already used a MOD. Active recruitment yielded a higher consent rate, but passive recruitment was more cost-effective. The prevalence of intentional non-adherence was 24.7% [n = 71, 95% confidence interval (CI) 19.7% to 29.6%] of participants. Of the remaining 76 participants, 46.1% (95% CI 34.8% to 57.3%) were unintentionally non-adherent. There was no indication of a difference in adherence between the study arms. Participants reported a high level of satisfaction with the design. Five adverse/serious adverse events were identified in the MOD study arms and none was identified in the control arms. There was no discernible difference in health economic outcomes between the four study arms; the mean intervention cost was £20 per month greater for MOD monthly relative to usual supply monthly. Conclusions: MOD provision to unintentionally non-adherent older people may cause medication-related adverse events. The primary outcome for a definitive MOD trial should be health outcomes. Such a trial should recruit patients by postal invitation and recruit younger patients

Facet joint injections for people with persistent non-specific low back pain (Facet injection study) : A feasibility study for a randomised controlled trial

All NIHR Journals Library reports have been produced under the terms of a commissioning contract issued by the Secretary of State for Health. Reports may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Permission to reproduce material from a published report is covered by the UK government’s non-commercial licence for public sector information. Applications for commercial reproduction should be addressed to the editorial office at: [email protected]: The National Institute for Health and Care Excellence (NICE) 2009 guidelines for persistent low back pain (LBP) do not recommend the injection of therapeutic substances into the back as a treatment for LBP because of the absence of evidence for their effectiveness. This feasibility study aimed to provide a stable platform that could be used to evaluate a randomised controlled trial (RCT) on the clinical effectiveness and cost-effectiveness of intra-articular facet joint injections (FJIs) when added to normal care. Objectives: To explore the feasibility of running a RCT to test the hypothesis that, for people with suspected facet joint back pain, adding the option of intra-articular FJIs (local anaesthetic and corticosteroids) to best usual non-invasive care is clinically effective and cost-effective. Design: The trial was a mixed design. The RCT pilot protocol development involved literature reviews and a consensus conference followed by a randomised pilot study with an embedded mixed-methods process evaluation. Setting: Five NHS acute trusts in England. Participants: Participants were patients aged ≥ 18 years with moderately troublesome LBP present (> 6 months), who had failed previous conservative treatment and who had suspected facet joint pain. The study aimed to recruit 150 participants (approximately 30 per site). Participants were randomised sequentially by a remote service to FJIs combined with ‘best usual care’ (BUC) or BUC alone. Interventions: All participants were to receive six sessions of a bespoke BUC rehabilitation package. Those randomised into the intervention arm were, in addition, given FJIs with local anaesthetic and steroids (at up to six injection sites). Randomisation occurred at the end of the first BUC session. Main outcome measures: Process and clinical outcomes. Clinical outcomes included a measurement of level of pain on a scale from 0 to 10, which was collected daily and then weekly via text messaging (or through a written diary). Questionnaire follow-up was at 3 months. Results: Fifty-two stakeholders attended the consensus meeting. Agreement informed several statistical questions and three design considerations: diagnosis, the process of FJI and the BUC package and informing the design for the randomised pilot study. Recruitment started on 26 June 2015 and was terminated by the funder (as a result of poor recruitment) on 11 December 2015. In total, 26 participants were randomised. Process data illuminate some of the reasons for recruitment problems but also show that trial processes after enrolment ran smoothly. No between-group analysis was carried out. All pain-related outcomes show the expected improvement between baseline and follow-up. The mean total cost of the overall treatment package (injection £419.22 and BUC £264.00) was estimated at £683.22 per participant. This is similar to a NHS tariff cost for a course of FJIs of £686.84. Limitations: Poor recruitment was a limiting factor. Conclusions: This feasibility study achieved consensus on the main challenges in a trial of FJIs for people with persistent non-specific low back pain.Peer reviewe