Managing mood, cognition and fatigue are top unmet needs reported by stroke survivors, which impact quality of life. There is currently no standardised UK care pathway to support post-stroke psychological outcomes. The ENhanced Reviews of PsychologIcal Changes (ENRICH) programme, an intervention co-designed with stroke survivors, carers and healthcare professionals, aims to fill this gap. Here, we describe the protocol for evaluating the feasibility and acceptability of ENRICH.

ENRICH reviews comprise cognition, mood and fatigue assessment, personalised psychoeducation and tools to communicate results and discuss self-management strategies, delivered at 1, 3 and 6 months post-stroke. N=140 participants (N=80 patients who had a stroke, N=45 carers, N=15 healthcare professionals) will be recruited to a single-arm multicentre feasibility study.

Patients who had a stroke and carers will complete demographics at baseline (T1) questionnaires of quality of life, mood and healthcare resource use at 6 months post-stroke (T2) and an optional interview on experiences of ENRICH. Process evaluation will include fidelity assessment via audio recordings. Descriptive statistics will be calculated for study outcomes.

Key qualitative acceptability outcomes are sought on intervention delivery by clinicians, patients and carers.

Key intervention delivery feasibility outcomes relate to training clinicians (including competency and fidelity delivering ENRICH), and review completion rates. Study feasibility outcomes will include site and participant recruitment and retention rates and completion of candidate primary outcome measures on quality of life.

The ENRICH study was approved by a UK Research Ethics Committee (reference: 24/LO/0341). Consent procedures include a waiver of consent to the intervention itself due ENRICH’s service-level design and written informed consent/consultee advice for participants providing research data. Results will be disseminated through peer-reviewed publications, conferences and lay summaries for study participants and healthcare professionals. Results will inform whether ENRICH is acceptable to delivering clinicians and receiving patients who had a stroke and carers, and provide key insights to inform a future randomised trial to determine effectiveness.

ISRCTN16018388.

The Needs Assessment Tool-Cancer (NAT-C) is a consultation guide to identify, triage and reduce unmet patient needs.

We aimed to assess NAT-C fidelity, mechanisms of action and implementation issues in UK primary care as part of a clinical and cost-effectiveness cluster randomised controlled trial of the NAT-C for people with cancer compared with usual care (registration: ISRCTN15497400).

Design: a mixed-methods process evaluation informed by normalisation process theory (NPT). Setting: 21 participating general practices in England were randomised to be trained to conduct an NAT-C guided consultation with people with cancer (excluding those in remission). General practitioner fidelity of intervention and clinical action resulting from the NAT-C consultation was noted. Two Normalisation MeAsure Development Questionnaire surveys were distributed to trained clinicians before (Survey 1) and after delivery of ≥2 NAT-C consultations (Survey 2). Semi-structured interviews were conducted with clinicians (post delivery ≥2 NAT-C consultations) and key stakeholders in primary and cancer care. Fidelity, action and paired before/after survey data were analysed using descriptive statistics. Interview data were analysed using a deductive thematic framework approach (NPT-informed). Data were narratively synthesised with cross-tabulated key findings.

Of the 360/376 (96%) NAT-C consultations delivered, 258/360 (72%) resulted in clinical action, including 50 (13%) external referrals. 14 paired before (Survey 1, n=53) and after (Survey 2, n=29) responses. Survey 1 showed positive responses across all NPT domains, but while continuing to see relevance, usefulness and legitimacy, Survey 2 highlighted concerns about insufficient resources and management support. 16 clinician participants (eight GPs, eight key stakeholders; 50% male) completed interviews. Following synthesis, we identified five themes: (1) the perceived value of the NAT-C; (2) ‘champions’ are important at all levels (practice, regionally and nationally); (3) research evidence is seen as important, but influences implementation indirectly through policy, clinical guidelines and resourced initiatives; (4) adequate resources are fundamental for implementation beyond practice level and (5) NAT-C practicalities; training is adequate, but robust functional information technology systems are needed.

Implementation requires champions and clinicians ‘buy-in’ to the patient value to legitimise use. In the context of current primary care pressures, resources were seen as essential to embed the NAT-C, but financial incentives were viewed with mixed feelings.

ISRCTN15497400.