Community ageing research 75+ study (CARE75+): an experimental ageing and frailty research cohort

Introduction: The Community Ageing Research 75+ Study (CARE75+) is a longitudinal cohort study collecting an extensive range of health, social and economic data, with a focus on frailty, independence and quality of life in older age. CARE75+ is the first international experimental frailty research cohort designed using Trial within Cohorts (TwiCs) methodology, to align applied epidemiological research with clinical trial evaluation of interventions to improve the health and well-being of older people living with frailty. Methods and analysis: Prospective cohort study using a TwiCs design. One thousand community-dwelling older people (≥75 years) will be recruited from UK general practices. Nursing home residents, those with an estimated life expectancy of 3 months or less and people receiving palliative care will be excluded. Data collection assessments will be face to face in the person’s home at baseline, 6 months, 12 months, 24 months and 48 months, including assessments of frailty, cognition, mood, health-related quality of life, comorbidity, medications, resilience, loneliness, pain and self-efficacy. A modified protocol for follow-up by telephone or web based will be offered at 6 months. Consent will be sought for data linkage and invitations to additional studies, including intervention studies using the TwiCs design. A blood sample biobank will be established for future basic science studies. Ethics and dissemination: CARE75+ was approved by the NRES Committee Yorkshire and the Humber—Bradford Leeds 10 October 2014 (14/YH/1120). Formal written consent is sought if an individual is willing to participate and has capacity to provide informed consent. Consultee assent is sought if an individual lacks capacity. Study results will be disseminated in peer-reviewed scientific journals and scientific conferences. Key study results will be summarised and disseminated to all study participants via newsletters, local older people’s publications and local engagement events. Results will be reported on a bespoke CARE75+ website. Trial registration number: ISRCTN16588124;Results stag

Evaluation of effectiveness and safety of pharmacist independent prescribers in care homes: cluster randomised controlled trial

Objective To estimate the effectiveness, cost effectiveness (to be reported elsewhere), and safety of pharmacy independent prescribers in care homes. Design Cluster randomised controlled trial, with clusters based on triads of a pharmacist independent prescriber, a general practice, and one to three associated care homes. Setting Care homes across England, Scotland, and Northern Ireland, their associated general practices, and pharmacy independent prescribers, formed into triads. Participants 49 triads and 882 residents were randomised. Participants were care home residents, aged ≥65 years, taking at least one prescribed drug, recruited to 20 residents/triad. Intervention Each pharmacy independent prescriber provided pharmaceutical care to approximately 20 residents across one to three care homes, with weekly visits over six months. Pharmacy independent prescribers developed a pharmaceutical care plan for each resident, did medicines reviews/reconciliation, trained staff, and supported with medicines related procedures, deprescribing, and authorisation of prescriptions. Participants in the control group received usual care. Main outcomes measures The primary outcome was fall rate/person at six months analysed by intention to treat, adjusted for prognostic variables. Secondary outcomes included quality of life (EQ-5D by proxy), Barthel score, Drug Burden Index, hospital admissions, and mortality. Assuming a 21% reduction in falls, 880 residents were needed, allowing for 20% attrition. Results The average age of participants at study entry was 85 years; 70% were female. 697 falls (1.55 per resident) were recorded in the intervention group and 538 falls (1.26 per resident) in the control group at six months. The fall rate risk ratio for the intervention group compared with the control group was not significant (0.91, 95% confidence interval 0.66 to 1.26) after adjustment for all model covariates. Secondary outcomes were not significantly different between groups, with exception of the Drug Burden Index, which significantly favoured the intervention. A third (185/566; 32.7%) of pharmacy independent prescriber interventions involved medicines associated with falls. No adverse events or safety concerns were identified. Conclusions Change in the primary outcome of falls was not significant. Limiting follow-up to six months combined with a small proportion of interventions predicted to affect falls may explain this. A significant reduction in the Drug Burden Index was realised and would be predicted to yield future clinical benefits for patients. This large trial of an intensive weekly pharmacist intervention with care home residents was also found to be safe and well received

Evaluating the experiences and support needs of people living with chronic cancer: Development and initial validation of the Chronic Cancer Experiences Questionnaire (CCEQ)

Background: Many advanced cancers are managed as chronic diseases, yet there are currently no international guidelines for the support of patients living with chronic cancer. It is important to understand whether care and service arrangements meet the needs of this rapidly growing patient group. This study aimed to develop and validate a questionnaire to capture patients' experiences of living with chronic cancer and their views of clinical and support services. Methods: The research was carried out between 1 July 2010 and 21 February 2013. A conceptual framework and initial item bank were derived from prior interviews with 56 patients with chronic cancer. Items were reviewed by 4 oncologists and 1 clinical nurse specialist and during 2 focus groups with 9 patients. Pilot questionnaires were completed by 416 patients across 5 cancer units. Item selection and scale reliability was explored using descriptive data, exploratory factor analysis, internal consistency analyses, multitrait scaling analyses and known-groups comparisons. Results: The final Chronic Cancer Experiences Questionnaire (CCEQ) includes 75 items. 62 items contribute to 14 subscales with internal consistency between α 0·68–0·88 and minimal scaling errors. Known-groups comparisons confirmed subscale utility in distinguishing between patient groups. Subscales were labelled: managing appointments, coordination of care, general practitioner involvement, clinical trials, information and questions, making treatment decisions, symptom non-reporting, key worker, limitations, sustaining normality, financial advice, worries and anxieties, sharing feelings with others, and accessing support. 13 items assessing symptom experiences were retained as single items. Conclusions: The CCEQ has the potential to be used as a clinical instrument to assess patient experiences of chronic cancer or to screen for patient needs. It may also be used as an outcome measure for evaluating programmes and models of care and may identify areas for service development that could ultimately improve the care and support received by patients with chronic cancer

Cancer as a chronic illness: support needs and experiences

Objectives Patients are living longer with active, advanced or metastatic disease that cannot be cured, but may be managed (ie, ‘chronic cancer’). The experiences and needs within this growing group are likely to be different from those shortly after diagnosis, on active curative treatment, or in the palliative or end-of-life phase, yet are poorly defined. We described chronic cancer patient experiences and support needs in a quantitative, multicentre cross-sectional study. Methods Patients from five district general hospitals in England completed the 75-item Chronic Cancer Experiences Questionnaire (CCEQ). Responses were described and linear regression analysis was performed to explore the associations between poorer patient experiences and clinical/sociodemographic variables. Results In total, 416 patients with prostate cancer (28%), breast cancer (24%), gynaecological cancer (19%), colorectal/gastrointestinal cancer (17%) and renal cancer (12%) completed the CCEQ (response rate 90%). Younger patients, those who had a longer interval between primary and advanced diagnosis and those not in a relationship, had worse experiences (R2=0.098, p<0.05). Cancer-specific symptoms were common, with 80% of participants experiencing fatigue. Areas related to poorest experiences include the coordination of care, general practitioner involvement, coping with limitations, and worries and anxieties. Conclusions Psychological burden remains high in the chronic phase of cancer, and patients experience ongoing difficulties in accessing support and services. Younger patients who have been ill for longer and those who have less social support may be particularly vulnerable, and future studies are needed to investigate the best way to meet the unique needs of this growing patient population

The Community Ageing Research 75+ Study (CARE75+): an experimental ageing and frailty research cohort

This is the final version. Available from BMJ Publishing Group via the DOI in this record.Introduction: The Community Ageing Research 75+ Study (CARE75+) is a longitudinal cohort study collecting an extensive range of health, social and economic data, with a focus on frailty, independence and quality of life in older age. CARE75+ is the first international experimental frailty research cohort designed using Trial within Cohort (TwiCs) methodology, to align applied epidemiological research with clinical trial evaluation of interventions to improve the health and wellbeing of older people living with frailty. Methods and analysis: Prospective cohort study using a trial within cohort (TwiCs) design. One thousand community-dwelling older people (≥75years) will be recruited from UK general practices. Nursing home residents, those with an estimated life expectancy of three months or less and people receiving palliative care will be excluded. Data collection assessments will be face-to-face in the person’s home at baseline, six months, 12 months, 24 month and 48 months, including assessments of frailty, cognition, mood, health-related quality of life, comorbidity, medications, resilience, loneliness, pain and self-efficacy. A modified protocol for follow-up by telephone or web-based will be offered at six months. Consent will be sought for data linkage and invitations to additional studies, including intervention studies using the TwiCs design. A blood sample bio-bank will be established for future basic science studies.National Institute for Health Research (NIHR