A cluster randomised trial of a Needs Assessment Tool for adult Cancer patients and their carers (NAT-C) in primary care: A feasibility study.

BACKGROUND: People with cancer often have unidentified symptoms and social care needs. The Needs Assessment Tool-Cancer (NAT-C) is a validated, structured method of assessing patient/carer concerns and prompting action, to address unmet need. AIMS: Assess feasibility and acceptability of a definitive two-armed cluster randomised trial of NAT-C in primary care by evaluating: recruitment of GP practices, patients and carers; most effective approach of ensuring NAT-C appointments, acceptability of study measures and follow-up. METHODS: Non-blinded, feasibility study in four General Practices, with cluster randomisation to method of NAT-C appointment delivery, and process evaluation. Adults with active cancer were invited to participate with or without carer. Practices cluster randomised (1:1) to Arm I: promotion and use of NAT-C with a NAT-C trained clinician or Arm II: clinician of choice irrespective of training status. Participants completed study questionnaires at: baseline, 1, 3 and 6 months. Patients booked a 20 minute needs-assessment appointment post-baseline. Patients, carers and GP practice staff views regarding the study sought through interviews/focus groups. Quantitative data were analysed descriptively. Qualitative data were analysed thematically, informed by Normalisation Process Theory. Progression to a definitive trial was assessed against feasibility outcomes, relating to: recruitment rate, uptake and delivery of the NAT-C, data collection and quality. RESULTS: Five GP practices approached, four recruited and trained to use the NAT-C. Forty-seven participants and 17 carers recruited. At baseline, 34/47 (72%) participants reported at least one moderate-severe unmet need, confirming study rationale. 32/47 (68%) participants received a NAT-C-guided consultation, 19 of which on Arm I. Study attrition at one month (n = 44 (94%), n = 16 (94%)), three months (n = 38 (81%), n = 14 (82%)) and six months (n = 32 (68%), n = 10 (59%)). Fifteen patient interviews conducted across the whole study and one focus group at each GP practice. Participants supported a definitive study and found measures acceptable. CONCLUSION: The feasibility trial indicated that recruitment rate, intervention uptake and data collection were appropriate, with refinements, for a definitive multi-centre cluster randomised controlled trial. Feasibility outcomes informed the design of a 2-armed cluster randomised controlled trial to test the effectiveness and cost-effectiveness of the NAT-C compared with usual care.

Activity Increase Despite Arthritis (AÏDA): phase II randomised controlled trial of an active management booklet for hip and knee osteoarthritis in primary care.

BACKGROUND: The Hip & Knee Book: Helping you cope with osteoarthritis was developed to change disadvantageous beliefs and encourage physical activity in people with hip or knee osteoarthritis. AIM: To assess the feasibility of conducting a definitive randomised controlled trial (RCT) of this evidence-based booklet in people with hip or knee osteoarthritis. DESIGN: Phase II feasibility randomised controlled trial (RCT). METHOD: Computerised searches of patients' record databases identified people with osteoarthritis of the hip or knee, who were invited to participate in the RCT comparing the new booklet with a control booklet. Outcomes were measured at baseline, 1 month, and 3 months, and included: beliefs about hip and knee pain, exercise, and fear avoidance; level of physical activity; and health service use. RESULTS: The trial methods were feasible in terms of recruitment, randomisation, and follow-up, but most participants recruited had longstanding established symptoms. After one and 3 months, there was a small relative improvement in illness, exercise, and fear-avoidance beliefs and physical activity level in The Hip & Knee Book group (n = 59) compared with the control group (n = 60), which provides some proof of principle for using these outcomes in future trials. CONCLUSION: This feasibility study provided proof of principle for testing The Hip & Knee Book in a larger definitive RCT.

The Hip and Knee Book: developing an active management booklet for hip and knee osteoarthritis.

BACKGROUND: The pain and disability of hip and knee osteoarthritis can be improved by exercise, but the best method of encouraging this is not known. AIM: To develop an evidence-based booklet for patients with hip or knee osteoarthritis, offering information and advice on maintaining activity. DESIGN OF STUDY: Systematic review of reviews and guidelines, then focus groups. SETTING: Four general practices in North East Wales. METHOD: Evidence-based messages were developed from a systematic review, synthesised into patient-centred messages, and then incorporated into a narrative. A draft booklet was examined by three focus groups to improve the phrasing of its messages and discuss its usefulness. The final draft was examined in a fourth focus group. RESULTS: Six evidence-based guidelines and 54 systematic reviews were identified. The focus groups found the draft booklet to be informative and easy to read. They reported a lack of clarity about the cause of osteoarthritis and were surprised that the pain could improve. The value of exercise and weight loss beliefs was accepted and reinforced, but there was a perceived contradiction about heavy physical work being causative, while moderate exercise was beneficial. There was a fear of dependency on analgesia and misinterpretation of the message on hyaluranon injections. The information on joint replacement empowered patients to discuss referral with their GP. The text was revised to accommodate these issues. CONCLUSION: The booklet was readable, credible, and useful to end-users. A randomised controlled trial is planned, to test whether the booklet influences beliefs about osteoarthritis and exercise.

Activity Increase Despite Arthritis (AIDA): design of a Phase II randomised controlled trial evaluating an active management booklet for hip and knee osteoarthritis [ISRCTN24554946].

BACKGROUND: Hip and knee osteoarthritis is a common cause of pain and disability, which can be improved by exercise interventions. However, regular exercise is uncommon in this group because the low physical activity level in the general population is probably reduced even further by pain related fear of movement. The best method of encouraging increased activity in this patient group is not known. A booklet has been developed for patients with hip or knee osteoarthritis. It focuses on changing disadvantageous beliefs and encouraging increased physical activity. METHODS/DESIGN: This paper describes the design of a Phase II randomised controlled trial (RCT) to test the effectiveness of this new booklet for patients with hip and knee osteoarthritis in influencing illness and treatment beliefs, and to assess the feasibility of conducting a larger definitive RCT in terms of health status and exercise behaviour. A computerised search of four general medical practice patients' record databases will identify patients older than 50 years of age who have consulted with hip or knee pain in the previous twelve months. A random sample of 120 will be invited to participate in the RCT comparing the new booklet with a control booklet, and we expect 100 to return final questionnaires. This trial will assess the feasibility of recruitment and randomisation, the suitability of the control intervention and outcome measurement tools, and will provide an estimate of effect size. Outcomes will include beliefs about hip and knee pain, beliefs about exercise, fear avoidance, level of physical activity, health status and health service costs. They will be measured at baseline, one month and three months. DISCUSSION: We discuss the merits of testing effectiveness in a phase II trial, in terms of intermediate outcome measures, whilst testing the processes for a larger definitive trial. We also discuss the advantages and disadvantages of testing the psychometric properties of the primary outcome measures concurrently with the trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN24554946.