We carried out an exploratory cluster RCT to evaluate the acceptability of the intervention and to determine key parameters for a larger definitive study. In the following section, we describe the quantitative and qualitative methods we used to conduct and evaluate the cluster RCT. This is then followed by a focus on several specific objectives about feasibility issues and the acceptability of the intervention:
l likely recruitment and retention rate to the trial groups at the level of the practice l feasibility and acceptability of data collection methods and measures
l impact of the intervention at the level of the practice population
l likely recruitment and retention of patients to the targeted patient intervention (intervention practices only)
l acceptability of the targeted patient intervention
l integration of the LHWs into the three intervention practices l impact of the targeted patient intervention.
Quantitative methods
The trial was a pragmatic, exploratory, two-arm practice-level cluster RCT evaluating outcomes and costs associated with the CHOICE programme intervention model. It combined elements of both a feasibility study and an exploratory study to maximise grant resource use. The general practice was the‘cluster’in the trial and we aimed to recruit six general practices as stipulated in our original application.
TABLE 42 Different components of the LHW intervention
Type of activity Example
Medication review and advice
Initiating or increasing antidepressant medication
Signposting of other services
Directing patients to health trainers, complementary practitioners, disability taxi services,‘good neighbour schemes’, local support groups and charities
Cognitive–behavioural intervention
Treatment of low mood; linking of physical and mental health; management of anger, panic and sleep problems; relaxation training plus relaxation CD
Education and information
Explaining COPD; providing worksheets leaflets about COPD; information on coping strategies to support activities of daily living
Health behaviour advice Smoking cessation, exercise and diet plans; accompanying patient in exercise; collaborative goal-setting
Empathic support Listening to patient’s accounts and difficulties; providing‘company’; talking informally about patient’s life; having tea with patient
Social interventions Identifying state benefits to which patient may be entitled; helping complete applications for state benefits, a bus pass and a disability parking badge; supporting applications for volunteering and employment; writing to utility companies to have debts written off; application for grants for essential household items; identification of charities and applications to relevant charities for support regarding finances and debt
Providing a positive perspective
Encouraging patients; re-enforcing achievement with praise; suggesting new ways to think about problems and reframe positively
Practical support Liaison with local services to effect practical adaptations in the home such as hand rails, fire alarms and chair supports; accompanying patients to local services or groups
CD, compact disc.
Adapted from Langeret al.316
© 2014 Langeret al.; licensee BioMed Central Ltd.316
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As a pragmatic trial of a clinical service embedded within a GP practice, the inclusion criteria were simple and broad with the specific intention of enhancing the external validity of the study without compromising the internal validity.
Eligibility
There were no specific eligibility criteria for practices regarding participation in the study, other than that they were in the footprint of the former Manchester PCT.
For patients, there were three levels of eligibility related to different methods of data collection and different kinds of intervention. As the main outcome measure for the practice-level intervention was based on pseudonymised health-care data, the eligibility for inclusion in this part of the study was that patients had to be aged≥18 years and have a clinical diagnosis of COPD, identified from existing primary care systems, using the QOF register.
To complete the baseline and 12-month assessment questionnaires, which included a measure of QoL and a measure of depression and anxiety, patients had to be deemed well enough and able to give informed consent as judged by their GP. Exclusion criteria for the questionnaires included patients who were terminally ill or who had problems that would impair their ability to provide consent. All eligible patients with COPD were included at this level.
To be referred to the LHW-targeted patient intervention, the patient had to meet all of the above criteria and have at least one of the following risk factors: recent use of unscheduled care, depression, living alone or social stressors. Only patients at risk of unscheduled care use were included at this level.
Practice recruitment and randomisation
Practices were recruited in pairs according to size. The six practices recruited to the trial were randomised to receive intervention or control using random number tables after stratifying them into small (53 and 100 patients), medium (140 and 181 patients) and large (227 and 249 patients) in terms of expected numbers of COPD patients on the practice list (two practices of each size). In each pair of practices, one was assigned to intervention and one to control using a random number table. The statistician for the programme (BT) carried out the randomisation procedure. Three of the practices had previously participated in the cohort study in phase 2 of the programme.
The recruitment of practices was challenging because of the study being undertaken during a period of significant change in the NHS and a complete reorganisation of primary care commissioning. Delays in securing agreements regarding treatment costs, owing to the changes in various organisations, resulted in there being a small window of time to recruit practices. In addition, practices in the north of the city were unable to participate because of participation in a self-care project. The National Institute for Health Research (NIHR) was informed of these difficulties at the time. There was a clear 12-month period between the ending of the cohort study and the start of the trial in any of the practices that participated in
both projects.
The practices provided age and sex information for every patient identified as having a QOF diagnosis of COPD on 1 February 2012. The presence of other LTCs, as recorded on the practice QOF electronic database, was also noted for each patient. There are a total of 16 possible LTCs in addition to COPD that are routinely recorded as part of the QOF: CHD, heart failure, stroke, hypertension, diabetes mellitus, epilepsy, hypothyroidism, cancer, mental health, asthma, dementia, depression, kidney disease, atrial fibrillation, obesity and learning difficulties.
Chronic obstructive pulmonary disease severity was classified using the FEV1per cent predicted values for the patient’s age, height and sex as recommended by the GOLD.239
Outcome of the intervention at the level of the practice Use of unscheduled care
The main outcome measure involved data about use of unscheduled care over the 12-month period of the trial (1 February 2013 to 31 January 2014), which corresponds to the year when the LHWs were in post. These data were collected on all patients with COPD at the intervention and control practices. They were obtained on a pseudonymised basis via NHS Digital and linked to the rest of the data collected, using our own study ID numbers. These data included, therefore, data for patients who completed the questionnaire and/or LHW aspects of the study, but also patients who declined to complete the questionnaire and those for whom participation was deemed unsuitable by practice GPs.
These data enabled us to assess the impact of the intervention at the level of the practices on use of unscheduled care. This chapter focuses on two indicators of unscheduled care: EHAs and attendances at an ED. These data, along with the total length of stay of all emergency admissions for each patient, and the total cost of these, were collected from the CCG and the Data Service for Commissioners Regional Office (DSCRO) for the year prior to the intervention (1 February 2012 to 31 January 2013) to assess any baseline differences between the groups, and from NHS Digital for the following year. The cost-effectiveness analysis, which is reported inChapter 9, estimated the total costs of scheduled and unscheduled care, using the cost data provided by the CCG/DSCRO and NHS Digital.
Anxiety, depression and quality of life
Each practice sent all eligible patients an invitation to participate in the study. Those who agreed completed a baseline assessment via postal questionnaire at the start of the trial, and a further assessment 12 months later at the end of the trial period.
The following data were collected: demographic information for each participant, which included age, sex and ethnicity; marital status; living alone or not; education level; and employment status.
Anxiety and depression were measured using the HADS. This is a well-recognised self-reported scale that measures the severity of symptoms of anxiety and depression.241There are seven items for depression and seven for anxiety. Each subscale has a maximum score of 21. Further details of the HADS are provided in
Chapter 3.
Health status and associated utility values were measured using the EuroQol-5 Dimensions (EQ-5D). This is a widely used generic instrument for measuring health status (URL: www.euroqol.org/about-eq-5d.html). It comprises the EQ-5D index scale and the EQ-5D visual analogue scale (VAS). The EQ-5D VAS scale is a 20-cm VAS in which the respondent is asked to mark his or her own current state of health on a thermometer-like line calibrated from 0 to 100. The EQ-5D index scale has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is divided into three degrees of severity, no problem, some problems or major problems, thus defining 243 possible health states, to which unconscious and dead have been added, for a total of 245 in all.317A single index score or utility weight can be produced using information from these five dimensions. The utility weights are an indication of the value or preferences for given health states. The utility values provide the quality-adjusted life-years (QALYs) for states less than full health.
Outcome of the targeted patient intervention
The subsample of patients in the intervention practices who were referred to and seen by the LHWs, completed the Patient Health Questionnaire-9 (PHQ-9)318and the Generalised Anxiety Scale-7 (GAD-7)319at the beginning and end of treatment. The PHQ-9 is an instrument for screening, diagnosing and monitoring the severity of depression and is widely used in general practice and IAPT services. PHQ-9 scores of 5, 10, 15 and 20 represent mild, moderate, moderately severe and severe depression, respectively. The GAD-7 is a seven-item, brief, self-reported measure for screening and measuring the severity of anxiety, which is widely used in general practice and IAPT services. Scores of 5, 10 and 15 on the GAD-7 are regarded as indications of mild, moderate and severe anxiety, respectively.
There was not an equivalent control group embedded within the control practices that could be used for comparison, as the absence of both the practice-level intervention and LHWs in the control practices meant similar referral pathways could not be identified.
Sample size
The data analysis is mainly descriptive and addresses the primary outcomes relating to the feasibility of conducting a future definitive RCT. We included a sample size calculation in the original grant application to help determine the future power and modelling for a definitive study. We updated this sample size calculation using data we collected from phase 2 of the programme. We used these data to power the trial at the level of the practice intervention but not at the level of the targeted patient intervention. In our longitudinal cohort study, 23% of COPD patients had an emergency inpatient admission in the prospective year. We determined that if the intervention was able to reduce this by 40% to 13.8%, then a two-group continuity-corrected chi-squared test with 0.10 two-sided significance level would have 90% power to detect the difference between intervention and control groups when the sample size in each group is 324 (nQuery Advisor, version 7; Statistical Solutions, Saugus, MA, USA).
We aimed to recruit 400 patients in each group, which would allow for modest levels of clustering within practices, although we did not find any in the longitudinal cohort study in which the intraclass correlation coefficient was zero.
This study involved 467 patients from the intervention practices and 483 from the control practices. Statistical analysis
The main analyses were based on intention-to-treat principles. Data on use of unscheduled care were obtained for all patients in the study. For categorical variables, the numbers and percentages of patients in each group are presented, and were compared using the chi-squared test. Means and SDs are presented for continuous variables at baseline and follow-up, and were compared usingt-tests. For follow-up on categorical measures (ED attendance and emergency admission), intervention effects were compared using logistic regression with the covariates age, sex, baseline score and intervention group, and for follow-up on continuous variables, regression was used. In both sets of analyses, robust standard errors were calculated specifying practices as the six clusters. Similar analyses were carried out to test for group differences on secondary outcome measures (HADS scores, EQ-5D VAS and EQ-5D utility scores).
Qualitative evaluation
We conducted a qualitative evaluation that was carried out in the intervention practices, with staff in those practices, and patients who had been offered, received, or declined the input of the LHWs. The main purpose of this work was to assess the acceptability of the intervention at the level of the practice and the patient.
Recruitment
We invited staff at the intervention practices to participate in interviews, seeking a range of staff in different roles, including GPs, PNs, HCAs and administrative staff. All participants received written information about the study and provided written consent for interview.
We also recruited patients who had been invited to see the LHW, using maximum variation sampling to recruit patients across the range of comorbidities and ages of those invited to see the LHW, and at a range of intervals from 1 to 22 weeks after the intervention ended. We made particularly strenuous efforts to recruit those who declined or withdrew from the intervention. For patients who completed the LHW intervention, the LHW provided a PIS describing the qualitative evaluation and a reply slip on which they could indicate interest in being interviewed and a pre-paid envelope. For patients who declined the intervention or withdrew from it, a member of the research team sent the information sheet and a reply slip. We then contacted patients whose replies were positive to arrange an interview.
Interviews and analysis
We conducted face-to-face interviews with practice staff in their practice (mean duration 30 minutes). The topic guide included their expectations and experience of the LHWs, effects on patients or the practice, and why patients were referred to the LHWs. We conducted semistructured, face-to-face interviews with patients (mean duration 47 minutes) either at their general practice or in their homes, according to participant preference. The topic guide included their health difficulties and psychosocial context; expectations of the LHW; experience of the LHW, including benefits or difficulties associated with the care from the LHW; comparison with other experienced treatments for mood difficulties; and
reflections on the intervention since it ended.
The three female researchers conducting the interviews all had experience in qualitative interviewing and were supervised by senior members of the study team. They were independent of the intervention and clinical teams. Recruitment, both of patients and of staff, stopped when the analysis reached theoretical saturation.
Data were anonymised and transcribed verbatim. Analysis was inductive, taking a constant comparative approach. The researchers and key members of the study team read and reread the transcripts, and discussion among the whole team identified analytic categories that we documented in continually updated analysis notes. We paid particular attention to deviant cases that challenged our analysis. The ellipsis (. . .) signifies omitted text. Square brackets denote explanatory text. Illustrative quotations are labelled with the practice identifier (R, G or B) and patient identification number and for staff, the staff category.
Ethics approval was received from National Research Ethics Service Committee Northwest–Greater Manchester East (reference number 12/NW/0068).