Title: A feasibility study and pilot RCT to establish methods for assessing the acceptability and clinical and cost-effectiveness of enhanced psychological care (EPC) in cardiac rehabilitation services for patients with new onset depression compared with treatment as usual: CADENCE
Funder: Department of Health (England)

Abstract: Consistent with MRC guidance a two phase mixed method study is proposed. Phase 1: FeasibilityObjectives: (1) to develop assess and refine the underlying intervention theory of a standardised Enhanced Psychological Care (EPC) intervention implemented by cardiac rehabilitation nurses; (2) describe routine psychological support offered via cardiac rehabilitation services; (3) determine the feasibility and acceptability of implementing EPC for staff and patients; (4) describe key process measures relating to patient eligibility and intervention fidelity; and (5) undertake preliminary testing of pilot study methods. Design: ‘before and after’ observational study and nested qualitative study. Patients attending the initial comprehensive CR programme appointment will be offered study entry and given detailed study information. Patients who wish to take part will be contacted by a researcher (independent of the clinical team) who will arrange a visit to obtain written consent and undertake baseline assessment (includes depression diagnosis using CIS-R) before the patient begins rehabilitation. One 5 month (post-intervention) assessment is planned. Setting: three cardiac rehabilitation teams in Devon. The NHS commissions cardiac rehabilitation services that conform to a standard 7 stage patient care pathway which complies with national (BACPR) quality standards. Our EPC intervention is embedded in stages 2-5 of the pathway.Patient population: Inclusion criteria: Patients eligible for cardiac rehabilitation based on local clinical referral protocols (national audit data identifies the major patient groups as STEMI or non-STEMI PCI CABG valve surgery) with new onset depressive symptoms identified by nurse screening (stage 2) using a structured checklist (PHQ-9 score >=10). Exclusion criteria: psychological/drug treatment for depression in the 6 months before the acute cardiac event; alcohol/drug dependency; bipolar disorder or psychotic symptomsIntervention development: Nurses will be trained to deliver EPC based on a training manual. There are two components: mental health care coordination and the psychological intervention of behavioural activation delivered as part of the rehabilitation programme. We will adapt pre-existing training materials for both components. Nurses will be trained to apply algorithms based on current best practice (e.g. NICE stepped care collaborative working). On completion of (or exiting) the rehabilitation programme (including behavioural activation) structured details of the psychological care received will be sent to the patient’s general practitioner. Non-responsive patients will be referred as per NICE guidelines.Sample size: No formal calculation; our target sample of three teams and 20 patients is sufficient to test the feasibility aims Outcomes: We will document cardiac rehabilitation programme and EPC adherence and study implementation (patient recruitment and attrition rates quality of data collection). As we are testing feasibility we will only assess a restricted range of patient outcomes. The content of ‘standard’ psychological support will also be described.Qualitative study: Two focus groups with staff (3-5 per group) and in-depth interviews with about 7-10 patients and 4 staff to explore the feasibility and acceptability of EPC and the training manual and of the study procedures and materials. Findings will be used to refine both study procedures and materials prior to the pilot trial. Phase 2 – Pilot Trial Objectives: (1) to quantify patient eligibility recruitment and study attrition rates; (2) collect outcome data to inform sample sizes calculations (number of teams/patients) for a definitive trial; (3) establish economic data collection procedures; (4) gather qualitative evidence from patients and nurses on the EPC intervention and study methods/procedures. Design: external pilot cluster randomised controlled trial (RCT) the testing of economic data collection methods and a nested qualitative study. Cardiac rehabilitation teams will be randomised to a standard care (control) or usual care plus EPC intervention. Cluster randomisation will be paired matched on the stratifying variables of rehabilitation setting (e.g. clinic based home-based) and staffing levels. Setting: 8 teams in Devon Cornwall and Bristol (eligibility as above).Patient population: as above.Intervention: as above.Comparator: Both groups receive standard cardiac rehabilitation care (stages 2-5). A nurse completes stages 2-3 (assessment care planning) within 2-4 weeks of hospital referral. Of patients offered structured care (stage 4) national audit data reports that around 44% attend within 2-10 weeks. Teams offer 1-2 sessions (lasting around 2 hours) per week for approximately 8-12 weeks. Sessions include structured exercise education (e.g. managing lifestyle and cardiac risk) and some psychological input (e.g. relaxation stress management). On exiting the programme a final assessment (stage 5) and discharge arrangements are made to community services (stage 6). Throughout the study we will document if patients access care for their depressive symptoms via established primary care pathways (e.g. the GP or community mental health care teams).Sample size: Using national audit data (2010-11) 55452 patients (for MI PCI CABG) undertook phase three cardiac rehabilitation from 280 teams; an average of 200 patients per team per year. Assuming 17% have depressive symptoms this equates to 35 eligible patients per team each year. The patient consent rate will be established through piloting. Based on patient throughput and a hypothesised patient participation rate of 50% we aim to recruit 64 patients through the 8 teams in six months. This sample size is sufficient to estimate a follow-up percentage as low as 50% with margin of error +/- 13% based on the width of the 95% CI and as high as 90% with a margin of error of +/-7.5%. We do not plan to use estimates from the pilot of the intra-cluster (intra-team) correlation coefficients (ICC) for key outcomes to plan the sample size for the definitive trial as the available pilot sample is small and estimates will be imprecise. Using data supplied by the national audit (2010-11; 6272 patients; 119 CR teams) we estimate the ICC for depression to be 0.047 (95% CI: 0.034 to 0.062). This estimate will be used to inform the sample size calculation for the definitive trial.Data collection: Patients in both arms will complete baseline measures prior to commencing (or electing not to attend) structured rehabilitation and then two face-to-face follow-up interviews with a researcher at 5 and 8 months post randomisation. The blinding of patients practitioners or researchers extracting data on study outcomes is not possible in this cluster design but the final analysis will be carried out by a statistician who is blind to treatment allocation. Data will be collected on process measures patient reported outcomes and resource use and costs.Outcomes: Trial data will estimate recruitment and study completion rates. We will not make definitive estimates of effectiveness and costs; our primary aim is to document the adequacy of trial procedures (see feasibility) and collection of outcome measures.Patient related outcomes: Depression severity (Beck Depression Inventory) and CIS-R confirmed depression diagnosis cardiac and non-cardiac related mortality and morbidity (e.g. infarction vascularisation) cardiac risk factors (BP BMI HbA1c lipids smoking status) cardiac rehabilitation uptake and adherence anxiety (Beck Anxiety Inventory) health-related quality of life (generic - EQ-5D specific - HeartQoL) use of antidepressant medication health services resource use and patient preferences for and experiences of rehabilitation care (Client Satisfaction Questionnaire).Data analysis: Trial data will estimate team recruitment and patient study completion rates. As this is a pilot study we will not make definitive estimates of effectiveness and costs; our primary aim is to document the adequacy of trial procedures intervention acceptability and outcome measures. All data will be collected and reported following the CONSORT statement for cluster trials. Pilot data will be used to estimate the sample size needed (number of teams and patients) for a definitive RCT. Patient outcome data (including resource use) will be analysed descriptively (e.g. means standard deviations) for each arm at each follow up; as per commissioned brief we will report outcome effect sizes (i.e. between group mean differences and 95% confidence intervals) based on an intention-to-treat analysis. Qualitative study: In-depth interviews with about 10 staff and 30 patients (includes patients who did not take part in the RCT or adhere to the EPC) will be held to explore their views and experiences of EPC and study methods. The final number interviewed will depend on when data saturation is reached. Data collection and analysis will proceed in parallel. All interview data will be transcribed verbatim and analysed thematically with the aid of NVivo and using a framework approach.Project timetable: Project set-up: 1-2 months. Feasibility study: Months 2-6 EPC development CR team recruitment and training; months 6-13 observational study patient recruitment and follow-ups; months 8-13. qualitative research; months 12-13 analysis and refinement of intervention materials/training. Pilot study: Months 10-13 team recruitment modify trial documents; month 14 randomisation team training; months 15-19 patient recruitment and data collection (trial baseline and qualitative); months 20-27 patient follow-ups note reviews (health economics); months 25-28 qualitative & quantitative analysis write-up and dissemination.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH;CARDIOVASCULAR