Patients referred to cardiac rehabilitations services identified with depressive symptoms Mental and Behavioural Disorders Depression
Conditions
Interventions
Phase 1: Feasibility Study
The enhanced psychological care (EPC) intervention will be developed by refining existing training materials describing collaborative care co-ordination and behavioural acti
cardiac risk factors (e.g. blood pressure, smoking status)
patient health related quality of life
use of antidepressant medication and health care services
and satisfaction with care. Focus groups with health professionals from the participating teams, and in-depth interviews with staff and patients will be held. The enhanced psychological care intervent
Sponsors
Royal Devon & Exeter NHS Foundation Trust, UK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A pragmatic approach will be adopted, whereby adult patients (18 years or over) referred for cardiac rehabilitation based on local clinical referral protocols of participating rehabilitation teams will be screened for eligibility by a specialist nurse. This includes patients admitted with an Acute Coronary Syndrome, i.e. ST elevation myocardial infarction or non-ST elevation myocardial infarction and unstable angina, and/or following a coronary revascularization procedure, i.e. coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). These currently constitute the majority of patients referred for rehabilitation. Within this group, eligible patients are those identified as experiencing a new episode of depression symptoms identified through nurse screening at the start of the comprehensive cardiac rehabilitation programme using the Patient Health Questionnaire-9 (PHQ-9 score of 10 or more).
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 12/11/2014: The following patient exclusion criteria will be applied during routine cardiac rehabilitation screening by a nurse specialist. Patients who report having been actively treated for depression (psychological or drug therapy) within 6 months before the acute cardiac event will be excluded. The nurse will also exclude patients where there is evidence of alcohol or drug dependency, being acutely suicidal, or having poorly controlled bipolar disorder or psychosis/psychotic symptoms based on a clinical review (and seeking external confirmation from the general practitioner or other clinicians as required). Previous exclusion criteria: The following patient exclusion criteria will be applied during routine cardiac rehabilitation screening by a nurse specialist. Patients who report having been actively treated for depression (psychological or drug therapy) within 6 months before the acute cardiac event will be excluded. The nurse will also exclude patients where there is evidence of alcohol or drug dependency, being acutely suicidal or cognitively impaired (e.g. diagnosed dementia), or having a bipolar disorder or psychosis/psychotic symptoms based on a clinical review (and seeking external confirmation from the general practitioner or other clinicians as required).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: Feasibility study Descriptive Process Measures 1. Patient study eligibility and recruitment: number of patients attending an initial comprehensive cardiac rehabilitation programme nurse assessment, the proportion identified with depressive symptoms during this assessment, the prevalence of new onset (as opposed to existing) depression symptoms and the number of patients eligible for study participation. Of eligible patients: the number offered study entry; and the number agreeing to be contacted by a researcher; and the number consented to take part and undergoing a baseline interview with a researcher. 2. Intervention fidelity: numbers of patients who do not attend intensive cardiac rehabilitation and the proportion of patients with documentary evidence of care coordination in their notes. For patients who commence intensive rehabilitation with behavioural activation: number of behavioural activation sessions offered and the number of sessions attended, and the number of patients with documentary evidence of care coordination on exiting the rehabilitation programme, and the type of referrals made (if appropriate). 3. Study compliance: number of patients completing the follow-up interview, the completeness of data recorded in patient schedules. Phase 2: External pilot trial and nested qualitative study Descriptive process measures (see feasibility study): The study is powered to detect the proportion of patients recruited who are successfully followed-up. 1. Patient reported outcome measure: depressive symptoms assessed using the Beck Depression Inventory (BDI-II). This 21-item self-report instrument measures severity of depressive symptoms with an emphasis on affective and cognitive symptoms. Higher scores represent greater depression severity (range 0-63), and minimal (0-13), mild (14-19), moderate (20-28) and severe (29-63) symptom severity ranges have been specified. Measured at baseline, 5 and 8 month assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1: Feasibility study Not applicable Phase 2: External pilot trial and nested qualitative study 1. Routine Records: Cardiac and non-cardiac related deaths between baseline and 8 months. Incidence of any new cardiac events between baseline and 8 months i.e. hospital admissions for acute coronary syndrome or revascularisation procedures (CABG or PCI), or mental health events (e.g. self-harm, suicidality) arising since study enrolment extracted from acute hospital and primary care records. 2. Patient reported outcome data Domain: Measure (assessment schedule) (i). Anxiety: Beck Anxiety Inventory. 21 items asking patients to report anxiety symptoms over the last week from 0 (none: it did not bother me at all), 1 (mildly: it did not bother me much), 2 (moderately: it was very unpleasant, but I could stand it), and 3 (severely: I could barely stand it). Item scores are summated with scores of 8-15, 26-25, and 26-63 taken as cut-off points for mild, moderate, or severe anxiety respectively. (baseline, 5 months, 8 months) (ii). Generic health related quality of life: EuroQOL EQ-5D. 5 items with 3 response categories representing no impairment, moderate impairment or severe impairment. (baseline, 5 months, 8 months) (iii). Disease specific health related quality of life: HeartQoL. 14-items with 10-item physical and 4-item emotional subscales which are scored from 0 (poor health related quality of life) to 3 (better). (baseline, 5 months, 8 months) (iv). Patient experiences of care: Client Satisfaction Questionnaire. 8 items completed using four-point Likert scales (1 to 4), with scores ranging from a possible 8 to 32 and higher values indicating higher satisfaction. (5 months only) (v) Patient Treatment Preferences Questionnaire. To be developed by research team. (Baseline only) 3. Economic data collection: Resource and service use data extracted from routine/administrative sources, and via patient self- report using the Service and Resource Use Questionnaire. (5 month | — |
Countries
United Kingdom
Outcome results
None listed