Example of HSR project: Cardiac Counselling and Rehabilitation: RCT of Complex Interventions Marie Johnston

‘History’ Initiation – 1991! Expertise + experience Grant application – funded by Chief Scientist Office Differences ‘now’ –Co-applicants –MRC Framework for Complex Interventions –Power calculations –Randomisation

Background MI: high frequency, disabling Effects on families Evidence that cardiac rehabilitation programmes effective Questions –Timing In patient vs outpatient? –Duration –Content Emotional outcome Recovery Risk reduction –Involvement of partners Partner emotional outcome Effects on patient

A B Ewart et al

CARDIAC REHABILITATION AND COUNSELLING TRIAL Patients within a few days of myocardial infarction Intervention using cognitive-behavioural technologies –increase information e.g. risk reduction –enhance perceived control –enhance coping with limitations and with emotions Randomly allocated to intervention (in-patient or extended) or control Outcome: changed - thoughts, emotions, activities Johnston et al., 1999

Research Questions After a first MI, do patients (and their partners) who receive an inpatient cardiac rehabilitation programme demonstrate: 1.Greater benefit than those receiving normal care? 2.Equal benefit to those receiving an extended programme? [benefit = knowledge, satisfaction with care, mood, disability]

Design Patients following first MI and their partners Randomised to: –Normal care –Inpatient CR –Extended CR up to 2 months following discharge Followed up 2 weeks 2, 6 and 12 months Blind assessment

Randomisation Simple randomisation not possible Randomisation of post CCU wards Avoided confounding with wards and retain blind assessment by changing randomisation at variable intervals Clearance periods

Cardiac Counselling and Rehabilitation Programme Delivery [Normal care – no formal programme] CR groups – within 3 days of admission –Inpatient up to 5 sessions [actual average 5.55, 3.69 hours] –Extended – up to 8 additional sessions [actual average 9.55, 8.43 hours] Nurse counsellor – control for individual by having two Manual Non-judgemental counselling

Cardiac Counselling and Rehabilitation Programme Content Aimed to enhance perceptions of control Information Action plans Advice Coping skills training Relaxation Leaflets and videos Individual tailoring –menu

Menu Explanation of heart attack Emotional effects Risk factors and their modification Recovery period: resumption of activities Investigations/treatment

Evidence based techniques for changing behaviour Goal/target Monitoring Contract Planning Contingencies Grading task Skill enhancement Skill rehearsal Prompts Modelling Stress management Environmental changes Social pressure/support Persuasive communication Information re behaviour and outcome Personalised message Homework Personal experiments Experiential

Inclusion criteria All patients admitted to Ninewells CCU ie all from region First MI (WHO criteria) <70 years Fluent in English Able to participate Informed consent (13 refused)

Participants 117 randomly allocated 10 withdrew 7 died Numbers in groups –Control 33 –Inpatient 38 –Extended 29 No significant differences between 3 groups on demographic or clinical factors

Illustrative Baseline data [only Misconceptions significant – used as covariate] ExtendedInpatientControl Men/women19/1027/1119/14 age Norris Risk Index Length of stay Knowledge misconceptions

Outcomes – I: no standardised measures Knowledge –New questionnaire –19 statements –Responses: true, false, don’t know –Scores Correct (α = 0.68) Misconceptions (α = 0.57) Uncertainty (α = 0.74) Satisfaction with care –1 item –‘how satisfied do you feel generally about the advice that you received after your/your partner’s heart attack?’ –Rated 1 to 10 1 = not at all satisfied 10 = extremely satisfied

Cardiac Rehabilitation and Counselling: Knowledge

Knowledge: Correct patients partners Significant group by time interaction: I and E > C at discharge and at 2 months Significant effects for Misconceptions and Uncertainty

Cardiac Rehabilitation and Counselling: Satisfaction Patients: significant main effect of group: significant interaction (E>I at 2mths) Partners: significant main effect of groups

Outcomes II: standard measures MOOD: Hospital Anxiety and Depression Scale DISABILITY/RESUMPTION OF NORMAL ACTIVITES: Functional Limitations Profile (UK version of Sickness Impact Profile)

Cardiac Rehabilitation and Counselling: Anxiety Significant interaction: I and E lower than C at 2 and 6 months

PatientsPartners Cardiac Rehabilitation and Counselling: Anxiety Partners: significant interaction: I < C at discharge and 2 months; E< C at 2,6,12 months; E< I at 2 and 6 months

Cardiac Rehabilitation and Counselling: Depression Significant interaction: I < C at 2mths; E < C at 2, 6 and 12 mths

patientspartners Cardiac Rehabilitation and Counselling: Depression Partners: significant interaction: I<C at 6mths; E<C at 2, 6 mths

totalphysicalpsychological Cardiac Rehabilitation and Counselling: Functional Limitations Profile Significant main effect of groups on all 3 measures: C>I, C>E

Discussion: Results Results show benefits of CR For both patients and partners Some lasting to 12 months Some extra benefit of extended programme – especially in partners No differences between 2 counsellors Did not have power to examine changes in risk factors

Discussion Levels of anxiety in partners Levels of satisfaction in partners Results on anxiety similar to other studies Differential effects on women and men Lack of CR programmes in UK Provided for highly selected patients This intervention is implementable

Secondary analyses Gender effects

control Gender and Activity Limitations at follow-up control Cardiac rehabilitation & counseling

Anxiety in Men following MI with and without Intervention

Anxiety in Women following MI with and without Intervention

Designing a Randomised Clinical Trial (RCT) to test if stress management reduces blood pressure in patients with hypertension ( ) Why do it? High BP major risk factor for cardiovascular disease Unclear how mildly raised BP should be treated Some evidence that relaxation/stress management effective but previous studies poorly controlled Unclear how well results generalised in previous studies

Main Design/measurement issues in this study Control, stability of BP over time, & Generalisation Control Placebo control group or non-specific intervention i.e. has all the common components of the therapy but none of the specific (active) ones. Exercise, flexibility training Stability Length of pre-treatment baseline (habituation). Multiple BP measures before start of treatment

Sample 7 Practices referred patients with 2/3 DBP referred 3 month baseline (BP measured twice per day) 88 excluded (96 allocated to 2 treatments 32 BP too low 13 BP too high 6 too heavy, too high alcohol consumption 7 other illness 30 withdrew

Tightly controlled trial of stress management (like Patel), in approx. 100 mild hypertensives. Flexibility exercises used as control group. Long baseline (3 months), clinic ambulatory and stress testing of BP

No effect on 12 hour ambulatory BP

Generalisation Is BP measured clinically adequate for evaluating relaxation? Ambulatory BP : Yes Enduring effects of successful therapy on CV system (Left Ventricular Mass (LVM) : Yes A clinical outcome: myocardial infarction (heart attack), death : No

Common issues in designing a RCT Power Analysis: “Intention to Treat” Blind assessment Cluster randomisation

Useful reference if contemplating conducting a RCT Whole issue of Epidemiologic Reviews, 2002, 24, 1. Edited by PW Lavori & JL Kelsey & covering Design Management Analysis Sample size Ethics More area specific topics

Assignment Rates of hospital induced infections are too high, possibly because the staff do not wash their hands. NHS Scotland proposes to introduce a new training package to improve staff hygiene but wish to evaluate it before requiring its use across the country. Design an RCT to evaluate the effectiveness of the package. 1 page single spaced. For Feb 13th