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 REHABILITATIONAND 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, activitiesJohnston 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 up2 weeks2, 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]

Extended Inpatient Control

Men/women 19/10 27/11 19/14

age 57 54 57

Norris 4.86 4.81 5.47

Risk Index 45 40 35

Length of stay 8.6 7.4 7.9

Knowledge

misconceptions

2.55 4.11 3.67

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

CR anxiety both.jpg

Patients Partners

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

patients partners

Cardiac Rehabilitation and Counselling: Depression

Partners: significant interaction: I<C at 6mths; E<C at 2, 6 mths

total physical psychological

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 analysesGender effects

FLP Physical by gender and intervention group

Intervention group

ExtendedInpatientControl

Me

an

FL

P P

hysic

al s

co

re

30

20

10

0

Gender

male

f emale

control

Gender andActivity Limitations at follow-up

control

Cardiac rehabilitation & counseling

Anxiety over Time : MEN

Time

12 months6 months2 monthsDisc hargeRecruitment

Me

an

An

xie

ty

12

10

8

6

4

2

Intervention group

Extended

Inpatient

Control

Anxiety in Men following MI with and without Intervention

Anxiety over Time: WOMEN

Time

12 months6 months2 monthsDisc hargeRecruitment

Me

an

an

xie

ty

12

10

8

6

4

2

Intervention group

Extended

Inpatient

Control

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 (1986-1990)

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 90-104

184 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

Pre-treatment Post-treatment70

76

82

88

94

100

DB

P m

m H

g

Stress Management v Exercise Clinic DBP(Johnston)

Stress management

Exercise

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

Pre-treatment Post-treatment70

76

82

88

94

100

DB

P m

m H

g

Stress Man. v Exercise ambulatory DBP(Johnston)

Stress management

Exercise

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