Example of HSR project: Cardiac Counselling and Rehabilitation: RCT of Complex Interventions Marie Johnston
Dec 25, 2015
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