1. health and fitness
2. exercise

How to Expand the Reach
of CR into Underserved
Populations
Sherry L. Grace, PhD
Associate Professor, York University
Director of Research, CVR&P University Health Network
Overview
•
•
Scope of the problem
Strategies:
1. Automatic referral
2. Modifiable barriers
3. Program tailoring
Sex Differences in CR Use
• In U.S. and Canada, only approximately 15-30% of
eligible patients participate in CR
– with the rate for women being much lower at approximately
11-20%
• In a cohort of all Medicare beneficiaries who had an
index hospitalization in 1997 in a U.S hospital with a
qualifying diagnosis, significantly fewer women
(14.3%) than men (22.1%) received CR.
• Others have shown that the percentage of women in
CR is 20% lower than what would be expected based
on coronary morbidity data
Jackson, 2005; Grace 2002, 2010; Schuster 1999; Ades 1992; Sanderson 2010; Mosca 2007
Age Differences in CR Use
• Despite its proven benefits and need, older
patients are significantly less likely to be
referred to CR.
• In a population-based study, MI patients 70
yrs + were 77% less likely to participate in
CR than those younger than 60, independent
of other characteristics.
• This is despite the fact that CPG recommend
patients participate in CR regardless of age,
– and that older patients adhere well to CR once
they are enrolled.
Oldridge 1992; Pasquali 2001; Ades 1992; Grace 2002; Cooper 2002, Witt 2004
1. Referral Strategies – Can
they increase reach?
CRCARE: Cardiac Rehab
Care Continuity through Automatic Referral Evaluation
Pasquali, S. K., Alexander, K. P., Lytle, B. L., Coombs, L. P., & Peterson, E.
D. (2001). Testing an intervention to increase cardiac rehabilitation enrollment
after coronary artery bypass grafting. The American Journal of Cardiology,
88(12), 1415-1416, A6.
JACC 50(7): e100
AHA GWTG Program
GWTG is a national initiative of the AHA to improve
guidelines adherence in patients hospitalized with
cardiovascular disease.
GWTG uses collaborative learning sessions,
conference calls, e-mail and staff support to assist
hospital teams improve acute and secondary
prevention care systems.
A web-based Patient Management Tool is used for
point of care data collection and decision support,
on-demand reporting, communication and patient
education
SIMPLE, ONE PAGE, ON-LINE FORM
CR
Interactively
checks
patient’s
data with the
AHA guidelines
©2001 Outcome Sciences, Inc.
Liaison Referral Strategy: PT,
NP, RN, Peer
11 Participating Ontario Sites
Sudbury Regional
William Osler
Ottawa Heart
St. Mary’s
(KW)
York Central
Sunnybrook
UHN
Windsor Regional
Hotel Dieu-Grace
Trillium
Hamilton Health
Sciences
CRCARE Flow Diagram
5781 CAD inpatients approached
from 11 hospitals
1537 ineligible
N =2636 participants
1608 declined
62% response rate
Chart Extraction
In-Hospital Survey
391 ineligible
N =1807 participants
438 declined
80.5% retention
1 YR Follow-up Mailed
Survey
Grace et al., in press AIM
CR Referral
RESULTS: CR Referral Rates by
Referral Strategy
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Male
Female
86%
71%
**
64%
34%
Automatic +
Liaison
n=471
Automatic
Allied
Only
Health/Liaison
n=551
Only
n=490
Usual
n=297
n=1809
**p < 0.01; x2 = 9.25, κ = .14
CR Enrollment
RESULTS: CR Enrollment Rates by
Referral Strategy
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Male
Female
75%
61%
**
55%
30%
Automatic +
Liaison
n=471
Automatic
Allied
Only
Health/Liaison
n=551
Only
Usual
n=297
n=1809
n=490
**p < 0.01; x2 = 7.12, κ = .11
RESULTS: Agreement b/w Referral
and Enrollment by Referral Strategy
Referral Strategy
Automatic +
Liaison
Automatic Only
Liaison Only
Usual
N=1809.
kappa
Males Females
.61
.52
.73
.76
.69
.76
.70
.85
Summary: Referral Strategies
• Limitations: non-randomized,
unadjusted analyses presented
• Systematic referral mechanisms using a
universal process can achieve high and
comparable referral rates for men &
women
– Bedside chats may introduce bias?
• 54-85% of referred women will enroll,
depending on referral strategy employed
– While more women referred through nonsystematic means will enroll (cherry-picking?),
ultimately fewer women will be given the initial
referral
• So best practice to ensure women receive
referral, but ultimately they will be less likely
to enroll than referred males
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
**
90%
73%
<66 yrs
≥66 yrs
***
70%
*
CR Referral
RESULTS:
CR Referral Rates by Age & Strategy
39%
Automatic +
Liaison
n=471
Automatic
Allied
Only
Health/Liaison
n=551
Only
n=490
Usual
n=297
N=1809
**p < 0.01; ***p < 0.001
CR Enrollment
RESULTS: CR Enrollment Rates by
Referral Strategy
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
**
80%
<66 yrs
≥66 yrs
*
65%
**
58%
35%
Automatic +
Liaison
n=471
Automatic
Allied
Only
Health/Liaison
n=551
Only
n=490
*
Usual
n=297
N=1809
**p < 0.01; x2 = 7.12, κ = .11
RESULTS: Agreement b/w Referral
and Enrollment by Strategy
Referral Strategy
kappa
<66 yrs ≥66 yrs
Automatic + Liaison
.57
.58
Automatic Only
Liaison Only
.74
.70
.69
.81
Usual
.68
.83
N=1809.
Summary: Referral and Age
• Similarly to the findings by sex, using
universal processes can result in the highest
referral rates, even for older patients
• Following the non-universal strategies, the
older referred patients are more likely to
enroll (likely because they were cherrypicked as the highly-motivated, ideal
candidates?!)
• Requires further study and replication
2. CR Barriers by Age and
Sex
Identification of modifiable barriers
to address, and expand reach?
CR Barriers Scale
• CR barriers are assessed through 19 items, which
were developed based on a review of the literature,
pilot-tested, and show good psychometric properties
• Items rated on a 5-point Likert-type scale that
ranges from 1=strongly disagree to 5=strongly
agree,
– higher scores indicating greater barriers
• Participants are asked to rate their level of
agreement with the statements regardless of CR
referral or enrollment
Grace et al., 2004; Grace et al., 2009; Grace et al., 2009
Total CR Barriers Scale Scores
by Sex and Age
Mean
SD
Males (n=902)
2.5
1.01
Females (n=360)
2.6
0.99
Older (>=65 y; n=698) ***
2.6
1.0
Younger (<65 y; n=575)
2.4
1.0
Note. ***p<.001
Sex Differences in CR Barriers for NonParticipants (n=226 females; n=507 males)
Already exercise at home
***
Don't need CR
*
I didn't know about CR
Exercise in my community
Females
Males
**
MD doesn't encourage me
Manage on my own
**
Heart condition not serious
1
2
3
4
5
Note. ***p<.001; **p<.01; *p<.05
Sex Differences for Non-Participants
Cont’d
**
Exercise tiring or painful
Distance
Many people don’t go
Females
Males
*
Transportation
**
Other health problems
Cost
Work
1
2
3
4
5
Note. **p<.01; *p<.05
Sex Differences for Non-Participants Cont’d
*
Family
Not improve health
Females
Males
Time
Caregiving
Not offered in my first language
1
Note. *p<.05
2
3
4
5
Sex Differences in CR Barriers for
Participants (n=133 females; n=396 males)
Already exercise at home
*
Exercise tiring or painful
Work
*
Females
Males
Already exercise in community
Other health problems
Family
Manage on my own
1
2
3
4
5
Note. *p<.05
Sex Differences for Participants Cont’d
Time
Distance
Heart condition not serious
Females
Males
Many people don't go
Transportation
Caregiving
I don't need CR
1
2
3
4
5
Sex Differences for Participants Cont’d
Cost
MD doesn't encourage me
Females
Males
Not improve health
I didn't know about CR
Not offered in my first language
1
2
3
4
5
Sex Differences: Summary
•
Overall, there were no significant differences in total CR
barriers
– This is contrary to previous literature which highlights women’s
CR barriers, (Heid et al., 2004; Lieberman et al., 1998; Plach et al., 2002; Marcuccio et al.,
2003) although sex differences had yet to be tested through an
overall barrier scale
•
However, male CR participants were significantly more likely
to rate work responsibilities as a barrier than females
•
Among patients not participating in CR, males rated the
following barriers significantly more highly than did females:
already exercising at home or in the community, and confidence
in self-managing their condition
– Female CR participants were significantly more likely to rate the
tiring or painful nature of exercise as a barrier than males
– Female CR non-participants rated the following barriers
significantly more highly than did males: transportation, family
responsibilities, lack of CR awareness, perceiving exercise as
tiring or painful, and comorbid conditions
Sex Differences: Implications
• Future research is needed to explore
interventions to promote greater CR
participation among women, and men
• Sex-specific recommendations to
overcome some of the identified CR
barriers such as provision of childcare
or home help, and offering exercise
variety and choice are made in a review
(Beswick et al., 2005)
Results – CR Barriers for <65 years
(n=575) vs >=65 years (n=698)
**
Already exercise at home
Already exercise in community
I don't need CR
**
Exercise tiring or painful
Heart condition not serious
*
I didn't know about CR
**
Note. **p<.01; *p<.05
>= 65
< 65
**
Manage on my own
1
2
3
4
5
Age Differences Cont’d
***
MD doesn't encourage me
Distance
Many people don't go
***
Other health problems
***
Work
>=65
<65
***
Transportation
Family
Note. ***p<.001; *p<.05
*
1
2
3
4
5
Age Differences Cont’d
Time
***
Cost
>=65
<65
***
Not improve
health
*
Caregiving
1
2
3
4
5
Note. ***p<.001; *p<.05
Age Differences in CR
Barriers: Implications
• Physicians should be encouraged to prescribe
CR to elderly patients following coronary
events and procedures, (Ferrrara, 2006) to provide
written information about CR, and to actively
encourage patient participation
• Exercise modes and intensities should be
carefully prescribed considering older
patients’ comorbidities and lower exercise
capacity
CRBS Resources
• Shanmugasegaram, S., Gagliese, L., Oh, P., Stewart,
D. E., Brister, S., Chan, V., & Grace, S. L. (Under
Review). Psychometric validation of the cardiac
rehabilitation barriers scale. Clinical Rehabilitation
• http://www.yorku.ca/sgrace/crbarrierssc
ale.html
Age and Sex Differences
JCRP 2009; 29(3), 183-187
REVIEW: Beswick, J Adv N 2005
3. Yet another strategy to
increase reach into
under-served populations
is to offer tailored
programming….
WOMEN-ONLY CR
CR4HER Pilot & RCT
• Completed pilot study
• Single-blind pragmatic randomized controlled
trial with 3 parallel arms: co-ed, women-only,
home based
• OBJ 1: to compare women’s CR program
adherence, to determine which condition results
in the greatest adherence.
• 2ndary: to compare (a) exercise capacity, and (b)
exercise, diet, medication adherence and
smoking behaviour by condition.
– Accrual underway
A Randomized Trial of Women’s Adherence to Women’s Only, Homebased, and Traditional Cardiac Rehabilitation by Program Model
Put your Title here
(Cardiac Rehabilitation for Heart Event Recovery [CR4HER])
Sherry L. Grace, PhD – PI1-4; C. Chessex2,3; P. Oh3,4; H.M. Arthur5; L. Pilote6; S. Brister2,3; T. Colella3,4; K. Melvin2,3; D.E. Stewart2,3
1York
University, 2University Health Network, 3University of Toronto, 4Toronto Rehabilitation Institute, 5McMaster University, 6McGill University Health Centre
sgrace@yorku.ca
Introduction
Methods
• Heart disease is a leading cause of morbidity
and mortality for women in Canada (Heart and Stroke
Trial Design
Foundation
of Canada, 2003).
• Cardiac rehabilitation (CR) is an outpatient
secondary prevention program composed of
structured exercise training and comprehensive
education and counseling
• CR has been shown to reduce mortality by
25%, to reduce the need for rehospitalization and the use of interventional
procedures, and to have beneficial effects
on cardiac risk factors, psychosocial wellbeing, health behaviours and exercise
capacity, all in a cost-effective manner (Taylor,
Brown).
Women are less likely to adhere to CR
programs than men (Grace,
2002; Daly, 2002; Carhart, 1998).
Women report these programs as failing
to
meet their needs and care
preferences (Filip, 1999; Moore, 1996).
• Alternative models of CR such as homebased and women-only programs have been
developed
• little is understood about women’s
perceptions of and adherence to these
Objectives
program models.
The primary objective of this study is to compare
women’s CR program adherence, to determine
which condition results in the greatest
adherence.
The secondary objectives of this study are to:
compare (a) exercise capacity, and (b) exercise,
diet, medication adherence and smoking
behaviour by condition.
Third, this study will explore psyc hos ocial and other
factors affecting women’s CR adherenc e by condition.
Procedure
Informed Cons ent
Randomization
• Referral to 1 of 3 CR program models is made
according to a computer-generated randomization
sequence
• Stratified by diagnosis/procedure
• Allocation is concealed
Eligibi lity Sc reening
Phy s ic ian Clearanc e for CR
• Multicentre, single-blind pragmatic randomized
(1:1) trial with 3 parallel arms:
Pre-tes t s urvey c ompletion + pedometer
Randomiz ation
1.mixed-sex traditional hospital-based CR;
2.women-only hospital-based CR;
Co-ed CR (n=109)
Intak e & D/C as s mt
3.monitored home-based CR (telephone)
Pos t-CR s urvey in mail + pedometer
Women-Only , n=109
Intak e & D/C as s mt
Pos t-CR s urvey in mail + pedometer
Home-bas ed, n=109
Intak e & D/C as s mt
Pos t-CR s urvey in mail + pedometer
• Each intervention is guideline-based (CACR)
Participants
• Female patients recruited as cardiac
inpatients, or outpatients newly referred to CR
• Location and setting: Toronto (UHN, MSH,
SHSC, TRI) and Hamilton (HHS), ON
Outcome Measures
• Primary DV of program adherence will be
assessed via masked program-report of
number of on-site or telephone sessions
prescribed and completed
• Inclusion Criteria:
• CAD, ACS, revascularization, and/or valve
surgery
• Proficient in English language
• to compute % of prescribed sessions
completed
• Secondary Outcomes: Exercise capacity will
be measured by an exercise stress test
(Modified Bruce protocol)
• written approval from to participate in CR by
the patient’s cardiac specialist or GP (in the
case of inpatients)
• Eligible for home-based CR
• i.e., low to moderate risk as demonstrated
by: [1] lack of complex ventricular
dysrhythmia,
• [2] NYHA Class of 1 or 2, and LVEF >40%,
or [3] CCS Class 1 or 2.
• Exclusion criteria: musculoskeletal,
neuromuscular, visual, cognitive or nondysphoric psychiatric condition, or any serious
or terminal illness not otherwise specified
which would preclude CR eligibility based on
CACR guidelines (Stone et al, 2009)
• Assessment of exercise behaviour will be
via pedometer and self-report (Godin
LTEQ).
• Diet Habit Survey (Conner)
• Medication Adherence Scale (Morisky)
Blinding
• Participants and CR programs cannot be blind to
condition assignment.
• We have attempted to ensure exercise staff are
blind to condition
• A blinded research assistant enters and extracts all
study data post-randomization, to mitigate against
the risk of ascertainment bias
Statistical methods
• Analyses will be conducted on an ‘intent-to-treat’ basis
• Primary outcom e: an analysis of c ovariance will be
perform ed, with program model as the independent variable
and % of s essions com pleted as the dependent variable
• Secondary objectives comparing exercise c apacity and
cardiac risk-reducing behaviours by c ondition, ANCOVAs
will be us ed
• Finally, an exploratory analysis of factors affecting CR
adherenc e by program m odel will be performed using
ANOVA.
Funding
• Smoking: self-report
• Third Obj: Cardiac Rehabilitation Barriers
Scale (Grace)
Sample Size
•
•
Based on pilot study, we require 261 participants with 87
randomized to each condition, to ensure 80% power at the 5%
significance level to detect a difference in program adherence.
Recruiting 326 at baseline to take attrition into account
Registration
The trial is registered at ClinicalTrials.gov,
number: NCT01019135
Acknowledgements
• CRCARE study co-investigators: Stewart,
Anand, Gupta, Reid, Alter, Oh, Rush
• Study staff and grad students: notably Kelly
Russell, Shamila Shanmugasegaram
• CONTACT: sgrace@yorku.ca