The effectiveness of a structured education pulmonary rehabilitation programme for improving the health status of people with chronic obstructive pulmonary disease in primary care

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• The effectiveness of a structured education
  pulmonary rehabilitation programme for improving
  the health status of people with chronic
  obstructive pulmonary disease in primary care
• PIs Prof Kathy Murphy Dr Dympna Casey
• Hot Topics - Developments in Respiratory
  Management
• 21st Jan 2012

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PRINCE Research Team Expertise
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PRINCE Research Study

• Funded Supported by
• HRB
• Unconditional educational grant from Pfizer
• Areas of expertise in research team include
  nursing, general practice, trial and systematic
  review methodology, health psychology,
  respiratory medicine, physiotherapy, economics,
  education, statistics and respiratory assessment

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Rationale for Developing PRINCE in Ireland

• By 2030, COPD will
• Rank 7th in the worldwide burden of disease
  (Mathers Loncar, 2006)
• Be the 3rd most frequent cause of death (WHO,
  2008)
• In Ireland, the ESRI (2002) found that 20 of
  inpatient hospital bed days were due to COPD and
  in those aged 65, COPD accounted for nearly 1/3
  of respiratory inpatient cases
• Recent European epidemiological data reports
  prevalence estimates of COPD ranging from 2.1 to
  26.1 (Atsou, 2011)

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Key strategy in improving care for people with
COPD is (PR) BUT In Ireland.

• PR programmes are based predominantly in acute
  hospital settings
• Typically people with COPD only accepted to PR
  from the secondary health care services and there
  are long waiting lists (EFA 2009)
• Only 8 of GPs can access these programmes

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Aim of PRINCE Study

• To evaluate the effectiveness of a primary care
  based Structured Education Pulmonary
  Rehabilitation Programme (SEPRP) on the health
  status of people with COPD

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Research Design

• The PRINCE Trial is a two-armed, single blind
  cluster randomised trial conducted in the primary
  care setting in Ireland comparing the outcomes of
  care for people with COPD following a PR
  programme with treatment as usual
• Randomisation to control and intervention is at
  the level of the General Practice
• DIVIDED INTO PHASES

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PRINCE Trial Site locations32 16
Intervention 16 Control
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Designing the Intervention
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Structured Education

• a planned and graded programme that is
  comprehensive in scope, flexible in content,
  responsive to an individuals clinical
  psychological needs, adaptable to his or her
  educational cultural background (NICE, 2003
  p.14)
• Philosophy
• Structured written curriculum
• Trained educators
• Quality assurance of delivery
• Audit of outcomes
• (DOH, 2005)

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The SEPRP - Philosophy

• Key elements
• Empowerment
• Adult learning principles
• Working collaboratively
• Promoting self-management

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The SEPRP - Structure

• A structured written curriculum.
• Consists of an 8 week programme with a 2 hour
  session each week.
• Reviewed by experts piloted.
• The SEPRP is facilitated by trained practice
  nurses and physiotherapists.

• Quality assurance process Audit.
• Programme Manual
• Manual available

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The research involved 32 practices

• Recruitment Issues
• Diagnosis
• Lists of people with COPD
• Spirometry
• Accessing information

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Research Issues

• Leaving the knowledge
• Trained practice nurses (3 days) and
  physiotherapists (1 day) to run SEPRP
• Release time

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The PRINCE Trial DesignProf Declan Devane Mr
Bernard McCarthy

• Participants in the intervention arm received the
  SEPRP and those allocated to the control arm
  received usual care
• Adheres to CONSORT

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The PRINCE Trial Participants

• GP Practices (clusters)
• Supported by a practice nurse
• Practice supported by a computerised patient
  (medication recording) system
• Commitment on the part of the practice team to
  participate in the proposed study
• Have a patient population of greater than 2500
• Participation by a minimum of 10 consenting
  patients meeting the eligibility criteria

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The PRINCE Trial Participants

• Patients
• Have an existing diagnosis or be suspected of
  having COPD
• Presence of COPD confirmed at baseline assessment
  by spirometry
• Able to converse in, and read English as initial
  delivery of the SEPRP will only be available in
  English
• Understand the study and give informed consent

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The PRINCE Trial Outcomes

• Primary
• Health status as measured by the Chronic
  Respiratory Questionnaire (CRQ) (Guyatt et al.
  1987)
• Secondary
• Incremental Shuttle Walking Test
• Self-Efficacy for Managing Chronic Disease 6-Item
  Scale (Lorig et al 2001)
• Economic analysis specific
• EQ-5D (Rabin de Charro 2001)
• Utilisation of health care services
• Collection
• At baseline and at 12-14 weeks post intervention
  or equivalent
• Outcome assessors blinded to group allocation

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The PRINCE Trial Sample Size

• Sample size calculations estimated that 32
  practices with a minimum of 10 participants per
  practice are required, in total, to be randomised
  to control and intervention arms for power of at
  least 80 with alpha levels of 0.05. This allowed
  for participant loss to follow-up of 20 plus a
  loss of 4 practices.
• Recruited 32 practices with 350 participants
• Experimental 16 clusters, 178 participants
• Control 16 clusters, 172 participants

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The PRINCE Trial Randomisation

• Allocation concealment
• Responsibility for allocation sequence generation
  and group allocation with independent researcher
• Implementation
• List of participating practices to independent
  researcher
• Participating practices consecutively numbered
• Random allocation sequence generated
• Computer generated random number list
• Practice assigned to group allocation

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The PRINCE Trial Data analysis

• Analysis based on the GP Practice with the
  patient as the unit of analysis whilst accounting
  for the intra-cluster correlation coefficient.
• All analyses by intention to treat
• Adjusted for difference in baseline and
  covariates

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The PRINCE Trial Findings

• Participants allocated to the intervention group
  had statistically significant higher mean
• CRQ Dyspnoea (MD 049, 95 CI 020, 0.78
• CRQ Physical scores (MD 037, 95 CI 014, 0.60)
• No other statistically significant difference
  between groups was found.

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Qualitative Findings Dr. Adeline Cooney Ms.
Lorraine Mee
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Aims

• To gain general insights into individuals
  experiences of COPD self-management
• To understand the impact that the structured
  education programme may have on self-management
  skills
• To gain insights into the factors that govern
  adherence to programme principles

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Qualitative Study Design

• Grounded theory (after Corbin Strauss 2008) was
  chosen to guide study design.
• Study participants (n 26) were recruited from
  the intervention group.
• To capture different perspectives, participants
  with different experiences were initially
  purposefully selected.
• Purposeful sampling was superseded by theoretical
  sampling once data analysis commenced.
• Data were collected using face-to-face
  semi-structured interviews.
• The constant comparative technique was used to
  analyse data.
• Participants were interviewed on three occasions.

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Data Collection and Analysis

• Qualitative longitudinal design
• Interview 1 concentrated on participants
  experience of living with COPD and how they
  manage their breathlessness before the SEPRP
• Interviews 2 and 3 concentrated on participants
  experience of living with COPD and how they
  manage their breathlessness after the SEPRP
  including their experience of the SEPRP, its
  impact on their ability to self-manage and
  overall adherence to the principles of the SEPRP
• Analysis within and across groups

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Data Analysis Interview 1 Phase

• Co-existing with COPD was conceptualised as the
  core category and was comprised of two
  interrelated categories hiding and battling
• Co-existing with COPD creates unique dilemmas for
  the person and how they live their life
• What makes it easier or more difficult for people
  to co-exist with COPD are either individual, at
  a service provision level or at an environmental
  level These are referred to as mediating
  factors because they mediate the challenges of
  co-existing with COPD

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Hiding

• COPD has a gradual onset, so much so that it is
  initially hidden from the person. People did
  not always recognise or respond to the early
  symptoms of breathlessness. Instead they
  unconsciously (unawareness) adapted their lives
  to accommodate their breathlessness by slowing
  down or modifying their behaviour.

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As symptoms became more pronounced some
participants consciously (actively concealing)
hid their breathlessness. They gave examples of
strategies they used to hide breathlessness.
These ranged from stopping when out walking to
look in a shop window (G138) to opting out
While initially it was possible to hide
eventually the symptoms of COPD become more
visible and overt.
We her partner don't go out Even the course
that I'm doing at the moment I always sit two
seats away from the next person ... I'm very
self-conscious (G1739)
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Battling

• Battling is about living a normal life despite
  having COPD. Having COPD restricted participants
  in countless ways, including limiting their
  options.
• Participants were creative in finding strategies
  e.g. pacing. Others strategies were more extreme.
  Participants simply avoided or completely stopped
  doing the activity that made them breathless.

I think the breathlessness without a doubt
reduces the freedom and the randomness with which
you would live your life. Even though we live
life to a routine the ability to be able to
do your own thing is limited. (G1922)
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Challenges were in many forms there were the
physical challenges of day-to-day activities such
as housekeeping, gardening or washing and
dressing. These tasks became military operations
requiring strategic planning.
I find changing the bed linen Im wrecked. I
get help Gardening, as I say, I just go out and
do my little bit and come in and go out again...
one time you'd have stayed out there for a couple
of hours. I can't Yesterday. I cleaned out a
couple of cupboards in the kitchen. I worked
for ten minutes. I don't want to overdo it.
(G1922)
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Battling COPD also encompassed social life and
relationships.
It has an awful effect on my life. Making love,
I can't make love very often because I can't
breathe I can't walk. I cant go running with
the kids or play with them because I'm out of
breath after five minutes. They're only young and
they keep saying Will you play table tennis with
me mammy? I'm not able to, honey. I'm drained
all the time. (G1739)
The battle with COPD brought with it some
measure of battle fatigue. Some participants
described themselves as depressed. They worried
about the future and it getting worse.
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Data Analysis Interviews 2 3 Phase

• Ability to self-manage
• the core category comprised of three
  interrelated categories
• mediators, perceived impact and changing
  behaviour (Doing).
• These combined to determine the extent to which
  the person was able to self-manage effectively
  (or not) and whether they implemented the
  programme principles (or not).

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Mediators

• These were unique to individuals and either
  facilitated or hindered their making lifestyle
  changes
• Facilitators/barriers were multifaceted and could
  be individual, programme related or centre on
  accessibility.

The breathing would help you. I'd be going
gulping this inhaler. I'd (now) do this breathing
they were saying. It kind of is nearly as good as
the inhaler, do you know what I mean? It is. It
is. It is. G545 you were looking at whoever
was sitting beside you and saying I'm certainly
going to be as good as you, you know. There was
one man there, he could walk up and down the
floor. You know the walk up and down the floor.
He could do it thirty two times. He was about a
foot taller than I was. That was my goal, to do
more than him but the programme ended and I still
was at 30 and he was at 32. G545 That 8 weeks
at the beginning with everybody meeting together
it gave me an incentive to get up and start
doing something about it and when I saw the other
people older than myself were able to do it and
they were making an effort, I though, well you
can do it. Get up off your backside. There's no
excuses anymore. G1739
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Perceived impact

• This category relates to the persons personal
  evaluation of the degree of impact of making
  lifestyle changes on overall well-being. The
  impacts that participants judged as most
  important related to ability, sickness,
  knowing, energy, or other observable changes.

Im proof as time went on, and we did try to
walk every day, which helped us enormously, and I
found my breathing improved, maybe about the
third week or fourth week it was much better, and
as I say my physical strength improved that I
could walk better. (G137) (Im) fitter and
not as breathless. You know, I'd be always
gasping after a bit and that wouldn't be running
or walking very fast. Now I can whip it along
nicely and I bring my dog with me for a walk and
of course she pulls me a lot of the way, but I
have to speed it up. (G1931) Especially
exercise (was useful) because it occupies you and
energises you and in some cases when youre
finished, it relaxes you. G2523
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Changing Behaviour (Doing)

• This category was in a dynamic relationship to
  Perceived impact i.e. if the person saw
  positive benefits they were more likely to
  maintain or make lifestyle changes. The need for
  new goals was key to changing behaviour.
  Motivation was key

anybody can just say that's great but you're
not actually exercising and that's what she (the
physiotherapist) was explaining to us. Try and
get to your limit and if you can then, as the
weeks went by to just go another wee bit higher,
a wee bit higher again. At the end of the
course, she was able to tell me by looking to the
graph that the early part of what I was doing,
even just the walking, that I was actually
increasing what I was doing with the different
exercises. That was just fantastic that I was
able to just in the space of two months, that I
had actually increased my ability to do these
exercises. Not a great pile, but it was an
increase from the first day G102
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• I know now what's wrong with me and I'm able to
  manage it. Do you know I used panic when I'd get
  the breathlessness before this and I didn't even
  know how to breathe G1931

And it kind of killed me not to be able to do
the things and not to be able to walk up a flight
of stairs and I'm determined now. I used to cycle
everywhere. I never drove and I want to get back
into it now. I want to have some kind of quality
of life. G1739
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Economic Evaluation Dr Paddy Gillespie Prof
Eamon O Shea

• Objective
• To assess the cost effectiveness of a structured
  education pulmonary rehabilitation programme
  (SEPRP) for people with chronic obstructive
  pulmonary disease in general practice.
• Intervention (SEPRP) versus Control (Usual Care)
• Methodology
• To identify, measure, value and compare the costs
  and effectiveness of the alternative healthcare
  programmes
• Time Horizon Trial-based analysis - follow up of
  22 weeks
• Incremental Cost Effectiveness Analysis
• Point Estimates and 95 CIs for Incremental
  Costs and Effects
• Expected C-E Cost Effectiveness Acceptability
  Curves

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Cost Analysis

• Three componente of cost included
• Intervention Costs
• Provider and Patient Recruitment, Preparation
  Programmes, SEPRP Sessions, Educational
  Informational Materials, Diagnosis, Provider and
  Patient Time Input, Administration
• Healthcare Utilisation Costs
• Consultations with GP, Practice Nurse, Hospital
  Consultant, Public Health Nurse, Physiotherapist,
  Dietician, Home Help, Social Worker
• Hospital Admissions Accident Emergency
  Outpatient Clinic
• COPD Medications and Oxygen Therapy
• 3. Patient Out-of-Pocket Costs
• Patient Own Time Input Travel Expenses

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Effectiveness Analysis

• Evidence of effectiveness for the economic
  evaluation adopted from the clinical
  effectiveness analysis
• Health Status measured using the CRQ Instrument
• Two summary measures included
• 1. CRQ Physical Summary Score
• Based on combined results for the dyspnoea and
  fatigue CRQ domains
• 2. CRQ Psychological Summary Score
• Based on combined results for emotional function
  and mastery CRQ domains

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Cost Effectiveness Plane
More costly
Quadrant 1
Quadrant 3
?C
SEPRP more effective and more costly
SEPRP less effective and more costly
Less effective
Usual Care
?E
More effective
SEPRP more effective and less costly
SEPRP less effective and less costly
Quadrant 2
Quadrant 4
Less costly
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Cost Effectiveness Plane
More costly
Quadrant 1
Quadrant 3
?C
?
Given ?, SEPRP not cost effective
SEPRP dominated, i.e. not cost effective
Given ?, SEPRP cost effective
Less effective
Usual Care
?E
More effective
Given ?, SEPRP not cost effective
SEPRP dominant, i.e. cost effective
Given ?, SEPRP cost effective
Quadrant 4
Quadrant 2
Less costly
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Let ? threshold value which represents the
maximum that a health system is willing to pay
for an additional unit of effectiveness Possible
values for ? 0, , 20,000,.., 45,000,..,
Infinity
More Costly
?
Given ?, SEPRP is not cost effective
?C
SEPRP is not cost effective
Given ?, SEPRP is cost effective
Less effective
Usual Care
?E
More effective
Given ?, SEPRP is not cost effective
Given ?, SEPRP is cost effective
SEPRP is cost effective
Less Costly
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Results
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Results

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Cost Effectiveness Acceptability Curve CRQ
Physical Score
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Cost Effectiveness Acceptability Curve
CRQ Psychological Score
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Cost effectiveness summary

• The SEPRP resulted in higher mean costs and
  higher mean CRQ summary scores per patient, when
  compared to Usual Care.
• Policy/decision makers must determine whether the
  level of evidence presented is sufficient to
  justify the adoption of the SEPRP in clinical
  practice
• In this case, they must assess whether the
  improved level of effectiveness is sufficient to
  justify the additional resources required to
  achieve it.
• For a range of potential threshold values per CRQ
  Physical Score, we estimate that the probability
  of the SEPRP being cost effective remained above
  0.90.
• For a range of potential threshold values per CRQ
  Psychological Score, we estimate that the
  probability of the SEPRP being cost effective
  ranged from 0.40 to 0.86.

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Policy Maker Interviews

• PRINCE demonstrated that a 22-24 week complex
  intervention (SEPRP) targeted at improving the
  health status of persons with COPD results in
  statistically significant improvements in CRQ
  dyspnoea and physical scores, we wanted to seek
  the advice of policy makers about framing the
  recommendations so

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Policy Maker Interviews

• Compiled an interview schedule from main findings
• Interviewed 10 policy makers across Ireland to
  seek comments on findings and views of how best
  to frame the recommendations

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Policy Makers

• Diagnosis
• Spirometry
• PR in primary care
• Use of PRINCE material
• Treatment of COPD in primary care

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Policy Makers

• Diagnosis and early detection real concern in
  Ireland
• Policy Makers endorsed the provision of PR in
  primary care
• The SEPRP materials will be made available for
  use in primary care
• Pulmonary Rehabilitation makes a difference to
  people lives, we must find ways of providing
  access

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Thanks to the following

• Participants with COPD
• Practice Nurses Physiotherapists
• GPs
• Steering Advisory Group
• Policy Maker participants

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Questions Discussion

• Thank you for listening