Transcript Authors Study Staff

A multi-site cluster randomised controlled trial
comparing the severity of constipation symptoms
experienced by palliative care patients receiving usual
care compared to those diagnosed and managed
according to the underlying pathophysiology.
“Management of constipation in palliative care”
Respect
Stewardship
Hospitality
Healing
Contents
• Authors and study staff
• Brief overview of the study
• What is working well?
• What is not working well?
• Future directions
• Some preliminary results or why persist with this?
• What would I do differently next time?
• Authors and study staff
• Brief overview of the study
• What is working well?
• What is not working well?
• Future directions
• Some preliminary results or why persist with this?
• What would I do differently next time?
Authors and Study staff
Authors
Study Staff
Katherine Clark
Naomi Byfieldt
David Currow
Belinda Fazekas
Nicholas Talley
Natalie Cutri
Phillip Dinning
Lawrence Lam
Meera Agar
Patricia Davidson
Jane Phillips
Tania Shelby-James
• Authors and study staff
• Brief overview of the study
• What is working well?
• What is not working well?
• Future directions
• Some preliminary results or why persist with this
• What would I do differently next time?
A cluster randomised controlled trial of an algorithmic approach
to the diagnosis and management of constipation in palliative
care versus standard current clinical care.
Intervention Units: 7 day assessment period to sub-categorise
participants (diagnostic testing) and collect pre-intervention data.
Once Assessment period complete, participants will commence
the two-week intervention period. Laxative medications will be
changed based on the sub-category allocation, participants will be
provided with exercises, toileting routine and positioning. All
participants will complete an intervention diary.
Usual Practice Units: 14 day study period with participants taking
their usual laxative medication and recording bowel habits in a
daily diary.
At the end of the 14 day period, all participants are offered the
opportunity to participate in the ‘sub-study’ in which the
diagnostic tests are performed and the results provided to their
GP.
Outcomes ?
• Primary outcome:
• Change in constipation symptoms as
measured by the PAC-SYM at 14 day
• Secondary outcomes:
• Change in constipation QoL
• Frequency with which BO
• Satisfaction
• Number and types of extra laxatives
• Relationship between SAS “bowels” item
and PAC-SYM
• Authors and study staff
• Brief overview of the study
• What is working well?
• What is not working well?
• Future directions
• Some preliminary results or why persist with this
• What would I do differently next time?
What is working well?
• Constipation has a whole new persona!
• The usual practice sites are managing well
mainly due to the that it is really a matter of
completing questionnaires;
• The results of the investigations suggest that
different physical problems really do underlie
constipation.
• Authors and study staff
• Brief overview of the study
• What is working well?
• What is not working well?
• Future directions
• Some preliminary results or why persist with this?
• What would I do differently next time?
What is not working well?
• Recruitment to the intervention arm is very
slow, much slower then expected;
• Some of the participants find the
questionnaires burdensome.
• Authors and study staff
• Brief overview of the study
• What is working well?
• What is not working well?
• Future directions
• Some preliminary results or why persist with this?
• What would I do differently next time?
Future directions
• Expanded recruitment sites:
• Liverpool
• Westmead
• Nepean
• Lower Mid-North Coast
• Altered emphasis:
• This study is really about the fact that up
to 60% of people admitted to palliative
care units are prescribed laxatives with
more than ½ taking more than two
simultaneously;
• Authors and study staff
•
Brief overview of the study
•
What is working well?
•
What is not working well?
•
Future directions
•
Some preliminary results or why persist with this?
•
What would I do differently next time?
Why persist with this?
• The results of the investigations suggest that
there are physical changes underlying
constipation symptoms, either slow transit or
impaired pelvic floor function or most
commonly, both.
• The symptom burden carried by these patients
is complex with the majority of people
describing abdominal symptoms or difficulties
actually passing a bowel action or most
commonly both.
• Although preliminary, there seems to be a
correlation between the burden of physical
symptoms and self-reported QoL.
•
Authors and study staff
• Brief overview of the study
• What is working well?
• What is not working well?
• Future directions
• Some preliminary results or why persist with this?
• What would I do differently next time?
What would I do differently next time?
• Different emphasis
• Greater consumer participation to explore the
best approach to describing the study
assessments
• Less patient questions (which is interesting as
we are using approaches very well accepted in
gastroenterology!)