a multi-site cluster randomised controlled trial comparing the severity of constipation symptoms...

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”

RespectStewardship

HealingHospitality

• 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?

Contents

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






• Some preliminary results or why persist with this


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.

• 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

Outcomes ?






• Some preliminary results or why persist with this


• 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.

What is working well?

• Recruitment to the intervention arm is very slow, much slower then expected;

• Some of the participants find the questionnaires burdensome.

What is not working well?

• 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;

Future directions

• 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.

Why persist with this?

• 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!)

What would I do differently next time?

a multi-site cluster randomised controlled trial comparing the severity of constipation symptoms...

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