Malignant Ascites: A Collaborative Effort Across Three Health

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Malignancy Related

Ascites: A Collaborative

Effort Across 3 Health

Authorities

The Challenges and Benefits!

Ruth Topolnicky, Hospice Palliative Care Clinical Nurse Specialist Fraser Health

Elizabeth Beddard – Huber, Advance Practice Nurse Pain and Symptom Management/ Palliative Care, BCCA

Vancouver

Ingrid See, Clinical Practice Leader, Vancouver Home Hospice Palliative Care Service

Nicole Wikjord, Hospice Palliative Care Clinical Nurse Specialist, Vancouver General Hospital (transitioned to

Fraser Health)

Sarah Cobb, Clinical Nurse Leader Palliative Care Unit St. Paul’s Hospital

Presenters:

Ruth Topolnicky, Hospice Palliative Care

CNS Hospice Residences, Fraser Health

Elizabeth Beddard Huber, Advanced

Practice Nurse, Pain and Symptom

Management BCCA Vancouver

Nicole Wikjord, Hospice Palliative Care

Clinical Nurse Specialist, Vancouver

General Hospital (transitioned to Fraser

Health)

Ingrid See, Clinical Practice Leader,

Vancouver Home Hospice Palliative Care

Service

Disclosures

 Supplies used in QI Project provided by MedQuest Medical

 Goal of the QI Project is to select the product that works best for patients, nurses and

Interventional Radiology independent of vendor support

 Evaluation not yet complete

Objectives

Identify common symptoms associated with malignancy related ascites

Briefly review the evidence base supporting the use of tunneled peritoneal catheters

Describe how 3 Health Authorities came together to design and implement a quality improvement project

Malignancy Related Ascites

 Ascites that develops with advanced or recurrent cancer

 Due to blockage of lymphatic channels and increased permeability (ovarian)

 Due to obstruction/compression of portal veins (i.e breast, colon, gastric, pancreatic and lung)

Malignancy Related Ascites

Symptoms

Symptoms can include:

 Shortness of Breath

 Early satiety

 Abdominal Pain (distention)

 Gastric Reflux

 Nausea and vomiting

 Fatigue

 Difficulty mobilizing

Malignancy Related Ascites:

Management

 Paracentesis:

 Done in hospital

May need repeat taps more frequently

Large volume drains (tolerated by some patients, not well with others)

Travel becomes a burden over time as disease progresses

 Indwelling peritoneal catheter:

Drainage can be done at home in smaller volumes

Smaller volumes better tolerated

No need for travel for drains

Patients/families can learn to do their own

The Heart of the Matter

Lack of a standardized catheter makes patient flow difficult!

 Several different devices are in use in Lower

Mainland (Pigtails, PleurX ™, Tenckhoff ™)

Supplies are not always readily available when needed or they outdate before use. Funding for multiple products becomes a problem!

A clinical pathway clarifies criteria and referral process

Staff education is challenging when multiple devices are used, often with little notice

The lack of approved procedures within each

Authority to guide practice and clinical decisionmaking poses a barrier to care

++ Stress for patients/families when interventions that are initiated in one Health Authority are not familiar to staff in another

2013: Malignancy Related Ascites

Practices and Resources

BC Cancer Agency (PHSA)

Ambulatory clients come to clinic for regular paracentesis

Insert ~ 8 PleurX ™ catheters per year and refer to

Vancouver Coastal Health community program to manage.

No business case.

A clinical pathway clarifies criteria and referral process.

Vancouver Coastal Health

 Provide drainage supplies for PleurX ™ Catheter

( VCH funding)

Nephrologists inserts peritoneal catheters for ascites

Provide Home Care Nursing to manage the drainage.

Fraser Health

Variation in access to catheter insertion

Estimate 20 peritoneal catheters inserted/year

No designated funding for catheter supplies (No business case).

Provide support for family to manage drainage.

The State of the Evidence:

Malignancy Related Ascites

 An overview (summary) of the body of evidence related to malignancy related ascites management was done by Fleming et al in 2009 1 .

 The state of the body of evidence was not sufficiently evolved to support a formal systematic review or meta-analysis 1

The State of the Evidence

 Early studies were retrospective in nature 1 often of low quality

and were

Multiple case series reports using:

 various peritoneal catheters, off label use of IVAD devices, tunneled and non tunneled catheters designs included varying quality/rigor in assessing and measuring symptom efficacy (if at all)

Prospective multi center studies are emerging but:

Validated measures of patient satisfaction are not always included measures of symptom efficacy are not standardized across studies

The State of the Evidence

 Focus of research has been on studying the impact of low volume drainage on serum albumin, electrolytes, blood volume with concerns re hemodynamics

Studies are becoming more sophisticated over time:

One cluster analysis of ascites related symptoms was done with patients receiving repeat paracentesis 2

A similar study with patients with tunneled indwelling catheters would be welcome!

What we learned

 Some patients like the marked change in girth with a high volume paracentesis

 RISK for some patients: hepato-renal failure!

 Low volume drains with intraperitoneal catheter drains result in less change in girth, so a change in pt expectations may be needed

Tunneled Peritoneal Catheters:

The State of the Evidence

 To date accumulative evidence dating back from the 1980 ’ s suggests:

 Low volume (2 litres or less ) drains several times a week are not associated with significant changes in lab values or blood volume depletion

 Some patients may need to drain larger volumes for comfort 3,4,5

The State of the Evidence

The goal of intermittent drains is improved symptom management

Patients need to adjust the volume and frequency of drains to achieve comfort while also maintaining hydration

Monitor for thirst, dizziness – as may be a sign of hypovolemia 3

Check point – is the patient already on diuretics? Are they necessary?

Women with ovarian cancer can drain large volumes with intermittent paracentesis without hemodynamic effects: 5-10 litres or more 4 Subject to individual tolerance!

Patient Monitoring

 Individualize the frequency and volume of drains

 Patients often experience fatigue after drains: moderate drain volume to reduce this while balancing ascites symptoms control

 The goal is NOT a flat abdomen or to drain all the fluid !

Choosing the right catheter: the Challenge

Non- tunneled :

 Pigtails: Risk of infection increases after 42 days (low level evidence). Reserve use for last days to weeks

Tunneled :

 Pleurx® Catheter

Self sealing one way valve and protective cap

Drainage line set is connected to a foley bag necessitating modification of equipment

Tenchkoff ®

Peritoneal dialysis catheter

Cook connector to a urinary drainage bag

No self sealing valve on the catheter

 Asept Catheter ®

Self sealing valve that will facilitate prn irrigation

Closed drainage system with leur lock

Drainage bag prevents reflux of drainage from bag to drainage tubing

How Did We Get Started?

 Frustration on the part of providers, and patients

 Serendipity: new ascites management system coincided with comment from Intervention

Radiology stakeholder “ Just tell us what you want us to do!

Getting Started: Engagement within each Health Authority

(September 2011):

 Stakeholders:

 Infection control

 Interventional Radiology

 Home Health Leadership,

 Palliative Care MDs

 Health Shared Services BC

(HSSBC)

 Nurses in Hospice, Home Health, and Palliative Care Units

Goal of it all….

Standardize on a product that all stakeholders find acceptable

 Patients:* the VIPs!

 Interventional Radiologists

 Nurses in Home Health,

Hospice and TPCU

Getting it started

(September/October 2011)

 Inter- Authority Stakeholder meeting to develop starting points:

 Checking for Health Canada approvals

 Invited stakeholder from Health Shared

Services BC (HSSBC) to ensure compliance with policies for new products

 Work began on common Clinical

Decision Support Tools to support practice to be tweaked in each area to meet agency formats, processes

Timeline: Spring of 2012

 Decision Support tools developed (lots of time needed for this!)

 Working on project methodology, evaluation plan, education plan (lots of paper!)

 Seeking funding for supplies

Spring 2012

 Funding tight within each Health

Authority

 Exploring other options including

Vendor Support with HSSBC assistance

Early Summer 2012

 Research Ethics Board (REB) support sought so we could present and/or publish

Acknowledgement from REB UBC of the intent to do a Quality

Improvement Project (Vancouver

Coastal and PHSA)

UBC Letter of Acknowledgement supported in Fraser Health

Funding for Supplies

 Process through HSSBC to obtain

Vendor support for trial product

 Med Quest Medical support received in December 2012 to provide supplies for 15 patients between

Vancouver Coastal, BCCA

Vancouver and Fraser Health.

January 2013 Pulling it together and Rolling it Out: Going Faster!

 Target Population

English speaking

PPS 50%, life expectancy 6 weeks to 6 months goal of care is palliative

Refractory symptomatic ascites: 2 episodes of recurrence in 30 days or less

Symptomatic improvement post paracentesis

No coagulopathy that cannot be managed for the time of insertion

Criteria for a Tunneled

Peritoneal Catheter

Medical Considerations:

 Curative interventions have ceased, focus is on palliative care plan

 Prognosis > 6 weeks and requiring frequent paracentesis for symptom relief

 Patient is transitioning to EOL

Exclusion Criteria

This protocol is not intended for patients: with non-malignant ascites i.e. cirrhotic patients (more prone to hemodynamic instability, infection) who are receiving active treatment aimed at cure with infection in the peritoneal cavity, significant coagulopathy, or when the ascites is multi-loculated

Exclusion Criteria (continued)

 Exclusion Criteria:

 Non English speaking

 Pt desiring acute chemo for cure

 Patient Screening: HPC MDs in collaboration with CNSs

Tweaking the Processes

Education Plan

Processes for roll out within each

Health Authority

 Education for Interventional Radiologists and Nurse Leaders in IR re catheter and post insertion care

Connecting with HPC Teams and MDs for case finding

Just in time teaching for nurses in Home

Health and Hospice and Tertiary

Palliative Care Units

Frequency of Evaluation

WHO

Intervention

Radiologist

Nurses who perform the drain (acute, community)

Patient:

WHAT WHEN Number of times

1 Ease and Use

5 point scale

After insertion of

ASEPT™ catheter

Ease and Use

5 point scale

After using the product 1 per patient

ESAS, modified 1. Prior to insertion

2. After 1 st Drain

3. Weekly

What I Think of my ASEPT: 5 point scale

1.

Before discharge 1 from hospital

2.

4 weeks post

insertion

1

1

1

Modified ESAS

March/April of 2012

 First patient receives a catheter

 Mid May: a total of 5 patients have received catheters

The Hurdles…Internal Challenges

Guidelines

 Developing a clinical pathway to support patients for in patients and community patients

Education

 Educating nurses across settings

Clinical

 Changes in patient status

 Revising our inclusion criteria: PPS 50% too low as these patients can deteriorate quickly!

Sorting the Role of the LPN

Many questions!

CLPNBC practice consultant advises:

RN establishes the care plan and works collaboratively with the LPN

LPN can assess the catheter exit site, drain the catheter for stable patients whose drainage schedule (volume/frequency) has been established and the outcome is predictable

Must have education and know the indicators of changing predictability and stability

Cannot irrigate the catheter

The Hurdles…Across Systems

 Working across 3

Health Authorities to develop standardized clinical protocols

 Ethics approval or acknowledgement for a QI Project:

Malignancy Related

Ascites Management

What we Learned

 PPS 50% was too low to be an effective criterion for a tunneled catheter

 Patients with advanced malignant disease may have a higher PPS post drain (mobility is a target symptom)

 Patient/family caregivers must be included in the evaluation plan (we forgot!)

Point of Emphasis

 Each patient has different needs in terms of drainage frequency and amount

 Start low, go slow is a good principle

Moving Forward

 Analysis of evaluations

 Decision re further direction for

QI project re further product trial

 IN THE END: business case that can be adapted for all participating Health Authorities

References

1.

Fleming, N. et al. (2009). Indwelling catheters for the management of refractory malignant ascites: A systematic literature overview and retrospective chart review. Journal of

Pain and Symptom Management. 38 (3), 341-349.

2.

Husain, A., Bezjak, A., Easson, A. Malignant Ascites

Symptom Cluster in Patients Referred for Paracentesis Ann

Surg Oncol; 2007. (Internet) Published online October 2009.

Cited Nov 11, 2009. Available from: Springer Science

3 . Courtney, A., Nemcek, A. et al. (2008). Prospective evaluation of the Pleurx ™ catheter when used to treat recurrent ascites associated with malignancy. Journal of Vascular Interventional Radiology. 19 (12), 1723-

1731.

References

4. O ’ Neill, M.J., Weissleder, R., Gervais,

D.A., Hahn, P.F., Mueller, P.R. (2001).

Tunnelled peritoneal catheter placed under sonographic and fluoroscopic guidance in the palliative treatment of malignant ascites. AJR:177, September

2001

5. Decruze, S.B., Macdonald, R., Smith, G.,

Herod, J.J. (2010). Paracentesis in ovarian cancer: A study of the physiology during free drainage. Journal of Palliative

Medicine, Vol 13, No. 3, 2010. pp 251-

617.

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