New study proposal:A stepped wedge randomised trial of

implementation of an observation chart for the dying part of usual care for people

dying in acute hospitals: promoting optimal care as usual practise

RespectStewardship

HealingHospitality

• Investigators

• Background and rationale

• Study objectives

• Null hypothesis

• Primary & Secondary outcomes

• Study population

• Investigational plan

• Analysis plan

• Ethics

• Links with other initiatives?

Contents

• Investigators /contributors

• Background and rationale

• Study objectives

• Null hypothesis

• Primary & Secondary outcomes

• Study population

• Investigational plan

• Analysis plan

• Ethics

• Links with other initiatives?

Investigators

Investigators Contributors

Katherine Clark Sue Hansen

Jane Phillips Helen Byrnes

Naomi Byfieldt Susan Newton

Peter Saul Caroline Short

Lisa Shaw Charles Pain

Jill Lack

Malcolm Green

Isabel Higgins

Brian Kelly

• Investigators /contributors

• Background and rationale

• Study objectives

• Null hypothesis

• Primary & Secondary outcomes

• Study population

• Investigational plan

• Analysis plan

• Ethics

• Links with other initiatives?

• A lack of an agreed minimum standard of care for the dying in hospitals ;

• Data to support this statement:• Local audit• CEC report• Literature review

• Track and trigger observation charts

• Adopting a “usual practice” approach to caring for the imminently dying

Background and Rationale

• Investigators /contributors

• Background and rationale

• Study objectives

• Null hypothesis

• Primary & Secondary outcomes

• Study population

• Investigational plan

• Analysis plan

• Ethics

• Links with other initiatives?

• This study will adopted a randomized, stepped-wedge approach to investigate if the process of integrating an observation chart for the dying.

• There are 3 separate aims of this project: • Are issues identified as important to people

dying more likely to be addressed when an observation chart is adopted?

• Does this approach modify staff’s attitude and competencies when caring for people in the last 24-48 hours of life in acute medical inpatient units.

• Are family’s concerns better addressed?

Study proposal and objectives

• Investigators /contributors

• Background and rationale

• Study objectives

• Null hypothesis

• Primary & Secondary outcomes

• Study population

• Investigational plan

• Analysis plan

• Ethics

• Links with other initiatives?

• Issues identified as important to people are not better addressed when a routine observation chart is integrated into usual practice compared to currently accepted practice in acute hospitals;

• The perception of the relatives of the dying

person regarding the quality of care is no different when usual care is delivered compared to when the observation chart for the dying is incorporated in to the care plan;

• Health care professionals will not find care of the dying less stressful when they understand what observations are applicable to dying people.

Null hypothesis

• Investigators /contributors

• Background and rationale

• Study objectives

• Null hypothesis

• Primary & Secondary outcomes

• Study population

• Investigational plan

• Analysis plan

• Ethics

• Links with other initiatives?

Patient outcomes:•Repeat original audit to examine whether care delivered better aligns with patient’s expectations.

Staff competency and attitudes:•Pre and post 7-item Thanatophobia score•Pre and post Self-efficacy in palliative care score adopting the communication and management sections;

Family experience:• 31-item Quality of Death and Dying scale

Primary outcomes

• Comparing the difference between ordering of investigations before and after the implementation of the chart with quality of prescribing and costs of prescribing considered;

• Difference in the numbers and types of investigations ordered;

• Change in the number of MET calls made;• Change in the complaints;• Difference in the results of external audits

regarding care of the dying.

Secondary outcomes

• Investigators /contributors

• Background and rationale

• Study objectives

• Null hypothesis

• Primary & Secondary outcomes

• Study population

• Investigational plan

• Analysis plan

• Ethics

• Links with other initiatives?

Inclusion criteria :•People identified as dying as per usual practice in acute hospital settings; :•Admitting clinician agrees that this person is imminently dying.

Exclusion criteria:•There is not agreement in the diagnosis of dying amongst family and clinicians.

Study population

• Investigators /contributors

• Background and rationale

• Study objectives

• Null hypothesis

• Primary & Secondary outcomes

• Study population

• Investigational plan

• Analysis plan

• Ethics

• Links with other initiatives?

A stepped wedge design is proposed with the participating sites allocated in a random fashion to commence training and implementation for sites randomly assigned. The study will be conducted as two discrete components:

a) Training of the medical and nursing staff in the use of the observation chart;

b) Real care of dying people when they have been identified as dying and have been placed on the Observation Chart for the Dying.

Investigational plan

• Investigators /contributors

• Background and rationale

• Study objectives

• Null hypothesis

• Primary & Secondary outcomes

• Study population

• Investigational plan

• Analysis plan

• Ethics

• Links with other initiatives?

• Patient outcomes

• Staff outcomes

• Family outcomes

• Cost

• Quality of prescribing

• Burdens to patient

Analysis plan

• Investigators /contributors

• Background and rationale

• Study objectives

• Null hypothesis

• Primary & Secondary outcomes

• Study population

• Investigational plan

• Analysis plan

• Ethics

• Links with other initiatives?

• Discussions with HNE HREC have advised that this project can be submitted as a low risk application;

• Other initiatives this link with include:• Other PaCCSC studies that are examining

evidence-based approaches to managing symptoms such as noisy breathing, breathlessness, nausea and delirium

• HNE LHD, NSW Health commitment to improving end of life care

Ethics and Links with other initiatives