Mixed Methods Study Web-based Life Support Decision Aid

Clinical Decision-Making Clinical Trial

— eLSDA  

Official title:

Development of an Individualized, Web-Based Life Support Decision Aid (eLSDA) Concerning Goals of Care for the Seriously Ill Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03271658
• Other study ID #: BEH12334
• Status: Completed
• Phase: N/A
• Start date: June 1, 2014
• Est. completion date: January 29, 2017

Study information

• Verified date: October 2018
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients and families want to be involved in healthcare decisions. When the decision-making process does not engage older patients and their families, the care provided does not match patient preferences or meet their needs. Healthcare teams can collaborate to support patients and families facing difficult healthcare decisions, such as decisions about the use of technology used to keep a person alive when they are critically ill. Tools called patient decision aids are used in many health care settings to help patients and families understand their options and figure out the benefits and harms of a treatment to decide what is right for them. The healthcare team can make sure that patients understand the information provided, give them opportunities to ask questions, and help them talk more about the decision with others. This research study is trialing a web based patient decision aid class of intervention. It is anticipated that 120 hospitalized, seriously ill, older adult patients/ families and their healthcare professionals will be recruited. The study will determine if the intervention can improve dialogue about whether life sustaining technology for seriously ill older patients. The findings will contribute to what is already known about overcoming challenges to involving patients and families with a goal of keeping patients and families at the centre of decisions about their health.

Description:

A concurrent mixed method study of a life support decision aid (eLSDA) intends to prepare hospitalized, seriously ill older adult patients and their families to participate in shared decision-making. The study includes 1) randomized controlled trial and 2) a qualitative (naturalistic observation) study. The experimental study compares a convenience cohort of participants who receive usual care (n=60 patients or patient/surrogate pairs) to a cohort of participants who receive the intervention (n=60 patients or patient/surrogate pairs). The investigators intend to measure a) knowledge of life-sustaining technologies, b) clarity of values, c) congruence between documented physician's orders and patient choice, d) decisional conflict, and e) quality of communication. For the intervention group only, investigators will measure comprehensibility and acceptability of the eLSDA. The observational qualitative study derived from naturalistic observation will involve participant observation to examine dialogue about life support between hospitalized, seriously ill older adult patients, families and their healthcare professionals. Quantitative and qualitative data will be collected to better understand the comprehensibility, acceptability, usability, feasibility and impact of the eLSDA used in routine clinical practice.

Questionnaires, patient/family/physician discussions and web based tool viewing will be completed in a hospital setting. The investigator will administer pre-intervention questionnaires to the participants, which will take approximately 15 minutes. Participants will then be randomized to groups, and be invited to use the web based eLSDA or usual care materials on a laptop computer or tablet (30 minutes). This will be followed by post-intervention questionnaires in a second interview (15 minutes). Physicians and nurses/social workers will be asked to complete a survey to examine the barriers to discussions about goals of care (15 minutes). The investigator will also fill out the chart abstraction tool after the participants give consent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 29, 2017
• Est. primary completion date: January 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Potential users of eLSDA, which are those who are hospitalized, seriously ill, older patients, their families, and their health care providers.

• Age 55 + with one or more of the following diseases:

1. Chronic obstructive lung disease

2. Congestive heart failure

3. Cirrhosis

4. Cancer

5. End-stage dementia

6. Renal failure

• Any patient 70 + admitted to the hospital from the community because of an acute medical or surgical condition.

• Any patient 55 - 69 years of age admitted to the hospital, who has high likelihood of death in the next 6 months, in the opinion of the treating physician.

Exclusion Criteria:

• People who are not hospitalized or do not have family members that are hospitalized and are not a potential user of the eLSDA.

Related Conditions & MeSH terms

• Clinical Decision-Making

Intervention

Behavioral:
• Web based life support patient decision aid
The web-based life support decision aid (eLSDA) was adapted from a print-based decision aid. The eLSDA includes information on the pros and cons of both life support and comfort care. The eLSDA lays out the decision about life support for an individual patient/family in a logical stepwise fashion to permit discussion, ask questions, and permit reflection on each step. At the end of the eLSDA, unmet decision-making needs are identified to seek support from the healthcare team.
• Decision coaching
During the interactive process of using the eLSDA, the study nurse provides decision coaching for patient/family, specifically a facilitated values clarification exercise.

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Saskatchewan Health Research Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006 Aug 26;333(7565):417. Epub 2006 Aug 14. — View Citation

Heyland DK, Groll D, Rocker G, Dodek P, Gafni A, Tranmer J, Pichora D, Lazar N, Kutsogiannis J, Shortt S, Lam M; Canadian Researchers at the End of Life Network (CARENET). End-of-life care in acute care hospitals in Canada: a quality finish? J Palliat Care. 2005 Autumn;21(3):142-50. — View Citation

O'Connor AM, Graham ID, Visser A. Implementing shared decision making in diverse health care systems: the role of patient decision aids. Patient Educ Couns. 2005 Jun;57(3):247-9. Review. — View Citation

The Change Foundation. Consumers and Canadian Health Care Trending Analysis 2004. The Change Foundation: Toronto. 2005.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability & Usability of the eLSDA	The acceptability and usability is assessed by conducting an Acceptability Survey which asks participants 8 validated questions about the use, amount of information, length, clarity, balance in presentation, willingness to recommend to others and overall suitability for decision making. The intervention will be considered acceptable if score of the acceptability survey exceeds 80%.	up to 15 minutes
Secondary	Knowledge about life-sustaining technologies	This knowledge of life-sustaining technologies will be measured after using the eLSDA using the self-report questionnaire. The knowledge questionnaire was developed for this study based on the eLSDA to test users' knowledge of life-sustaining technologies.	up to 15 minutes
Secondary	Clarity of values regarding life-sustaining technologies	The patient's values will be collected in the eLSDA.	up to 30 minutes
Secondary	Congruence between the documented physician's orders and patient choice	Congruence between documented physician orders and patient choice when participants use the eLSDA and/or based on patient communication during the discussion with their physician will be reported as simple agreement: (Yes/No)	up to 5 minutes
Secondary	Feasibility of Evaluation Process	The measures of feasibility are established by the rate of completion of the eLSDA, debriefing and study procedures. The study will be considered feasible if 60% of those approached agreed to participate in the study; >75% of participants discuss the decision about life support during the encounter, <5% of the participants are distressed by the eLSDA, and 80% of participants complete data collection.	up to 30 minutes

External Links

•   Decide Together Survey - Life Support Decision Aid