Mixed Methods Study Web-based Life Support Decision Aid

NCT03271658 | Completed

• 1 other identifier: BEH12334
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clinical Decision-Making

Keywords

patient decision aid; end-of-life care; shared decision making; informed decision; decision-making; clinical decision-making; web-based decision aid; palliative; critical care; nursing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Knowledge about life-sustaining technologies

  up to 15 minutes

• Clarity of values regarding life-sustaining technologies

  up to 30 minutes

• Congruence between the documented physician's orders and patient choice

  up to 5 minutes

• Feasibility of Evaluation Process

  up to 30 minutes

Study Arms (2)

Intervention

EXPERIMENTAL

Patient/family are randomized to either the active intervention (web based life support patient decision aid - eLSDA and decision coaching) or usual care comparison.

Behavioral: Web based life support patient decision aid; Behavioral: Decision coaching

Usual Care Comparison

NO INTERVENTION

Patients may also randomized to review current web based resources provided by the health region for seriously ill patients.

Interventions

Web based life support patient decision aid BEHAVIORAL

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.

Also known as: eLSDA

Intervention

Decision coaching BEHAVIORAL

During the interactive process of using the eLSDA, the study nurse provides decision coaching for patient/family, specifically a facilitated values clarification exercise.

Also known as: expert facilitation

Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Chronic obstructive lung disease
• Congestive heart failure
• Cirrhosis
• Cancer
• End-stage dementia
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatchewan Health Research Foundation: collaborator

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (4)

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

  BACKGROUND

• 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.

  PMID: 16334968 BACKGROUND

• 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. doi: 10.1136/bmj.38926.629329.AE. Epub 2006 Aug 14.

  PMID: 16908462 BACKGROUND

• 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. doi: 10.1016/j.pec.2005.04.010. No abstract available.

  PMID: 15893205 BACKGROUND

Related Links

• Decide Together Survey - Life Support Decision Aid

Study Officials

• Jennifer Kryworuchko, PhD RN CNCC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Wanda Martin, PhD RN

  University of Saskatchewan

  STUDY DIRECTOR

• Donna Goodridge

  University of Saskatchewan

  STUDY CHAIR

• Petrina McGrath

  Saskatoon Health Region

  STUDY CHAIR

• Karen Levesque

  Saskatoon Health Region

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The doctor will not be told which intervention was used with the patient. The patient/family are told that they will have one of two ways to see the information about life support, but are blind to which is classified as the study intervention and standard care.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study includes 1) a randomized controlled trial and 2) an embedded observational qualitative study. The randomized control trial will compare a convenience cohort of participants who receive usual care (approximately n=60 patients or patient/surrogate pairs) to a cohort of participants who receive the intervention (approximately n=60 patients or patient/surrogate pairs).

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 5, 2017
• Study Start: June 1, 2014
• Primary Completion: January 29, 2017
• Study Completion: January 29, 2017
• Last Updated: October 30, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)