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Completed

NCT Number: NCT03271658

Mixed Methods Study Web-based Life Support Decision Aid

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.

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Key information

Conditions

Clinical Decision-making

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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.

Treatment and study plan

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.

Other names: eLSDA

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.

Other names: expert facilitation

Primary outcomes

  1. Acceptability & Usability of the eLSDA

    Time frame: up to 15 minutes

    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%.

Secondary outcomes

  1. Knowledge about life-sustaining technologies

    Time frame: up to 15 minutes

    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.

  2. Clarity of values regarding life-sustaining technologies

    Time frame: up to 30 minutes

    The patient's values will be collected in the eLSDA.

  3. Congruence between the documented physician's orders and patient choice

    Time frame: up to 5 minutes

    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)

  4. Feasibility of Evaluation Process

    Time frame: up to 30 minutes

    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.

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Saskatchewan Health Research Foundation

Registry information

Official study title

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

Acronym: eLSDA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 5, 2017
Registry last updated
Oct 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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