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Mixed Methods Study Web-based Life Support Decision Aid (eLSDA)

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ClinicalTrials.gov Identifier: NCT03271658
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : September 5, 2017
Sponsor:
Collaborator:
Saskatchewan Health Research Foundation
Information provided by (Responsible Party):
University of Saskatchewan

Brief Summary:
Patients and families want to be involved in healthcare decisions [1]. 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 [2]. 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 [3,4]. The healthcare team can make sure that they 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 an internet 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 center of decisions about their health.

Condition or disease Intervention/treatment Phase
Clinical Decision-Making Behavioral: Web based life support patient decision aid Behavioral: decision coaching Not Applicable

Detailed 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 will compare 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). We 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, we 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 research assistant will administer pre-intervention questionnaires to the participants, which will take approximately 15 minutes. They 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). Research Assistants will also fill out the chart abstraction tool after the patient/family give consent.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Double (Participant, Care Provider)
Masking Description: 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.
Primary Purpose: Health Services Research
Official Title: Development of an Individualized, Web-Based Life Support Decision Aid (eLSDA) Concerning Goals of Care for the Seriously Ill Patient
Actual Study Start Date : June 1, 2014
Estimated Primary Completion Date : October 31, 2017
Estimated Study Completion Date : October 31, 2017

Arm Intervention/treatment
Experimental: Intervention
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
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 Name: eLSDA

Behavioral: 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.
Other Name: expert facilitation

No Intervention: Usual Care Comparison
Patients may also randomized to review current web based resources provided by the health region for seriously ill patients.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271658


Contacts
Contact: Jennifer Kryworuchko, PhD RN CNCC 604 822 4361 jennifer.kryworuchko@ubc.ca
Contact: Wanda Martin, PhD RN 306 966 5429 wanda.martin@usask.ca

Locations
Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Jennifer Kryworuchko, PhD RN CNCC    604 822 4361    jennifer.kryworuchko@ubc.ca   
Sponsors and Collaborators
University of Saskatchewan
Saskatchewan Health Research Foundation
Investigators
Principal Investigator: Jennifer Kryworuchko, PhD RN CNCC University of British Columbia
Study Director: Wanda Martin, PhD RN University of Saskatchewan
Study Chair: Donna Goodridge University of Saskatchewan
Study Chair: Petrina McGrath Saskatoon Health Region
Study Chair: Karen Levesque Saskatoon Health Region

Additional Information:
Publications:
Responsible Party: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT03271658     History of Changes
Other Study ID Numbers: BEH12334
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Saskatchewan:
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