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
|Condition or disease||Intervention/treatment||Phase|
|Clinical Decision-Making||Behavioral: Web based life support patient decision aid Behavioral: decision coaching||Not Applicable|
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|
|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|
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.
- 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%.
- 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.
- Clarity of values regarding life-sustaining technologies [ Time Frame: up to 30 minutes ]The patient's values will be collected in the eLSDA.
- 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)
- 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.
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
|Contact: Jennifer Kryworuchko, PhD RN CNCC||604 822 email@example.com|
|Contact: Wanda Martin, PhD RN||306 966 firstname.lastname@example.org|
|Royal University Hospital||Recruiting|
|Saskatoon, Saskatchewan, Canada, S7N 0W8|
|Contact: Jennifer Kryworuchko, PhD RN CNCC 604 822 4361 email@example.com|
|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|