Clinical Decision-MakingeLSDANCT03271658
Mixed Methods Study Web-based Life Support Decision Aid
A study testing Web based life support patient decision aid and Decision coaching in people with Clinical Decision-Making, run by University of Saskatchewan at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Decision-Making
- What is being tested?
- Web based life support patient decision aid and Decision coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2014to 29 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- People who are not hospitalized or do not have family members that are hospitalized and are not a potential user of the eLSDA.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Individualized, Web-Based Life Support Decision Aid (eLSDA) Concerning Goals of Care for the Seriously Ill Patient
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.
Read the 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 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.
- Conditions
- Clinical Decision-Making
- Being tested
- Web based life support patient decision aid, Decision coaching
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web based life support patient decision aidBehavioural
Also called eLSDA
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 coachingBehavioural
Also called expert facilitation
During the interactive process of using the eLSDA, the study nurse provides decision coaching for patient/family, specifically a facilitated values clarification exercise.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: up to 15 minutes
Secondary outcomes (4)
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.
Measured: up to 15 minutes
Clarity of values regarding life-sustaining technologies
The patient's values will be collected in the eLSDA.
Measured: up to 30 minutes
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)
Measured: up to 5 minutes
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.
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start1 Jun 2014
- Primary completion29 Jan 2017
- Study completion29 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Clinical Decision-MakingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Responsible party
- Principal investigator, Anh Pham, University of Saskatchewan
- Investigators
- Jennifer Kryworuchko, PhD RN CNCC, Principal investigator, University of British ColumbiaWanda Martin, PhD RN, Study director, University of SaskatchewanDonna Goodridge, Study chair, University of SaskatchewanPetrina McGrath, Study chair, Saskatoon Health RegionKaren Levesque, Study chair, Saskatoon Health Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271658
- Sponsor's protocol ID
- BEH12334
- Acronym
- eLSDA
- Status last verified
- Oct 2018
- First submitted
- 29 Aug 2017
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
The Change Foundation. Consumers and Canadian Health Care Trending Analysis 2004. The Change Foundation: Toronto. 2005.
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.
PubMed 16334968Elwyn 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.
PubMed 16908462O'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.
PubMed 15893205
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Individualized, Web-Based Life Support Decision Aid (eLSDA) Concerning Goals of Care for the Seriously Ill Patient
- ClinicalTrials.gov ID
- NCT03271658
- Acronym / sponsor ID
- eLSDA / BEH12334
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 29 Jan 2017 (actual)
- Study completion
- 29 Jan 2017 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Web based life support patient decision aid, Behavioral: Decision coachingPatient/family are randomized to either the active intervention (web based life support patient decision aid - eLSDA and decision coaching) or usual care comparison. |
| Usual Care Comparison | No intervention | –Patients may also randomized to review current web based resources provided by the health region for seriously ill patients. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (1 listed)
- People who are not hospitalized or do not have family members that are hospitalized and are not a potential user of the eLSDA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web based life support patient decision aidAlso: eLSDAThe 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. | Behavioural | Intervention |
| Decision coachingAlso: expert facilitationDuring the interactive process of using the eLSDA, the study nurse provides decision coaching for patient/family, specifically a facilitated values clarification exercise. | Behavioural | Intervention |
Primary outcome
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%.
4 secondary outcomes
Knowledge about life-sustaining technologies
Time frame: up to 15 minutes
Clarity of values regarding life-sustaining technologies
Time frame: up to 30 minutes
Congruence between the documented physician's orders and patient choice
Time frame: up to 5 minutes
Feasibility of Evaluation Process
Time frame: up to 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- BackgroundThe Change Foundation. Consumers and Canadian Health Care Trending Analysis 2004. The Change Foundation: Toronto. 2005.
- Background: PubMed 16334968Heyland 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.
- Background: PubMed 16908462Elwyn 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.
- Background: PubMed 15893205O'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.
- Decide Together Survey - Life Support Decision AidLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Kryworuchko, PhD RN CNCC principal investigator
University of British Columbia
Wanda Martin, PhD RN study director
University of Saskatchewan
Donna Goodridge study chair
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web based life support patient decision aid and Decision coaching in people with Clinical Decision-Making, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability & Usability of the eLSDA (time frame: up to 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03271658, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.