Palliative CareNCT01190488
Feasibility Of An Advanced Care Decision Aid Among Patients And Physicians_Matlock
A study testing End-of-Life / Advanced Care Decision Aid and Active Comparator in people with Palliative Care and Decision Making, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The investigators propose an evaluation of an end of life patient decision aid (EOL-PtDA) developed by the Foundation for Informed Medical Decision Making using the RE-AIM (Reach Effectiveness, Adoption, Implementation, and Maintenance) framework. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Palliative Care, Decision Making, Decision Support Techniques
- What is being tested?
- End-of-Life / Advanced Care Decision Aid and Active Comparator
- 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 siteUnited States
- Study dates
- Nov 2009to Nov 2011
- 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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Aim 1: To determine the Reach and Effectiveness of an end-of-life patient decision aid by conducting a pilot randomized clinical trial in an inpatient palliative care service.
- Participants/Setting: Inpatient Palliative Care Service - University of Colorado Hospital: Patients may be included in this study if they are hospitalized at University of Colorado Hospital (UCH) and the UCH inpatient palliative care service has been consulted. This service, which consists of 6 physicians and two advanced practice nurses, sees approximately 40 new consults per month. More than 30% of consults originate from the hematology and oncology services, with the bulk of the remaining consults originating from the critical care services, cardiology, internal medicine, pulmonology and oncologic surgery. More than half of consults are for "goal clarification," others are for assistance with symptom control or disposition issues. We have chosen this population for the pilot because they are a high risk population with significant advanced care planning needs and they are captive and easily accessible to both PIs of this study. We will include adult patients and/or decision makers (ages 18 or greater) with end-of-life decisional needs as judged by the practitioners on the palliative care service. In cases where the patient is unable to participate due to an altered mental status, the person identified as the decision maker will be invited to participate in the study. Patients will be considered eligible if the UCH palliative care service has been consulted for "goal clarification" and/or assistance with end-of-life discussions rather than symptom control.
Who cannot join
- For Aim 1: We will exclude patients who cannot speak English or who are visually impaired as the decision aid is visual and only available in English. We will also exclude patients and decision makers with cognitive impairment as determined by ability to consent to the study. Ability to consent will be determined by the potential subject's ability, after being informed, to comprehend and explain the purposes, risks and benefits, and components of the study. If through the consent process, we determine that the person designated as the decision maker is unable to consent to the study, we will notify the primary team taking care of this patient. Additionally, we will exclude patients for whom the primary decision maker is unclear.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Feasibility Of An Advanced Care Decision Aid Among Patients And Physicians
The investigators propose an evaluation of an end of life patient decision aid (EOL-PtDA) developed by the Foundation for Informed Medical Decision Making using the RE-AIM (Reach Effectiveness, Adoption, Implementation, and Maintenance) framework. To evaluate the Reach and Effectiveness, the investigators propose a pilot randomized clinical trial of the EOL-PtDA among patients on the inpatient palliative care service at University Hospital in Colorado. To evaluate barriers and facilitators of Adoption, Implementation, and Maintenance of the EOL-PtDA, we propose focus groups of non-palliative care physicians as we perceive these physicians to be the largest barrier to ultimate adoption of the EOL-PtDA. Additionally we propose a focus group of the palliative care physicians who participated in the implementation of this decision guide study to evaluate the feasibility of conducting a randomized control trial within a pall. care service and to evaluate the acceptability of this decision aid as it was implemented. The investigators also propose to conduct focus groups of normal, healthy clinic patients to determine the acceptability among that population. The End-of-Life decision aid is different from other decision aids. From the vantage point of decision quality, a major difference is that its primary focus is on helping patients clarify their values rather than gain knowledge. The results from this study will provide critical preliminary data to inform a randomized clinical trial and/or widespread implementation of the EOL-PtDA.
Specific Aims/Research question(s):Aim 1: To determine the Reach and Effectiveness of an end-of-life patient decision aid by conducting a pilot randomized clinical trial in an inpatient palliative care service. Aim 2: To determine physicians' attitudes towards the end-of-life patient decision aid and to gain insights into potential barriers and facilitators to Adoption, Implementation, and Maintenance by conducting a qualitative study of non-palliative care, and separately, palliative care physicians. Aim 3: To determine healthy clinic patients' attitudes towards the end-of-life patient decision aid and to gain insight into its Reach and Effectiveness.
Read the detailed description
The aims 2-3 of this study include focus groups for physicians (both palliative care and non-palliative care physicians, aim 2) as well as healthy clinic patients (aim 3). Since these two arms are not randomized, they are not reported here. For additional information on the protocol and findings, please contact the PI, Daniel.Matlock@ucdenver.edu or the study coordinator, Tarah.Keech@ucdenver.edu.
- Conditions
- Palliative Care, Decision Making, Decision Support Techniques, Decision Support Systems, Clinical, Hospices
- Being tested
- End-of-Life / Advanced Care Decision Aid, Active Comparator
- Keywords
- End of life decision making, End of life decision aid, Palliative care decision making, Palliative care decision aid, Advanced care planning, Decision Aid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-of-Life / Advanced Care Decision AidBehavioural
Also called FIMDM, Looking Ahead: Choices for medical care when you're seriously ill
Patients assigned to the control group will receive usual care which includes a discussion of knowledge about their medical condition as well as their goals of care. Typically, this discussion includes one physician and one advanced practice nurse however there are occasions such as weekends and during clinic time where the consult will have only one palliative care team member. This consultation typically includes a discussion of advanced directives using the five wishes document.
Active ComparatorBehavioural
TAU
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Decision Aid | Experimental | In addition to usual care, patients assigned to the intervention group will also be asked to view and/or read the EOL-PtDA during their hospitalization. The EOL-PtDA can be utilized anytime in the course of their hospitalization (all hospital rooms at UCH have a DVD player). This could be before, during, or after the palliative care team consultation. Receives: Behavioral: End-of-Life / Advanced Care Decision Aid |
| Active comparison | Active comparator | Patients assigned to the control group will receive usual care which includes a discussion of knowledge about their medical condition as well as their goals of care. Typically, this discussion includes one physician and one advanced practice nurse however there are occasions such as weekends and during clinic time where the consult will have only one palliative care team member. This consultation typically includes a discussion of advanced directives using the five wishes document. Receives: Behavioral: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare trajectory
We will follow enrolled patients for the duration of the study and examine the following metrics: days in the ICU, place of death, resuscitation status, chemotherapy, feeding tube, discharge disposition and re-hospitalization status. Patients in both groups will be asked to complete a brief quantitative survey.
Measured: For intervention group, post intervention. For AC group, >= 24 hours after first assessment.
Secondary outcomes (1)
Quantitative measures of knowledge and values items
Measured: For intervention group, post intervention. For AC group, >= 24 hours after first assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Matlock, MD, MPH, Principal investigator, UCD, UCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190488
- Sponsor's protocol ID
- 09-0819
- Other IDs
- 630-92754
- Status last verified
- Oct 2012
- First submitted
- 25 Aug 2010
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Of An Advanced Care Decision Aid Among Patients And Physicians
- ClinicalTrials.gov ID
- NCT01190488
- Acronym / sponsor ID
- 09-0819
- Conditions
- Palliative Care, Decision Making, Decision Support Techniques, Decision Support Systems, Clinical, Hospices
- Keywords
- End of life decision making, End of life decision aid, Palliative care decision making, Palliative care decision aid, Advanced care planning, Decision Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 27 Aug 2010 (estimated)
- 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.
The investigators propose an evaluation of an end of life patient decision aid (EOL-PtDA) developed by the Foundation for Informed Medical Decision Making using the RE-AIM (Reach Effectiveness, Adoption, Implementation, and Maintenance) framework. To evaluate the Reach and Effectiveness, the investigators propose a pilot randomized clinical trial of the EOL-PtDA among patients on the inpatient palliative care service at University Hospital in Colorado. To evaluate barriers and facilitators of Adoption, Implementation, and Maintenance of the EOL-PtDA, we propose focus groups of non-palliative care physicians as we perceive these physicians to be the largest barrier to ultimate adoption of the EOL-PtDA. Additionally we propose a focus group of the palliative care physicians who participated in the implementation of this decision guide study to evaluate the feasibility of conducting a randomized control trial within a pall. care service and to evaluate the acceptability of this decision aid as it was implemented. The investigators also propose to conduct focus groups of normal, healthy clinic patients to determine the acceptability among that population. The End-of-Life decision aid is different from other decision aids. From the vantage point of decision quality, a major difference is that its primary focus is on helping patients clarify their values rather than gain knowledge. The results from this study will provide critical preliminary data to inform a randomized clinical trial and/or widespread implementation of the EOL-PtDA.
Specific Aims/Research question(s):Aim 1: To determine the Reach and Effectiveness of an end-of-life patient decision aid by conducting a pilot randomized clinical trial in an inpatient palliative care service. Aim 2: To determine physicians' attitudes towards the end-of-life patient decision aid and to gain insights into potential barriers and facilitators to Adoption, Implementation, and Maintenance by conducting a qualitative study of non-palliative care, and separately, palliative care physicians. Aim 3: To determine healthy clinic patients' attitudes towards the end-of-life patient decision aid and to gain insight into its Reach and Effectiveness.
Detailed description
The aims 2-3 of this study include focus groups for physicians (both palliative care and non-palliative care physicians, aim 2) as well as healthy clinic patients (aim 3). Since these two arms are not randomized, they are not reported here. For additional information on the protocol and findings, please contact the PI, Daniel.Matlock@ucdenver.edu or the study coordinator, Tarah.Keech@ucdenver.edu.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - Decision Aid | Experimental | Behavioral: End-of-Life / Advanced Care Decision AidIn addition to usual care, patients assigned to the intervention group will also be asked to view and/or read the EOL-PtDA during their hospitalization. The EOL-PtDA can be utilized anytime in the course of their hospitalization (all hospital rooms at UCH have a DVD player). This could be before, during, or after the palliative care team consultation. |
| Active comparison | Active comparator | Behavioral: Active ComparatorPatients assigned to the control group will receive usual care which includes a discussion of knowledge about their medical condition as well as their goals of care. Typically, this discussion includes one physician and one advanced practice nurse however there are occasions such as weekends and during clinic time where the consult will have only one palliative care team member. This consultation typically includes a discussion of advanced directives using the five wishes document. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For Aim 1: To determine the Reach and Effectiveness of an end-of-life patient decision aid by conducting a pilot randomized clinical trial in an inpatient palliative care service.
- Participants/Setting: Inpatient Palliative Care Service - University of Colorado Hospital: Patients may be included in this study if they are hospitalized at University of Colorado Hospital (UCH) and the UCH inpatient palliative care service has been consulted. This service, which consists of 6 physicians and two advanced practice nurses, sees approximately 40 new consults per month. More than 30% of consults originate from the hematology and oncology services, with the bulk of the remaining consults originating from the critical care services, cardiology, internal medicine, pulmonology and oncologic surgery. More than half of consults are for "goal clarification," others are for assistance with symptom control or disposition issues. We have chosen this population for the pilot because they are a high risk population with significant advanced care planning needs and they are captive and easily accessible to both PIs of this study. We will include adult patients and/or decision makers (ages 18 or greater) with end-of-life decisional needs as judged by the practitioners on the palliative care service. In cases where the patient is unable to participate due to an altered mental status, the person identified as the decision maker will be invited to participate in the study. Patients will be considered eligible if the UCH palliative care service has been consulted for "goal clarification" and/or assistance with end-of-life discussions rather than symptom control.
Key exclusion criteria (1 listed)
- For Aim 1: We will exclude patients who cannot speak English or who are visually impaired as the decision aid is visual and only available in English. We will also exclude patients and decision makers with cognitive impairment as determined by ability to consent to the study. Ability to consent will be determined by the potential subject's ability, after being informed, to comprehend and explain the purposes, risks and benefits, and components of the study. If through the consent process, we determine that the person designated as the decision maker is unable to consent to the study, we will notify the primary team taking care of this patient. Additionally, we will exclude patients for whom the primary decision maker is unclear.
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 |
|---|---|---|
| End-of-Life / Advanced Care Decision AidAlso: FIMDM, Looking Ahead: Choices for medical care when you're seriously illPatients assigned to the control group will receive usual care which includes a discussion of knowledge about their medical condition as well as their goals of care. Typically, this discussion includes one physician and one advanced practice nurse however there are occasions such as weekends and during clinic time where the consult will have only one palliative care team member. This consultation typically includes a discussion of advanced directives using the five wishes document. | Behavioural | Intervention - Decision Aid |
| Active ComparatorTAU | Behavioural | Active comparison |
Primary outcome
Healthcare trajectory
Time frame: For intervention group, post intervention. For AC group, >= 24 hours after first assessment.
We will follow enrolled patients for the duration of the study and examine the following metrics: days in the ICU, place of death, resuscitation status, chemotherapy, feeding tube, discharge disposition and re-hospitalization status. Patients in both groups will be asked to complete a brief quantitative survey.
1 secondary outcome
Quantitative measures of knowledge and values items
Time frame: For intervention group, post intervention. For AC group, >= 24 hours after first assessment.
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 15 Oct 2012.
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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.
Daniel Matlock, MD, MPH principal investigator
UCD, UCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing End-of-Life / Advanced Care Decision Aid and Active Comparator in people with Palliative Care and Decision Making, run by University of Colorado, Denver at 1 site in United States.
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 2 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 15 Oct 2012. 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 United States. 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?
Healthcare trajectory (time frame: For intervention group, post intervention. For AC group, >= 24 hours after first assessment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2012; AzTrials last refreshed its copy on 26 Oct 2026.