Coronary Artery DiseaseVADASNCT01032551
Vascular Access Decision Aid
A study testing Vascular Access Decision Aid in people with Coronary Artery Disease and Atherosclerosis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Coronary angiogram (CA) procedures, with and without angioplasty, can be performed via vascular access in the wrist (radial artery) or leg (femoral artery). Both radial and femoral artery vascular access have their advantages and disadvantages, but neither has yet been proven to have superior health outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis
- What is being tested?
- Vascular Access Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to Dec 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years old
- English speaking
- able to provide informed consent
- is able to read the English language (however, if a patient is not able to read due to visual impairment, they may still be considered for enrollment if a family member is present to read and relay the content of the PtDA)
- candidates for both femoral and radial access as defined by the pre-assessment checklist and subsequently approved by their treating physician
Who cannot join
- any patients not meeting the inclusion criteria
- the interventional cardiologist performing the procedure does not feel comfortable or believes the patient is ineligible for either access (may include reason's not specifically outlined in the pre-assessment checklist)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences-General Site, Heart Investigation Unit
Hamilton, Ontario, L8P 2X2
About this study
Official title: Vascular Access Options in Coronary Angiogram Procedures: A Patient Decision Aid Randomized Controlled Trial
Coronary angiogram (CA) procedures, with and without angioplasty, can be performed via vascular access in the wrist (radial artery) or leg (femoral artery). Both radial and femoral artery vascular access have their advantages and disadvantages, but neither has yet been proven to have superior health outcomes. Often patients are eligible for both access sites but are not well informed regarding the potential advantages and disadvantages of each site. Vascular access in cardiac catheterization can be considered a "grey zone", where the benefits and harms may have different levels of significance depending on the individual's preferences and values. For example, patients with significant back pain may not prefer the femoral approach as it requires the patient to lie flay for an extended period of time compared to the radial approach.
For "grey zone" health care options, Patient Decision Aids (PtDA) have been demonstrated to improve the quality of decision making by significantly improving knowledge of the patient's health care options, improving the patient's accurate risk perception, and improving value congruence with the chosen options.
Read more
The investigators propose a randomized controlled trial (RCT) to evaluate the decision quality impact of a vascular access PtDA compared to "usual care" in eligible patient's undergoing elective CA procedures. If the PtDA is demonstrated to positively impact the decision quality of patients prior to CA procedures, it would be an invaluable bedside tool to promote patient informed medical decision making.
Hypothesis:
The investigators believe that a PtDA, when compared to usual care, will positively impact the decision quality and the process of decision making, relating to vascular access options in eligible patients undergoing elective CA procedures.
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Being tested
- Vascular Access Decision Aid
- Keywords
- Coronary Angiogram, Decision Aid, Vascular Access, Radial, Femoral
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular Access Decision AidBehavioural
The intervention group will receive a PtDA addressing vascular access for CA procedures. The PtDA is a brief lay summary that outlines, the purpose of the PtDA, a description of both femoral and radial approaches for CA procedures, what to expect from both approaches, the known risks/benefits of each access site (including a grading of the evidence), and a short assessment of the patients values. The values assessment is included in the PtDA as a means to help guide the patient through the decision making process. This section will ask the patient to explicitly state which features, risks, and benefits of each approach are important to them.
| Study group | Role | What they receive |
|---|---|---|
| Vascular Access Patient Decision Aid | Experimental | The intervention group will receive a PtDA addressing vascular access for CA procedures. The PtDA is a brief lay summary that outlines, the purpose of the PtDA, a description of both femoral and radial approaches for CA procedures, what to expect from both approaches, the known risks/benefits of each access site (including a grading of the evidence), and a short assessment of the patients values. The values assessment is included in the PtDA as a means to help guide the patient through the decision making process. This section will ask the patient to explicitly state which features, risks, and benefits of each approach are important to them. Receives: Behavioral: Vascular Access Decision Aid |
| Usual Care | No intervention | The control group (those not randomized to the PtDA) will have "usual care". Usual care involves a brief discussion, just prior to the CA procedure, with the treating physician, regarding the patient's eligibility for both vascular accesses, followed by the advantages and disadvantages of both. The details and duration of the discussion is left to the discretion of the treating physician as per their individual standard of care. There will be no access to a formal PtDA in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome involves evaluation of the decision process leading to decision quality as assessed by the Decisional Conflict Scale (DCS). The DCS is a validated scale that has been used in more than 30 PtDA studies across different decisions.
Measured: 1 Day
Secondary outcomes (6)
Improved knowledge and accurate risk perception of the patient's health care option assessed by a pre-discharge questionnaire.
Measured: 1 Day
Improved value congruence with the patient's chosen option as assessed by a pre-discharge questionnaire.
Measured: 1 Day
Angiographic Success (PCI) as determined by interventionalist performing the procedure.
Impact of patients choosing their vascular access with the help of a PtDA versus usual care as evidenced by various procedural outcomes
Measured: 1 day
Vascular access success-ability to successfully gain vascular access through the selected site (radial versus femoral).
Impact of patients choosing their vascular access with the help of a PtDA versus usual care as evidenced by procedural outcomes
Measured: 1 Day
Procedural time (minutes)
Impact of patients choosing their vascular access with the help of a PtDA versus usual care as evidenced by procedural outcomes
Measured: 1 day
Access site Complications (Significant bleeding, hematoma, pseudoaneurysm, or vascular compromise requiring intervention)
Hematoma, bleeding, thrombosis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, University of Ottawa
- Investigators
- Jon-David R Schwalm, BSc, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032551
- Sponsor's protocol ID
- MU-09-340
- Acronym
- VADAS
- Status last verified
- Dec 2009
- First submitted
- 9 Dec 2009
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
McMillan I, Murie JA. Vascular injury following cardiac catheterization. Br J Surg. 1984 Nov;71(11):832-5. doi: 10.1002/bjs.1800711108.
PubMed 6498455Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J. 2009 Jan;157(1):132-40. doi: 10.1016/j.ahj.2008.08.023. Epub 2008 Nov 1.
PubMed 19081409Hamon M, Mehta S, Steg G, et al. Major bleeding in patients with acute coronary syndrome undergoing early invasive management can be reduced by fondaparinux, even in the context of trans-radial coronary intervention: insights from OASIS-5 trial. Circulation 2006; 114(Supplement II):552.
Agostoni P, Biondi-Zoccai GG, de Benedictis ML, Rigattieri S, Turri M, Anselmi M, Vassanelli C, Zardini P, Louvard Y, Hamon M. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; Systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol. 2004 Jul 21;44(2):349-56. doi: 10.1016/j.jacc.2004.04.034.
PubMed 15261930Bertrand OF, Rodes-Cabau J, Larose E, Nguyen CM, Roy L, Dery JP, Courtis J, Nault I, Poirier P, Costerousse O, De Larochelliere R. One-year clinical outcome after abciximab bolus-only compared with abciximab bolus and 12-hour infusion in the Randomized EArly Discharge after Transradial Stenting of CoronarY Arteries (EASY) Study. Am Heart J. 2008 Jul;156(1):135-40. doi: 10.1016/j.ahj.2008.02.006. Epub 2008 Apr 25.
PubMed 18585508Ziakas A, Klinke P, Fretz E, Mildenberger R, Williams MB, Siega AD, Kinloch RD, Hilton JD. Same-day discharge is preferred by the majority of the patients undergoing radial PCI. J Invasive Cardiol. 2004 Oct;16(10):562-5.
PubMed 15505350Wennberg JE. Unwarranted variations in healthcare delivery: implications for academic medical centres. BMJ. 2002 Oct 26;325(7370):961-4. doi: 10.1136/bmj.325.7370.961. No abstract available.
PubMed 12399352Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango). Soc Sci Med. 1997 Mar;44(5):681-92. doi: 10.1016/s0277-9536(96)00221-3.
PubMed 9032835O'Connor AM, Bennett C, Stacey D, Barry MJ, Col NF, Eden KB, Entwistle V, Fiset V, Holmes-Rovner M, Khangura S, Llewellyn-Thomas H, Rovner DR. Do patient decision aids meet effectiveness criteria of the international patient decision aid standards collaboration? A systematic review and meta-analysis. Med Decis Making. 2007 Sep-Oct;27(5):554-74. doi: 10.1177/0272989X07307319. Epub 2007 Sep 14.
PubMed 17873255Kryworuchko J, Stacey D, Bennett C, Graham ID. Appraisal of primary outcome measures used in trials of patient decision support. Patient Educ Couns. 2008 Dec;73(3):497-503. doi: 10.1016/j.pec.2008.07.011. Epub 2008 Aug 12.
PubMed 18701235Man-Son-Hing M, Laupacis A, O'Connor AM, Biggs J, Drake E, Yetisir E, Hart RG. A patient decision aid regarding antithrombotic therapy for stroke prevention in atrial fibrillation: a randomized controlled trial. JAMA. 1999 Aug 25;282(8):737-43. doi: 10.1001/jama.282.8.737.
PubMed 10463708Cranney A, O'Connor AM, Jacobsen MJ, Tugwell P, Adachi JD, Ooi DS, Waldegger L, Goldstein R, Wells GA. Development and pilot testing of a decision aid for postmenopausal women with osteoporosis. Patient Educ Couns. 2002 Jul;47(3):245-55. doi: 10.1016/s0738-3991(01)00218-x.
PubMed 12088603Elwyn 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. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
PubMed 7898294Goel V, Sawka CA, Thiel EC, Gort EH, O'Connor AM. Randomized trial of a patient decision aid for choice of surgical treatment for breast cancer. Med Decis Making. 2001 Jan-Feb;21(1):1-6. doi: 10.1177/0272989X0102100101.
PubMed 11206942
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Access Options in Coronary Angiogram Procedures: A Patient Decision Aid Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01032551
- Acronym / sponsor ID
- VADAS / MU-09-340
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Keywords
- Coronary Angiogram, Decision Aid, Vascular Access, Radial, Femoral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University, University of Ottawa
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Dec 2009 (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.
Coronary angiogram (CA) procedures, with and without angioplasty, can be performed via vascular access in the wrist (radial artery) or leg (femoral artery). Both radial and femoral artery vascular access have their advantages and disadvantages, but neither has yet been proven to have superior health outcomes. Often patients are eligible for both access sites but are not well informed regarding the potential advantages and disadvantages of each site. Vascular access in cardiac catheterization can be considered a "grey zone", where the benefits and harms may have different levels of significance depending on the individual's preferences and values. For example, patients with significant back pain may not prefer the femoral approach as it requires the patient to lie flay for an extended period of time compared to the radial approach.
For "grey zone" health care options, Patient Decision Aids (PtDA) have been demonstrated to improve the quality of decision making by significantly improving knowledge of the patient's health care options, improving the patient's accurate risk perception, and improving value congruence with the chosen options.
The investigators propose a randomized controlled trial (RCT) to evaluate the decision quality impact of a vascular access PtDA compared to "usual care" in eligible patient's undergoing elective CA procedures. If the PtDA is demonstrated to positively impact the decision quality of patients prior to CA procedures, it would be an invaluable bedside tool to promote patient informed medical decision making.
Hypothesis:
The investigators believe that a PtDA, when compared to usual care, will positively impact the decision quality and the process of decision making, relating to vascular access options in eligible patients undergoing elective CA procedures.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vascular Access Patient Decision Aid | Experimental | Behavioral: Vascular Access Decision AidThe intervention group will receive a PtDA addressing vascular access for CA procedures. The PtDA is a brief lay summary that outlines, the purpose of the PtDA, a description of both femoral and radial approaches for CA procedures, what to expect from both approaches, the known risks/benefits of each access site (including a grading of the evidence), and a short assessment of the patients values. The values assessment is included in the PtDA as a means to help guide the patient through the decision making process. This section will ask the patient to explicitly state which features, risks, and benefits of each approach are important to them. |
| Usual Care | No intervention | –The control group (those not randomized to the PtDA) will have "usual care". Usual care involves a brief discussion, just prior to the CA procedure, with the treating physician, regarding the patient's eligibility for both vascular accesses, followed by the advantages and disadvantages of both. The details and duration of the discussion is left to the discretion of the treating physician as per their individual standard of care. There will be no access to a formal PtDA in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 18 years old
- English speaking
- able to provide informed consent
- is able to read the English language (however, if a patient is not able to read due to visual impairment, they may still be considered for enrollment if a family member is present to read and relay the content of the PtDA)
- candidates for both femoral and radial access as defined by the pre-assessment checklist and subsequently approved by their treating physician
Key exclusion criteria (2 listed)
- any patients not meeting the inclusion criteria
- the interventional cardiologist performing the procedure does not feel comfortable or believes the patient is ineligible for either access (may include reason's not specifically outlined in the pre-assessment checklist)
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 |
|---|---|---|
| Vascular Access Decision AidThe intervention group will receive a PtDA addressing vascular access for CA procedures. The PtDA is a brief lay summary that outlines, the purpose of the PtDA, a description of both femoral and radial approaches for CA procedures, what to expect from both approaches, the known risks/benefits of each access site (including a grading of the evidence), and a short assessment of the patients values. The values assessment is included in the PtDA as a means to help guide the patient through the decision making process. This section will ask the patient to explicitly state which features, risks, and benefits of each approach are important to them. | Behavioural | Vascular Access Patient Decision Aid |
Primary outcome
The primary outcome involves evaluation of the decision process leading to decision quality as assessed by the Decisional Conflict Scale (DCS). The DCS is a validated scale that has been used in more than 30 PtDA studies across different decisions.
Time frame: 1 Day
6 secondary outcomes
Improved knowledge and accurate risk perception of the patient's health care option assessed by a pre-discharge questionnaire.
Time frame: 1 Day
Improved value congruence with the patient's chosen option as assessed by a pre-discharge questionnaire.
Time frame: 1 Day
Angiographic Success (PCI) as determined by interventionalist performing the procedure.
Time frame: 1 day
Vascular access success-ability to successfully gain vascular access through the selected site (radial versus femoral).
Time frame: 1 Day
Procedural time (minutes)
Time frame: 1 day
Access site Complications (Significant bleeding, hematoma, pseudoaneurysm, or vascular compromise requiring intervention)
Time frame: 1 day
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 19 Jan 2011.
- Background: PubMed 6498455McMillan I, Murie JA. Vascular injury following cardiac catheterization. Br J Surg. 1984 Nov;71(11):832-5. doi: 10.1002/bjs.1800711108.
- Background: PubMed 19081409Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J. 2009 Jan;157(1):132-40. doi: 10.1016/j.ahj.2008.08.023. Epub 2008 Nov 1.
- BackgroundHamon M, Mehta S, Steg G, et al. Major bleeding in patients with acute coronary syndrome undergoing early invasive management can be reduced by fondaparinux, even in the context of trans-radial coronary intervention: insights from OASIS-5 trial. Circulation 2006; 114(Supplement II):552.
- Background: PubMed 15261930Agostoni P, Biondi-Zoccai GG, de Benedictis ML, Rigattieri S, Turri M, Anselmi M, Vassanelli C, Zardini P, Louvard Y, Hamon M. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; Systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol. 2004 Jul 21;44(2):349-56. doi: 10.1016/j.jacc.2004.04.034.
- Background: PubMed 18585508Bertrand OF, Rodes-Cabau J, Larose E, Nguyen CM, Roy L, Dery JP, Courtis J, Nault I, Poirier P, Costerousse O, De Larochelliere R. One-year clinical outcome after abciximab bolus-only compared with abciximab bolus and 12-hour infusion in the Randomized EArly Discharge after Transradial Stenting of CoronarY Arteries (EASY) Study. Am Heart J. 2008 Jul;156(1):135-40. doi: 10.1016/j.ahj.2008.02.006. Epub 2008 Apr 25.
- Background: PubMed 15505350Ziakas A, Klinke P, Fretz E, Mildenberger R, Williams MB, Siega AD, Kinloch RD, Hilton JD. Same-day discharge is preferred by the majority of the patients undergoing radial PCI. J Invasive Cardiol. 2004 Oct;16(10):562-5.
- Background: PubMed 12399352Wennberg JE. Unwarranted variations in healthcare delivery: implications for academic medical centres. BMJ. 2002 Oct 26;325(7370):961-4. doi: 10.1136/bmj.325.7370.961. No abstract available.
- Background: PubMed 9032835Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango). Soc Sci Med. 1997 Mar;44(5):681-92. doi: 10.1016/s0277-9536(96)00221-3.
- Background: PubMed 17873255O'Connor AM, Bennett C, Stacey D, Barry MJ, Col NF, Eden KB, Entwistle V, Fiset V, Holmes-Rovner M, Khangura S, Llewellyn-Thomas H, Rovner DR. Do patient decision aids meet effectiveness criteria of the international patient decision aid standards collaboration? A systematic review and meta-analysis. Med Decis Making. 2007 Sep-Oct;27(5):554-74. doi: 10.1177/0272989X07307319. Epub 2007 Sep 14.
- Background: PubMed 18701235Kryworuchko J, Stacey D, Bennett C, Graham ID. Appraisal of primary outcome measures used in trials of patient decision support. Patient Educ Couns. 2008 Dec;73(3):497-503. doi: 10.1016/j.pec.2008.07.011. Epub 2008 Aug 12.
- Background: PubMed 10463708Man-Son-Hing M, Laupacis A, O'Connor AM, Biggs J, Drake E, Yetisir E, Hart RG. A patient decision aid regarding antithrombotic therapy for stroke prevention in atrial fibrillation: a randomized controlled trial. JAMA. 1999 Aug 25;282(8):737-43. doi: 10.1001/jama.282.8.737.
- Background: PubMed 12088603Cranney A, O'Connor AM, Jacobsen MJ, Tugwell P, Adachi JD, Ooi DS, Waldegger L, Goldstein R, Wells GA. Development and pilot testing of a decision aid for postmenopausal women with osteoporosis. Patient Educ Couns. 2002 Jul;47(3):245-55. doi: 10.1016/s0738-3991(01)00218-x.
- Ottawa Hospital Research Institute Patient Decision AidsLink provided by the sponsor.
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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.
Jon-David R Schwalm, BSc, MD principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular Access Decision Aid in people with Coronary Artery Disease and Atherosclerosis, run by Hamilton Health Sciences Corporation 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 5 inclusion and 2 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 19 Jan 2011. 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?
The primary outcome involves evaluation of the decision process leading to decision quality as assessed by the Decisional Conflict Scale (DCS). The DCS is a validated scale that has been used in more than 30 PtDA studies across different decisions. (time frame: 1 Day). 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 NCT01032551, which also lists 16 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 19 Jan 2011; AzTrials last refreshed its copy on 27 Oct 2026.