Knee ArthroplastyNCT01582984
Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty
A study testing video or education session in addition to standard consent in people with Knee Arthroplasty, run by jasvinder singh at 1 site in United States.
Trial summary
A structured consent process, in combination with one or a number of the aforementioned modalities (nursing education, handout, video, etc), may reasonably be expected to improve surgical informed consent. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- video or education session in addition to standard consent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Aug 2009
- 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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- recommended total knee arthroplasty
Who cannot join
- Unwilling to participate
- Unable to complete questionnaire in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
About this study
A structured consent process, in combination with one or a number of the aforementioned modalities (nursing education, handout, video, etc), may reasonably be expected to improve surgical informed consent. The investigators hypothesized that overall patient knowledge/retention would be influenced by the type of consent process and that more intensive training and review would result in better patient retention and recall. The investigators further hypothesized that the knowledge retention would decline following the consent process and surgery, but in a stratified manner based on the nature of preoperative teaching.
Read the detailed description
please see details above
- Conditions
- Knee Arthroplasty
- Being tested
- video or education session in addition to standard consent
- Keywords
- consent, Patient Understanding, Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video or education session in addition to standard consentOther
Video added to standard consent + handout Video + education session added to standard consent + handout
| Study group | Role | What they receive |
|---|---|---|
| iMedConsentTM and customized written handout group | Active comparator | iMedConsentTM and a customized written handout Receives: Other: video or education session in addition to standard consent |
| iMedConsentTM, handout, and standard video g | Experimental | iMedConsentTM, handout, and standard AAOS video Receives: Other: video or education session in addition to standard consent |
| iMedConsentTM, handout, video, and formal education | Experimental | iMedConsentTM, the handout, the video, and a formal education session Receives: Other: video or education session in addition to standard consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of efficacy and complications
answers to questionnaire assessing knowledge
Measured: 6-week postoperative
Secondary outcomes (4)
knowledge regarding procedural questions with regard to the surgery and implants
Answers to Question 4-6 on knowledge questionnaire
Measured: Day of surgery and 6-week postoperative
knowledge regarding risks of surgery
answers to Questions 7-9 on quetionnaire
Measured: day of surgery and postoperative 6-weeks
Knowledge regarding peri- and post-operative results
answers to Questions 10-13 on quetionnaire
Measured: day of surgery and postoperative 6-weeks
Patient satisfaction
answers to satisfaction Question on quetionnaire
Measured: day of surgery and postoperative 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startFeb 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies 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
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- jasvinder singh
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, jasvinder singh, Minneapolis Veterans Affairs Medical Center
- Investigators
- Terence Gioe, MD, Principal investigator, Minneapolis VA Med crt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582984
- Sponsor's protocol ID
- MSPVA-124
- Status last verified
- Mar 2024
- First submitted
- 18 Apr 2012
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01582984
- Acronym / sponsor ID
- MSPVA-124
- Conditions
- Knee Arthroplasty
- Keywords
- consent, Patient Understanding, Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- jasvinder singhUS federal agency
- Study start
- Feb 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 23 Apr 2012 (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.
A structured consent process, in combination with one or a number of the aforementioned modalities (nursing education, handout, video, etc), may reasonably be expected to improve surgical informed consent. The investigators hypothesized that overall patient knowledge/retention would be influenced by the type of consent process and that more intensive training and review would result in better patient retention and recall. The investigators further hypothesized that the knowledge retention would decline following the consent process and surgery, but in a stratified manner based on the nature of preoperative teaching.
Detailed description
please see details above
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iMedConsentTM and customized written handout group | Active comparator | Other: video or education session in addition to standard consentiMedConsentTM and a customized written handout |
| iMedConsentTM, handout, and standard video g | Experimental | Other: video or education session in addition to standard consentiMedConsentTM, handout, and standard AAOS video |
| iMedConsentTM, handout, video, and formal education | Experimental | Other: video or education session in addition to standard consentiMedConsentTM, the handout, the video, and a formal education session |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- recommended total knee arthroplasty
Key exclusion criteria (2 listed)
- Unwilling to participate
- Unable to complete questionnaire in English
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 |
|---|---|---|
| video or education session in addition to standard consentVideo added to standard consent + handout Video + education session added to standard consent + handout | Other | iMedConsentTM and customized written handout group, iMedConsentTM, handout, and standard video g, iMedConsentTM, handout, video, and formal education |
Primary outcome
Knowledge of efficacy and complications
Time frame: 6-week postoperative
answers to questionnaire assessing knowledge
4 secondary outcomes
knowledge regarding procedural questions with regard to the surgery and implants
Time frame: Day of surgery and 6-week postoperative
knowledge regarding risks of surgery
Time frame: day of surgery and postoperative 6-weeks
Knowledge regarding peri- and post-operative results
Time frame: day of surgery and postoperative 6-weeks
Patient satisfaction
Time frame: day of surgery and postoperative 6-weeks
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 13 Mar 2024.
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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.
Terence Gioe, MD principal investigator
Minneapolis VA Med crt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video or education session in addition to standard consent in people with Knee Arthroplasty, run by jasvinder singh 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 1 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 13 Mar 2024. 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?
Knowledge of efficacy and complications (time frame: 6-week postoperative). 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 13 Mar 2024.