Parental ConsentNCT00630136
Effectiveness of the Consent Process
An observational study of Parental Consent, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of the consent process currently used for outpatient endoscopy procedures at our hospital. Results from this study will be used to assist in making improvements in the way we communicate with parents, thereby enhancing the ability to provide informed consents. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parental Consent
- What is being tested?
- interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Mar 2008
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Gastroenterology primary care clinic
Who may be able to join
- Adult parent or legally authorized representative (LAR) of child who has consented to undergo an out-patient endoscopy at CMHC as a diagnostic procedure
- Ability to converse in English
- Provided implied consent prior to data collection and verbal consent after data collection to participate in this research study
Who cannot join
- Any parent/ LAR under the age of 18 years
- Time constraint or verbally stating they do not wish to provide study data prior to child undergoing endoscopy
- Stating they do not wish to have these data used as study data after completion of the interview
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Effectiveness of the Consent Process Used for Outpatient Endoscopy
The purpose of this study is to evaluate the effectiveness of the consent process currently used for outpatient endoscopy procedures at our hospital. Results from this study will be used to assist in making improvements in the way we communicate with parents, thereby enhancing the ability to provide informed consents.
Read the detailed description
Obtaining informed consent before performing an invasive medical procedure or treatment is a crucial component of patient care. The manner in which the consent process is conducted impacts the doctor/patient relationship, patient safety and patient satisfaction. Many times, patients sign consent forms without reading or understanding them. Although the form has been signed, true informed consent has not been obtained. While there are many variables that impact the ability to truly consent, ineffective communication between the patient and health care providers hampers the process.
Evidence shows that improving the consent process by ensuring effective communication between the child's parent and health care team affords substantial benefit. A consent process well done strengthens the parent-provider relationship. It positively impacts risk management. It improves patient safety. It diffuses would-be litigants by helping parents have realistic expectations of care. The consent process should allow and encourage parents to exercise both their right and their responsibility to take an active role in their child's health care.
- Conditions
- Parental Consent
- Being tested
- interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewBehavioural
The parent/LAR who has consented to have their child undergo an outpatient endoscopy procedure will be interviewed prior to the procedure being performed.
| Study group | Role | What they receive |
|---|---|---|
| A | Adult parent or legally authorized representative (LAR) of child who has consented to undergo an out-patient endoscopy at Children's Mercy Hospital as a diagnostic procedure Receives: Behavioral: interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine if the parent/LAR has an understanding of why the endoscopy procedure has been recommended and what it involves
Measured: after obtaining consent for endoscopy but prior to endoscopy procedure
determine if the parent/ LAR has an understanding of the probable benefits and risks associated with endoscopy
Measured: after obtaining consent for endoscopy but prior to endoscopy procedure
Secondary outcomes (2)
determine if the parent/LAR knows who will be present during the procedure
Measured: after obtaining consent for endoscopy but prior to endoscopy procedure
determine if the parent/LAR has an understanding of the importance of the consent process
Measured: after obtaining consent for endoscopy but prior to endoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Parental ConsentStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Investigators
- Nancy A Neilan, MT (ASCP), Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630136
- Sponsor's protocol ID
- CMH080104
- Status last verified
- Oct 2008
- First submitted
- 27 Feb 2008
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Rozovsky FA, Consent to Treatment: A practical Guide, 4th ed. Aspen Publishers 2007
Communicating with patients who have limited literacy skills. Report of the National Work Group on Literacy and Health. J Fam Pract. 1998 Feb;46(2):168-76.
PubMed 9487325Dewalt DA, Berkman ND, Sheridan S, Lohr KN, Pignone MP. Literacy and health outcomes: a systematic review of the literature. J Gen Intern Med. 2004 Dec;19(12):1228-39. doi: 10.1111/j.1525-1497.2004.40153.x.
PubMed 15610334Sudore RL, Landefeld CS, Williams BA, Barnes DE, Lindquist K, Schillinger D. Use of a modified informed consent process among vulnerable patients: a descriptive study. J Gen Intern Med. 2006 Aug;21(8):867-73. doi: 10.1111/j.1525-1497.2006.00535.x.
PubMed 16881949Cassileth BR, Zupkis RV, Sutton-Smith K, March V. Informed consent -- why are its goals imperfectly realized? N Engl J Med. 1980 Apr 17;302(16):896-900. doi: 10.1056/NEJM198004173021605.
PubMed 7360175Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ. 1993 Apr 3;306(6882):885-90. doi: 10.1136/bmj.306.6882.885.
PubMed 8490411
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Consent Process Used for Outpatient Endoscopy
- ClinicalTrials.gov ID
- NCT00630136
- Acronym / sponsor ID
- CMH080104
- Conditions
- Parental Consent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 6 Mar 2008 (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 purpose of this study is to evaluate the effectiveness of the consent process currently used for outpatient endoscopy procedures at our hospital. Results from this study will be used to assist in making improvements in the way we communicate with parents, thereby enhancing the ability to provide informed consents.
Detailed description
Obtaining informed consent before performing an invasive medical procedure or treatment is a crucial component of patient care. The manner in which the consent process is conducted impacts the doctor/patient relationship, patient safety and patient satisfaction. Many times, patients sign consent forms without reading or understanding them. Although the form has been signed, true informed consent has not been obtained. While there are many variables that impact the ability to truly consent, ineffective communication between the patient and health care providers hampers the process.
Evidence shows that improving the consent process by ensuring effective communication between the child's parent and health care team affords substantial benefit. A consent process well done strengthens the parent-provider relationship. It positively impacts risk management. It improves patient safety. It diffuses would-be litigants by helping parents have realistic expectations of care. The consent process should allow and encourage parents to exercise both their right and their responsibility to take an active role in their child's health care.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Behavioral: interviewAdult parent or legally authorized representative (LAR) of child who has consented to undergo an out-patient endoscopy at Children's Mercy Hospital as a diagnostic procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Gastroenterology primary care clinic
Key inclusion criteria (3 listed)
- Adult parent or legally authorized representative (LAR) of child who has consented to undergo an out-patient endoscopy at CMHC as a diagnostic procedure
- Ability to converse in English
- Provided implied consent prior to data collection and verbal consent after data collection to participate in this research study
Key exclusion criteria (3 listed)
- Any parent/ LAR under the age of 18 years
- Time constraint or verbally stating they do not wish to provide study data prior to child undergoing endoscopy
- Stating they do not wish to have these data used as study data after completion of the interview
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 |
|---|---|---|
| interviewThe parent/LAR who has consented to have their child undergo an outpatient endoscopy procedure will be interviewed prior to the procedure being performed. | Behavioural | A |
Primary outcome
determine if the parent/LAR has an understanding of why the endoscopy procedure has been recommended and what it involves
Time frame: after obtaining consent for endoscopy but prior to endoscopy procedure
determine if the parent/ LAR has an understanding of the probable benefits and risks associated with endoscopy
Time frame: after obtaining consent for endoscopy but prior to endoscopy procedure
2 secondary outcomes
determine if the parent/LAR knows who will be present during the procedure
Time frame: after obtaining consent for endoscopy but prior to endoscopy procedure
determine if the parent/LAR has an understanding of the importance of the consent process
Time frame: after obtaining consent for endoscopy but prior to endoscopy procedure
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 24 Mar 2010.
- BackgroundRozovsky FA, Consent to Treatment: A practical Guide, 4th ed. Aspen Publishers 2007
- Background: PubMed 9487325Communicating with patients who have limited literacy skills. Report of the National Work Group on Literacy and Health. J Fam Pract. 1998 Feb;46(2):168-76.
- Results publication: PubMed 15610334Dewalt DA, Berkman ND, Sheridan S, Lohr KN, Pignone MP. Literacy and health outcomes: a systematic review of the literature. J Gen Intern Med. 2004 Dec;19(12):1228-39. doi: 10.1111/j.1525-1497.2004.40153.x.
- Results publication: PubMed 16881949Sudore RL, Landefeld CS, Williams BA, Barnes DE, Lindquist K, Schillinger D. Use of a modified informed consent process among vulnerable patients: a descriptive study. J Gen Intern Med. 2006 Aug;21(8):867-73. doi: 10.1111/j.1525-1497.2006.00535.x.
- Results publication: PubMed 7360175Cassileth BR, Zupkis RV, Sutton-Smith K, March V. Informed consent -- why are its goals imperfectly realized? N Engl J Med. 1980 Apr 17;302(16):896-900. doi: 10.1056/NEJM198004173021605.
- Results publication: PubMed 8490411Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ. 1993 Apr 3;306(6882):885-90. doi: 10.1136/bmj.306.6882.885.
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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.
Nancy A Neilan, MT (ASCP) principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parental Consent, run by Children's Mercy Hospital Kansas City 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 3 inclusion and 3 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 24 Mar 2010. 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?
determine if the parent/LAR has an understanding of why the endoscopy procedure has been recommended and what it involves (time frame: after obtaining consent for endoscopy but prior to endoscopy procedure). The study lists 2 primary outcomes in all. 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 NCT00630136, which also lists 6 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 24 Mar 2010.