SurgeryPhase 1NCT00288899
Benefits of 'Repeat Back' Protocols Within A Computer-Based Informed Consent Program
A Phase 1 study testing Enhanced surgical iMedConsent process (with "repeat back") and standard surgical iMedConsent process in people with Surgery and Cholecystectomy, Laparoscopic, run by VA Office of Research and Development at 7 sites in United States.
Trial summary
This is a VA Merit Review Study involving 7 VA medical centers participating in a parallel group randomized trial comparing "repeat back" versus standard electronic consent for 4 common elective surgical procedures (total hip arthroplasty, carotid endarterectomy, laparoscopic cholecystectomy, and radical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Cholecystectomy, Laparoscopic, Prostatectomy
- What is being tested?
- Enhanced surgical iMedConsent process (with "repeat back") and standard surgical iMedConsent process
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 575 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 Aug 2006to 31 Mar 2009
- Phase
- Phase 1
- 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
- Veterans who are scheduled for one of the four elective surgical procedures;
- who give informed consent to participate in the study;
- and who are also part of the NSQIP.
Who cannot join
- Inability to give informed consent;
- requirement for surrogate consent;
- non-elective surgery;
- requirement for more than one elective surgery;
- refusal to participate;
- inability to communicate in English;
Show all 9Show fewer
- severe visual problems;
- severe psychiatric illness;
- ongoing substance abuse.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, 80220
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
About this study
This is a VA Merit Review Study involving 7 VA medical centers participating in a parallel group randomized trial comparing "repeat back" versus standard electronic consent for 4 common elective surgical procedures (total hip arthroplasty, carotid endarterectomy, laparoscopic cholecystectomy, and radical prostatectomy). Baseline covariates include health status (SF-12), reading ability (REALM), and demographics. Primary outcomes are patient comprehension of the informed consent, patient satisfaction with the informed consent and decision making processes, patient satisfaction with care, anxiety (STAI), and provider assessment of the "repeat back" process. In addition, we are electronically capturing data detailing time spent in each phase of the consent process including "repeat back".
Read the detailed description
Background: Informed consent for surgical procedures is critical to patient care in the VA and in other health care settings. Many studies document limitations in current methods of obtaining informed consent. These limitations include poor patient comprehension, inadequate time for discussion, poor documentation of consent, and heightening of patient anxiety regarding surgery. In hopes of addressing these shortcomings, both the NQF and AHRQ have recommended that "repeat back" protocols be added to informed consent methodologies. The VA has opted to address the informed consent issue by computerization of the informed consent process utilizing the iMedConsent program. This latter program is fully integrated with the computerized patient record system (CPRS), includes extensive patient education materials, standardizes risk information and guides the clinician through the consent process. The iMedConsent program is being disseminated via an ongoing national rollout. Despite its apparent advantages, the current iMedConsent platform does not incorporate any methodology to support "repeat back". Dialog Medical, the iMedConsent vendor, has recently developed a new module that can enhance the current version of the program by supporting "repeat back" protocols.
Objectives: We hypothesize that use of the enhanced iMedConsent program (with "repeat back") will improve the surgical patient's comprehension about the surgical technique, treatment alternatives, and risks and benefits of the proposed surgery in comparison with the standard iMedConsent program. We believe that this enhanced program will also lead to better patient satisfaction with the consent process, decision making and the health care received, less anxiety about the operation, and that this program will be acceptable to surgical providers and might lead to better clinical outcomes.
Methods: To address these hypotheses we are conducting a multi-site (7 VA Medical Centers) randomized trial comparing the use of the "standard" and "enhanced" iMedConsent program. We will enroll 600 subjects who are scheduled for elective surgery. Subjects will be individually randomized to the standard or enhanced versions of the iMedConsent program. The surgical procedures to be studied include carotid endarterectomy, total hip arthroplasty, radical prostatectomy and laparoscopic cholecystectomy. The study will be linked to the National Surgical Quality Improvement Program data which will provide baseline data on patient characteristics, intraoperative variables (e.g. operation type, time, anesthesia method, etc.), and the data on 30 day surgical outcomes. We will assess endpoints including patient comprehension, patient satisfaction with the consent process, patient anxiety, providers' acceptance of the informed consent process, and patient satisfaction with health care and with decision making using validated self-report survey instruments.
Findings: We are currently in the final phase of data analysis. The final study report will be submitted within the next several weeks to HSR\&D.
Status: Study recruitment and enrollment began in August 2006 and ended June 30, 2008. 575 study subjects were randomized, with 502 study subjects completing the study. 214 surgical providers participated and 192 completed provider questionnaires. We continue with final data analysis phase of the study. Manuscripts are being written, with final HSR\&D report due within the next several weeks.
Impact: The results of this study will have important implications for improving the consent process within the VA and beyond.
- Conditions
- Surgery, Cholecystectomy, Laparoscopic, Prostatectomy, Arthroplasty, Replacement, Hip, Endarterectomy, Carotid
- Being tested
- Enhanced surgical iMedConsent process (with "repeat back"), standard surgical iMedConsent process
- Keywords
- Informed Consent, Medical Record Systems, computerized, Comprehension, Anxiety, Personal Satisfactin
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced surgical iMedConsent process (with "repeat back")Other
Consent process engages patient in discussion about why they are having procedure, risks, benefits, alternatives. Then provider asks patient to "repeat back"what they understand.
standard surgical iMedConsent processOther
Patients are consented in standard VA consent process, where are not necessarily asked to repeat back and no discussion is necessarily documented.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | standard VA surgical iMedConsent process Receives: Other: standard surgical iMedConsent process |
| Arm 2 | Experimental | enhanced version of VA surgical iMedConsent process (repeat-back) Receives: Other: Enhanced surgical iMedConsent process (with "repeat back") |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient comprehension; Patient satisfaction; Patient anxiety; Patient compliance; Provider acceptance
Measured: 45 days
Secondary outcomes (1)
Risk-adjusted surgical outcomes
Measured: Surgical outcome data is collected by VA NSQIP program within 45 days of each surgical procedure. This data will be linked with study data at end of study enrollment, during the data analysis phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study start7 Aug 2006
- Primary completion31 Mar 2009
- Study completion31 Mar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 575 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Aaron S Fink, MD, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288899
- Sponsor's protocol ID
- IAF 05-308
- Status last verified
- Jun 2017
- First submitted
- 6 Feb 2006
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kaafarani HM, Itani KM. Classification versus valuation and grading of surgical complications. J Am Coll Surg. 2009 Aug;209(2):290-1; author reply 291-2. doi: 10.1016/j.jamcollsurg.2009.05.020. No abstract available.
PubMed 19632618Itani KM. Let us not forget the Association of VA Surgeons (AVAS). Surgery. 2009 Sep;146(3):525; author reply 525-6. doi: 10.1016/j.surg.2008.11.013. No abstract available.
PubMed 19715815Itani KM, Kim L. Mechanical bowel preparation or not for elective colorectal surgery. Surg Infect (Larchmt). 2008 Dec;9(6):563-5. doi: 10.1089/sur.2008.9957.
PubMed 19216667Itani KM, Akhras KS, Stellhorn R, Quintana A, Budd D, Merchant S. Outcomes associated with initial versus later vancomycin use in patients with complicated skin and skin-structure infections. Pharmacoeconomics. 2009;27(5):421-30. doi: 10.2165/00019053-200927050-00006.
PubMed 19586079Fink AS, Prochazka AV, Henderson WG, Bartenfeld D, Nyirenda C, Webb A, Berger DH, Itani K, Whitehill T, Edwards J, Wilson M, Karsonovich C, Parmelee P. Predictors of comprehension during surgical informed consent. J Am Coll Surg. 2010 Jun;210(6):919-26. doi: 10.1016/j.jamcollsurg.2010.02.049.
PubMed 20510800Fink AS, Prochazka AV, Henderson WG, Bartenfeld D, Nyirenda C, Webb A, Berger DH, Itani K, Whitehill T, Edwards J, Wilson M, Karsonovich C, Parmelee P. Enhancement of surgical informed consent by addition of repeat back: a multicenter, randomized controlled clinical trial. Ann Surg. 2010 Jul;252(1):27-36. doi: 10.1097/SLA.0b013e3181e3ec61.
PubMed 20562609Rosen AK, Loveland SA, Romano PS, Itani KM, Silber JH, Even-Shoshan OO, Halenar MJ, Teng Y, Zhu J, Volpp KG. Effects of resident duty hour reform on surgical and procedural patient safety indicators among hospitalized Veterans Health Administration and Medicare patients. Med Care. 2009 Jul;47(7):723-31. doi: 10.1097/MLR.0b013e31819a588f.
PubMed 19536029Volpp KG, Rosen AK, Rosenbaum PR, Romano PS, Itani KM, Bellini L, Even-Shoshan O, Cen L, Wang Y, Halenar MJ, Silber JH. Did duty hour reform lead to better outcomes among the highest risk patients? J Gen Intern Med. 2009 Oct;24(10):1149-55. doi: 10.1007/s11606-009-1011-z. Epub 2009 May 20.
PubMed 19455368Prochazka AV, Fink AS, Bartenfeld D, Henderson WG, Nyirenda C, Webb A, Berger DH, Itani K, Whitehill T, Edwards J, Wilson M, Karsonovich C, Parmelee P. Patient perceptions of surgical informed consent: is repeat back helpful or harmful? J Patient Saf. 2014 Sep;10(3):140-5. doi: 10.1097/PTS.0b013e3182a00317.
PubMed 24522223
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of 'Repeat Back' Protocols Within A Computer-Based Informed Consent Program
- ClinicalTrials.gov ID
- NCT00288899
- Acronym / sponsor ID
- IAF 05-308
- Conditions
- Surgery, Cholecystectomy, Laparoscopic, Prostatectomy, Arthroplasty, Replacement, Hip, Endarterectomy, Carotid
- Keywords
- Informed Consent, Medical Record Systems, computerized, Comprehension, Anxiety, Personal Satisfactin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 7 Aug 2006 (actual)
- Primary completion
- 31 Mar 2009 (actual)
- Study completion
- 31 Mar 2009 (actual)
- First posted
- 8 Feb 2006 (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.
This is a VA Merit Review Study involving 7 VA medical centers participating in a parallel group randomized trial comparing "repeat back" versus standard electronic consent for 4 common elective surgical procedures (total hip arthroplasty, carotid endarterectomy, laparoscopic cholecystectomy, and radical prostatectomy). Baseline covariates include health status (SF-12), reading ability (REALM), and demographics. Primary outcomes are patient comprehension of the informed consent, patient satisfaction with the informed consent and decision making processes, patient satisfaction with care, anxiety (STAI), and provider assessment of the "repeat back" process. In addition, we are electronically capturing data detailing time spent in each phase of the consent process including "repeat back".
Detailed description
Background: Informed consent for surgical procedures is critical to patient care in the VA and in other health care settings. Many studies document limitations in current methods of obtaining informed consent. These limitations include poor patient comprehension, inadequate time for discussion, poor documentation of consent, and heightening of patient anxiety regarding surgery. In hopes of addressing these shortcomings, both the NQF and AHRQ have recommended that "repeat back" protocols be added to informed consent methodologies. The VA has opted to address the informed consent issue by computerization of the informed consent process utilizing the iMedConsent program. This latter program is fully integrated with the computerized patient record system (CPRS), includes extensive patient education materials, standardizes risk information and guides the clinician through the consent process. The iMedConsent program is being disseminated via an ongoing national rollout. Despite its apparent advantages, the current iMedConsent platform does not incorporate any methodology to support "repeat back". Dialog Medical, the iMedConsent vendor, has recently developed a new module that can enhance the current version of the program by supporting "repeat back" protocols.
Objectives: We hypothesize that use of the enhanced iMedConsent program (with "repeat back") will improve the surgical patient's comprehension about the surgical technique, treatment alternatives, and risks and benefits of the proposed surgery in comparison with the standard iMedConsent program. We believe that this enhanced program will also lead to better patient satisfaction with the consent process, decision making and the health care received, less anxiety about the operation, and that this program will be acceptable to surgical providers and might lead to better clinical outcomes.
Methods: To address these hypotheses we are conducting a multi-site (7 VA Medical Centers) randomized trial comparing the use of the "standard" and "enhanced" iMedConsent program. We will enroll 600 subjects who are scheduled for elective surgery. Subjects will be individually randomized to the standard or enhanced versions of the iMedConsent program. The surgical procedures to be studied include carotid endarterectomy, total hip arthroplasty, radical prostatectomy and laparoscopic cholecystectomy. The study will be linked to the National Surgical Quality Improvement Program data which will provide baseline data on patient characteristics, intraoperative variables (e.g. operation type, time, anesthesia method, etc.), and the data on 30 day surgical outcomes. We will assess endpoints including patient comprehension, patient satisfaction with the consent process, patient anxiety, providers' acceptance of the informed consent process, and patient satisfaction with health care and with decision making using validated self-report survey instruments.
Findings: We are currently in the final phase of data analysis. The final study report will be submitted within the next several weeks to HSR\&D.
Status: Study recruitment and enrollment began in August 2006 and ended June 30, 2008. 575 study subjects were randomized, with 502 study subjects completing the study. 214 surgical providers participated and 192 completed provider questionnaires. We continue with final data analysis phase of the study. Manuscripts are being written, with final HSR\&D report due within the next several weeks.
Impact: The results of this study will have important implications for improving the consent process within the VA and beyond.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Other: standard surgical iMedConsent processstandard VA surgical iMedConsent process |
| Arm 2 | Experimental | Other: Enhanced surgical iMedConsent process (with "repeat back")enhanced version of VA surgical iMedConsent process (repeat-back) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veterans who are scheduled for one of the four elective surgical procedures;
- who give informed consent to participate in the study;
- and who are also part of the NSQIP.
Key exclusion criteria (9 listed)
- Inability to give informed consent;
- requirement for surrogate consent;
- non-elective surgery;
- requirement for more than one elective surgery;
- refusal to participate;
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 |
|---|---|---|
| Enhanced surgical iMedConsent process (with "repeat back")Consent process engages patient in discussion about why they are having procedure, risks, benefits, alternatives. Then provider asks patient to "repeat back"what they understand. | Other | Arm 2 |
| standard surgical iMedConsent processPatients are consented in standard VA consent process, where are not necessarily asked to repeat back and no discussion is necessarily documented. | Other | Arm 1 |
Primary outcome
Patient comprehension; Patient satisfaction; Patient anxiety; Patient compliance; Provider acceptance
Time frame: 45 days
1 secondary outcome
Risk-adjusted surgical outcomes
Time frame: Surgical outcome data is collected by VA NSQIP program within 45 days of each surgical procedure. This data will be linked with study data at end of study enrollment, during the data analysis phase.
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 6 Jun 2017.
- Results publication: PubMed 19632618Kaafarani HM, Itani KM. Classification versus valuation and grading of surgical complications. J Am Coll Surg. 2009 Aug;209(2):290-1; author reply 291-2. doi: 10.1016/j.jamcollsurg.2009.05.020. No abstract available.
- Results publication: PubMed 19715815Itani KM. Let us not forget the Association of VA Surgeons (AVAS). Surgery. 2009 Sep;146(3):525; author reply 525-6. doi: 10.1016/j.surg.2008.11.013. No abstract available.
- Results publication: PubMed 19216667Itani KM, Kim L. Mechanical bowel preparation or not for elective colorectal surgery. Surg Infect (Larchmt). 2008 Dec;9(6):563-5. doi: 10.1089/sur.2008.9957.
- Results publication: PubMed 19586079Itani KM, Akhras KS, Stellhorn R, Quintana A, Budd D, Merchant S. Outcomes associated with initial versus later vancomycin use in patients with complicated skin and skin-structure infections. Pharmacoeconomics. 2009;27(5):421-30. doi: 10.2165/00019053-200927050-00006.
- Results publication: PubMed 20510800Fink AS, Prochazka AV, Henderson WG, Bartenfeld D, Nyirenda C, Webb A, Berger DH, Itani K, Whitehill T, Edwards J, Wilson M, Karsonovich C, Parmelee P. Predictors of comprehension during surgical informed consent. J Am Coll Surg. 2010 Jun;210(6):919-26. doi: 10.1016/j.jamcollsurg.2010.02.049.
- Results publication: PubMed 20562609Fink AS, Prochazka AV, Henderson WG, Bartenfeld D, Nyirenda C, Webb A, Berger DH, Itani K, Whitehill T, Edwards J, Wilson M, Karsonovich C, Parmelee P. Enhancement of surgical informed consent by addition of repeat back: a multicenter, randomized controlled clinical trial. Ann Surg. 2010 Jul;252(1):27-36. doi: 10.1097/SLA.0b013e3181e3ec61.
- Results publication: PubMed 19536029Rosen AK, Loveland SA, Romano PS, Itani KM, Silber JH, Even-Shoshan OO, Halenar MJ, Teng Y, Zhu J, Volpp KG. Effects of resident duty hour reform on surgical and procedural patient safety indicators among hospitalized Veterans Health Administration and Medicare patients. Med Care. 2009 Jul;47(7):723-31. doi: 10.1097/MLR.0b013e31819a588f.
- Results publication: PubMed 19455368Volpp KG, Rosen AK, Rosenbaum PR, Romano PS, Itani KM, Bellini L, Even-Shoshan O, Cen L, Wang Y, Halenar MJ, Silber JH. Did duty hour reform lead to better outcomes among the highest risk patients? J Gen Intern Med. 2009 Oct;24(10):1149-55. doi: 10.1007/s11606-009-1011-z. Epub 2009 May 20.
- Derived from this study: PubMed 24522223Prochazka AV, Fink AS, Bartenfeld D, Henderson WG, Nyirenda C, Webb A, Berger DH, Itani K, Whitehill T, Edwards J, Wilson M, Karsonovich C, Parmelee P. Patient perceptions of surgical informed consent: is repeat back helpful or harmful? J Patient Saf. 2014 Sep;10(3):140-5. doi: 10.1097/PTS.0b013e3182a00317.
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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.
Aaron S Fink, MD principal investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Enhanced surgical iMedConsent process (with "repeat back") and standard surgical iMedConsent process in people with Surgery and Cholecystectomy, Laparoscopic, run by VA Office of Research and Development at 7 sites 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 9 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 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Patient comprehension; Patient satisfaction; Patient anxiety; Patient compliance; Provider acceptance (time frame: 45 days). 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 NCT00288899, which also lists 9 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 6 Jun 2017.