Improve the Informed Consent Process
Conditions
Brief summary
The study has two parts: (1) Randomized Study to evaluate the effectiveness of ETRIC, and (2) Evaluation Study to understand barriers to implementation of ETRIC.
Detailed description
A two-arm, randomized study will be conducted in patients about to undergo consent discussion for participation in two large, multicenter BMT CTN clinical trials. Once they agree to participate in this Easy-to-Read Informed Consent (ETRIC) study, they will go through the consent process for the parent trial using either a standard or the ETRIC consent form. The content of both forms will be similar but the ETRIC form will incorporate a two-column format with specific attention towards enhanced readability and processability. Following the consent discussion for the BMT CTN parent trial, patients will complete assessments of health literacy, comprehension of the parent trial and satisfaction and anxiety related to the consent process. These assessments will be completed within 7 business days of the consent discussion of the parent trial. Notes: Enrollment on the BMT CTN 0901 trial (NCT01339910) was closed to further accrual on April 18, 2014. Enrollment on the BMT CTN 1203 trial (NCT02208037) completed accrual on May 13, 2016.
Interventions
OTHERConsent Form Specific Format 1
The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.
OTHERConsent Form Specific Format 2
The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Blood and Marrow Transplant Clinical Trials Network
National Marrow Donor Program
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion and
Exclusion criteria
for the ETRIC randomized study will be the same as the eligibility criteria for the BMT CTN parent studies. Please refer to BMTCTN0901 (NCT01339910) Reduced Intensity Regimen vs Myeloablative Regimen for Myeloid Leukemia or Myelodysplastic Syndrome, BMTCTN1101 (NCT01597778) Double Cord Versus Haploidentical, BMTCTN1203 (NCT02208037) Novel Approaches for Graft-versus-Host Disease Prevention Compared to Contemporary Controls, and BMTCTN1301 (NCT02345850) Calcineurin Inhibitor-Free Interventions for Prevention of Graft-versus-Host Disease for detailed eligibility criteria. Notes: Enrollment on the BMT CTN 0901 trial (NCT01339910) was closed to further accrual on April 18, 2014. Enrollment on the BMT CTN 1203 trial (NCT02208037) completed accrual on May 13, 2016. Additional inclusion criteria specific for the ETRIC study will include: 1. Adult patients (≥ 18 years) 2. Speaking and reading proficiency in English (as most of this study's instruments have not been translated and validated in languages other than English) 3. Willing and able to provide informed consent 4. Stated willingness to comply with study procedures and reporting requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Informed Consent Part A (QuIC-A) Score | Within 7 days of consent discussion | The primary objective of the trial is to compare objective comprehension scores on the Quality of Informed Consent (part A) instrument between subjects randomized to the ETRIC versus the standard consent arms. The QuIC-A is scored on a normalized scale from 0 to 100, with a higher score indicating a greater level of comprehension. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Informed Consent Part B (QuIC-B) Score | Within 7 days of consent discussion | The Quality of Informed Consent Part B measures participants' perception of their understanding of cancer clinical trials to address 13 independent domains of informed consent. The QuIC-B is scored on a normalized scale from 0 to 100, with a higher score indicating a greater level of perceived understanding. |
| Modified Deaconess Informed Consent Comprehension Test (DICCT) | WIthin 7 days of consent discussion | The Modified Deaconess Informed Consent Comprehension Test (DICCT) uses semi-structured interviews to assess subject's understanding of the study for which they participated in an informed consent discussion. This modification of the DICCT has 11 items, each scored from 0 to 2 (0 = incorrect, 1 = partially correct, 2 = correct). The item scores are summed to produce a total score ranging from 0 to 22. A higher score indicates a higher level of comprehension. |
| REALM-R Score | Within 7 days of consent discussion | The Rapid Estimate of Adult Literacy in Medicine-Revised (REALM-R) is an 8-item word recognition test to provide clinicians with a valid quick assessment of patient health literacy. The score is computed as the number of words out of 8 that the patient pronounces correctly. |
| Newest Vital Sign (NVS) Score | Within 7 days of consent discussion | The Newest Vital Sign is a screening tool that identifies patients at risk for low health literacy. It consists of a nutritional label accompanied by five questions about information on the label. The score is equal to the number of questions answered correctly. |
| State Trait Anxiety Inventory (STAI) Score | Within 7 days of consent discussion | The State Trait Anxiety Inventory (STAI) measures anxiety and distinguishes it from depressive syndromes. It has two subscales: the State Anxiety Scale evaluates the current state of anxiety, asking how respondents feel right now, and Trait Anxiety Scale evaluating relatively stable aspects of anxiety proneness. The STAI has 40 items, 20 items allocated to each subscale, with each item scored on a 4 point Likert scale. The subscale scores shown are averages of the items in the subscale ranging from 1.0 to 4.0, with a higher score indicating a greater level of anxiety. |
| Participant Satisfaction With Consent Process | Within 7 days of consent discussion | A short study specific questionnaire and selected questions from the Quality of Informed Consent (QuIC) supplement questionnaire will query participants about their overall satisfaction with the consent process, helpfulness of information provided, and comprehension of key study-specific elements of treatment. Seven questions are included, each scored on a five point Likert scale. The overall score is the average of the item scores, ranging from 1.0 to 5.0, with a higher score indicating a higher level of satisfaction. |
| Participant Information Location Time | Within 7 days of consent discussion | Participants are asked to identify select items within the consent document and the time taken to locate items is measured. Patients who were not able to identify a given section were assigned the maximum time allotted to find each section (180 seconds). |
| Consent Rate on Parent Trial | Within 7 days of consent discussion | The consent rate is the rate at which participants provided consent to participate in the parent trial. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Consent This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.
Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials. | 98 |
| Easy-to-Read Informed Consent This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.
Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language. | 100 |
| Total | 198 |
Baseline characteristics
| Characteristic | Total | Standard Consent | Easy-to-Read Informed Consent |
|---|---|---|---|
| Age, Continuous | 61 years | 61 years | 61 years |
| Annual Household Income $40,000-79,999 | 45 Participants | 25 Participants | 20 Participants |
| Annual Household Income $80,000 or More | 48 Participants | 22 Participants | 26 Participants |
| Annual Household Income Less than $40,000 | 30 Participants | 11 Participants | 19 Participants |
| Annual Household Income Unknown or Not Reported | 75 Participants | 40 Participants | 35 Participants |
| Education Level Graduate Degree or More | 26 Participants | 15 Participants | 11 Participants |
| Education Level High School or Less | 55 Participants | 20 Participants | 35 Participants |
| Education Level Other | 11 Participants | 5 Participants | 6 Participants |
| Education Level Post-high School, but Less than Graduate Degree | 56 Participants | 29 Participants | 27 Participants |
| Education Level Unknown or Not Reported | 50 Participants | 29 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 181 Participants | 87 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 6 Participants | 4 Participants |
| Parent Clinical Trial BMT CTN 0901 | 21 Participants | 10 Participants | 11 Participants |
| Parent Clinical Trial BMT CTN 1101 | 47 Participants | 25 Participants | 22 Participants |
| Parent Clinical Trial BMT CTN 1203 | 101 Participants | 50 Participants | 51 Participants |
| Parent Clinical Trial BMT CTN 1301 | 29 Participants | 13 Participants | 16 Participants |
| Race/Ethnicity, Customized Black | 15 Participants | 7 Participants | 8 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 6 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 173 Participants | 85 Participants | 88 Participants |
| Sex: Female, Male Female | 88 Participants | 45 Participants | 43 Participants |
| Sex: Female, Male Male | 110 Participants | 53 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Quality of Informed Consent Part A (QuIC-A) Score
The primary objective of the trial is to compare objective comprehension scores on the Quality of Informed Consent (part A) instrument between subjects randomized to the ETRIC versus the standard consent arms. The QuIC-A is scored on a normalized scale from 0 to 100, with a higher score indicating a greater level of comprehension.
Time frame: Within 7 days of consent discussion
Population: Participants completing the QuIC-A assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Consent | Quality of Informed Consent Part A (QuIC-A) Score | 81.8 units on a scale | Standard Deviation 9.5 |
| Easy-to-Read Informed Consent | Quality of Informed Consent Part A (QuIC-A) Score | 80.5 units on a scale | Standard Deviation 8.7 |
Comparison: The null hypothesis is that there is no difference in comprehension of the parent clinical trial, as measured by the QuIC-A, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Mean QuIC-A scores were compared between arms, which should be approximately equal under the null hypothesis.p-value: 0.37t-test, 2 sided
Secondary
Consent Rate on Parent Trial
The consent rate is the rate at which participants provided consent to participate in the parent trial.
Time frame: Within 7 days of consent discussion
Population: Consent rates are computed specific to each trial
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Consent | Consent Rate on Parent Trial | BMT CTN 1101 | 13 Participants |
| Standard Consent | Consent Rate on Parent Trial | BMT CTN 1501 | 9 Participants |
| Standard Consent | Consent Rate on Parent Trial | BMT CTN 1203 | 22 Participants |
| Standard Consent | Consent Rate on Parent Trial | BMT CTN 0901 | 2 Participants |
| Easy-to-Read Informed Consent | Consent Rate on Parent Trial | BMT CTN 1203 | 25 Participants |
| Easy-to-Read Informed Consent | Consent Rate on Parent Trial | BMT CTN 1101 | 10 Participants |
| Easy-to-Read Informed Consent | Consent Rate on Parent Trial | BMT CTN 0901 | 3 Participants |
| Easy-to-Read Informed Consent | Consent Rate on Parent Trial | BMT CTN 1501 | 7 Participants |
Comparison: The null hypothesis is that there is no difference in the consent rates to BMT CTN 0901 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 0901 were compared between arms in participants considering enrollment, which should be equal under the null hypothesis.p-value: 1Fisher Exact
Comparison: The null hypothesis is that there is no difference in the consent rates to BMT CTN 1101 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1101 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.p-value: 0.77Fisher Exact
Comparison: The null hypothesis is that there is no difference in the consent rates to BMT CTN 1203 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1203 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.p-value: 0.69Fisher Exact
Comparison: The null hypothesis is that there is no difference in the consent rates to BMT CTN 1301 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1501 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.p-value: 0.26Fisher Exact
Secondary
Modified Deaconess Informed Consent Comprehension Test (DICCT)
The Modified Deaconess Informed Consent Comprehension Test (DICCT) uses semi-structured interviews to assess subject's understanding of the study for which they participated in an informed consent discussion. This modification of the DICCT has 11 items, each scored from 0 to 2 (0 = incorrect, 1 = partially correct, 2 = correct). The item scores are summed to produce a total score ranging from 0 to 22. A higher score indicates a higher level of comprehension.
Time frame: WIthin 7 days of consent discussion
Population: Participants completing the modified DICCT assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Consent | Modified Deaconess Informed Consent Comprehension Test (DICCT) | 15 units on a scale |
| Easy-to-Read Informed Consent | Modified Deaconess Informed Consent Comprehension Test (DICCT) | 15 units on a scale |
Comparison: The null hypothesis is that there is no difference in participants' comprehension of the parent clinical trial, as measured by the DICCT, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median DICCT scores were compared between arms, which should be approximately equal under the null hypothesis.p-value: 0.17Wilcoxon (Mann-Whitney)
Secondary
Newest Vital Sign (NVS) Score
The Newest Vital Sign is a screening tool that identifies patients at risk for low health literacy. It consists of a nutritional label accompanied by five questions about information on the label. The score is equal to the number of questions answered correctly.
Time frame: Within 7 days of consent discussion
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Consent | Newest Vital Sign (NVS) Score | Less Than 4 | 11 Participants |
| Standard Consent | Newest Vital Sign (NVS) Score | 4 | 53 Participants |
| Standard Consent | Newest Vital Sign (NVS) Score | 5 | 13 Participants |
| Standard Consent | Newest Vital Sign (NVS) Score | Not Completed | 21 Participants |
| Easy-to-Read Informed Consent | Newest Vital Sign (NVS) Score | Not Completed | 14 Participants |
| Easy-to-Read Informed Consent | Newest Vital Sign (NVS) Score | Less Than 4 | 16 Participants |
| Easy-to-Read Informed Consent | Newest Vital Sign (NVS) Score | 5 | 18 Participants |
| Easy-to-Read Informed Consent | Newest Vital Sign (NVS) Score | 4 | 52 Participants |
Secondary
Participant Information Location Time
Participants are asked to identify select items within the consent document and the time taken to locate items is measured. Patients who were not able to identify a given section were assigned the maximum time allotted to find each section (180 seconds).
Time frame: Within 7 days of consent discussion
Population: Participants completing the information location assessment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard Consent | Participant Information Location Time | Finding Main Goal for Study | 22 seconds |
| Standard Consent | Participant Information Location Time | Finding Who to Contact for Questions | 15 seconds |
| Standard Consent | Participant Information Location Time | Finding Risks and Benefits Section | 20 seconds |
| Standard Consent | Participant Information Location Time | Finding How to Leave the Study | 24 seconds |
| Standard Consent | Participant Information Location Time | Finding Study Procedures | 43 seconds |
| Easy-to-Read Informed Consent | Participant Information Location Time | Finding Study Procedures | 36 seconds |
| Easy-to-Read Informed Consent | Participant Information Location Time | Finding Main Goal for Study | 30 seconds |
| Easy-to-Read Informed Consent | Participant Information Location Time | Finding How to Leave the Study | 30 seconds |
| Easy-to-Read Informed Consent | Participant Information Location Time | Finding Who to Contact for Questions | 20 seconds |
| Easy-to-Read Informed Consent | Participant Information Location Time | Finding Risks and Benefits Section | 20 seconds |
Comparison: The null hypothesis is that there is no difference in the time required to find the main goal of the study between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find the main goal of the study was compared between arms, which should be equal under the null hypothesis.p-value: 0.73Wilcoxon (Mann-Whitney)
Comparison: The null hypothesis is that there is no difference in the time required to find who to contact for questions between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find who to contact for questions was compared between arms, which should be equal under the null hypothesis.p-value: 0.26Wilcoxon (Mann-Whitney)
Comparison: The null hypothesis is that there is no difference in the time required to find the risks and benefits section between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find the risks and benefits section was compared between arms, which should be equal under the null hypothesis.p-value: 0.74Wilcoxon (Mann-Whitney)
Comparison: The null hypothesis is that there is no difference in the time required to find how to leave the study between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find how to leave the study was compared between arms, which should be equal under the null hypothesis.p-value: 0.56Wilcoxon (Mann-Whitney)
Comparison: The null hypothesis is that there is no difference in the time required to find study procedures between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find study procedures was compared between arms, which should be equal under the null hypothesis.p-value: 0.79Wilcoxon (Mann-Whitney)
Secondary
Participant Satisfaction With Consent Process
A short study specific questionnaire and selected questions from the Quality of Informed Consent (QuIC) supplement questionnaire will query participants about their overall satisfaction with the consent process, helpfulness of information provided, and comprehension of key study-specific elements of treatment. Seven questions are included, each scored on a five point Likert scale. The overall score is the average of the item scores, ranging from 1.0 to 5.0, with a higher score indicating a higher level of satisfaction.
Time frame: Within 7 days of consent discussion
Population: Participants completing the satisfaction questionnaire
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Consent | Participant Satisfaction With Consent Process | 4.2 units on a scale |
| Easy-to-Read Informed Consent | Participant Satisfaction With Consent Process | 4.1 units on a scale |
Comparison: The null hypothesis is that there is no difference in satisfaction with the consent process, as measured by a study-specific questionnaire, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median participant satisfaction scores were compared between arms, which should be equal under the null hypothesis.p-value: 0.8Wilcoxon (Mann-Whitney)
Secondary
Quality of Informed Consent Part B (QuIC-B) Score
The Quality of Informed Consent Part B measures participants' perception of their understanding of cancer clinical trials to address 13 independent domains of informed consent. The QuIC-B is scored on a normalized scale from 0 to 100, with a higher score indicating a greater level of perceived understanding.
Time frame: Within 7 days of consent discussion
Population: Participants completing the QuIC-B assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Consent | Quality of Informed Consent Part B (QuIC-B) Score | 98.2 units on a scale |
| Easy-to-Read Informed Consent | Quality of Informed Consent Part B (QuIC-B) Score | 96.4 units on a scale |
Comparison: The null hypothesis is that there is no difference in participants' perception of their comprehension of the parent clinical trial, as measured by the QuIC-B, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median QuIC-B scores were compared between arms, which should be approximately equal under the null hypothesis.p-value: 0.39Wilcoxon (Mann-Whitney)
Secondary
REALM-R Score
The Rapid Estimate of Adult Literacy in Medicine-Revised (REALM-R) is an 8-item word recognition test to provide clinicians with a valid quick assessment of patient health literacy. The score is computed as the number of words out of 8 that the patient pronounces correctly.
Time frame: Within 7 days of consent discussion
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Consent | REALM-R Score | 8 | 62 Participants |
| Standard Consent | REALM-R Score | Not Completed | 21 Participants |
| Standard Consent | REALM-R Score | Less Than 8 | 15 Participants |
| Easy-to-Read Informed Consent | REALM-R Score | Less Than 8 | 17 Participants |
| Easy-to-Read Informed Consent | REALM-R Score | 8 | 69 Participants |
| Easy-to-Read Informed Consent | REALM-R Score | Not Completed | 14 Participants |
Secondary
State Trait Anxiety Inventory (STAI) Score
The State Trait Anxiety Inventory (STAI) measures anxiety and distinguishes it from depressive syndromes. It has two subscales: the State Anxiety Scale evaluates the current state of anxiety, asking how respondents feel right now, and Trait Anxiety Scale evaluating relatively stable aspects of anxiety proneness. The STAI has 40 items, 20 items allocated to each subscale, with each item scored on a 4 point Likert scale. The subscale scores shown are averages of the items in the subscale ranging from 1.0 to 4.0, with a higher score indicating a greater level of anxiety.
Time frame: Within 7 days of consent discussion
Population: Participants completing the STAI assessment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard Consent | State Trait Anxiety Inventory (STAI) Score | Trait Anxiety Scale | 2.4 units on a scale |
| Standard Consent | State Trait Anxiety Inventory (STAI) Score | State Anxiety Scale | 2.5 units on a scale |
| Easy-to-Read Informed Consent | State Trait Anxiety Inventory (STAI) Score | Trait Anxiety Scale | 2.3 units on a scale |
| Easy-to-Read Informed Consent | State Trait Anxiety Inventory (STAI) Score | State Anxiety Scale | 2.5 units on a scale |
Comparison: The null hypothesis is that there is no difference in participants' state anxiety, as measured by the STAI, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median state anxiety subscores of the STAI were compared between arms, which should be equal under the null hypothesis.p-value: 0.21Wilcoxon (Mann-Whitney)
Comparison: The null hypothesis is that there is no difference in participants' trait anxiety, as measured by the STAI, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median trait anxiety subscores of the STAI were compared between arms, which should be equal under the null hypothesis.p-value: 0.25Wilcoxon (Mann-Whitney)