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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA181191 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
| University Hospital, Basel, Switzerland | OTHER |
| Center for Diagnostic Imaging | OTHER |
| Community Health Network |
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This is a pragmatic stepped-wedge cluster randomized controlled trial to explore variation in doses used for diagnostic CT by pooling radiation dose data across diverse healthcare delivery systems.
To compare different strategies for lowering and optimizing dose and identify the barriers and facilitators to implementing successful dose optimization strategies and standardizing practice.
The investigators are using a stepped-wedge cluster randomized controlled trial, collecting radiation dose information on CT from across all collaborating health care facilities, and leading several different interventions to optimize dose across facilities. In addition to collecting the CT radiation dose data, and using these results to provide feedback to the collaborating health care facilities, they will be conducting surveys of several individuals at each site, including key informants, such as lead radiologists, technologists, and medical physicist, and radiology administrators.
They will compare and identify facilitators and barriers (assessed through surveys of participating facilities) associated with successful and failed implementation of dose optimization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Track A | Active Comparator | Simple Audit Report; In-Person Meeting (timed to coincide with the multi-component intervention); Multi-Component Intervention |
|
| Track B | Active Comparator | In-Person Meeting (timed to coincide with the simple audit report); Simple Audit Report; Multi-Component Intervention |
|
| Track C | Other | Simple Audit Report; Multi-Component Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simple Audit Report | Other | The simple audit provides comparison and feedback on radiation doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Effective Dose (ED) | We will assess the change in the mean effective dose after the simple audit and multi-component interventions (MCI) in comparison to before the audit and multi-component interventions. The numbers given below reflect absolute change in mean dose (in millisieverts) relative to the baseline period. | Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81 |
| Percentage of CT Scans With an Effective Dose Above Benchmark | We will assess the change in the percentage of examinations with an effective dose above the benchmark after the simple audit and after multi-component intervention (MCI) in comparison to doses before the audit and MCI. The benchmark for each anatomic area is defined as the 75th percentile of the dose distribution during the pre-intervention (baseline) period. | Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Dose Length Product | We will assess the change in the dose length product after the audit and MCI in comparison to before the audit and MCI. | Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Smith-Bindman, MD | University of California, San Francisco | Principal Investigator |
| Judy Yee, MD | San Francisco Veterans Administration | Principal Investigator |
| Tom Nelson, PhD | University of California, San Diego | Principal Investigator |
| Tony Seibert, PhD | University of California, Davis | Principal Investigator |
| Mayil Krishnam, MD | University of California, Irvine | Principal Investigator |
| Michael Flynn, PhD | Henry Ford Health System | Principal Investigator |
| Mary Cocker, MSc, Csci | Oxford University Hospitals NHS Trust | Principal Investigator |
| William Boswell, MD | City of Hope Medical Center | Principal Investigator |
| Sebastian Schindera, MD | University Hospital of Basel | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17548853 | Background | Solberg LI. Improving medical practice: a conceptual framework. Ann Fam Med. 2007 May-Jun;5(3):251-6. doi: 10.1370/afm.666. | |
| 18539980 | Background | Solberg LI, Asche SE, Margolis KL, Whitebird RR. Measuring an organization's ability to manage change: the change process capability questionnaire and its use for improving depression care. Am J Med Qual. 2008 May-Jun;23(3):193-200. doi: 10.1177/1062860608314942. |
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Study subjects were passively enrolled in this study; we had a waiver of informed consent and there was no direct contact with subjects. We have listed the number of unique subjects enrolled into each track; however, ALL ANALYSES WERE PERFORMED AT THE LEVEL OF THE CT SCAN, not at the individual subject level.
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| ID | Title | Description |
|---|---|---|
| FG000 | Track A | Track A received the simple audit intervention at week 40 and the multi-component intervention at week 68. The simple audit provided feedback on radiation doses including comparison with other participating sites. The multi-component intervention gave tailored, actionable feedback on needed changes in addition to a 7-week quality improvement collaborative that included guidance on quality improvement methods, webinars, interactive lectures by experts, case reviews, and best practices sharing. |
| FG001 | Track B | Track B received the simple audit intervention at week 44 and the multi-component intervention at week 74. The simple audit provided feedback on radiation doses including comparison with other participating sites. The multi-component intervention gave tailored, actionable feedback on needed changes in addition to a 7-week quality improvement collaborative that included guidance on quality improvement methods, webinars, interactive lectures by experts, case reviews, and best practices sharing. |
| FG002 | Track C | Track C received the simple audit intervention at week 53 and the multi-component intervention at week 81. The simple audit provided feedback on radiation doses including comparison with other participating sites. The multi-component intervention gave tailored, actionable feedback on needed changes in addition to a 7-week quality improvement collaborative that included guidance on quality improvement methods, webinars, interactive lectures by experts, case reviews, and best practices sharing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
THE UNIT OF ANALYSIS IS CT SCANS, NOT PATIENTS. The arms in this section do not reflect the randomization tracks (A,B,C) but rather study periods: before intervention; after simple audit; after multi-component intervention. We excluded scans obtained during transition ("washout") periods immediately following each intervention. The numbers here reflect unique CT scans, not unique patients. Units are not counted more than once.
| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Period | Reflects CT scans analyzed during a baseline period of usual care (before intervention). The duration of this period differed by randomization Track (A, B, or C). |
| BG001 | Simple Audit Intervention Period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Patient age distribution by decade. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Effective Dose (ED) | We will assess the change in the mean effective dose after the simple audit and multi-component interventions (MCI) in comparison to before the audit and multi-component interventions. The numbers given below reflect absolute change in mean dose (in millisieverts) relative to the baseline period. | The unit of analysis is CT scans; there were no data collected at the participant level. We excluded scans obtained during transition ("washout") periods immediately following each intervention. The numbers given below reflect absolute change in mean dose (in millisieverts) relative to the baseline period. | Posted | Mean | 95% Confidence Interval | Millisieverts (mSv) | Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81 | CT scans | CT scans |
|
Adverse events were not collected.
Adverse event data were not reported in this study. Study data were collected from consecutive patients who underwent a standard of care procedure (CT imaging). No tests, treatments, or interactions with any patients were performed as part of this study. There was no way to capture, nor any need to capture for the purpose of our research, adverse events related to their imaging procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Track A | Simple Audit Report In-Person Meeting Multi-Component Intervention Simple Audit Report: The simple audit provides comparison and feedback on radiation doses. Multi-Component Intervention: The multi-component intervention gives tailored feedback on needed changes plus guidance using quality improvement methods that facilitate organizational change. Provides access to experts, detailed audit, collaborative calls, and site visits (as needed). In-Person Meeting: Collaborator meeting with an emphasis on quality improvement. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Smith-Bindman, MD | University of California San Francisco | 415-353-4946 | rebecca.smith-bindman@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2017 | Sep 1, 2023 | Prot_SAP_002.pdf |
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| OTHER |
| Children's Mercy Hospital Kansas City | OTHER |
| City of Hope Medical Center | OTHER |
| Albert Einstein Healthcare Network | OTHER |
| Universität Duisburg-Essen | OTHER |
| East Texas Medical Center Regional Healthcare System | OTHER |
| Emory University | OTHER |
| Henry Ford Health System | OTHER |
| Huntsville Hospital Health System | OTHER |
| Nicklaus Children's Hospital f/k/a Miami Children's Hospital | OTHER |
| Mount Sinai Hospital, New York | OTHER |
| Maastricht University Medical Center | OTHER |
| Olive View-UCLA Education & Research Institute | OTHER |
| Oxford University Hospitals NHS Trust | OTHER |
| San Francisco VA Health Care System | FED |
| St. Joseph Hospital of Orange | OTHER |
| St. Luke's International Hospital, Japan | OTHER |
| University of Virginia | OTHER |
| University of California, Irvine | OTHER |
| University of California, San Diego | OTHER |
| National Cancer Institute (NCI) | NIH |
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| Multi-Component Intervention | Other | The multi-component intervention gives tailored feedback on needed changes plus guidance using quality improvement methods that facilitate organizational change. Provides access to experts, detailed audit, collaborative calls, and site visits (as needed). |
|
| In-Person Meeting | Other | Collaborator meeting with an emphasis on quality improvement. |
|
| Proportion of CT Scans With a Dose Length Product Above Benchmark | We will assess the change in the proportion of examinations with a dose length product above the benchmark after the audit and after the MCI in comparison to doses before the audit and MCI. The benchmark for each anatomic area is defined as the 75th percentile of the dose distribution during the pre intervention period. | Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81 |
| Change in Mean Volume Computed Tomography Dose Index (CTDIvol) | We will assess the change in the mean volume CT dose index (CTDIvol) from before versus after the audit and MCI intervention. CTDIvol (in units of milligray, mGy) is a measure of radiation dose, reflecting the amount of radiation imparted per CT slice by the scanner. Higher CTDIvol signifies more radiation dose. In general, a reduction in CTDIvol would be a sign of quality improvement, minimizing excess radiation exposure to the patient. | Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81 |
| Percentage of CT Scans With a CTDIvol Above Benchmark | We will assess the change in the percentage of examinations with a CTDIvol above the benchmark after the audit and after multicomponent intervention in comparison to doses before the audit and multicomponent intervention. The benchmark for each anatomic area is defined as the 75th percentile of the dose distribution during the pre intervention period. | Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81 |
| Change in Mean Organ Doses: Brain Dose for Head CT; Lung Dose For Chest CT; Colon and Liver Dose for Abdomen CT | We will assess the change in organ doses after the simple audit and multi-component interventions (MCI) in comparison to before the audit and multi-component interventions. The numbers given below reflect absolute change in mean dose (in millisieverts) relative to the baseline period. | Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81 |
| Erin Bell, MHP |
| Community Health Network |
| Principal Investigator |
| Phuong-Anh Duong, MD | Emory University | Principal Investigator |
| Nima Kasraie, PhD, MSc | Children's Mercy Hospital Kansas City | Principal Investigator |
| Pavlina Pike, PhD | Huntsville Hospital | Principal Investigator |
| Luisa Cervantes, MD | Nicklaus Children's Hospital f/k/a Miami Children's Hospital | Principal Investigator |
| Joachim Wildberger, PhD | Maastricht University Medical Center | Principal Investigator |
| Michael Forsting, MD | University of Duisburg-Essen | Principal Investigator |
| Fady Kassem, PhD | St. Joseph Hospital of Orange | Principal Investigator |
| Darrell Fendrick, CT | East Texas Medical Center | Principal Investigator |
| Sugoto Mukherjee, MD | University of Virginia Health System | Principal Investigator |
| Brad Delman, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Jodi Roehm | Center for Diagnostic Imaging | Principal Investigator |
| Anokh Pahwa, MD | Olive View - UCLA | Principal Investigator |
| Ryan Lee, MD, MBA | Einstein Medical Center | Principal Investigator |
| Jay Starkey, MD | St. Luke's International Hospital, Tokyo | Principal Investigator |
| Diana Miglioretti, PhD | University of California, Davis | Principal Investigator |
| Saravanabavaan Suntharalingam, MD | University of Duisburg-Essen | Principal Investigator |
| Sara Lewis, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
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| Background | Huberman MM. Qualitative Data Analysis: An Expanded Sourcebook. Thousand Oaks, CA: Sage Publications; 1994. |
| Background | Patton MQ. Qualitative Research and Evaluation Methods. 3rd ed. Newbury Park: Sage Publications; 2002. |
| Background | Padgett D. Qualitative Methods in Social Work Research: Challenges and Rewards. Thousand Oaks, CA: Sage; 1998 |
| Background | Seale C. The Quality of Qualitative Research. Thousand Oaks: Sage Publications; 1999 |
| 15054030 | Background | Greevy R, Lu B, Silber JH, Rosenbaum P. Optimal multivariate matching before randomization. Biostatistics. 2004 Apr;5(2):263-75. doi: 10.1093/biostatistics/5.2.263. |
| 22552990 | Background | Greevy RA Jr, Grijalva CG, Roumie CL, Beck C, Hung AM, Murff HJ, Liu X, Griffin MR. Reweighted Mahalanobis distance matching for cluster-randomized trials with missing data. Pharmacoepidemiol Drug Saf. 2012 May;21 Suppl 2(0 2):148-54. doi: 10.1002/pds.3260. |
| Background | 171. Morgan KL, Rubin, D.L. Rerandomization to improve covariate balance in experiments. The Annals of Statistics 2012;40:1263-82. |
| 32227142 | Result | Smith-Bindman R, Chu P, Wang Y, Chung R, Lopez-Solano N, Einstein AJ, Solberg L, Cervantes LF, Yellen-Nelson T, Boswell W, Delman BN, Duong PA, Goode AR, Kasraie N, Lee RK, Neill R, Pahwa A, Pike P, Roehm J, Schindera S, Starkey J, Suntharalingam S, Jeukens CRLPN, Miglioretti DL. Comparison of the Effectiveness of Single-Component and Multicomponent Interventions for Reducing Radiation Doses in Patients Undergoing Computed Tomography: A Randomized Clinical Trial. JAMA Intern Med. 2020 May 1;180(5):666-675. doi: 10.1001/jamainternmed.2020.0064. |
| 30602590 | Derived | Smith-Bindman R, Wang Y, Chu P, Chung R, Einstein AJ, Balcombe J, Cocker M, Das M, Delman BN, Flynn M, Gould R, Lee RK, Nelson TR, Schindera S, Seibert A, Starkey J, Suntharalingam S, Wetter A, Wildberger JE, Miglioretti DL. International variation in radiation dose for computed tomography examinations: prospective cohort study. BMJ. 2019 Jan 2;364:k4931. doi: 10.1136/bmj.k4931. |
Reflects CT scans analyzed after receiving the simple audit report intervention. The duration of this period differed by randomization Track (A, B, or C).
| BG002 | Multi-component Intervention Period | Reflects CT scans analyzed after receiving the multi-component intervention. The duration of this period differed by randomization Track (A, B, or C). |
| BG003 | Total | Total of all reporting groups |
| CT scans |
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| Count of Units |
| CT scans |
| CT scans |
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| Sex: Female, Male | Count of Units | CT scans | CT scans |
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| Ethnicity (NIH/OMB) | Race and Ethnicity data not collected | Count of Units | CT scans | CT scans |
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| Race (NIH/OMB) | Race and Ethnicity data not collected | Count of Units | CT scans | CT scans |
|
| Type of scan | Anatomical region imaged. | Count of Units | CT scans | CT scans |
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| Age, by type of scan | Mean | Standard Deviation | Years | CT scans |
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| Patient diameter | Patient diameter, as measured in cm on mid-scan images, is an indicator of patient size. | Mean | Standard Deviation | Centimeters (cm) | CT scans |
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Reflects CT scans analyzed after receiving the simple audit report intervention. |
| OG001 | Multi-component Intervention Period | Reflects CT scans analyzed after receiving the multi-component intervention. |
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| Primary | Percentage of CT Scans With an Effective Dose Above Benchmark | We will assess the change in the percentage of examinations with an effective dose above the benchmark after the simple audit and after multi-component intervention (MCI) in comparison to doses before the audit and MCI. The benchmark for each anatomic area is defined as the 75th percentile of the dose distribution during the pre-intervention (baseline) period. | The unit of analysis is CT scans; there were no data collected at the participant level. We excluded scans obtained during transition ("washout") periods immediately following each intervention. | Posted | Number | Percent of CT scans over benchmark | Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81 | CT scans | CT scans |
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| Secondary | Mean Dose Length Product | We will assess the change in the dose length product after the audit and MCI in comparison to before the audit and MCI. | Data were not collected. | Posted | Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81 |
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| Secondary | Proportion of CT Scans With a Dose Length Product Above Benchmark | We will assess the change in the proportion of examinations with a dose length product above the benchmark after the audit and after the MCI in comparison to doses before the audit and MCI. The benchmark for each anatomic area is defined as the 75th percentile of the dose distribution during the pre intervention period. | Data were not collected. | Posted | Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81 |
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| Secondary | Change in Mean Volume Computed Tomography Dose Index (CTDIvol) | We will assess the change in the mean volume CT dose index (CTDIvol) from before versus after the audit and MCI intervention. CTDIvol (in units of milligray, mGy) is a measure of radiation dose, reflecting the amount of radiation imparted per CT slice by the scanner. Higher CTDIvol signifies more radiation dose. In general, a reduction in CTDIvol would be a sign of quality improvement, minimizing excess radiation exposure to the patient. | The unit of analysis is CT scans; there were no data collected at the participant level. We excluded scans obtained during transition ("washout") periods immediately following each intervention. The numbers given below reflect absolute change in mean dose (in milligray, mGy) relative to the baseline period. | Posted | Mean | 95% Confidence Interval | Milligrays (mGy) | Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81 | CT scans | CT scans |
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| Secondary | Percentage of CT Scans With a CTDIvol Above Benchmark | We will assess the change in the percentage of examinations with a CTDIvol above the benchmark after the audit and after multicomponent intervention in comparison to doses before the audit and multicomponent intervention. The benchmark for each anatomic area is defined as the 75th percentile of the dose distribution during the pre intervention period. | The unit of analysis is CT scans; there were no data collected at the participant level. We excluded scans obtained during transition ("washout") periods immediately following each intervention. | Posted | Number | Percentage of CT scans | Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81 | CT scans | CT scans |
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| Secondary | Change in Mean Organ Doses: Brain Dose for Head CT; Lung Dose For Chest CT; Colon and Liver Dose for Abdomen CT | We will assess the change in organ doses after the simple audit and multi-component interventions (MCI) in comparison to before the audit and multi-component interventions. The numbers given below reflect absolute change in mean dose (in millisieverts) relative to the baseline period. | The unit of analysis is CT scans; there were no data collected at the participant level. We excluded scans obtained during transition ("washout") periods immediately following each intervention. The numbers given below reflect absolute change in mean dose (in millisieverts) relative to the baseline period. | Posted | Mean | 95% Confidence Interval | Milligrays (mGy) | Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81 | CT scans | CT scans |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Track B | Simple Audit Report In-Person Meeting Multi-Component Intervention Simple Audit Report: The simple audit provides comparison and feedback on radiation doses. Multi-Component Intervention: The multi-component intervention gives tailored feedback on needed changes plus guidance using quality improvement methods that facilitate organizational change. Provides access to experts, detailed audit, collaborative calls, and site visits (as needed). In-Person Meeting: Collaborator meeting with an emphasis on quality improvement. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Track C | Simple Audit Report Multi-Component Intervention Simple Audit Report: The simple audit provides comparison and feedback on radiation doses. Multi-Component Intervention: The multi-component intervention gives tailored feedback on needed changes plus guidance using quality improvement methods that facilitate organizational change. Provides access to experts, detailed audit, collaborative calls, and site visits (as needed). | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| Title | Measurements |
|---|---|
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| Combined chest and abdomen |
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| Head |
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| Combined abdomen and chest |
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| Head |
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| Title | Measurements |
|---|---|
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| Combined chest and abdomen |
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| Head |
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| Combined chest and abdomen (lung organ dose) |
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| Combined chest and abdomen (colon organ dose) |
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| Head (brain organ dose) |
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