Asymptomatic Bacteriuria, Prostate Specific Antigen Screening, Type 2 Diabetes
Conditions
Keywords
Geriatrics, Quality of care
Brief summary
Investigators will evaluate clinical decision support nudges informed by behavioral science and directed at primary care clinicians. These will be used to reduce commonly misused, and potentially harmful, diagnostic and therapeutic actions that occur in the care of older adults (e.g. overtreatment of type 2 diabetes, misuse of PSA screening, misuse of urine testing in women with nonspecific symptoms or no symptoms.
Detailed description
Diagnostic and therapeutic strategies misapplied to older adults can lead to increased morbidity and mortality. Despite recommendations from the American Geriatrics Society for the Choosing Wisely Initiative, there are clear examples where clinicians do not often follow best practices leading to patient harm. These include: (1) testing and treatment for asymptomatic bacteriuria (ASB) in older women, (2) prostate specific antigen (PSA) screening in older men, and (3) aggressive treatment with insulin or oral hypoglycemics for type 2 diabetes. Clinical decision support nudges, informed by behavioral economics and social psychology and delivered via electronic health records (EHRs), are promising strategies to reduce the misuse of services. Behavioral economics-informed interventions influence conscious and unconscious drivers of decision making, are low cost, and can be incorporated into existing systems. This randomized controlled trial will evaluate the effects of three clinical decision support nudges on three clinical quality measures, indicators of patient safety, and clinician attitudes.
Interventions
BEHAVIORALEHR clinical decision support nudges
Clinical decision support nudges delivered within the EHR when conditions meet alert triggering criteria.
BEHAVIORALBrief clinician education
Clinicians will be invited to view brief education material.
Sponsors
University of Southern California
University of California, Los Angeles
National Institute on Aging (NIA)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Cluster-randomized by primary care clinic using a constrained randomization process.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Northwestern Medicine primary care clinician who sees patients under department code of a randomized clinic
Exclusion criteria
* Resident physicians will be excluded * Clinicians who participated in pilot study of these interventions * Clinician study investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA Screening in Older Men | 18 months | Measure defined as the presence of a PSA laboratory result in the EHR during the measurement period among men aged 76 years and older at the start of the measurement period with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer. |
| Urine Testing for Non-specific Reasons | 18 months | Measure defined as the absence of a diagnostic code for a specific genitourinary sign, symptoms or other potentially relevant indication among instances where a urinalysis and/or urine culture is obtained in the interval 24 hours before to 48 hours after a face-to-face ambulatory care visit by a woman aged 65 years or older with a primary care clinician during the measurement period. |
| Diabetes Overtreatment in the Elderly | 18 months | Measure defined as having the most recent hemoglobin A1C during the measurement period of less than 7.0 and insulin or an oral hypoglycemic drug on their active medication list at the end of the measurement period among adults aged 75 years and older with a diagnosis of diabetes mellitus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Hyperglycemia Requiring Hospital Care Among Previously Tightly Controlled | 18 months | Emergency department visit or hospitalization for hyperglycemia among patients who previously had a HbA1c \<7.0 and met the criteria for treatment deintensification intervention and had one or more outpatient primary care encounters during the study period. |
| Rate of UTI Requiring Hospital Care Among Women 65 and Over Following Clinical Decision Support Exposure | 18 months | Emergency department visit or hospitalization for an infection originating from the urinary tract within 28 days of any primary care office visit with decision support exposure. |
| Rate of Hypoglycemia Requiring Urgent Care Among Previously Tightly Controlled | 18 months | Emergency department visit or hospitalization for hypoglycemia among patients who previously had a HbA1c \<7.0 and met the criteria for treatment deintensification intervention and had one or more outpatient primary care encounters during the study period |
| Rate of Poor Diabetes Control Among Previously Tightly Controlled | 18 months | Occurrence of HbA1c \>9.0 among patients who previously had a HbA1c \<7.0 and met the criteria for treatment deintensification intervention and had one or more outpatient primary care encounters during the study period. |
| Rate of UTI Requiring Hospital Care Among Women 65 and Over Following an Office Visit | 18 months | Emergency department visit or hospitalization for an infection originating from the urinary tract within 28 days of any primary care office visit |
| Rate of Hyperglycemia Requiring Hospital Care Following Clinical Decision Support Exposure | 18 months | Emergency department visit or hospitalization for hyperglycemia within 90 days of an index visit where the clinician was exposed to the diabetes decision support. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of Treatment for Antibiotics for UTI in Women 65 and Older | 18 months and 19-30 months | Proportion of all women with one or more encounter to an eligible clinic during the prior 12 months receiving an antibiotic for confirmed or possible UTI. |
| Dose Reduction in Insulin, Sulfonylurea or Meglitinides | 18 months, 24 months | Proportion of patients 75 years old and older with initial HbA1c \<7.0 and treated with insulin, sulfonylurea or meglitinides who have a dose reduction |
| PSA Screening in Older Men by Race | 18 months | NIH-required analysis. Measure defined as the presence of a PSA laboratory result in the EHR during the measurement period among men aged 76 years and older at the start of the measurement period with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer. |
| PSA Screening in Older Men by Ethnicity | 18 months | NIH-required analysis. Measure defined as the presence of a PSA laboratory result in the EHR during the measurement period among men aged 76 years and older at the start of the measurement period with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer. |
| PSA Screening in Older Men | 19-30 months | Measure defined as the presence of a PSA laboratory result in the EHR during the measurement period among men aged 76 years and older at the start of the measurement period with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer. |
| Urine Testing for Non-specific Reasons by Ethnicity | 18 months | NIH-required analysis. Measure defined as the absence of a diagnostic code for a specific genitourinary sign, symptoms or other potentially relevant indication among instances where a urinalysis and/or urine culture is obtained in the interval 24 hours before to 48 hours after a face-to-face ambulatory care visit by a woman aged 65 years or older with a primary care clinician during the measurement period. |
| Diabetes Overtreatment in the Elderly by Sex | 18 months | NIH-required analysis. Measure defined as having the most recent hemoglobin A1C during the measurement period of less than 7.0 and insulin or an oral hypoglycemic drug on their active medication list at the end of the measurement period among adults aged 75 years and older with a diagnosis of diabetes mellitus. |
| Diabetes Overtreatment in the Elderly by Race | 18 months | NIH-required analysis. Measure defined as having the most recent hemoglobin A1C during the measurement period of less than 7.0 and insulin or an oral hypoglycemic drug on their active medication list at the end of the measurement period among adults aged 75 years and older with a diagnosis of diabetes mellitus. |
| Diabetes Overtreatment in the Elderly by Ethnicity | 18 months | NIH-required analysis. Measure defined as having the most recent hemoglobin A1C during the measurement period of less than 7.0 and insulin or an oral hypoglycemic drug on their active medication list at the end of the measurement period among adults aged 75 years and older with a diagnosis of diabetes mellitus. |
| Urine Testing for Non-specific Reasons by Race | 18 months | NIH-required analysis. Measure defined as the absence of a diagnostic code for a specific genitourinary sign, symptoms or other potentially relevant indication among instances where a urinalysis and/or urine culture is obtained in the interval 24 hours before to 48 hours after a face-to-face ambulatory care visit by a woman aged 65 years or older with a primary care clinician during the measurement period. |
| Urine Testing for Non-specific Reasons | 19-30 months | Measure defined as the absence of a diagnostic code for a specific genitourinary sign, symptoms or other potentially relevant indication among instances where a urinalysis and/or urine culture is obtained in the interval 24 hours before to 48 hours after a face-to-face ambulatory care visit by a woman aged 65 years or older with a primary care clinician during the measurement period. |
| Diabetes Overtreatment in the Elderly | 19-30 months | Measure defined as having the most recent hemoglobin A1C during the measurement period of less than 7.0 and insulin or an oral hypoglycemic drug on their active medication list at the end of the measurement period among adults aged 75 years and older with a diagnosis of diabetes mellitus. |
| Rates of Prostate Biopsy | 18 months and 19-30 months | Rate of prostate biopsy among men \>=76 with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer at the beginning of the measurement period |
| Rate of Prostate MRI | 18 months and 19-30 months | Rate of prostate MRI among men \>=76 with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer at the beginning of the measurement period |
| Rate of Prostate Cancer Diagnosis | 18 months and 19-30 months | Rate of prostate cancer diagnosis among men \>=76 with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer at the beginning of the measurement period |
| PSA Screening Done by Non PCP in Men Over 76 Years Old | 18 months and 19-30 months | Presence of a PSA laboratory result in the EHR during the measurement period among men aged 76 years and older at the start of the measurement period ordered by a non-primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer. |
| PSA Screening in Men Aged 55 to 69 and Age 70 to 75 | 18 months and 19-30 months | Measure defined as the presence of a PSA laboratory result in the EHR during the measurement period for men aged 55-69 and men aged 70-75 who are without a diagnosis suggesting a history of prostate cancer |
| Rates of Urinalysis and Urine Culture Use in Women 65 and Older | 18 months and 19-30 months | Proportion of all women with one or more visit to an eligible clinic during the prior 12 months receiving urinalysis and/or urine culture |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brief Clinician Education Clinicians attributed to clinics in the brief clinician education arm will receive invitation to view an online educational module and be recruited to complete an online survey at baseline and 18 months.
Brief clinician education: Clinicians will be invited to view brief education material. | 18,709 |
| Clinical Decision Support Nudges and Brief Clinician Education Clinicians attributed to clinics randomized to the clinical decision support nudges and brief clinician decision support arm will receive clinical decision support within the EHR when conditions meet alert triggering criteria. These clinicians will also receive invitation to view an online educational module and be recruited to complete an online survey at baseline and 18 months.
EHR clinical decision support nudges: Clinical decision support nudges delivered within the EHR when conditions meet alert triggering criteria.
Brief clinician education: Clinicians will be invited to view brief education material. | 18,425 |
| Total | 37,134 |
Baseline characteristics
| Characteristic | Brief Clinician Education | Clinical Decision Support Nudges and Brief Clinician Education | Total |
|---|---|---|---|
| Age, Continuous | 78.0 years STANDARD_DEVIATION 7.5 | 77.7 years STANDARD_DEVIATION 7.4 | 77.8 years STANDARD_DEVIATION 7.5 |
| Race/Ethnicity, Customized Hispanic | 699 Participants | 974 Participants | 1673 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 1227 Participants | 1338 Participants | 2565 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 15209 Participants | 14721 Participants | 29930 Participants |
| Race/Ethnicity, Customized Other | 1574 Participants | 1392 Participants | 2966 Participants |
| Region of Enrollment United States | 18709 participants | 18425 participants | 37134 participants |
| Sex: Female, Male Female | 11244 Participants | 11435 Participants | 22679 Participants |
| Sex: Female, Male Male | 7465 Participants | 6990 Participants | 14455 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 511 / 18,709 | 469 / 18,425 |
| other Total, other adverse events | 11 / 668 | 22 / 782 |
| serious Total, serious adverse events | 996 / 38,607 | 1,100 / 35,786 |
Outcome results
Primary
Diabetes Overtreatment in the Elderly
Measure defined as having the most recent hemoglobin A1C during the measurement period of less than 7.0 and insulin or an oral hypoglycemic drug on their active medication list at the end of the measurement period among adults aged 75 years and older with a diagnosis of diabetes mellitus.
Time frame: 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brief Clinician Education | Diabetes Overtreatment in the Elderly | 603 Participants |
| Clinical Decision Support Nudges and Brief Clinician Education | Diabetes Overtreatment in the Elderly | 605 Participants |
95% CI: [0.7, 1]
Primary
PSA Screening in Older Men
Measure defined as the presence of a PSA laboratory result in the EHR during the measurement period among men aged 76 years and older at the start of the measurement period with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer.
Time frame: 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brief Clinician Education | PSA Screening in Older Men | 1675 Participants |
| Clinical Decision Support Nudges and Brief Clinician Education | PSA Screening in Older Men | 1373 Participants |
95% CI: [0.46, 0.69]
Primary
Urine Testing for Non-specific Reasons
Measure defined as the absence of a diagnostic code for a specific genitourinary sign, symptoms or other potentially relevant indication among instances where a urinalysis and/or urine culture is obtained in the interval 24 hours before to 48 hours after a face-to-face ambulatory care visit by a woman aged 65 years or older with a primary care clinician during the measurement period.
Time frame: 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brief Clinician Education | Urine Testing for Non-specific Reasons | 1127 Participants |
| Clinical Decision Support Nudges and Brief Clinician Education | Urine Testing for Non-specific Reasons | 1032 Participants |
95% CI: [0.55, 0.85]
Secondary
Rate of Hyperglycemia Requiring Hospital Care Among Previously Tightly Controlled
Emergency department visit or hospitalization for hyperglycemia among patients who previously had a HbA1c \<7.0 and met the criteria for treatment deintensification intervention and had one or more outpatient primary care encounters during the study period.
Time frame: 18 months
Secondary
Rate of Hyperglycemia Requiring Hospital Care Following Clinical Decision Support Exposure
Emergency department visit or hospitalization for hyperglycemia within 90 days of an index visit where the clinician was exposed to the diabetes decision support.
Time frame: 18 months
Secondary
Rate of Hypoglycemia Requiring Urgent Care Among Previously Tightly Controlled
Emergency department visit or hospitalization for hypoglycemia among patients who previously had a HbA1c \<7.0 and met the criteria for treatment deintensification intervention and had one or more outpatient primary care encounters during the study period
Time frame: 18 months
Secondary
Rate of Poor Diabetes Control Among Previously Tightly Controlled
Occurrence of HbA1c \>9.0 among patients who previously had a HbA1c \<7.0 and met the criteria for treatment deintensification intervention and had one or more outpatient primary care encounters during the study period.
Time frame: 18 months
Secondary
Rate of UTI Requiring Hospital Care Among Women 65 and Over Following an Office Visit
Emergency department visit or hospitalization for an infection originating from the urinary tract within 28 days of any primary care office visit
Time frame: 18 months
Secondary
Rate of UTI Requiring Hospital Care Among Women 65 and Over Following Clinical Decision Support Exposure
Emergency department visit or hospitalization for an infection originating from the urinary tract within 28 days of any primary care office visit with decision support exposure.
Time frame: 18 months
Other Pre-specified
Diabetes Overtreatment in the Elderly
Measure defined as having the most recent hemoglobin A1C during the measurement period of less than 7.0 and insulin or an oral hypoglycemic drug on their active medication list at the end of the measurement period among adults aged 75 years and older with a diagnosis of diabetes mellitus.
Time frame: 19-30 months
Other Pre-specified
Diabetes Overtreatment in the Elderly by Ethnicity
NIH-required analysis. Measure defined as having the most recent hemoglobin A1C during the measurement period of less than 7.0 and insulin or an oral hypoglycemic drug on their active medication list at the end of the measurement period among adults aged 75 years and older with a diagnosis of diabetes mellitus.
Time frame: 18 months
Other Pre-specified
Diabetes Overtreatment in the Elderly by Race
NIH-required analysis. Measure defined as having the most recent hemoglobin A1C during the measurement period of less than 7.0 and insulin or an oral hypoglycemic drug on their active medication list at the end of the measurement period among adults aged 75 years and older with a diagnosis of diabetes mellitus.
Time frame: 18 months
Other Pre-specified
Diabetes Overtreatment in the Elderly by Sex
NIH-required analysis. Measure defined as having the most recent hemoglobin A1C during the measurement period of less than 7.0 and insulin or an oral hypoglycemic drug on their active medication list at the end of the measurement period among adults aged 75 years and older with a diagnosis of diabetes mellitus.
Time frame: 18 months
Other Pre-specified
Dose Reduction in Insulin, Sulfonylurea or Meglitinides
Proportion of patients 75 years old and older with initial HbA1c \<7.0 and treated with insulin, sulfonylurea or meglitinides who have a dose reduction
Time frame: 18 months, 24 months
Other Pre-specified
PSA Screening Done by Non PCP in Men Over 76 Years Old
Presence of a PSA laboratory result in the EHR during the measurement period among men aged 76 years and older at the start of the measurement period ordered by a non-primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer.
Time frame: 18 months and 19-30 months
Other Pre-specified
PSA Screening in Men Aged 55 to 69 and Age 70 to 75
Measure defined as the presence of a PSA laboratory result in the EHR during the measurement period for men aged 55-69 and men aged 70-75 who are without a diagnosis suggesting a history of prostate cancer
Time frame: 18 months and 19-30 months
Other Pre-specified
PSA Screening in Older Men
Measure defined as the presence of a PSA laboratory result in the EHR during the measurement period among men aged 76 years and older at the start of the measurement period with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer.
Time frame: 19-30 months
Other Pre-specified
PSA Screening in Older Men by Ethnicity
NIH-required analysis. Measure defined as the presence of a PSA laboratory result in the EHR during the measurement period among men aged 76 years and older at the start of the measurement period with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer.
Time frame: 18 months
Other Pre-specified
PSA Screening in Older Men by Race
NIH-required analysis. Measure defined as the presence of a PSA laboratory result in the EHR during the measurement period among men aged 76 years and older at the start of the measurement period with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer.
Time frame: 18 months
Other Pre-specified
Rate of Prostate Cancer Diagnosis
Rate of prostate cancer diagnosis among men \>=76 with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer at the beginning of the measurement period
Time frame: 18 months and 19-30 months
Other Pre-specified
Rate of Prostate MRI
Rate of prostate MRI among men \>=76 with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer at the beginning of the measurement period
Time frame: 18 months and 19-30 months
Other Pre-specified
Rate of Treatment for Antibiotics for UTI in Women 65 and Older
Proportion of all women with one or more encounter to an eligible clinic during the prior 12 months receiving an antibiotic for confirmed or possible UTI.
Time frame: 18 months and 19-30 months
Other Pre-specified
Rates of Prostate Biopsy
Rate of prostate biopsy among men \>=76 with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer at the beginning of the measurement period
Time frame: 18 months and 19-30 months
Other Pre-specified
Rates of Urinalysis and Urine Culture Use in Women 65 and Older
Proportion of all women with one or more visit to an eligible clinic during the prior 12 months receiving urinalysis and/or urine culture
Time frame: 18 months and 19-30 months
Other Pre-specified
Urine Testing for Non-specific Reasons
Measure defined as the absence of a diagnostic code for a specific genitourinary sign, symptoms or other potentially relevant indication among instances where a urinalysis and/or urine culture is obtained in the interval 24 hours before to 48 hours after a face-to-face ambulatory care visit by a woman aged 65 years or older with a primary care clinician during the measurement period.
Time frame: 19-30 months
Other Pre-specified
Urine Testing for Non-specific Reasons by Ethnicity
NIH-required analysis. Measure defined as the absence of a diagnostic code for a specific genitourinary sign, symptoms or other potentially relevant indication among instances where a urinalysis and/or urine culture is obtained in the interval 24 hours before to 48 hours after a face-to-face ambulatory care visit by a woman aged 65 years or older with a primary care clinician during the measurement period.
Time frame: 18 months
Other Pre-specified
Urine Testing for Non-specific Reasons by Race
NIH-required analysis. Measure defined as the absence of a diagnostic code for a specific genitourinary sign, symptoms or other potentially relevant indication among instances where a urinalysis and/or urine culture is obtained in the interval 24 hours before to 48 hours after a face-to-face ambulatory care visit by a woman aged 65 years or older with a primary care clinician during the measurement period.
Time frame: 18 months