Back to resultsShared Decision-Making for the Promotion of Patient-Centered Imaging in the ED: Suspected Kidney Stones (ED-KSS)
Primary Purpose
Shared Decision-making, Kidney Stone, Emergencies
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid
Standardized Educational Material (informational pamphlet)
Sponsored by
About this trial
This is an interventional other trial for Shared Decision-making
Eligibility Criteria
Inclusion Criteria:
- Age 18-55,
- with acute flank pain - for whom clinician believes acute flank pain may be from renal colic
- who are deemed by the treating clinician to be at low risk for dangerous alternative diagnoses.
- Clinician is considering imaging patient for kidney stones (any imaging)
Exclusion Criteria:
- Recent trauma related to pain (including minor such as lifting/turning)
- Pregnancy (previous or discovered during ED visit)
- Recent surgical procedure on abdomen or pelvis (30d)
- Recent urologic procedure (30d)
- Recent childbirth (30d)
- Signs of Systemic Infection: Fever >100.9 (101 and up), SBP <90, HR>120
- Moderate or severe abdominal tenderness or rebound/guarding, consistently present (present for more than one exam, or present after patient treated with pain medication)
- Second doctor's visit (ED, PCP, urgent care) for THIS episode of pain (previous similar visits ok if pain gone for >30d in between episodes) (if seen at PCP or urgent care in same day or 24 hour period, this is not an exclusion, but if seen at PCP/urgent care or ED 1-30 days prior to index visit, with same pain, excluded)
- Known history of one kidney or other urological/renal abnormality (including neurogenic bladder, ESRD and paraplegia; or if solitary kidney discovered on US)
- Known malignancy (any) within past year (or received treatment in the past 12 months)
- Immunocompromised (chronic steroids, HIV, crohns, immunomodulators or severely ill chronically)
- On anticoagulation
- Crisis patient (behavioral health)/belligerent
- Lacks capacity for medical decision-making
- Unlikely to respond to follow-up calls (IVDA, homeless, no phone)
- Clinician is concerned for alternative diagnosis requiring CT scan (appendicitis) (>5% likelihood by clinician gestalt)
- Patient is not improving clinically and clinician is considering admission
Sites / Locations
- Baystate Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Shared Decision-Making (via Decision Aid)
standardized educational intervention (pamphlet +usual care)
Arm Description
The intervention is a decision aid, which both encourages and facilitates a shared decision-making conversation between the clinician and the patient. The decision aid educates patients regarding evidence-based approaches to the management of suspected kidney stones in the ED. Clinicians will receive training specific to this decision aid, though the decision aid is designed to be used with no additional training.
The control arm will receive Usual Care and a standardized educational intervention (pamphlet). This intervention (pamphlet) contains information about kidney stones. Usual care for this clinical scenario generally involves the clinician choosing the management plan. Clinicians of subjects assigned to the usual care group will be asked to practice usual, evidence-based medical care, without shared decision-making.
Outcomes
Primary Outcome Measures
Feasibility
Is this study feasible? We will collect number of patients screened, number approached, number consented, number randomized and whether follow-up was completed (was patient contacted). An enrollment of at least three patients per month will indicate feasibility.
Fidelity
Does the DA do what we think it is doing? Fidelity will be examined after 50 patients are enrolled: conversations between patients and clinicians will be scored for whether shared decision-making occurred. If SDM is NOT occurring in the intervention group (>75% of interactions) or IS occurring in the usual care group (>50% of interactions), fidelity will not be considered met.
Patient Knowledge
We hypothesize that the intervention group will have increased knowledge regarding radiation exposure and diagnostic options. This will be tested with a 10 question Knowledge Test developed by stakeholders for this study and delivered at the end of the index visit. The scores for this test range from 0-10 with 10 indicating higher knowledge (more correct answers)
CT scan rate
We hypothesize that SDM will lead to a change in CT scans performed at the index visits and in the first 60 days
Radiation exposure
We hypothesize that SDM will lead to a change in exposure to radiation. We will record radiation exposure for each CT done between day 0 and day 60, as indicated by DLP on CT reports.
Secondary Outcome Measures
Patient Satisfaction
Measure of satisfaction (HCAHPS measure: Provider rating where 0 = worst provider possible and 10 = best provider possible)
Patient engagement
Measure of engagement: CollaboRATE 3-question measure (where 10/10 for all three is the highest score possible, and 0/0 is the lowest possible, with highest indicating better patient engagement)
Patient engagement
Measure of engagement: modified CPS (Scale from 1-5, where 1 indicates the doctor made the decision, 5 indicates the patient made the decision, and 2,3, and 4 indicate levels of shared decision-making)
Patient engagement
Measure of engagement: direct SDM question (Measures patients' perception of "Did SDM occur" on a likert scale of 1-7 with 1 = no and 7 = yes, and higher scores = more SDM)
Occurrence of SDM
"As involved" question: "Were you as involved in today's decisions as you would have liked to be?" With three response options: Yes, No, and "There were no decisions for me to be involved in" Greater proportion of patients choosing "yes" indicates more SDM.
Occurrence of SDM
Whether SDM took place from a third party observer's perspectives: OPTION-5 Score (where scale goes from 0-5, and is re-scaled to 0-100, where higher score indicates more SDM)
Overall Radiation Burden
Radiation burden from diagnostic imaging (numeric DLP from CT reports)
Trust in physician
Trust in physician scale (0-25 with 25 indicating higher trust in the physician)
ED revisits
Repeat visits to any Emergency Department
Safety: missed diagnosis
High Risk Diagnoses with Complications, as previously described by Smith-Bindman.
ED Length of Stay
Total minutes of ED stay
Implementation Outcomes
Clinician's perceptions of the conversation/intervention. We will ask about whether the clinician found the decision aid helpful, whether they would recommend it to another clinician, and whether they would use it again (likert scale 1-7 for each, with higher number indicating more acceptance/helpfulness)
Qualitative evaluation
We will ask open ended questions to providers about their interaction, to ask about what went well, what did not, how else could SDM be facilitated, how this intervention would work outside of a study, what other feedback they have. This will be collected via recorded interview and open ended questions.
Full Information
NCT ID
NCT04234035
First Posted
December 2, 2019
Last Updated
February 28, 2022
Sponsor
Baystate Medical Center
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT04234035
Brief Title
Shared Decision-Making for the Promotion of Patient-Centered Imaging in the ED: Suspected Kidney Stones
Acronym
ED-KSS
Official Title
Shared Decision-Making for the Promotion of Patient-Centered Imaging in the Emergency Department: Suspected Kidney Stones
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baystate Medical Center
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Although a CT scan is required for some Emergency Department patients with signs and symptoms of a kidney stone, recent evidence has shown that routine scanning is unnecessary and may expose young patients to significant cumulative radiation, increasing their risk of future cancers. Shared Decision-Making may facilitate diagnostic imaging decisions that are more inline with patients' values and preferences. By comparing a shared approach to diagnostic decision-making to a traditional, physician-directed approach, this study lays the foundation for a future randomized trial that will reduce radiation exposure, improve engagement, and improve the quality and patient-centeredness of Emergency Department care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shared Decision-making, Kidney Stone, Emergencies, Radiation Exposure, Communication
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Shared Decision-Making (via Decision Aid)
Arm Type
Experimental
Arm Description
The intervention is a decision aid, which both encourages and facilitates a shared decision-making conversation between the clinician and the patient. The decision aid educates patients regarding evidence-based approaches to the management of suspected kidney stones in the ED. Clinicians will receive training specific to this decision aid, though the decision aid is designed to be used with no additional training.
Arm Title
standardized educational intervention (pamphlet +usual care)
Arm Type
Active Comparator
Arm Description
The control arm will receive Usual Care and a standardized educational intervention (pamphlet). This intervention (pamphlet) contains information about kidney stones. Usual care for this clinical scenario generally involves the clinician choosing the management plan. Clinicians of subjects assigned to the usual care group will be asked to practice usual, evidence-based medical care, without shared decision-making.
Intervention Type
Behavioral
Intervention Name(s)
Decision Aid
Intervention Description
Decision aid to facilitated shared decision-making
Intervention Type
Other
Intervention Name(s)
Standardized Educational Material (informational pamphlet)
Intervention Description
Pamphlet with information about kidney stones
Primary Outcome Measure Information:
Title
Feasibility
Description
Is this study feasible? We will collect number of patients screened, number approached, number consented, number randomized and whether follow-up was completed (was patient contacted). An enrollment of at least three patients per month will indicate feasibility.
Time Frame
Up to 12 months
Title
Fidelity
Description
Does the DA do what we think it is doing? Fidelity will be examined after 50 patients are enrolled: conversations between patients and clinicians will be scored for whether shared decision-making occurred. If SDM is NOT occurring in the intervention group (>75% of interactions) or IS occurring in the usual care group (>50% of interactions), fidelity will not be considered met.
Time Frame
Up to 12 months
Title
Patient Knowledge
Description
We hypothesize that the intervention group will have increased knowledge regarding radiation exposure and diagnostic options. This will be tested with a 10 question Knowledge Test developed by stakeholders for this study and delivered at the end of the index visit. The scores for this test range from 0-10 with 10 indicating higher knowledge (more correct answers)
Time Frame
Measured at the end of the index visit. (Day 0)
Title
CT scan rate
Description
We hypothesize that SDM will lead to a change in CT scans performed at the index visits and in the first 60 days
Time Frame
Day 0 and Day 60 (Day 60 evaluation will include all days from 0-60)
Title
Radiation exposure
Description
We hypothesize that SDM will lead to a change in exposure to radiation. We will record radiation exposure for each CT done between day 0 and day 60, as indicated by DLP on CT reports.
Time Frame
Day 0 and Day 60 (Day 60 evaluation will include all days from 0-60)
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
Measure of satisfaction (HCAHPS measure: Provider rating where 0 = worst provider possible and 10 = best provider possible)
Time Frame
Day 0, end of visit
Title
Patient engagement
Description
Measure of engagement: CollaboRATE 3-question measure (where 10/10 for all three is the highest score possible, and 0/0 is the lowest possible, with highest indicating better patient engagement)
Time Frame
Day 0, end of visit
Title
Patient engagement
Description
Measure of engagement: modified CPS (Scale from 1-5, where 1 indicates the doctor made the decision, 5 indicates the patient made the decision, and 2,3, and 4 indicate levels of shared decision-making)
Time Frame
Day 0, end of visit
Title
Patient engagement
Description
Measure of engagement: direct SDM question (Measures patients' perception of "Did SDM occur" on a likert scale of 1-7 with 1 = no and 7 = yes, and higher scores = more SDM)
Time Frame
Day 0, end of visit
Title
Occurrence of SDM
Description
"As involved" question: "Were you as involved in today's decisions as you would have liked to be?" With three response options: Yes, No, and "There were no decisions for me to be involved in" Greater proportion of patients choosing "yes" indicates more SDM.
Time Frame
Day 0, end of visit
Title
Occurrence of SDM
Description
Whether SDM took place from a third party observer's perspectives: OPTION-5 Score (where scale goes from 0-5, and is re-scaled to 0-100, where higher score indicates more SDM)
Time Frame
Day 0, end of visit
Title
Overall Radiation Burden
Description
Radiation burden from diagnostic imaging (numeric DLP from CT reports)
Time Frame
within 60 days from index ED visit
Title
Trust in physician
Description
Trust in physician scale (0-25 with 25 indicating higher trust in the physician)
Time Frame
Day 0, end of visit
Title
ED revisits
Description
Repeat visits to any Emergency Department
Time Frame
60 days
Title
Safety: missed diagnosis
Description
High Risk Diagnoses with Complications, as previously described by Smith-Bindman.
Time Frame
60 days from index ED visit
Title
ED Length of Stay
Description
Total minutes of ED stay
Time Frame
Day 0, end of visit
Title
Implementation Outcomes
Description
Clinician's perceptions of the conversation/intervention. We will ask about whether the clinician found the decision aid helpful, whether they would recommend it to another clinician, and whether they would use it again (likert scale 1-7 for each, with higher number indicating more acceptance/helpfulness)
Time Frame
Day 0, end of visit
Title
Qualitative evaluation
Description
We will ask open ended questions to providers about their interaction, to ask about what went well, what did not, how else could SDM be facilitated, how this intervention would work outside of a study, what other feedback they have. This will be collected via recorded interview and open ended questions.
Time Frame
Day 0, end of visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-55,
with acute flank pain - for whom clinician believes acute flank pain may be from renal colic
who are deemed by the treating clinician to be at low risk for dangerous alternative diagnoses.
Clinician is considering imaging patient for kidney stones (any imaging)
Exclusion Criteria:
Recent trauma related to pain (including minor such as lifting/turning)
Pregnancy (previous or discovered during ED visit)
Recent surgical procedure on abdomen or pelvis (30d)
Recent urologic procedure (30d)
Recent childbirth (30d)
Signs of Systemic Infection: Fever >100.9 (101 and up), SBP <90, HR>120
Moderate or severe abdominal tenderness or rebound/guarding, consistently present (present for more than one exam, or present after patient treated with pain medication)
Second doctor's visit (ED, PCP, urgent care) for THIS episode of pain (previous similar visits ok if pain gone for >30d in between episodes) (if seen at PCP or urgent care in same day or 24 hour period, this is not an exclusion, but if seen at PCP/urgent care or ED 1-30 days prior to index visit, with same pain, excluded)
Known history of one kidney or other urological/renal abnormality (including neurogenic bladder, ESRD and paraplegia; or if solitary kidney discovered on US)
Known malignancy (any) within past year (or received treatment in the past 12 months)
Immunocompromised (chronic steroids, HIV, crohns, immunomodulators or severely ill chronically)
On anticoagulation
Crisis patient (behavioral health)/belligerent
Lacks capacity for medical decision-making
Unlikely to respond to follow-up calls (IVDA, homeless, no phone)
Clinician is concerned for alternative diagnosis requiring CT scan (appendicitis) (>5% likelihood by clinician gestalt)
Patient is not improving clinically and clinician is considering admission
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kye Poronsky
Phone
413-794-8680
Email
Kye.Poronsky@baystatehealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Schoenfeld, MD, MS
Organizational Affiliation
University of Massachusetts Medical School - Baystate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kye Poronsky, MS
Phone
413-794-8680
Email
Kye.Poronsky@baystatehealth.org
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no current plan for data sharing. This could change.
Citations:
PubMed Identifier
33691760
Citation
Schoenfeld EM, Poronsky KE, Westafer LM, DiFronzo BM, Visintainer P, Scales CD, Hess EP, Lindenauer PK. Feasibility and efficacy of a decision aid for emergency department patients with suspected ureterolithiasis: protocol for an adaptive randomized controlled trial. Trials. 2021 Mar 10;22(1):201. doi: 10.1186/s13063-021-05140-9.
Results Reference
derived
Learn more about this trial
Shared Decision-Making for the Promotion of Patient-Centered Imaging in the ED: Suspected Kidney Stones
We'll reach out to this number within 24 hrs