Shared Decision-makingED-KSSNCT04234035
Shared Decision-Making for the Promotion of Patient-Centered Imaging in the ED: Suspected Kidney Stones
A study testing Decision Aid and Standardized Educational Material (informational pamphlet) in people with Shared Decision-making and Kidney Stone, run by Baystate Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Shared Decision-making, Kidney Stone, Emergencies
- What is being tested?
- Decision Aid and Standardized Educational Material (informational pamphlet)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2019to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: Shared Decision-Making for the Promotion of Patient-Centered Imaging in the Emergency Department: Suspected Kidney Stones
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.
- Being tested
- Decision Aid, Standardized Educational Material (informational pamphlet)
- Medical subject headings
- Kidney Calculi, Emergencies, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidBehavioural
Decision aid to facilitated shared decision-making
Standardized Educational Material (informational pamphlet)Other
Pamphlet with information about kidney stones
| Study group | Role | What they receive |
|---|---|---|
| Shared Decision-Making (via Decision Aid) | Experimental | 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. Receives: Behavioral: Decision Aid; Other: Standardized Educational Material (informational pamphlet) |
| standardized educational intervention (pamphlet +usual care) | Active comparator | 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. Receives: Other: Standardized Educational Material (informational pamphlet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study
Is this study feasible? Investigators will record number of patients enrolled. An enrollment of at least three patients per month will indicate feasibility.
Measured: Up to 12 months
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.
Measured: Up to 12 months
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)
Measured: Measured at the end of the index visit. (Day 0)
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
Measured: Day 0 and Day 60 (Day 60 evaluation will include all days from 0-60)
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.
Measured: Day 0 and Day 60 (Day 60 evaluation will include all days from 0-60)
Secondary outcomes (13)
Patient Satisfaction
Measure of satisfaction (HCAHPS measure: Provider rating where 0 = worst provider possible and 10 = best provider possible)
Measured: Day 0, end of visit
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)
Measured: Day 0, end of visit
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)
Measured: Day 0, end of visit
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)
Measured: Day 0, end of visit
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.
Measured: Day 0, end of visit
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)
Measured: Day 0, end of visit
Overall Radiation Burden
Radiation burden from diagnostic imaging (numeric DLP from CT reports)
Measured: within 60 days from index ED visit
Trust in physician
Trust in physician scale (0-25 with 25 indicating higher trust in the physician)
Measured: Day 0, end of visit
ED revisits
Repeat visits to any Emergency Department
Measured: 60 days
Safety: missed diagnosis
High Risk Diagnoses with Complications, as previously described by Smith-Bindman.
Measured: 60 days from index ED visit
ED Length of Stay
Total minutes of ED stay
Measured: Day 0, end of visit
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)
Measured: Day 0, end of visit
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.
Measured: Day 0, end of visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start11 Dec 2019
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shared Decision-makingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Elizabeth Schoenfeld, MD, Baystate Medical Center
- Investigators
- Elizabeth Schoenfeld, MD, MS, Principal investigator, University of Massachusetts Medical School - Baystate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234035
- Sponsor's protocol ID
- BH-19-168
- Acronym
- ED-KSS
- Status last verified
- Jul 2024
- First submitted
- 2 Dec 2019
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan for data sharing. This could change.
Publications
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.
PubMed 33691760
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision-Making for the Promotion of Patient-Centered Imaging in the Emergency Department: Suspected Kidney Stones
- ClinicalTrials.gov ID
- NCT04234035
- Acronym / sponsor ID
- ED-KSS / BH-19-168
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared Decision-Making (via Decision Aid) | Experimental | Behavioral: Decision Aid, Other: Standardized Educational Material (informational pamphlet)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. |
| standardized educational intervention (pamphlet +usual care) | Active comparator | Other: Standardized Educational Material (informational pamphlet)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision AidDecision aid to facilitated shared decision-making | Behavioural | Shared Decision-Making (via Decision Aid) |
| Standardized Educational Material (informational pamphlet)Pamphlet with information about kidney stones | Other | Shared Decision-Making (via Decision Aid), standardized educational intervention (pamphlet +usual care) |
Primary outcome
Feasibility of study
Time frame: Up to 12 months
Is this study feasible? Investigators will record number of patients enrolled. An enrollment of at least three patients per month will indicate feasibility.
Fidelity
Time frame: Up to 12 months
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
Time frame: Measured at the end of the index visit. (Day 0)
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
Time frame: Day 0 and Day 60 (Day 60 evaluation will include all days from 0-60)
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
Time frame: Day 0 and Day 60 (Day 60 evaluation will include all days from 0-60)
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.
13 secondary outcomes
Patient Satisfaction
Time frame: Day 0, end of visit
Patient engagement
Time frame: Day 0, end of visit
Patient engagement
Time frame: Day 0, end of visit
Patient engagement
Time frame: Day 0, end of visit
Occurrence of SDM
Time frame: Day 0, end of visit
Occurrence of SDM
Time frame: Day 0, end of visit
Overall Radiation Burden
Time frame: within 60 days from index ED visit
Trust in physician
Time frame: Day 0, end of visit
ED revisits
Time frame: 60 days
Safety: missed diagnosis
Time frame: 60 days from index ED visit
ED Length of Stay
Time frame: Day 0, end of visit
Implementation Outcomes
Time frame: Day 0, end of visit
Qualitative evaluation
Time frame: Day 0, end of visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Background: PubMed 33691760Schoenfeld 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.
- Individual participant dataSharing planned: No. There is no current plan for data sharing. This could change.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Schoenfeld, MD, MS principal investigator
University of Massachusetts Medical School - Baystate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid and Standardized Educational Material (informational pamphlet) in people with Shared Decision-making and Kidney Stone, run by Baystate Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study (time frame: Up to 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04234035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.