- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06062940
SHARE Approach Evaluation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Population to be enrolled include clinicians and any practice staff who participate in the SHARE Approach training in 12 practices to be recruited across Colorado.
Patients will also be enrolled for the card surveys and audio recordings if they are meeting with a clinician who has taken the SHARE Approach training.
Description
Inclusion Criteria:
- Population to be enrolled include clinicians and any practice staff who participate in the SHARE Approach training in 12 practices to be recruited across Colorado.
- Patients will also be enrolled for the card surveys and audio recordings if they are meeting with a clinician who has taken the SHARE Approach training.
- 18 to 89 years old
Exclusion Criteria:
- Children
- Decisionally challenged
- Prisoners
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Primary Care Practice
We recruited 10 primary care practices from across Colorado, from all regions of the state (e.g., Eastern Plains, Mountain West, Front Range), and a mix of rural and urban practices of varying sizes.
We recruited both practice staff and patients for this cohort.
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The SHARE Approach training was given at each of these centers, teaching skills to clinicians about shared decision making.
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Cardiology Practice
We recruited 2 cardiology practices from across Colorado, from all regions of the state (e.g., Eastern Plains, Mountain West, Front Range), and a mix of rural and urban practices of varying sizes.
We recruited both practice staff and patients for this cohort.
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The SHARE Approach training was given at each of these centers, teaching skills to clinicians about shared decision making.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usefulness of the SHARE Approach training
Time Frame: up to 1 day post-training
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Usefulness of the SHARE approach training will be measured using a training evaluation survey question that asks participants how useful they found the SHARE approach.
Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.
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up to 1 day post-training
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Usefulness of the SHARE Approach training
Time Frame: 2 months post-training
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Usefulness of the SHARE approach training will be measured using a training evaluation survey question that asks participants how useful they found the SHARE approach.
Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.
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2 months post-training
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Ability to engage in shared decision making
Time Frame: up to 1 day post-training
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Engagement of Shared Decision Making from the SHARE approach training will be measured using a training evaluation survey question that asks participants how able they feel to engage in shared decision making after the SHARE approach training.
Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.
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up to 1 day post-training
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Ability to engage in shared decision making
Time Frame: 2 months post-training
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Engagement of Shared Decision Making from the SHARE approach training will be measured using a training evaluation survey question that asks participants how able they feel to engage in shared decision making after the SHARE approach training.
Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.
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2 months post-training
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Overall evaluation of the SHARE Approach
Time Frame: up to 1 day post-training
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Overall evaluation of the SHARE approach training will be measured using a training evaluation survey question that asks participants whether they would positively or negatively evaluate the SHARE approach.
Possible scores range from 1 to 5, with lower scores indicating more negative values and higher scores indicating more positive values.
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up to 1 day post-training
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Overall evaluation of the SHARE Approach
Time Frame: 2 months post-training
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Overall evaluation of the SHARE approach training will be measured using a training evaluation survey question that asks participants whether they would positively or negatively evaluate the SHARE approach.
Possible scores range from 1 to 5, with lower scores indicating more negative values and higher scores indicating more positive values.
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2 months post-training
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Confidence in doing shared decision making
Time Frame: up to 6 months pre-training
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Clinician confidence in doing shared decision making was measured by a brief card survey question with a 5 point Likert scale.
Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.
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up to 6 months pre-training
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Confidence in doing shared decision making
Time Frame: 2 months post-training
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Clinician confidence in doing shared decision making was measured by a brief card survey question with a 5 point Likert scale.
Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.
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2 months post-training
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Confidence in doing shared decision making
Time Frame: up to 6 months post-training
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Clinician confidence in doing shared decision making was measured by a brief card survey question with a 5 point Likert scale.
Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.
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up to 6 months post-training
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Confidence in understanding shared decision making
Time Frame: up to 6 months pre-training
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Clinician confidence in understanding shared decision making was measured by a brief card survey question with a 5 point Likert scale.
Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.
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up to 6 months pre-training
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Confidence in understanding shared decision making
Time Frame: up to 6 months post-training
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Clinician confidence in understanding shared decision making was measured by a brief card survey question with a 5 point Likert scale.
Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.
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up to 6 months post-training
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Clinician satisfaction with encounter
Time Frame: up to 6 months pre-training
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Clinician satisfaction with encounter was measured by a brief card survey question with a 5 point Likert scale.
Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.
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up to 6 months pre-training
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Clinician satisfaction with encounter
Time Frame: up to 6 months post-training
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Clinician satisfaction with encounter was measured by a brief card survey question with a 5 point Likert scale.
Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.
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up to 6 months post-training
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Patient satisfaction with encounter
Time Frame: up to 6 months pre-training
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Patient satisfaction with encounter was measured by a brief card survey question with a 5 point Likert scale.
Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.
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up to 6 months pre-training
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Patient satisfaction with encounter
Time Frame: up to 6 months post-training
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Patient satisfaction with encounter was measured by a brief card survey question with a 5 point Likert scale.
Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.
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up to 6 months post-training
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Clinician shared decision making (self-reported)
Time Frame: up to 6 months pre-training
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After clinician/patient encounters, clinicians were asked to fill out a brief card survey rating shared decision making that occurred during the encounter.
These include questions from the Dyadic OPTION (observing patient involvement in decision making) scale.
Higher scores reflected better experiences of shared decision making, whereas lower scores reflected poorer experiences of shared decision making.
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up to 6 months pre-training
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Clinician shared decision making (self-reported)
Time Frame: up to 24 hours post-training
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After clinician/patient encounters, clinicians were asked to fill out a brief card survey rating shared decision making that occurred during the encounter.
These include questions from the Dyadic OPTION (observing patient involvement in decision making) scale.
Higher scores reflected better experiences of shared decision making, whereas lower scores reflected poorer experiences of shared decision making.
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up to 24 hours post-training
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Clinician shared decision making (self-reported)
Time Frame: 2 months post-training
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After clinician/patient encounters, clinicians were asked to fill out a brief card survey rating shared decision making that occurred during the encounter.
These include questions from the Dyadic OPTION (observing patient involvement in decision making) scale.
Higher scores reflected better experiences of shared decision making, whereas lower scores reflected poorer experiences of shared decision making.
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2 months post-training
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Patient shared decision making (self-reported)
Time Frame: up to 6 months pre-training
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After clinician/patient encounters, patients were asked to fill out a brief card survey rating their experiences with shared decision making during the encounter.
These included questions modified from the Dyadic OPTION (observing patient involvement in decision making) scale.
Higher scores reflected better experiences of shared decision making, whereas lower scores reflected poorer experiences of shared decision making.
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up to 6 months pre-training
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Patient shared decision making (self-reported)
Time Frame: up to 24 hours post-training
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After clinician/patient encounters, patients were asked to fill out a brief card survey rating their experiences with shared decision making during the encounter.
These included questions modified from the Dyadic OPTION scale.
Higher scores reflected better experiences of shared decision making, whereas lower scores reflected poorer experiences of shared decision making.
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up to 24 hours post-training
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Patient shared decision making (self-reported)
Time Frame: 2 months post-training
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After clinician/patient encounters, patients were asked to fill out a brief card survey rating their experiences with shared decision making during the encounter.
These included questions modified from the Dyadic OPTION (observing patient involvement in decision making) scale.
Higher scores reflected better experiences of shared decision making, whereas lower scores reflected poorer experiences of shared decision making.
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2 months post-training
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Shared Decision Making (highest score)
Time Frame: At clinic visit, up to 12 months post-training
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A subset of clinician/patient encounters were audio recorded, and then coded using a modified OPTION (observing patient involvement in decision making) 12 coding schema for elements of shared decision making occurring within the encounter.
As a primary outcome, we selected the highest-scored topic discussed in each encounter.
Higher scores reflected better experiences of shared decision making, whereas lower scores reflected poorer experiences of shared decision making.
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At clinic visit, up to 12 months post-training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shared Decision Making (total score)
Time Frame: At clinic visit, up to 12 months post-training
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Clinician/patient encounters were audio recorded, and then coded using a modified OPTION (observing patient involvement in decision making) 12 coding schema for different elements of shared decision making within the encounter. The secondary outcome was the total score for each encounter, which averaged across scores for all topics discussed. Higher scores reflected better experiences of shared decision making, whereas lower scores reflected poorer experiences of shared decision making. |
At clinic visit, up to 12 months post-training
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laura Scherer, PhD, University of Colorado, Denver
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19-3053
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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