Shared Decision MakingNCT06062940
SHARE Approach Evaluation
An observational study of Shared Decision Making, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The SHARE Approach Evaluation study was meant to evaluate the SHARE Approach, designed by AHRQ and updated by UCD. The SHARE Approach is a training program for clinicians on shared decision making. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Shared Decision Making
- What is being tested?
- SHARE Approach
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 30 Nov 2023
- Phase
- Observational
- 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 89 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Children
- Decisionally challenged
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
The SHARE Approach Evaluation study was meant to evaluate the SHARE Approach, designed by AHRQ and updated by UCD. The SHARE Approach is a training program for clinicians on shared decision making.
Read the detailed description
This research group has been selected by the Agency for Healthcare Research and Quality (AHRQ) to evaluate its SHARE Approach Model. This model is designed to improve shared-decision making (SDM) between providers and patients, and teaches clinicians skills that are applicable to SDM in the context of preference-sensitive treatment choice and problem-solving. It remains one of the only freely available SDM toolkits that provides clinician-facing resources for comprehensive SDM training. This study will assess the effectiveness of the SHARE model training using training evaluation surveys, card survey data with providers who have received the SHARE training, and their patients, and audio recordings of clinician/patient encounters. The training and evaluations will be done at a total of 12 health care practices (10 primary care practices and 2 cardiology practices). All research data will be de-identified and kept confidential.
- Conditions
- Shared Decision Making
- Being tested
- SHARE Approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHARE ApproachBehavioural
The SHARE Approach training was given at each of these centers, teaching skills to clinicians about shared decision making.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SHARE Approach | |
| 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. Receives: Behavioral: SHARE Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician training evaluation: Confidence in ability to do shared decision making
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.
Measured: pre-training, post-training, 2-month follow-up
Clinician training evaluation: Confidence in understanding what shared decision making is
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.
Measured: pre-training, post-training
Card survey: Clinician satisfaction with encounter
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.
Measured: pre-training, 1 month post-training, 6 month follow-up
Card survey: Patient satisfaction with encounter
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.
Measured: pre-training, 1 month post-training, 6 month follow-up
Card survey: Clinician shared decision making (self-reported)
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.
Measured: pre-training, 1 month post-training, 6 month follow-up
Card survey: Patient shared decision making (self-reported)
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.
Measured: pre-training, 1 month post-training, 6 month follow-up
Audio recordings: Shared Decision Making (highest score of topics discussed)
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.
Measured: pre-training, 1 month post-training, 6 month follow-up
Clinician training evaluation: Overall evaluation of the SHARE training
clinicians answered the question: Overall, what was your experience of the training you received today. Likert rating scale was "Very positive" to "Very negative"
Measured: post-training
Secondary outcomes (1)
Shared Decision Making (total score)
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.
Measured: pre-training, 1 month post-training, 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Aug 2019
- Primary completion30 Mar 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shared Decision MakingStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Laura Scherer, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062940
- Sponsor's protocol ID
- 19-3053
- Status last verified
- Aug 2024
- First submitted
- 7 Sep 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHARE Approach Evaluation
- ClinicalTrials.gov ID
- NCT06062940
- Acronym / sponsor ID
- 19-3053
- Conditions
- Shared Decision Making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 2 Oct 2023 (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.
The SHARE Approach Evaluation study was meant to evaluate the SHARE Approach, designed by AHRQ and updated by UCD. The SHARE Approach is a training program for clinicians on shared decision making.
Detailed description
This research group has been selected by the Agency for Healthcare Research and Quality (AHRQ) to evaluate its SHARE Approach Model. This model is designed to improve shared-decision making (SDM) between providers and patients, and teaches clinicians skills that are applicable to SDM in the context of preference-sensitive treatment choice and problem-solving. It remains one of the only freely available SDM toolkits that provides clinician-facing resources for comprehensive SDM training. This study will assess the effectiveness of the SHARE model training using training evaluation surveys, card survey data with providers who have received the SHARE training, and their patients, and audio recordings of clinician/patient encounters. The training and evaluations will be done at a total of 12 health care practices (10 primary care practices and 2 cardiology practices). All research data will be de-identified and kept confidential.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Care Practice | – | Behavioral: SHARE ApproachWe 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. |
| Cardiology Practice | – | Behavioral: SHARE ApproachWe 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Children
- Decisionally challenged
- Prisoners
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 |
|---|---|---|
| SHARE ApproachThe SHARE Approach training was given at each of these centers, teaching skills to clinicians about shared decision making. | Behavioural | Cardiology Practice, Primary Care Practice |
Primary outcome
Clinician training evaluation: Confidence in ability to do shared decision making
Time frame: pre-training, post-training, 2-month follow-up
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.
Clinician training evaluation: Confidence in understanding what shared decision making is
Time frame: pre-training, post-training
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.
Card survey: Clinician satisfaction with encounter
Time frame: pre-training, 1 month post-training, 6 month follow-up
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.
Card survey: Patient satisfaction with encounter
Time frame: pre-training, 1 month post-training, 6 month follow-up
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.
Card survey: Clinician shared decision making (self-reported)
Time frame: pre-training, 1 month post-training, 6 month follow-up
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.
Card survey: Patient shared decision making (self-reported)
Time frame: pre-training, 1 month post-training, 6 month follow-up
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.
Audio recordings: Shared Decision Making (highest score of topics discussed)
Time frame: pre-training, 1 month post-training, 6 month follow-up
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.
Clinician training evaluation: Overall evaluation of the SHARE training
Time frame: post-training
clinicians answered the question: Overall, what was your experience of the training you received today. Likert rating scale was "Very positive" to "Very negative"
1 secondary outcome
Shared Decision Making (total score)
Time frame: pre-training, 1 month post-training, 6 month follow-up
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 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Laura Scherer, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shared Decision Making, run by University of Colorado, Denver 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 3 inclusion and 3 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 Aug 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?
Clinician training evaluation: Confidence in ability to do shared decision making (time frame: pre-training, post-training, 2-month follow-up). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2024.