SHARE Approach Evaluation

Shared Decision Making Clinical Trial

Official title:

SHARE Approach Evaluation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06062940
• Other study ID #: 19-3053
• Status: Active, not recruiting
• Start date: August 1, 2019
• Est. completion date: November 30, 2023

Study information

• Verified date: September 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The SHARE Approach Evaluation study was meant to evaluate the SHARE Approach, designed by AHRQ and UCD. The SHARE Approach is a training program for clinicians on shared decision making.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 176
• Est. completion date: November 30, 2023
• Est. primary completion date: March 30, 2023
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Shared Decision Making

Intervention

Behavioral:
• SHARE Approach
The SHARE Approach training was given at each of these centers, teaching skills to clinicians about shared decision making.

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usefulness of the SHARE Approach training	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.	up to 1 day post-training
Primary	Usefulness of the SHARE Approach training	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.	2 months post-training
Primary	Ability to engage in shared decision making	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.	up to 1 day post-training
Primary	Ability to engage in shared decision making	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.	2 months post-training
Primary	Overall evaluation of the SHARE Approach	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.	up to 1 day post-training
Primary	Overall evaluation of the SHARE Approach	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.	2 months post-training
Primary	Confidence in doing 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.	up to 6 months pre-training
Primary	Confidence in doing 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.	2 months post-training
Primary	Confidence in doing 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.	up to 6 months post-training
Primary	Confidence in understanding shared decision making	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.	up to 6 months pre-training
Primary	Confidence in understanding shared decision making	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.	up to 6 months post-training
Primary	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.	up to 6 months pre-training
Primary	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.	up to 6 months post-training
Primary	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.	up to 6 months pre-training
Primary	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.	up to 6 months post-training
Primary	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.	up to 6 months pre-training
Primary	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.	up to 24 hours post-training
Primary	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.	2 months post-training
Primary	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.	up to 6 months pre-training
Primary	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 scale. Higher scores reflected better experiences of shared decision making, whereas lower scores reflected poorer experiences of shared decision making.	up to 24 hours post-training
Primary	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.	2 months post-training
Primary	Shared Decision Making (highest score)	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.	At clinic visit, up to 12 months post-training
Secondary	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.	At clinic visit, up to 12 months post-training