Incorporating Patient Capacity Into the Clinical Landscape

• ClinicalTrials.gov Identifier: NCT02390570
• Recruitment Status: Completed
• First Posted: March 17, 2015
• Last Update Posted: January 9, 2019
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Kasey R. Boehmer, Mayo Clinic

Tracking Information

• First Submitted Date: February 19, 2015
• First Posted Date: March 17, 2015
• Last Update Posted Date: January 9, 2019
• Actual Study Start Date: September 2015
• Actual Primary Completion Date: February 22, 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 16, 2015): Number of resource limitations measured by medical record review [ Time Frame: Baseline up to 18 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Incorporating Patient Capacity Into the Clinical Landscape
• Official Title: Incorporating Patient Capacity Into the Clinical Landscape

Brief Summary

This study is designed to answer why "patient capacity" (i.e. patient available abilities and resources to enact self-care and access healthcare) is not regularly documented in the Electronic Medical Record (EMR) in a way that is useful for clinicians.

Through the implementation of communication tools designed for patient capacity assessment and engagement of stakeholders in a process of user-centered design, the study team hypothesizes that the study can help clinicians elicit this information in conversation and regularly document it in the medical record for future healthcare discussions.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Chronic Disease

Intervention

Other: Patient Capacity Assessment Instrument

The Patient Capacity Assessment instrument is a conversational tool designed to help patients and clinicians discuss capacity in clinicial conversations of primary care.

Study Arms

Experimental: Implementation Arm

Intervention: Other: Patient Capacity Assessment Instrument

• Publications *: Boehmer KR, Dobler CC, Thota A, Branda M, Giblon R, Behnken E, Organick P, Allen SV, Shaw K, Montori VM. Changing conversations in primary care for patients living with chronic conditions: pilot and feasibility study of the ICAN Discussion Aid. BMJ Open. 2019 Sep 3;9(9):e029105. doi: 10.1136/bmjopen-2019-029105.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 7, 2019): 111
• Original Estimated Enrollment (submitted: March 16, 2015): 490
• Actual Study Completion Date: December 2018
• Actual Primary Completion Date: February 22, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients who have one or more chronic condition and do not have any barriers to consent (such as major cognitive disabilities) will be eligible for enrollment.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02390570
• Other Study ID Numbers: 14-008621
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Kasey R. Boehmer, Mayo Clinic
• Original Responsible Party: Same as current
• Current Study Sponsor: Mayo Clinic
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kasey Boehmer, MPH; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: January 2019