NCT02390570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2017

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

February 19, 2015

Last Update Submit

January 7, 2019

Conditions

Chronic Disease

Keywords

Patient Capacity

Outcome Measures

Primary Outcomes (1)

  • Number of resource limitations measured by medical record review

    Baseline up to 18 months

Study Arms (1)

Implementation Arm

EXPERIMENTAL
Other: Patient Capacity Assessment Instrument

Interventions

Patient Capacity Assessment InstrumentOTHER

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

Implementation Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 31481553DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kasey Boehmer, MPH

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Health Services Analyst

Study Record Dates

First Submitted

February 19, 2015

First Posted

March 17, 2015

Study Start

September 1, 2015

Primary Completion

February 22, 2017

Study Completion

December 1, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations

US(1)