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Improving Communication About Patient Priorities in Multimorbidity (ICOM-APP)

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Customized Care
Care As Usual
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Disease focused on measuring Multimorbidity, Communication, Primary Care, Mental Health

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients attending a primary care clinic for routine follow-up care
  • age 40 or older
  • diagnosed with 2 or more chronic medical conditions including: diabetes, heart disease, arthritis, asthma, COPD
  • positive screen for symptoms of depression and/or anxiety

Exclusion Criteria:

  • non-English speakers
  • patients with a diagnosis of dementia or cognitive deficit
  • patients with acute medical needs requiring urgent treatment

Sites / Locations

  • Highland Family Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Care As Usual

Customized Care

Arm Description

Before the office visit with the PCP, patient participants in the Care As Usual arm will interact with the research staff who will help the participant use an iPad in the waiting room to complete baseline health assessments. Consented patient-participants will be told that the subsequent office visit with the PCP will be audio-recorded to assess patient-PCP communication.

Before the office visit with the PCP, patient participants in the intervention group will interact with the computer based components of the customized care intervention while in the waiting room. The research staff will help the participant use an iPad in the waiting room and direct them to the Discussion Prioritization tool (DPT). After participants use the DPT, the program automatically generates a customized questions prompt list (QPL) which will be printed out in the office. Study staff will hand the QPL to intervention patients to bring to their office visit with the PCP. Consented patient-participants will be told that the subsequent office visit with the PCP will be audio-recorded to assess patient-PCP communication.

Outcomes

Primary Outcome Measures

Patient-PCP communication
After the patient completes the experimental or active comparator intervention on the iPad, the patient will proceed with their office visit. The subsequent conversations between the patient and PCP will be audio-recorded and transcribed. We will use a coding scheme to measure communication during the patient-PCP office visit.

Secondary Outcome Measures

Full Information

First Posted
March 19, 2014
Last Updated
April 24, 2018
Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02100982
Brief Title
Improving Communication About Patient Priorities in Multimorbidity
Acronym
ICOM-APP
Official Title
Developing a Customized Care Intervention to Improve Mental Health Outcomes in Multimorbidity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
April 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this study is to develop and test Customized Care, an intervention to help patients dealing with depression and/or anxiety in the context of multiple chronic conditions. Customized Care is designed to help patients communicate about important issues, such as financial and safety concerns, with their primary care providers (PCPs). The intervention will be delivered in patient waiting rooms prior to a routine follow-up visit with the PCP. Phase 1 of the project will ensure that the main components of Customized Care are acceptable to patients and PCPs. Phase 2 will include a pilot study to test the effects of Customized Care on patient-PCP communication. Participants aged 40 years or older who have a diagnosis of two or more common chronic medical conditions will be recruited from primary care clinics. Patients screening positive for either depression or anxiety will be randomized to Customized Care vs. an active control. The investigators hypothesize that the Customized Care will improve patient-Primary Care-Provider communication.
Detailed Description
Patients with depression or anxiety in the context of multimorbidity (2 or more chronic conditions such as Diabetes, Heart Disease, Arthritis, COPD, Asthma) are often preoccupied with day-to-day concerns related to issues such as finances, safety and functional ability. Determining which issues to discuss, and when to discuss it, is always difficult in the 15-minute primary care visit, but it is especially challenging when patients have multiple diagnoses, symptoms and concerns. In this application the investigators will develop and test the feasibility of Customized Care, an intervention that capitalizes on decision technology and will be deployed in primary care waiting rooms. The investigators will assess whether customized care will improve outcomes among patients with depression and/or anxiety in the context of multimorbidity. Customized Care consists of two different components designed to improve health outcomes by improving patient-provider communication. The first component is a computer-based discussion prioritization tool (DPT). The DPT forces patients to make trade-offs between competing concerns to help them determine which are the most important to discuss. The second component is a customized question prompt list (QPL) to help patients communicate their priorities to the PCP. The QPL will be generated after patients use the DPT, and consists of question prompts tailored to the patients' priorities. When patients express their day-to-day concerns, and PCPs become aware of these concerns, the patient-provider alliance can deepen. In addition, patient motivation (perceived autonomy, competence) to manage those everyday concerns and engage in care for chronic disease and associated mental health conditions will increase. This project will lay the ground work for a larger randomized trial to assess whether customized care can improve mental health outcomes among patients with multimorbidity. The specific aims are: To assess usability of the Customized Care components (the DPT and QPL) To assess feasibility of Customized Care in primary care settings To conduct a pilot study of the effects of Customized Care on patient-PCP communication

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Multimorbidity, Communication, Primary Care, Mental Health

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Customized Care (intervention) vs. care as usual
Masking
Participant
Masking Description
Participants in both arms use iPad to complete assessments, Customized Care (intervention arm) receives intervention on iPad, care as usual completes assessments only
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Care As Usual
Arm Type
Other
Arm Description
Before the office visit with the PCP, patient participants in the Care As Usual arm will interact with the research staff who will help the participant use an iPad in the waiting room to complete baseline health assessments. Consented patient-participants will be told that the subsequent office visit with the PCP will be audio-recorded to assess patient-PCP communication.
Arm Title
Customized Care
Arm Type
Experimental
Arm Description
Before the office visit with the PCP, patient participants in the intervention group will interact with the computer based components of the customized care intervention while in the waiting room. The research staff will help the participant use an iPad in the waiting room and direct them to the Discussion Prioritization tool (DPT). After participants use the DPT, the program automatically generates a customized questions prompt list (QPL) which will be printed out in the office. Study staff will hand the QPL to intervention patients to bring to their office visit with the PCP. Consented patient-participants will be told that the subsequent office visit with the PCP will be audio-recorded to assess patient-PCP communication.
Intervention Type
Other
Intervention Name(s)
Customized Care
Intervention Description
Customized Care consists of two components. The first component is a Discussion Prioritization Tool (DPT) which forces patients to make trade-offs between competing concerns to help them determine which are the most important to discuss. The second component is a customized question prompt list (QPL) to help patients communicate their priorities to the PCP. The QPL will be generated after patients use the DPT, and consists of question prompts tailored to the patients' priorities. Consented patient-participants will be told that the subsequent office visit with the PCP will be audio-recorded to assess patient-PCP communication.
Intervention Type
Other
Intervention Name(s)
Care As Usual
Intervention Description
Participants in this condition will interact with the research staff who will help the participant use an iPad in the waiting room to complete baseline health assessments. Consented patient-participants will be told that the subsequent office visit with the PCP will be audio-recorded to assess patient-PCP communication.
Primary Outcome Measure Information:
Title
Patient-PCP communication
Description
After the patient completes the experimental or active comparator intervention on the iPad, the patient will proceed with their office visit. The subsequent conversations between the patient and PCP will be audio-recorded and transcribed. We will use a coding scheme to measure communication during the patient-PCP office visit.
Time Frame
from the beginning to the end of the patient-PCP office visit, average duration of 20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients attending a primary care clinic for routine follow-up care age 40 or older diagnosed with 2 or more chronic medical conditions including: diabetes, heart disease, arthritis, asthma, COPD positive screen for symptoms of depression and/or anxiety Exclusion Criteria: non-English speakers patients with a diagnosis of dementia or cognitive deficit patients with acute medical needs requiring urgent treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marsha N Wittink, MD, MBE
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Highland Family Medicine
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available on request once cleaned and initial analyses by primary team are completed.
Citations:
PubMed Identifier
28191546
Citation
Wittink MN, Yilmaz S, Walsh P, Chapman B, Duberstein P. Customized Care: An intervention to Improve Communication and health outcomes in multimorbidity. Contemp Clin Trials Commun. 2016 Dec 15;4:214-221. doi: 10.1016/j.conctc.2016.10.002. Epub 2016 Oct 11.
Results Reference
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PubMed Identifier
28844522
Citation
Wittink MN, Walsh P, Yilmaz S, Mendoza M, Street RL Jr, Chapman BP, Duberstein P. Patient priorities and the doorknob phenomenon in primary care: Can technology improve disclosure of patient stressors? Patient Educ Couns. 2018 Feb;101(2):214-220. doi: 10.1016/j.pec.2017.08.004. Epub 2017 Aug 8.
Results Reference
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Improving Communication About Patient Priorities in Multimorbidity

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