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

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ClinicalTrials.gov Identifier: NCT02100982
Recruitment Status : Completed
First Posted : April 1, 2014
Last Update Posted : April 26, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Marsha Wittink, University of Rochester

Tracking Information
First Submitted Date  ICMJE March 19, 2014
First Posted Date  ICMJE April 1, 2014
Last Update Posted Date April 26, 2018
Study Start Date  ICMJE June 2015
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
Patient-PCP communication [ Time Frame: from the beginning to the end of the patient-PCP office visit, average duration of 20 minutes ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
Patient centered communication [ Time Frame: from the beginning to the end of the patient-PCP office visit, average duration of 20 minutes ]
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 the Measure of Patient Centered Communication (MPCC), a validated observational measure, to rate patient centered communication during of the patient-PCP office visit.
Change History Complete list of historical versions of study NCT02100982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Communication About Patient Priorities in Multimorbidity
Official Title  ICMJE Developing a Customized Care Intervention to Improve Mental Health Outcomes in Multimorbidity
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:

  1. To assess usability of the Customized Care components (the DPT and QPL)
  2. To assess feasibility of Customized Care in primary care settings
  3. To conduct a pilot study of the effects of Customized Care on patient-PCP communication
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Customized Care (intervention) vs. care as usual
Masking: Single (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
Primary Purpose: Other
Condition  ICMJE Chronic Disease
Intervention  ICMJE
  • Other: Customized Care
    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.
  • Other: Care As Usual
    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.
Study Arms  ICMJE
  • Care As Usual
    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.
    Intervention: Other: Care As Usual
  • Experimental: Customized Care
    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: Other: Customized Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2017)
60
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2014)
70
Actual Study Completion Date  ICMJE April 24, 2018
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02100982
Other Study ID Numbers  ICMJE MH101236
5R34MH101236 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be made available on request once cleaned and initial analyses by primary team are completed.
Responsible Party Marsha Wittink, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Marsha N Wittink, MD, MBE University of Rochester
PRS Account University of Rochester
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP