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OpenTrials
Completed

NCT Number: NCT02100982

Improving Communication About Patient Priorities in Multimorbidity

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.

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Key information

Conditions

Chronic Disease Behavior Communication Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Highland Family Medicine

Rochester, New York, 14620, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Customized Care

Other

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.

Care as usual

Other

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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Developing a Customized Care Intervention to Improve Mental Health Outcomes in Multimorbidity

Acronym: ICOM-APP

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Apr 1, 2014
Registry last updated
Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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