Visit Summaries + Audio Recordings for Chronic Disease Care

(CHRONICLE Trial)

Recruiting at 2 trial locations

Overseen By Renata W. Yen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Schizophrenia, Substance-use disorders, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve the quality of life for older adults with long-term health issues. It compares two methods: providing patients with written visit notes versus offering both notes and audio recordings of their doctor visits. The goal is to determine which method better aids patients in managing their conditions. Suitable participants are those aged 65 or older with multiple chronic conditions, such as diabetes and arthritis, who have visited their doctor at least twice in the past year. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance patient care and management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, as the trial focuses on providing visit information and recordings.

What prior data suggests that these methods are safe for chronic disease care?

Research shows that sharing audio recordings of clinic visits with patients is generally considered feasible and acceptable. Patients feel comfortable with this practice and manage it well. However, its effectiveness compared to other types of care remains uncertain.

Studies on written visit information shared through patient portals have shown that patients often find these notes helpful and accurate. They understand them well and benefit from having access to their notes.

In summary, both audio and written notes treatments appear safe and well-tolerated by patients, according to previous research. No major safety concerns have been reported for either method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how visit summaries and audio recordings can enhance chronic disease care. Unlike standard care, which often relies on verbal communication alone, these methods aim to improve understanding and retention of medical information. The NOTES intervention provides written summaries, helping patients recall and follow medical advice more effectively. Meanwhile, the NOTES + AUDIO arm combines written notes with audio recordings of medical visits, potentially offering an even more comprehensive support system for patients to manage their conditions. This approach could lead to better patient engagement and adherence to treatment plans.

What evidence suggests that this trial's treatments could be effective for chronic disease care?

This trial will compare two methods of providing patients with information about their clinic visits. One arm will offer written visit information through online portals (NOTES). Studies have shown that this method helps patients understand their health better and prepare for appointments, potentially improving health outcomes and healthcare efficiency. The other arm will provide both written information and audio recordings of clinic visits (NOTES + AUDIO). Research indicates that sharing audio recordings can help patients manage chronic conditions better by improving self-care and health results. Both methods aim to give patients a clearer understanding of their health, with each offering different strengths to enhance quality of life. ^{1 2 3 5 6}

Who Is on the Research Team?

Paul J Barr, PhD

Principal Investigator

Dartmouth College

Kerri L Cavanaugh, MD

Principal Investigator

Vanderbilit University Medical Center

Meredith C Masel, PhD

Principal Investigator

University Texas Medical Branch

Are You a Good Fit for This Trial?

This trial is for older adults (65+) with chronic diseases like high blood pressure or diabetes, plus another condition. They must have used the clinic twice in the last year and plan to continue there. Caregivers can join if they're over 18 and speak English or Spanish. Excluded are those with severe mental health issues, no internet/email access, or who live in nursing homes/hospice.

Inclusion Criteria

Patients must have had two or more clinic visits in the previous 12 months

I, as a caregiver, can legally agree to participate in research.

I have diabetes or hypertension and at least one other listed condition.

Exclusion Criteria

Patients with cognitive impairment as identified by a score of ≤3 on the six-item screener (SIS)

You live in a skilled nursing home or hospice.

I do not have an email and am not willing to create one for this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are assigned to either the NOTES or NOTES + AUDIO group and receive guidance on using visit notes and audio recordings.

6 months

Regular visits as per primary care schedule

Follow-up

Participants are monitored for changes in quality of life, satisfaction, self-management ability, treatment adherence, and visit communication.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• AUDIO
• NOTES

Trial Overview

The CHRONICLE study compares two methods: providing patients written summaries of their visits via a portal (NOTES) versus adding audio recordings of the visits (AUDIO). It aims to see which method better improves quality of life for older adults managing chronic illnesses.

How Is the Trial Designed?

Group I: NOTES Active Control 1 Intervention

Patients in this arm will receive only the NOTES intervention.

Group II: NOTES + AUDIO Active Control 2 Interventions

Patients in this arm will receive both the NOTES and AUDIO intervention.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

The University of Texas Medical Branch, Galveston

Collaborator

Trials

263

Recruited

55,400+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

A survey of 57 emergency department providers revealed that only 35% believed patients should have the right to record medical conversations, indicating a general discomfort with the idea of being recorded during patient encounters.

The primary concern among providers (63%) was potential legal liability, suggesting that fears of legal repercussions and HIPAA violations are significant barriers to adopting audio or video recordings as standard practice in emergency care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider Perspective on Being Recorded During Emergency Medicine Discharge Conversations. Meier, N., Little, A., Morales-Yurik, T., et al.[2022]

HealthPAL is a user-centered audio personal health library designed to help patients and caregivers access and navigate recordings of clinic visits, with key information automatically tagged for easier understanding.

The development involved 40 participants, primarily older adults, and resulted in a user-friendly interface that received positive feedback, indicating it could enhance patient engagement and self-management in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Audio Personal Health Library of Clinic Visit Recordings for Patients and Their Caregivers (HealthPAL): User-Centered Design Approach. Barr, PJ., Haslett, W., Dannenberg, MD., et al.[2022]

A study involving 27 patients with poorly controlled diabetes revealed that 89% found their clinic notes useful, indicating a positive perception of electronic access to medical information.

Patients expressed a desire for more detailed notes and identified issues like medical jargon and inaccuracies in templated notes, highlighting areas for improvement in communication between healthcare providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' perceptions of their doctors' notes and after-visit summaries: A mixed methods study of patients at safety-net clinics. Belyeu, BM., Klein, JW., Reisch, LM., et al.[2021]

Primary care visit notes are significantly longer than specialty care notes, with the history of present illness (HPI) averaging 187 words compared to 119 words in specialty care, and the impression and plan (IP) averaging 270 words versus 170 words, indicating a more detailed documentation in primary care.

A taxonomy of narrative note content was developed, identifying 45 different types of data communicated, which can inform the design of more efficient electronic health record systems and improve clinical documentation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The anatomy of clinical documentation: an assessment and classification of narrative note sections format and content. Colicchio, TK., Dissanayake, PI., Cimino, JJ.[2021]

The study evaluated a voice-generated electronic note system (VGEENS) for creating hospital progress notes, but found no significant improvements in note timeliness, quality, or physician satisfaction compared to traditional methods, despite intervention subjects creating 709 notes and control subjects 1143 notes.

While the VGEENS system allows for near-real-time note availability within 10 minutes of patient rounds, the early development stage of the system and the short trial duration may have impacted its effectiveness and user satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using voice to create inpatient progress notes: effects on note timeliness, quality, and physician satisfaction. Payne, TH., Alonso, WD., Markiel, JA., et al.[2022]

Patients and clinicians find electronic health record (EHR)-generated after-visit summaries (AVSs) valuable for summarizing health visits, but both groups suggest improvements in content organization and clarity, such as preferring a single 'current' medication list.

Concerns about patient privacy and clinician workflow challenges were highlighted, indicating that while AVSs are useful, their effectiveness can be hindered by these issues, suggesting a need for collaboration between EHR vendors and stakeholders to enhance their utility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and clinician perspectives on the outpatient after-visit summary: a qualitative study to inform improvements in visit summary design. Federman, AD., Sanchez-Munoz, A., Jandorf, L., et al.[2022]

The systematic review identified 12 studies on electronic health record (EHR)-integrated systems for remote symptom reporting in patients with long-term conditions, with most systems being fully integrated and allowing for regular symptom tracking between visits.

Despite the potential benefits of improved communication and health outcomes, there is currently limited evidence that these systems actually enhance patient care, highlighting the need for more robust studies to evaluate their efficacy and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote symptom monitoring integrated into electronic health records: A systematic review. Gandrup, J., Ali, SM., McBeth, J., et al.[2021]

The implementation of a patient-collected audio quality improvement program over three years showed that clinicians initially worried about the program being disruptive, but these concerns decreased as they recognized the value of constructive feedback, leading to increased confidence in the intervention's benefits.

Patients generally viewed the audio recordings positively, seeing them as a way to enhance care, despite some initial concerns about privacy; overall, the program was perceived as safe and beneficial for improving healthcare delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a patient-collected audio recording audit & feedback quality improvement program to prevent contextual error: stakeholder perspective. Ball, SL., Weiner, SJ., Schwartz, A., et al.[2021]

Citations

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pcori.org

pcori.org/research-results/2022/comparing-effectiveness-sharing-audio-recordings-clinic-visits-visit-notes-alone-quality-life-among-older-adults-multiple-chronic-conditions-primary-care

Comparing the Effectiveness of Sharing Audio Recordings ...

This study compares the effectiveness of clinic notes with and without an audio recording of the clinical visit on quality of life among older ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11708983/

Audio-Based Care for Managing Chronic Conditions in ...

We generally found low to very low certainty of evidence of comparable effectiveness in the use of audio-based care to replace other care.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04344301

The Impact of Sharing Audio Recorded Clinic Visits on Self ...

1.3 Potential effectiveness by collecting data on the impact of audio recordings on self-management, health-related outcomes, healthcare utilization, and ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0738399124004415

The feasibility of sharing digital audio-recordings of clinic ...

The objective of this trial was to determine the feasibility, acceptability, and preliminary effectiveness of sharing audio recordings of primary care visits ...

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opennotes.org

opennotes.org/news/research-team-to-study-audio-recordings-as-way-of-sharing-medical-visit-information-with-older-adults/

Research team to study audio recordings as way of sharing ...

The CHRONICLE Trial will study audio recordings as method of sharing clinic visit information with older adults.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10100602/

Telehealth for Chronic Disease Management Among ...

Medicaid patients were 8% less likely to use telehealth and 21% more likely to have audio visits when compared to Medicare patients. The ...