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

Trial Summary

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 data supports the effectiveness of the treatment Visit Summaries + Audio Recordings for Chronic Disease Care?

Using patient audio recordings of medical visits can improve health care delivery and outcomes by helping doctors better understand patients' life situations, which can lead to more personalized care. ^{1 2 3 4 5}

How does the treatment 'Visit Summaries + Audio Recordings for Chronic Disease Care' differ from other treatments for chronic diseases?

This treatment is unique because it provides patients with audio recordings of their clinic visits and written visit information, which can enhance patient engagement and understanding by allowing them to revisit the information at their own pace. Unlike traditional treatments that focus solely on medication or physical interventions, this approach emphasizes improving communication and information retention for better chronic disease management. ^{4 5 6 7 8}

What is the purpose of this trial?

CHRONICLE is a randomized trial assessing the comparative effectiveness of providing written visit information via the patient portal (NOTES) versus NOTES plus visit audio recording (AUDIO) to older adult patients with chronic diseases on quality of life and other outcomes. During the trial, the team will also invite caregivers identified by patients to join the project.

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

Eligibility Criteria

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Implementation of a patient-collected audio recording audit & feedback quality improvement program to prevent contextual error: stakeholder perspective. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Remote symptom monitoring integrated into electronic health records: A systematic review. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Using voice to create inpatient progress notes: effects on note timeliness, quality, and physician satisfaction. [2022]

4. England 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. [2022]

5. England 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Provider Perspective on Being Recorded During Emergency Medicine Discharge Conversations. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

An Audio Personal Health Library of Clinic Visit Recordings for Patients and Their Caregivers (HealthPAL): User-Centered Design Approach. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The anatomy of clinical documentation: an assessment and classification of narrative note sections format and content. [2021]