The Impact of Sharing Audio Recorded Clinic Visits on Self-management in Older Adults

Browse trials for

• Diabetes Mellitus 10,925
• Hypertension 6,689

Keywords

• Audio recording
• Diabetes Mellitus
• Hypertension
• Patient-centered communication
• Self-management
• Older adults

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 91 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Lead sponsor

Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.

Eligibility criteria

Study arms

• Experimental
  AUDIO

  Participant clinic visits will be audio recorded locally on a secure, HIPAA-compliant server. Patient access to recordings will be performed via a secure web-based platform. Additionally, participants will be offered the After Visit Summary (AVS) prior to clinic departure, per Usual Care (UC)

  Other: Audio recording

• No intervention
  Usual Care

  During the trial, patients will be offered to receive the AVS prior to clinic departure as is the current standard at each site.

Interventions

• OtherAudio recording

  The investigators will audio record the visits of patients in the intervention group. An RA will enter the exam room and begin the recording with the patient's permission. The patient and clinician can choose to stop or start the recording at any time. Once the visit is complete, the RA will enter the room, turn off the recording, and bring the patient to a private room where the RA will follow standardized instructions demonstrating how to access recordings. Patient access to recordings will be possible via a secure web-based platform. Patients will also receive reminders to listen to their recordings.

Primary outcomes

1. Participant Retention (Feasibility)

   The proportion of included participants completing the 3-month (T2) follow up assessment.

   Time frame: 3 months from baseline

2. Intervention Fidelity (Feasibility)

   The proportion of participants in the intervention arm that received the audio recording intervention with full adherence to a pre-defined protocol fidelity checklist. Any deviations will be documented.

   Time frame: 3 months from baseline

3. Feasibility of Intervention Measure (FIM)

   The FIM is a four-item patient-reported measure of intervention feasibility. Each item is scored from 1 (completely disagree) to 5 (completely agree), with a higher score indicating greater feasibility. We consider a score of ≥ 3 or higher to indicate the acceptable Feasibility of the intervention. We report the proportion of patients in the Intervention arm who scored ≥ 3.

   Time frame: 3 months from baseline

4. Participant Recruitment Rate (Acceptability)

   We considered our trial to be acceptable to patients if we could meet recruitment targets at each site of 30 patients. We also calculated our recruitment rate based on the number of potentially eligible patients contacted.

   Time frame: Baseline

5. Intervention Use (Acceptability)

   The proportion of participants in the intervention arm that listen to the recordings received during the study period.

   Time frame: 3 months from baseline

6. Acceptability of Intervention Measure (AIM)

   The AIM is a four-item patient-reported measure of intervention acceptability. Each item is scored from 1 (completely disagree) to 5 (completely agree), with a higher score indicating greater acceptability. We consider a score of ≥ 3 or higher to indicate adequate acceptability of the intervention. We report the proportion of patients in the Intervention arm who scored ≥ 3.

   Time frame: 3 months from baseline

Other outcomes

1. Patient Activation Measure-Short Form (PAM-SF)

   The Patient Activation Measure-Short Form is a 13-item patient reported measure. Scores range from 0 (low activation) to 100 (high activation).

   Time frame: 3-Months from enrollment

2. Interpersonal Processes of Care Scale (IPC)

   Interpersonal Processes of Care Scale is an 18-item patient-reported measure assessing 7 sub-domains of interpersonal communication (Hurried communication; Elicited concerns, responded; Explained results, medications; Patient-centered decision making; Compassionate, respectful; Discrimination; Disrespectful office staff ). Direction of scoring: All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process. Thus, higher scores sometimes indicate better processes (e.g., decided together) and sometimes worse processes (e.g., lack of clarity). Calculating scores: All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Scale scores are calculated as the mean of non-missing responses to the corresponding items (i.e., item responses are averaged). Thus, scores have a possible range of 1-5 and can be calculated for an individual if at least one item per scale has a valid response.

   Time frame: 1-Week from baseline visit

3. Patient Satisfaction Questionnaire-18 (PSQ-18)

   Patient Satisfaction Questionnaire-18 is a patient reported measure of satisfaction with seven dimensions: general satisfaction; technical quality; interpersonal manner; communication; financial aspects; time spent with doctor; accessibility and convenience. Responses are on a 5-point scale (Strongly agree - strongly disagree). Scores are averaged between 1 - 5; items 1,2,3,5,6,8,11,15,18 should be reversed scored i.e., 1 to 5, 2 to 4, 4 to 2, 5 to 1. Higher agreement reflects higher satisfaction with care.

   Time frame: Baseline,1-Week, and 3-Months from enrollment

4. Medical Outcomes Study General Adherence Measure

   The Medical Outcomes Study General Adherence measure, is a five-item patient reported measure of general treatment adherence.

   Time frame: 3-Months from enrollment

5. Adherence to Refills and Medications (ARMS- 7)

   Adherence to Refills and Medications is a Seven-item patient reported measure of medication adherence.

   Time frame: 3-Months from enrollment

6. Global PROMIS-10

   Global PROMIS (Patient-Reported Outcome Measurement Information System) is a 10-item patient reported measure with two domains: mental and physical health.

   Time frame: 3-Months from enrollment

7. EURO-QoL (EQ-5D)

   EURO-QOL is patient reported measure of quality of life (QOL) that can be calculated using responses to Global PROMIS.

   Time frame: Baseline,1-Week, and 3-Months from enrollment

8. Primary Care Contact, ER Visits & Hospitalization

   Information on primary care contacts (phone calls, visits), ER visits \& hospitalization will be collected via EMR. Baseline assessment will calculate primary care contacts, ER visits \& hospitalization for each participant.

   Time frame: 3-Months from enrollment

9. Quality of Diabetes and Hypertension Care

   Information on quality of diabetes and hypertension, including referrals to specialists and intensification of medication therapy, will be collected via EMR.

   Time frame: 3-Months from enrollment

10. Patient Health Questionnaire (PHQ- 8)

    The eight-item depression scale PHQ-8 is a patient-reported multipurpose instrument to diagnose and measure the severity of depression. Scores range from 0 (no symptoms) - 24 (severe symptoms).

    Time frame: Baseline,1-Week, and 3-Months from enrollment

11. Generalized Anxiety Disorder (GAD-7)

    The seven-item GAD-7 is a patient reported measure assessing severity of anxiety.

    Time frame: 3-Months from enrollment

12. Comprehensive Diabetes Stigma Scale (CDSS-15)

    The comprehensive diabetes stigma scale (CDSS-15) is a validated 15-item assessment of diabetes-related stigma.

    Time frame: Baseline,1-Week, and 3-Months from enrollment

13. Stigma Scale for Chronic Illness (SSCI-8)

    The Stigma Scale for Chronic Illness (SSCI-8) is validated, eight-item assessment of stigma related to chronic disease.

    Time frame: Baseline,1-Week, and 3-Months from enrollment

Baseline characteristics

Study documents

• Protocol, analysis plan and consent form · Jun 29, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Upon publication of results in peer-reviewed journals, access to the de-identified data for research purposes will be considered if a request is made by a qualified individual (i.e., a researcher from a research institute), IRB secured, and mutually agreed upon by the PIs. Any potential users of the data will sign an agreement that no attempt to reveal personal or private information may be made. The investigators will follow the Safe Harbour Methods outlined in the guidance regarding methods for de-identification of protected health information in accordance with the HIPAA Privacy Rule.

Supporting information: Study protocol