Adoption of Audio Recording in the Outpatient Supportive Care Center

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04871477
Collaborator
(none)
200
1
5
39.8

Study Details

Study Description

Brief Summary

This study evaluates how patients feel about having an audio recording of their visit to help remember information given to them and share that information with family members and/or caregivers not present during a clinic visit. Information from this study may help evaluate the effectiveness of using technology to help improve patient care by recording consultation recommendations.

Condition or Disease Intervention/Treatment Phase
  • Other: Communication Intervention
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVE:
  1. To assess the patient's perception of the usefulness of the audio recording in helping to recall information given to him/her in the visit along with the perception of usefulness in the dissemination of information to family member(s) and/or caregiver(s) not present at the clinic visit.
SECONDARY OBJECTIVES:
  1. To assess the number of times the recording is listened to. II. To assess the ease of use of the technology. III. To assess the ability to share the information with the patient's family member(s) and/or caregiver(s) if he or she chooses to do so.

  2. To assess the patient perception of whether the audio recording caused any disruption to the clinic.

  3. To estimate the participation rate of patients. VI. To explore association between patient's perception of the usefulness of the audio recording and patient's demographic/clinical characteristics.

  4. To explore the association between age and sex of the caregiver and frequency of caregiver's use of the audio recording.

  5. To explore the association of the ease of use of the technology and the type of device and application used.

OUTLINE:

Patients audio record the recommendations and instructions given to them by the doctor record as part of their clinic visit at the Supportive Care Center.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
The Adoption of Audio Recording in the Outpatient Supportive Care Center
Anticipated Study Start Date :
Aug 30, 2022
Anticipated Primary Completion Date :
Jan 30, 2023
Anticipated Study Completion Date :
Jan 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Observational (audio recording)

Patients audio record the recommendations and instructions given to them by the doctor record as part of their clinic visit at the Supportive Care Center.

Other: Communication Intervention
Audio record part of clinic visit

Other: Questionnaire Administration
Ancillary studies

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients who will select "Complete Agree/Partially Agree" in Question 1 "I found the audio recording useful after the visit" [through study completion, an average of 1 year]

    Will be summarized using proportion along with a 95% confidence interval.

  2. Proportion of patients who will select "Complete Agree/Partially Agree" in Question 2 "I was able to effectively discuss my medical condition with my family member(s) and/or caregiver(s) who were not present at the clinical visit [through study completion, an average of 1 year]

    Will be summarized using proportion along with a 95% confidence interval.

Secondary Outcome Measures

  1. Number of times the recording is listened to [through study completion, an average of 1 year]

    Descriptive statistics will be used to summarize the results. Wilcoxon rank sum test or Kruskal-Wallis test will be applied to examine differences in continuous variables between or among patient's demographic/clinical characteristics.

  2. To assess the ease of use of the technology. [through study completion, an average of 1 year]

    Descriptive statistics will be used to summarize the results. Chi squared test or Fisher's exact test will be applied to examine the association between the ease of use of the technology and patient's demographic/clinical characteristics.

  3. To assess the ability to share the information with the patient's family member(s) and/or caregiver(s) if he or she chooses to do so. [through study completion, an average of 1 year]

    Descriptive statistics will be used to summarize the results. Chi-squared test or Fisher's exact test will be applied to examine the association between the ability to share and patient's demographic/clinical characteristics.

  4. To assess the patient perception of whether the audio recording caused any disruption to the clinic [through study completion, an average of 1 year]

    Descriptive statistics will be used to summarize the results. Chi-squared test or Fisher's exact test will be applied to examine the association between the patient perception of whether audio recording caused any disruption to the clinic and patient's demographic/clinical characteristics.

  5. Patient participation rate [through study completion, an average of 1 year]

    The participation rate of patients in this study will be estimate using proportion along with 95% confidence interval.

  6. To explore the association between the frequency of caregivers' use of audio recording [through study completion, an average of 1 year]

    Pearson or Spearman correlation coefficient will be used to assess the association between caregivers' age and frequency of their use of the audio recording. Wilcoxon rank sum test will be applied to examine differences in frequency of caregivers' use of audio recording between their sexes.

  7. To explore the association of the ease of use of the technology and the type of device and application used [through study completion, an average of 1 year]

    Chi-squared test or Fisher's exact test will be applied to examine the association between the ease of use of the technology and the types of recording devices/applications.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients with the diagnosis of advanced cancer as defined as locally advanced, recurrent or metastatic cancer. Both solid and liquid tumors are eligible for the study

  • Patients who are seen in the outpatient supportive care center at M.D. Anderson Cancer Center

  • Patients who have access to a recording device or cellphone with recording technology

  • Patients who can be contacted 7 to 11 days from the clinic visit that the recording took place

  • Patients who can sign informed consent

  • Patients who are able to read and write in English

  • Patients 18 years or older

Exclusion Criteria:
  • Patients who have been diagnosed with delirium or cognitive impairment. This will be defined by chart review along with review of the MD Anderson Symptom Inventory (MDAS) the day of clinic visit. An MDAS of 7 or greater will be considered to define delirium in this study

  • Patients who are unwilling to sign informed consent

  • Patients who have used audio recordings before in clinic visits

  • Patients who have severe hearing impairments without access to assisted devices or programs to aid in listening to the recorded material

Contacts and Locations

Locations

Site City State Country Postal Code
1 M D Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Michael J Tang, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT04871477
Other Study ID Numbers:
  • 2020-0240
  • NCI-2021-02621
  • 2020-0240
First Posted:
May 4, 2021
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022