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| ID | Type | Description | Link |
|---|---|---|---|
| JT 8256 | Other Identifier | JeffTrial Number |
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This pilot clinical trial studies how well telehealth works in patients during post radiation therapy visits. A telehealth virtual office visit can be performed from the patient's home or workplace, decreasing time spent traveling to visit site, time spent in waiting room, and cost to patient. Studying telehealth may improve quality of life in patients during post radiation therapy visit.
PRIMARY OBJECTIVES:
I. To examine feasibility of conducting a trial comparing a telehealth visit and an in person office visit.
SECONDARY OBJECTIVES:
I. To examine patient satisfaction, patient assessment of physician communication during a telehealth visit.
II. To examine patient distrust in the healthcare system following a telehealth visit.
III. To examine physician ability to perform a patient assessment during a telehealth visit.
IV. To examine physician perceptions of telehealth visits. V. To examine monetary and time cost to patients for telehealth visit. VI. To calculate clinic savings derived from telehealth visits.
OUTLINE:
Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health services research (telehealth) | Experimental | Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine | Other | Attend a virtual visit via the JeffConnect telehealth app |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Conducting a Future Randomized Clinical Trial Comparing Telehealth and in Person Visits (i.e., Rate of Accrual) | The number of patients accrued each month will be analyzed via Poisson regression. The mean (monthly rate) will be estimated and tested against the null value of 4 patients per month using a 1-sided test with alpha 0.05. The proportion of enrolled subjects who are lost to follow-up will also be summarized. | 24 months from first patient enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction With Telehealth Visits as Measured by the Patients Satisfaction With Cancer Care Score | Patients Satisfaction with Cancer Care score is an 18-item questionnaire with answers on a 5-point Likert scale. Lower scores are associated with higher satisfaction with caner care. The average will be computed and tested against the null value of 75 using a one-sample t-test with alpha 0.05. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Simone, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center | View source |
| Jefferson University Hospitals | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Health Services Research (Telehealth) | Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device. Telemedicine: Attend a virtual visit via the JeffConnect telehealth app Questionnaire Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Health Services Research (Telehealth) | Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device. Telemedicine: Attend a virtual visit via the JeffConnect telehealth app Questionnaire Administration: Ancillary studies |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Conducting a Future Randomized Clinical Trial Comparing Telehealth and in Person Visits (i.e., Rate of Accrual) | The number of patients accrued each month will be analyzed via Poisson regression. The mean (monthly rate) will be estimated and tested against the null value of 4 patients per month using a 1-sided test with alpha 0.05. The proportion of enrolled subjects who are lost to follow-up will also be summarized. | 13 participants did not complete the Telehealth visit: 7 did not show for their appointment, 4 were never scheduled, 1 patient passed away prior to completion of visit and 1 patient canceled the appointment in favor of hospice care | Posted | Mean | Standard Deviation | participants accrued per month | 24 months from first patient enrolled |
|
baseline through 16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Health Services Research (Telehealth) | Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device. Telemedicine: Attend a virtual visit via the JeffConnect telehealth app Questionnaire Administration: Ancillary studies |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Simone, MD | Sidney Kimmel Cancer Center at Thomas Jefferson University | 215-955-6702 | nicole.simone@jefferson.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2017 | Oct 7, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Questionnaire Administration | Other | Ancillary studies |
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| 4 months from enrollment |
| Number of Patients Satisfied With Physician Communication During Telehealth Visit | 14 item communication assessment tool (CAT). The CAT addresses specifically patient satisfaction with key aspects of communication and interpersonal skills and items are scored on a 1-5 scale where 1 = poor and 5 = excellent and a higher score would indicate better communication skills | 4 months from enrollment |
| Patient Distrust in the Healthcare System as Measured by the Health Care System Distrust Scale in Relation to Privacy of Medical Record (MR) | healthcare system distrust scale, designed to assess the belief that physicians would act in a patient's best interest to prevent a potentially negative important outcome (ref). This is a 10 item survey scored 1-5 where 1 = "strongly disagree" and 5 = "strongly agree" and higher scores generally indicate more distrust. Patient distrust was measured by asking if patients felt their Medical Record (MR) would be kept private or would be accessed without their permission. | 4 months from enrollment |
| Physicians Ability to Evaluate a Patient During a Telehealth Visit as Measured by the Physician Questionnaire | 9 question survey regarding the ease of use and efficacy of the telehealth platform. The items were yes or no questions (scored on 1 = yes and 0 = no) scale. Higher scores represent greater satisfaction with the platform. | 4 months from enrollment |
| Physician Satisfaction With Post-treatment Telehealth Visit as Measured by the Modified Physician Satisfaction Scale | 9-question survey regarding the ease of use and efficacy of the telehealth platform. The items were yes or no questions (scored on 1=yes and 0=no) scale. Higher scores represented greater satisfaction with the platform. Specifically looked at responses to the items regarding: accurate assessment of symptoms via telehealth, accurately assess treatment-related toxicity via telehealth, feeling sure they obtained all information needed to care for the patient, and if providers would use the telehealth system in the future. | 4 months from enrollment |
| Patient Costs for Telehealth Visit | Patient costs for telehealth visit based on questionnaire response | Through study completion |
| Clinic Savings Derived From Telehealth Visits | Clinic savings derived from telehealth visits v in-person visits | Through study completion |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Patient Satisfaction With Telehealth Visits as Measured by the Patients Satisfaction With Cancer Care Score | Patients Satisfaction with Cancer Care score is an 18-item questionnaire with answers on a 5-point Likert scale. Lower scores are associated with higher satisfaction with caner care. The average will be computed and tested against the null value of 75 using a one-sample t-test with alpha 0.05. | Posted | Count of Participants | Participants | 4 months from enrollment |
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| Secondary | Number of Patients Satisfied With Physician Communication During Telehealth Visit | 14 item communication assessment tool (CAT). The CAT addresses specifically patient satisfaction with key aspects of communication and interpersonal skills and items are scored on a 1-5 scale where 1 = poor and 5 = excellent and a higher score would indicate better communication skills | All 37 patients analyzed report satisfaction | Posted | Count of Participants | Participants | 4 months from enrollment |
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| Secondary | Patient Distrust in the Healthcare System as Measured by the Health Care System Distrust Scale in Relation to Privacy of Medical Record (MR) | healthcare system distrust scale, designed to assess the belief that physicians would act in a patient's best interest to prevent a potentially negative important outcome (ref). This is a 10 item survey scored 1-5 where 1 = "strongly disagree" and 5 = "strongly agree" and higher scores generally indicate more distrust. Patient distrust was measured by asking if patients felt their Medical Record (MR) would be kept private or would be accessed without their permission. | Posted | Count of Participants | Participants | 4 months from enrollment |
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| Secondary | Physicians Ability to Evaluate a Patient During a Telehealth Visit as Measured by the Physician Questionnaire | 9 question survey regarding the ease of use and efficacy of the telehealth platform. The items were yes or no questions (scored on 1 = yes and 0 = no) scale. Higher scores represent greater satisfaction with the platform. | 9 physicians and 2 nurses evaluated the use of telehealth platform | Posted | Count of Participants | Participants | 4 months from enrollment |
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| Secondary | Physician Satisfaction With Post-treatment Telehealth Visit as Measured by the Modified Physician Satisfaction Scale | 9-question survey regarding the ease of use and efficacy of the telehealth platform. The items were yes or no questions (scored on 1=yes and 0=no) scale. Higher scores represented greater satisfaction with the platform. Specifically looked at responses to the items regarding: accurate assessment of symptoms via telehealth, accurately assess treatment-related toxicity via telehealth, feeling sure they obtained all information needed to care for the patient, and if providers would use the telehealth system in the future. | 9 physicians and 2 nurse practitioners | Posted | Count of Participants | Participants | 4 months from enrollment |
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| Secondary | Patient Costs for Telehealth Visit | Patient costs for telehealth visit based on questionnaire response | Sincere efforts have been made to obtain the results information from the Principal Investigator, but no reportable information has been obtained. | Posted | Through study completion |
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| Secondary | Clinic Savings Derived From Telehealth Visits | Clinic savings derived from telehealth visits v in-person visits | Sincere efforts have been made to obtain the results information from the Principal Investigator, but no reportable information has been obtained. | Posted | Through study completion |
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| 2 |
| 37 |
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| 37 |
| 0 |
| 37 |
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| Title | Measurements |
|---|---|
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| Agreed Would Use Telehealth in future |
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