Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03041571
Other study ID # IRB201601597
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date March 1, 2017
Est. completion date October 18, 2019

Study information

Verified date January 2020
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A qualitative study assessing the impact of early narrative medicine practice on Medical Honors Program (MHP) students' attitudes regarding patient-centered interactions, through interviewing patients with chronic or life-limiting illnesses to obtain their illness stories.

MHP students will develop a patient narrative for the patients interviewed. These narratives will be edited by the patient, and, with the permission of the patients, may be published as a collection of stories.


Description:

Teach MHP Students about obtaining the illness story and narrative medicine. This will be done during the curriculum of the Medical Humanities class in the fall of 2016.

Recruit patients on units and floors in Shands University of Florida (UF) Health that may potentially have patients that will be good candidates for enrollment in the patient narratives. These may include pediatric hematology and oncology patients, adult hematology and oncology patients, patients with diabetes, organ transplant patients, cystic fibrosis patients, and rheumatologic disorder patients. Investigators will communicate with child life/social workers, as well as faculty medical providers on these inpatient services to help identify appropriate patients for referral and recruitment. These faculty members will obtain authorization from the patient for the investigators to approach the patient regarding recruitment.

Once a patient has been identified, a co-investigator will introduce the project to the patient, review examples of the types of questions to be asked by the MHP student, provide opportunity for questions, obtain informed consent, and provide them with the patient-practitioner orientation scale (PPOS) for completion.

A MHP student will meet with the co-investigator, fill out the PPOS, and then interview the patient. The co-investigator will be present for the interview, but the investigator would like the MHP student to conduct the interview. The interview will be voice recorded with encryption for later transcription.

Following the interview, a co-investigator will lead a discussion to determine patient and student observations/opinions about such conversations. The co-investigator will address differences in PPOS responses from patient vs student, without specifically revealing the personal answers of each, and allow for discussion of how scales can be aligned to better the patient-physician relationship. This discussion will be voice recorded for transcription and qualitative analysis by the investigators

Following the interview, the MHP students will transcribe the patient narrative. During the interview, the student and patient will agree on whether the narrative is written from the first or third person point of view.

The initial informed consent will have a specific series of check boxes to address whether the patient approves of dissemination of their story. This initial consent will specifically state that this narrative will not be published prior to their approval of the final product. The patient will also have the opportunity to declare which patient identifiers, if any, will be changed for the publication. The narrative will be presented to the patient, who will then have the opportunity to make changes and edits. If extensive edits are necessary, a subsequent narrative will be presented to the patient for final approval prior to publication. The investigators will make every effort to get the patient approval in person, however because of the possibility of the patient being discharged before the narrative has been composed, investigators will identify an acceptable method of communication with the patient outside of the hospital (email, phone call) for this purpose. In the case of the patient being discharged and needing to obtain approval, verbal approval over the phone will be obtained by a co-investigator and a witness, and will keep this documentation in a binder locked in the PI's office.

Following the completion of the interviews, the MHP students will meet for a focus group to discuss as a group their observations from their patient encounters. This focus group will be audio recorded and transcribed by the co-investigators for qualitative analysis

After all patient narratives have been completed, narratives may be published in an online or book format, following the consent that the patient provided.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 18, 2019
Est. primary completion date October 18, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 100 Years
Eligibility Inclusion Criteria:

- Patient inclusion criteria:

- Patient of Shands UF Health or Shands Children's hospital

- Children must be at least 8 years old

- Patients diagnosed with chronic or potentially life-limiting illnesses

- Patients must be English speaking

- Student Inclusion criteria

- UF students enrolled in the Medical Honors Program

- Medical Honors students must be up to date on HIPAA training and Confidentiality statement agreement

- Students must take the Medical Humanities course

- UF college of medicine students

Exclusion Criteria:

- Patient exclusion criteria:

- Anyone that the medical social worker or Child life specialist feels would be unwilling or unable to participate in the study

- Patients who at the time of interview are unfit to communicate (ex. Ventilated, comatose)

- Patients less than eight years old

- Patients that do not speak English

- Student exclusion criteria:

- Students not enrolled in the UF College of Medicine

- Students not enrolled in the Medical Humanities course

Study Design


Intervention

Behavioral:
Patient Provider Orientation Scale
Investigators are interested in the impact that our activity has on the students' patient-centeredness. Investigators will use the Patient-Practitioner Orientation Scale (PPOS), which will be completed by both the student and the patient prior to the encounter. Following the interview, the co-investigators will lead a discussion with the patient and student. Investigators will discuss differences in patient and student PPOS scores, and how each party felt the interview went. Investigators will examine if the patients feel the interview differed from typical interactions with health care providers, and how this made the patient feel. The students will describe what was learned from the patients story as well as try to explore reasons why providers may not always learn the patient's illness story.
Interview performed by MHP student
The MHP students took a course called Medical Humanities in the fall of 2016. MHP students learned patient interviewing skills and the importance of gathering the patients "illness story". The students will conduct an interview with a patient with chronic illness, which will be focused on gather information about how the patients illness affects daily life as well as interactions with the health care system.

Locations

Country Name City State
United States University of Florida Gainesville Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (10)

Batt-Rawden SA, Chisolm MS, Anton B, Flickinger TE. Teaching empathy to medical students: an updated, systematic review. Acad Med. 2013 Aug;88(8):1171-7. doi: 10.1097/ACM.0b013e318299f3e3. Review. — View Citation

Griffith CH 3rd, Wilson JF. The loss of student idealism in the 3rd-year clinical clerkships. Eval Health Prof. 2001 Mar;24(1):61-71. — View Citation

Haidet P, Dains JE, Paterniti DA, Chang T, Tseng E, Rogers JC. Medical students' attitudes toward patient-centered care and standardized patients' perceptions of humanism: a link between attitudes and outcomes. Acad Med. 2001 Oct;76(10 Suppl):S42-4. — View Citation

Hojat M, Vergare MJ, Maxwell K, Brainard G, Herrine SK, Isenberg GA, Veloski J, Gonnella JS. The devil is in the third year: a longitudinal study of erosion of empathy in medical school. Acad Med. 2009 Sep;84(9):1182-91. doi: 10.1097/ACM.0b013e3181b17e55. Erratum in: Acad Med. 2009 Nov;84(11):1616. — View Citation

Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. — View Citation

Kim SS, Kaplowitz S, Johnston MV. The effects of physician empathy on patient satisfaction and compliance. Eval Health Prof. 2004 Sep;27(3):237-51. — View Citation

Krupat E, Bell RA, Kravitz RL, Thom D, Azari R. When physicians and patients think alike: patient-centered beliefs and their impact on satisfaction and trust. J Fam Pract. 2001 Dec;50(12):1057-62. — View Citation

Krupat E, Pelletier S, Alexander EK, Hirsh D, Ogur B, Schwartzstein R. Can changes in the principal clinical year prevent the erosion of students' patient-centered beliefs? Acad Med. 2009 May;84(5):582-6. doi: 10.1097/ACM.0b013e31819fa92d. — View Citation

Krupat E, Rosenkranz SL, Yeager CM, Barnard K, Putnam SM, Inui TS. The practice orientations of physicians and patients: the effect of doctor-patient congruence on satisfaction. Patient Educ Couns. 2000 Jan;39(1):49-59. — View Citation

Stacy R, Spencer J. Patients as teachers: a qualitative study of patients' views on their role in a community-based undergraduate project. Med Educ. 1999 Sep;33(9):688-94. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Patient provider orientation scale score (PPOS) The PPOS is an 18 item questionnaire developed to evaluate patient centered care. The items are rated on a 6 point Likert-type scale. It has two separate parts, sharing and caring, that can be either summed or divided for scoring purposes. Higher scores indicate more patient centeredness. baseline
Secondary Patient provider orientation scale- "Sharing" portion Total from the questions related to "sharing" on the PPOS. The sharing portion relates to how open the provider is in sharing power in the patient-physician relationship, or in the case of the patient filling out the form, how much the patient wishes to share the power in the patient-physician relationship. baseline
Secondary Patient provider orientation scale- "Caring" portion Total from the questions related to "caring" on the PPOS. The caring portion relates to how oriented the provider is in caring for the patient as a person and not just a disease. baseline
Secondary Patient and Student post-interview discussion qualitative measurement of topics and themes discussed in immediate post-interview discussion between the co-investigator, MHP student, and patient immediately post-interview, up to 1 day
Secondary Medical honors students focus group qualitative measurement of topics and themes discussed in the focus group held following all MHP students completing their individual interviews following completion of all MHP/Patient interviews, up to 4 months
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients

External Links