Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386776
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2006-10-11
Brief Title:
Patient Computer Dialog in Primary Care
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Cybermedicine for the Patient and Physician
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
With this clinical study we hoped to find out if interactive computer-based medical interviews when carefully tested and honed and made available to patients in their homes on the Internet will improve both the efficiency and quality of medical care and be well received and found helpful by patients and their physicians We developed the computer-based medical interview consisting of over 6000 questions and a corresponding program that provides a concisely written summary of the patients responses to the questions in the interview We then conducted read aloud and testretest reliability evaluations of the interview and summary programs and determined the programs to be reliable Results were published in the November 27 2010 issue of the Journal of the American medical Informatics Association We also developed edited and revised a program that provides a concisely written summary of the patients responses to the questions in the interview
We obtained a grant from the Rx Foundation to conduct clinical trial of our medical history At the time of the office visit the summary of the computer-based history of those patients who had completed the interview was available on the doctors computer screen for the doctor and patient to use together on a voluntary basis The results of this trial were published in the January 2012 issue of the Journal of the American Informatics Association
We obtained a grant from the Rx Foundation to conduct clinical trial of our medical history At the time of the office visit the summary of the computer-based history of those patients who had completed the interview was available on the doctors computer screen for the doctor and patient to use together on a voluntary basis The results of this trial were published in the January 2012 issue of the Journal of the American Informatics Association
Detailed Description:
We developed a computer-based medical history for patients to take in their homes via the Internet The history is divided into 24 modules- family history social history cardiac history pulmonary history and the like So far as possible it is designed to model the comprehensive inclusive general medical history traditionally taken when time permits by a primary care doctor seeing a patient for the first time It contains 232 primary questions asked of all patients about the presence or absence of medical problems Of these 215 have the preformatted mutually exclusive responses Yes No Uncertain Dont Know Maybe Dont understand and Id rather not answer 10 have other sets of multiple choices one response permitted five have multiple choices with more than one response permitted and two have numerical responses In addition more than 6000 questions explanations suggestions and recommendations are available for presentation as determined by the patients responses and the branching logic of the program These questions are available to explore in detail medical problems elicited by one or more of the primary questions If for example a patient responds with Yes to the question about chest pain the program branches to multiple qualifying questions about characteristics of the pain such as onset location quality severity relationship to exertion and course Once we had completed the interview in preliminary form we made it available to members of our medical advisory board for their criticisms and suggestions We then conducted a formal read-aloud assessment in which 10 volunteer patients read each primary question aloud to an investigator in attendance and offered their understanding and general assessment of the questions We revised our program based on comments from the advisory board and the patients
We then conducted a testretest reliability study of the 215 of the 232 primary questions that have the preformatted allowable response set of Yes No Uncertain Dont know Maybe Dont understand and Id rather not answer the 10 questions that have other response sets with one answer permitted and the 5 questions with more than one response permitted Email messages were sent via PatientSite our patients portal to their electronic medical record to inform patients of the study and how to sign on to the informed consent form and for those that had consented to the study to remind them to take interview for the first and then the second time
From randomly selected patients of doctors affiliated with Beth Israel Deaconess Medical Center in Boston 48 patients took the history twice with intervals between sessions ranging from one to 35 days mean seven days median five days When we analyzed the inconsistency between first and second interviews with which the 48 patients responded to each of the primary questions We found that the 215 questions with response options of Yes No Uncertain Dont understand and Id rather not answer had the lowest incidence 6 percent the 10 other multiple choice questions with one response permitted had a 13 percent incidence and the five multiple choice questions with more than one response permitted had a 14 percent incidence Whenever an inconsistency was detected with the repeat interview the patient was asked to choose when appropriate from four possible reasons Reasons chosen were clicked on the wrong choice 23 percent not sure about the answer 23 percent medical situation changed 6 percent and didnt understand the question less than 1 percent With the remaining 47 percent of the inconsistencies no reason was given
We then computed the percentage of agreement for each of the primary questions together with Cohens Kappa Index of Reliability Of the 215 Yes No Uncertain Dont know Maybe Dont understand and Id rather not answer questions 96 45 percent had kappa values greater than 75 excellent agreement by the criteria of Landis and Koch and of these 38 had kappa values of one perfect agreement an additional 24 primary questions 12 percent to which all patients had made identical responses both times perfect consistency had no Kappa values Sixty-eight of these questions 32 percent had kappa values between 40 and 75 fair to good agreement and 26 13 percent had kappa values less than 40 poor agreement Of the 27 questions with poor kappa values 15 had percentages of agreement greater than 90 percent and we deemed these to be sufficiently reliable within their clinical context to remain unrevised We selected the 12 questions with poor kappa values and percentages of agreement less than 90 percent for rewording Of the 15 primary questions with varying sets of responses half had kappa values in the excellent range and half had kappa values in the fair to good range and we kept these in place unrevised Fifteen of the primary questions 7 percent received a dont understand response Although there was but a single dont understand response for each of these questions we were able to isolate seven with which the possibility of confusion seemed to be evident and we revised these accordingly
With the first of the two interviews-with a mean of 545 frames presented and a completion time of 45 to 90 minutes based on an estimated 7 seconds per frame -the volunteers were for the most part favorable in their assessment of the interview when asked a set of 10 10-point Likert-scale questions
These results were published in the November 2010 issue of the Journal of the American Informatics Association
We also developed edited and revised a program that provides a concisely written summary of the patients responses to the questions in the interview This was a formidable project that took considerably longer than we had anticipated The phrase is the basic unit of the summary Identified by its unique reference number each phrase contains the words to be generated the conditions for writing them and the branching logic that determines the course of the program as it progresses from phrase to phrase The summary program for the General Medical Interview which contains over 5000 phrases is organized by sections that are related by name and content to their corresponding interview sections Designed for use by both doctor and patient and available in both electronic and printed form the summary is presented in a legible but otherwise traditional format
We were not able to complete the randomized control study at this time due to a couple of factors First it took substantially longer than anticipated to develop and evaluate our program in our effort to have a comprehensive detailed computer-based medical interview that would compare favorably with that of a thoughtful physician It took us two years to develop test and revise the General Medical Interview and far longer than we had anticipated to complete the test-retest reliability study and to develop test and revise the summary program In addition our medical centers current policy is to obtain a patients e-mail address only after the patient has had a first visit to the center and only if the patient has been registered in PatientSite after a first visit Therefore although we could readily recruit by e-mail our participants for the test-retest study we were limited to the far more labor-intensive process of telephone recruitment for the randomized controlled study
We later obtained a grant from the Rx Foundation us to conduct clinical trial of our newly revised medical history After completing the medical history the patients were asked to complete an online 10 item 10-point Likert-scale post-history assessment questionnaire At the time of the office visit the summary of the computer-based history of those patients who had completed the interview was available on the doctors computer screen for the doctor and patient to use together on a voluntary basis At the option of the doctor the summary could then be edited and incorporated into the patients online medical record The day after the visit the patients and the doctors were asked to complete a 10-point Likert-scale questionnaire consisting of six questions that asked about the effect of the medical history and its summary on the quality of the visit from the patients and the doctors perspectives with provision for them to record comments and suggestions for improvement
The results of this were published in the January 2012 issue of the Journal of the American Informatics Association
We then conducted a testretest reliability study of the 215 of the 232 primary questions that have the preformatted allowable response set of Yes No Uncertain Dont know Maybe Dont understand and Id rather not answer the 10 questions that have other response sets with one answer permitted and the 5 questions with more than one response permitted Email messages were sent via PatientSite our patients portal to their electronic medical record to inform patients of the study and how to sign on to the informed consent form and for those that had consented to the study to remind them to take interview for the first and then the second time
From randomly selected patients of doctors affiliated with Beth Israel Deaconess Medical Center in Boston 48 patients took the history twice with intervals between sessions ranging from one to 35 days mean seven days median five days When we analyzed the inconsistency between first and second interviews with which the 48 patients responded to each of the primary questions We found that the 215 questions with response options of Yes No Uncertain Dont understand and Id rather not answer had the lowest incidence 6 percent the 10 other multiple choice questions with one response permitted had a 13 percent incidence and the five multiple choice questions with more than one response permitted had a 14 percent incidence Whenever an inconsistency was detected with the repeat interview the patient was asked to choose when appropriate from four possible reasons Reasons chosen were clicked on the wrong choice 23 percent not sure about the answer 23 percent medical situation changed 6 percent and didnt understand the question less than 1 percent With the remaining 47 percent of the inconsistencies no reason was given
We then computed the percentage of agreement for each of the primary questions together with Cohens Kappa Index of Reliability Of the 215 Yes No Uncertain Dont know Maybe Dont understand and Id rather not answer questions 96 45 percent had kappa values greater than 75 excellent agreement by the criteria of Landis and Koch and of these 38 had kappa values of one perfect agreement an additional 24 primary questions 12 percent to which all patients had made identical responses both times perfect consistency had no Kappa values Sixty-eight of these questions 32 percent had kappa values between 40 and 75 fair to good agreement and 26 13 percent had kappa values less than 40 poor agreement Of the 27 questions with poor kappa values 15 had percentages of agreement greater than 90 percent and we deemed these to be sufficiently reliable within their clinical context to remain unrevised We selected the 12 questions with poor kappa values and percentages of agreement less than 90 percent for rewording Of the 15 primary questions with varying sets of responses half had kappa values in the excellent range and half had kappa values in the fair to good range and we kept these in place unrevised Fifteen of the primary questions 7 percent received a dont understand response Although there was but a single dont understand response for each of these questions we were able to isolate seven with which the possibility of confusion seemed to be evident and we revised these accordingly
With the first of the two interviews-with a mean of 545 frames presented and a completion time of 45 to 90 minutes based on an estimated 7 seconds per frame -the volunteers were for the most part favorable in their assessment of the interview when asked a set of 10 10-point Likert-scale questions
These results were published in the November 2010 issue of the Journal of the American Informatics Association
We also developed edited and revised a program that provides a concisely written summary of the patients responses to the questions in the interview This was a formidable project that took considerably longer than we had anticipated The phrase is the basic unit of the summary Identified by its unique reference number each phrase contains the words to be generated the conditions for writing them and the branching logic that determines the course of the program as it progresses from phrase to phrase The summary program for the General Medical Interview which contains over 5000 phrases is organized by sections that are related by name and content to their corresponding interview sections Designed for use by both doctor and patient and available in both electronic and printed form the summary is presented in a legible but otherwise traditional format
We were not able to complete the randomized control study at this time due to a couple of factors First it took substantially longer than anticipated to develop and evaluate our program in our effort to have a comprehensive detailed computer-based medical interview that would compare favorably with that of a thoughtful physician It took us two years to develop test and revise the General Medical Interview and far longer than we had anticipated to complete the test-retest reliability study and to develop test and revise the summary program In addition our medical centers current policy is to obtain a patients e-mail address only after the patient has had a first visit to the center and only if the patient has been registered in PatientSite after a first visit Therefore although we could readily recruit by e-mail our participants for the test-retest study we were limited to the far more labor-intensive process of telephone recruitment for the randomized controlled study
We later obtained a grant from the Rx Foundation us to conduct clinical trial of our newly revised medical history After completing the medical history the patients were asked to complete an online 10 item 10-point Likert-scale post-history assessment questionnaire At the time of the office visit the summary of the computer-based history of those patients who had completed the interview was available on the doctors computer screen for the doctor and patient to use together on a voluntary basis At the option of the doctor the summary could then be edited and incorporated into the patients online medical record The day after the visit the patients and the doctors were asked to complete a 10-point Likert-scale questionnaire consisting of six questions that asked about the effect of the medical history and its summary on the quality of the visit from the patients and the doctors perspectives with provision for them to record comments and suggestions for improvement
The results of this were published in the January 2012 issue of the Journal of the American Informatics Association
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01LM008255-01A1 | NIH | None | httpsreporternihgovquickSearchR01LM008255-01A1 |