Patient Computer DialogPhase 3NCT00386776
Patient Computer Dialog in Primary Care
A Phase 3 study testing Computer-based medical history in people with Patient Computer Dialog, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Computer Dialog
- What is being tested?
- Computer-based medical history
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Request for an initial appointment with a primary care physician at Beth Israel Deaconess Medical Center who has agreed to participate in the study
- English as first language
- Internet access at home
Who cannot join
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Cybermedicine for the Patient and Physician
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 patient's responses to the questions in the interview. We then conducted read aloud and test/retest 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 patient's 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 doctor's 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.
Read the 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 (Don't Know, Maybe)," "Don't understand," and "I'd 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 patient's 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 test/retest reliability study of the 215 of the 232 primary questions that have the preformatted, allowable response set of "Yes," "No," "Uncertain (Don't know, Maybe)," "Don't understand," and "I'd 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," "Don't understand," and "I'd 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 "didn't 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 Cohen's Kappa Index of Reliability. Of the 215 "Yes," "No," "Uncertain (Don't know, Maybe)," "Don't understand," and "I'd 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 "don't understand" response. Although there was but a single "don't 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 patient's 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 5,000 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 center's current policy is to obtain a patient's 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 doctor's 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 patient's 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 patient's and the doctor's 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.
- Conditions
- Patient Computer Dialog
- Being tested
- Computer-based medical history
- Keywords
- computers, diagnosis, medical records, physician patient relations, medical history taking, medical informatics applications
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based medical historyOther
The intervention is a computer-based medical interview, which contains 232 primary questions that are asked of all respondents, and over 6000 frames (questions, explanations, suggestions, recommendations, and words of encouragement) that are available for presentation as determined by the patient's responses and the branching logic of the program.
| Study group | Role | What they receive |
|---|---|---|
| 'Computer-based medical history | Experimental | A computer-based medical history 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. Receives: Other: Computer-based medical history |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Post Medical History Assessment Questionnaire
The questionnaire consisted of 10 Likert scales questions assessing the computer-based history. The Likert scale ranged from 1 for 'Not at all' to 10 for 'Very'.
We computed the mean of the responses to the question "How helpful were the questions when thinking about your health?" We also calculated a total score by averaging the mean scores of the 10 questions.
Measured: Immediately after taking the medical history
Patient Post Visit Questionnaire
The questionnaire consisted of 6 Likert scales questions assessing helpfulness of the computer-based history for the patient at the time of the visit. The Likert scale ranged from 1 for 'Not at all helpful' to 10 for 'Very helpful'. We computed the mean of the responses to the question "How helpful was it for you to have taken the computer interview before seeing your doctor?" We also calculated a total score by averaging the mean scores of the 6 questions. In addition we calculated the combined mean of the responses of three of the patients whose doctors did not complete their post-visit questionnaire.
Measured: One day after the visit with the physician
Physician Post Visit Questionnaire
The questionnaire consisted of 6 Likert scales questions assessing helpfulness of the computer-based history for the physician at the time of the patient visit. The Likert scale ranged from 1 for 'Not at all helpful' to 10 for 'Very helpful'. We computed the mean of the responses to the questions "How helpful was it for your patient to have taken the computer interview before seeing you?" " and the question "To what extent do you think the computer summary helped you to provide better care to your patient?" We also calculated a total score by averaging the mean scores of the 6 questions. In addition we calculated the combined mean of the physician responses to the post-visit questionnaires when physicians filled out the questionnaire but their patients did not.
Measured: One day after the patient visit
Secondary outcomes (4)
Number of Office Visits by Patients
The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.
Time Per Visit
The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.
Number of Telephone Calls and E-mail Messages Between Patients and Physicians
The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.
Completeness of Patients' Problem Lists
The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startJan 2005
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (93)Papers the sponsor has linked to this study.
- Other trials for Patient Computer DialogStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Responsible party
- Principal investigator, Warner Slack, Beth Israel Deaconess Medical Center
- Investigators
- Warner V Slack, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386776
- Sponsor's protocol ID
- 2004P-000420
- Other IDs
- R01LM008255-01A1
- Status last verified
- Jun 2013
- First submitted
- 11 Oct 2006
- Last updated
- 20 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Slack WV, Hicks GP, Reed CE, Van Cura LJ. A computer-based medical-history system. N Engl J Med. 1966 Jan 27;274(4):194-8. doi: 10.1056/NEJM196601272740406. No abstract available.
PubMed 5902618Bachman JW. The patient-computer interview: a neglected tool that can aid the clinician. Mayo Clin Proc. 2003 Jan;78(1):67-78. doi: 10.4065/78.1.67.
PubMed 12528879Sands DZ, Halamka JD, Pellaton D. PatientSite: a Web-based clinical communication and health education tool. Proc Annu Conf Health Information Management Systems Society 2001, Chicago, IL (on CD).
Slack WV. The computer and the doctor-patient relationship. MD Comput. 1989 Nov-Dec;6(6):320-1. No abstract available.
PubMed 2607929Slack WV. Patient-Computer Dialogue: A Review. Yearb Med Inform. 2000;(1):71-78.
PubMed 27699348Slack WV. Cybermedicine: how computing empowers doctors and patients for better health care (revised and updated edition). San Francisco: Jossey-Bass, 2001
Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003 Feb 4;138(3):161-7. doi: 10.7326/0003-4819-138-3-200302040-00007.
PubMed 12558354BRODMAN K, ERDMANN AJ Jr, et al. The Cornell medical index; a adjunct to medical interview. J Am Med Assoc. 1949 Jun 11;140(6):530-4. doi: 10.1001/jama.1949.02900410026007. No abstract available.
PubMed 18144531BRODMAN K, VAN WOERKOM AJ, ERDMANN AJ Jr, GOLDSTEIN LS. Interpretation of symptoms with a data-processing machine. AMA Arch Intern Med. 1959 May;103(5):776-82. doi: 10.1001/archinte.1959.00270050098015. No abstract available.
PubMed 13636498COLLEN MF, RUBIN L, NEYMAN J, DANTZIG GB, BAER RM, SIEGELAUB AB. AUTOMATED MULTIPHASIC SCREENING AND DIAGNOSIS. Am J Public Health Nations Health. 1964 May;54(5):741-50. doi: 10.2105/ajph.54.5.741. No abstract available.
PubMed 14153274Slack WV, Van Cura LJ. Computer-based patient interviewing. Postgrad Med. 1968 Apr;43(4):115-20 concl. doi: 10.1080/00325481.1968.11693217. No abstract available.
PubMed 5689697Slack WV, Van Cura LJ. Computer-based patient interviewing. 1. Postgrad Med. 1968 Mar;43(3):68-74. doi: 10.1080/00325481.1968.11693177. No abstract available.
PubMed 5650983Peckham BM, Slack WV, Carr WF, Van Cura LJ, Schultz AE. Computerized data collection in the management of uterine cancer. Clin Obstet Gynecol. 1967 Dec;10(4):1003-15. doi: 10.1097/00003081-196712000-00015. No abstract available.
PubMed 4871715Maultsby MC Jr, Slack WV. A computer-based psychiatry history system. Arch Gen Psychiatry. 1971 Dec;25(6):570-2. doi: 10.1001/archpsyc.1971.01750180090014. No abstract available.
PubMed 5141376Chun RW, Van Cura LJ, Spencer M, Slack WV. Computer interviewing of patients with epilepsy. Epilepsia. 1976 Dec;17(4):371-5. doi: 10.1111/j.1528-1157.1976.tb04448.x.
PubMed 1001281
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cybermedicine for the Patient and Physician
- ClinicalTrials.gov ID
- NCT00386776
- Acronym / sponsor ID
- 2004P-000420
- Conditions
- Patient Computer Dialog
- Keywords
- computers, diagnosis, medical records, physician patient relations, medical history taking, medical informatics applications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Study start
- Jan 2005
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 12 Oct 2006 (estimated)
- Results
- Posted 10 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patient's responses to the questions in the interview. We then conducted read aloud and test/retest 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 patient's 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 doctor's 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 (Don't Know, Maybe)," "Don't understand," and "I'd 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 patient's 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 test/retest reliability study of the 215 of the 232 primary questions that have the preformatted, allowable response set of "Yes," "No," "Uncertain (Don't know, Maybe)," "Don't understand," and "I'd 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," "Don't understand," and "I'd 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 "didn't 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 Cohen's Kappa Index of Reliability. Of the 215 "Yes," "No," "Uncertain (Don't know, Maybe)," "Don't understand," and "I'd 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 "don't understand" response. Although there was but a single "don't 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 patient's 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 5,000 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 center's current policy is to obtain a patient's 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 doctor's 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 patient's 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 patient's and the doctor's 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 'Computer-based medical history | Experimental | Other: Computer-based medical historyA computer-based medical history 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Request for an initial appointment with a primary care physician at Beth Israel Deaconess Medical Center who has agreed to participate in the study
- English as first language
- Internet access at home
Key exclusion criteria (1 listed)
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-based medical historyThe intervention is a computer-based medical interview, which contains 232 primary questions that are asked of all respondents, and over 6000 frames (questions, explanations, suggestions, recommendations, and words of encouragement) that are available for presentation as determined by the patient's responses and the branching logic of the program. | Other | 'Computer-based medical history |
Primary outcome
Patient Post Medical History Assessment Questionnaire
Time frame: Immediately after taking the medical history
The questionnaire consisted of 10 Likert scales questions assessing the computer-based history. The Likert scale ranged from 1 for 'Not at all' to 10 for 'Very'. We computed the mean of the responses to the question "How helpful were the questions when thinking about your health?" We also calculated a total score by averaging the mean scores of the 10 questions.
Patient Post Visit Questionnaire
Time frame: One day after the visit with the physician
The questionnaire consisted of 6 Likert scales questions assessing helpfulness of the computer-based history for the patient at the time of the visit. The Likert scale ranged from 1 for 'Not at all helpful' to 10 for 'Very helpful'. We computed the mean of the responses to the question "How helpful was it for you to have taken the computer interview before seeing your doctor?" We also calculated a total score by averaging the mean scores of the 6 questions. In addition we calculated the combined mean of the responses of three of the patients whose doctors did not complete their post-visit questionnaire.
Physician Post Visit Questionnaire
Time frame: One day after the patient visit
The questionnaire consisted of 6 Likert scales questions assessing helpfulness of the computer-based history for the physician at the time of the patient visit. The Likert scale ranged from 1 for 'Not at all helpful' to 10 for 'Very helpful'. We computed the mean of the responses to the questions "How helpful was it for your patient to have taken the computer interview before seeing you?" " and the question "To what extent do you think the computer summary helped you to provide better care to your patient?" We also calculated a total score by averaging the mean scores of the 6 questions. In addition we calculated the combined mean of the physician responses to the post-visit questionnaires when physicians filled out the questionnaire but their patients did not.
4 secondary outcomes
Number of Office Visits by Patients
Time Per Visit
Number of Telephone Calls and E-mail Messages Between Patients and Physicians
Completeness of Patients' Problem Lists
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 5902618Slack WV, Hicks GP, Reed CE, Van Cura LJ. A computer-based medical-history system. N Engl J Med. 1966 Jan 27;274(4):194-8. doi: 10.1056/NEJM196601272740406. No abstract available.
- Background: PubMed 12528879Bachman JW. The patient-computer interview: a neglected tool that can aid the clinician. Mayo Clin Proc. 2003 Jan;78(1):67-78. doi: 10.4065/78.1.67.
- BackgroundSands DZ, Halamka JD, Pellaton D. PatientSite: a Web-based clinical communication and health education tool. Proc Annu Conf Health Information Management Systems Society 2001, Chicago, IL (on CD).
- Background: PubMed 2607929Slack WV. The computer and the doctor-patient relationship. MD Comput. 1989 Nov-Dec;6(6):320-1. No abstract available.
- Background: PubMed 27699348Slack WV. Patient-Computer Dialogue: A Review. Yearb Med Inform. 2000;(1):71-78.
- BackgroundSlack WV. Cybermedicine: how computing empowers doctors and patients for better health care (revised and updated edition). San Francisco: Jossey-Bass, 2001
- Background: PubMed 12558354Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003 Feb 4;138(3):161-7. doi: 10.7326/0003-4819-138-3-200302040-00007.
- Background: PubMed 18144531BRODMAN K, ERDMANN AJ Jr, et al. The Cornell medical index; a adjunct to medical interview. J Am Med Assoc. 1949 Jun 11;140(6):530-4. doi: 10.1001/jama.1949.02900410026007. No abstract available.
- Background: PubMed 13636498BRODMAN K, VAN WOERKOM AJ, ERDMANN AJ Jr, GOLDSTEIN LS. Interpretation of symptoms with a data-processing machine. AMA Arch Intern Med. 1959 May;103(5):776-82. doi: 10.1001/archinte.1959.00270050098015. No abstract available.
- Background: PubMed 14153274COLLEN MF, RUBIN L, NEYMAN J, DANTZIG GB, BAER RM, SIEGELAUB AB. AUTOMATED MULTIPHASIC SCREENING AND DIAGNOSIS. Am J Public Health Nations Health. 1964 May;54(5):741-50. doi: 10.2105/ajph.54.5.741. No abstract available.
- Background: PubMed 5689697Slack WV, Van Cura LJ. Computer-based patient interviewing. Postgrad Med. 1968 Apr;43(4):115-20 concl. doi: 10.1080/00325481.1968.11693217. No abstract available.
- Background: PubMed 5650983Slack WV, Van Cura LJ. Computer-based patient interviewing. 1. Postgrad Med. 1968 Mar;43(3):68-74. doi: 10.1080/00325481.1968.11693177. No abstract available.
- Beth Israel Deaconess Medical CenterLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warner V Slack, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Computer-based medical history in people with Patient Computer Dialog, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Post Medical History Assessment Questionnaire (time frame: Immediately after taking the medical history). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00386776, which also lists 93 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.