Patient Computer Dialog in Primary Care

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00386776
• Collaborator: National Library of Medicine (NLM) (NIH)
• Enrollment: 45
• Location: 1
• Arm: 1
• Duration (Months): 72
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Patient Computer Dialog	Other: Computer-based medical history	Phase 3

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

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Cybermedicine for the Patient and Physician
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 'Computer-based medical history 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.	Other: Computer-based medical history; 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.

Outcome Measures

Primary Outcome Measures

1. Patient Post Medical History Assessment Questionnaire [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.

2. Patient Post Visit Questionnaire [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.

3. Physician Post Visit Questionnaire [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.

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria

• Under 18 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center
• National Library of Medicine (NLM)

Investigators

• Principal Investigator: Warner V Slack, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Beth Israel Deaconess Medical Center

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• Responsible Party: Warner Slack, Professor of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT00386776
• Other Study ID Numbers: 2004P-000420; R01LM008255-01A1
• First Posted: Oct 12, 2006
• Last Update Posted: Jun 20, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Warner Slack, Professor of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center: computers; diagnosis; medical records; physician patient relations; medical history taking; medical informatics applications

Study Results

Participant Flow

Recruitment Details	We recruited patients from the Healthcare Associates (HCA)and the Affiliated Physicians Group (APG) clinics of Beth Israel Deaconess Medical Center who were to see their primary care physician for the first time.
Pre-assignment Detail	Forty-five patients enrolled in the Computer-based medical history study. Forty of these patients started the medical history and 32 of these patients completed the program.

Arm/Group Title	Computer-based Medical History
Arm/Group Description	The intervention is a computer-based medical history designed 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
Period Title: Overall Study
STARTED	40
COMPLETED	32
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Experimental
Arm/Group Description	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.
Overall Participants	40
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	36 90%
>=65 years	4 10%
Sex: Female, Male (Count of Participants)
Female	22 55%
Male	18 45%

Outcome Measures

1. Primary Outcome

Title	Patient Post Medical History Assessment Questionnaire
Description	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.
Time Frame	Immediately after taking the medical history

Outcome Measure Data

Analysis Population Description

We analyzed post medical history questionnaire responses for the 32 patients who completed the medical history patients.

Arm/Group Title	Computer-based Medical History
Arm/Group Description	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.
Measure Participants	32
Helpfulness questions thinking about health	8.4
Combined mean score for all 10 questions	8.3

2. Primary Outcome

Title	Patient Post Visit Questionnaire
Description	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.
Time Frame	One day after the visit with the physician

Outcome Measure Data

Analysis Population Description

We analyzed post medical history questionnaire responses for the 23 patients who completed the medical history patients.

Arm/Group Title	Computer-based Medical History
Arm/Group Description	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.
Measure Participants	23
Helpfulness computer interview before visit	8.3
Combined mean for all 6 questions	7.8
Combined mean when 3 pts but not MDs entered data	5.9

3. Primary Outcome

Title	Physician Post Visit Questionnaire
Description	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.
Time Frame	One day after the patient visit

Outcome Measure Data

Analysis Population Description

We analyzed post visit physician questionnaire responses for the patients who completed the medical history and who showed up for their appointment.

Arm/Group Title	Computer-based Medical History
Arm/Group Description	The intervention is a computer-based medical history designed 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. There are also 6000 questions, explanations and suggestions, available for presentation dependent upon the patient's responses,
Measure Participants	23
Helpfulness pt taking computer hx before visit	7.7
How helpful was summary in providing care	7.5
Combined mean of all 6 questions	7.6
Combined mean MD's but not pts entered data	7.2

4. Secondary Outcome

Title	Number of Office Visits by Patients
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Computer-based Medical History
Arm/Group Description	The intervention is a computer-based medical history designed 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
Measure Participants	0

5. Secondary Outcome

Title	Time Per Visit
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Computer-based Medical History
Arm/Group Description	The intervention is a computer-based medical history designed 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
Measure Participants	0

6. Secondary Outcome

Title	Number of Telephone Calls and E-mail Messages Between Patients and Physicians
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Computer-based Medical History
Arm/Group Description	The intervention is a computer-based medical history designed 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
Measure Participants	0

7. Secondary Outcome

Title	Completeness of Patients' Problem Lists
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Computer-based Medical History
Arm/Group Description	The intervention is a computer-based medical history designed 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
Measure Participants	0

Adverse Events

Adverse Event Reporting Description	Adverse Events were not collected/assessed for this study
Arm/Group Title	Computer-based Medical History
Arm/Group Description	The intervention is a computer-based medical history designed 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. There are also 6000 questions, explanations and suggestions, available for presentation dependent upon the patient's responses,
All Cause Mortality
	Computer-based Medical History
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Computer-based Medical History
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Computer-based Medical History
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.