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Patient Computer Dialog in Primary Care

2013년 6월 11일 업데이트: Warner Slack, Beth Israel Deaconess Medical Center

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

45

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Massachusetts
      • Boston, Massachusetts, 미국, 02215
        • Beth Israel Deaconess Medical Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 특수 증상
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: '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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Patient Post Medical History Assessment Questionnaire
기간: 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.

Immediately after taking the medical history
Patient Post Visit Questionnaire
기간: 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.
One day after the visit with the physician
Physician Post Visit Questionnaire
기간: 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.
One day after the patient visit

2차 결과 측정

결과 측정
측정값 설명
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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Warner V Slack, MD, Beth Israel Deaconess Medical Center

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2005년 1월 1일

기본 완료 (실제)

2011년 1월 1일

연구 완료 (실제)

2011년 1월 1일

연구 등록 날짜

최초 제출

2006년 10월 11일

QC 기준을 충족하는 최초 제출

2006년 10월 11일

처음 게시됨 (추정)

2006년 10월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 6월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 6월 11일

마지막으로 확인됨

2013년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2004P-000420
  • R01LM008255-01A1 (미국 NIH 보조금/계약)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다