Patient Computer Dialog in Primary Care

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Warner Slack, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00386776
First received: October 11, 2006
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Patient Computer Dialog
Other: Computer-based medical history
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cybermedicine for the Patient and Physician

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Patient Post Medical History Assessment Questionnaire [ Time Frame: Immediately after taking the medical history ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Number of Office Visits by Patients [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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.


Enrollment: 45
Study Start Date: January 2005
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386776

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Warner V Slack, MD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
Publications:
Slack WV, Hicks GP, Reed CE, Van Cura LJ. A computer based medical history system. N Engl J Med 1966; 274: 194-8.
Slack WV. Patient-computer dialogue: a review. In: van Bemmel JH, McCray AT, eds. Yearbook of medical informatics 2000: patient-centered systems. Stuttgart, Germany: Schattauer, 2000, 71-8
Slack WV. Cybermedicine: how computing empowers doctors and patients for better health care (revised and updated edition). San Francisco: Jossey-Bass, 2001
Lucas RW. A study of patients' attitudes to computer interrogation. Int J Man Machine Studies 1977; 9: 69-86.
Greist JH, Klein MH. Computer programs for patients, clinicians, and researchers in psychiatry. In: Sidowski JB, Johnson JH, Williams TA, eds. Technology in mental health care delivery systems. Norwood, Conn.: Ablex, 1980: 161-82.
Slack WV. Patient power: a patient oriented value system. In: Jacques JA, ed. Computer diagnosis and diagnostic methods. Proceedings of the Second Conference on the Diagnostic Process held at the University of Michigan. Springfield, IL: Charles C. Thomas, 1972: 3-7.
Slack WV. The patient's right to decide. Lancet 1977; 2: 240.
Bleich HL, Beckley RF, Horowitz G, Jackson J, Moody E, Franklin C, Goodman SR, McKay MW, Pope RA, Walden T, Bloom SA, Slack WV. Clinical computing in a teaching hospital. N Engl J Med 1985; 312: 756-64.
Weizenbaum JE. ELIZA: a computer program for the study of natural language communication between man and machine. Commun Assoc Comput Mach 1966; 9: 36-45.
Slack WV, Slack CW. Patient computer dialogue. N Engl J Med 1972; 286: 1304-9.
Slack WV, Slack CW. Talking to a computer about emotional problems: a comparative study. Psychotherapy: Theory, Research, and Practice 1977; 14: 156-64.
Swedlow DB, Barnett GO, Grossman JH, Souder DE. A simple programming system (DRIVER) Comput Biomed Res 1972; 5: 90-8. PMID 5019502
Angle HV, Carroll JA. Computer interview language: programming the on line interactive computer. Behav Res Meth Instrumentation 1979; 11: 379-83.
Sands DZ, Halamka JD. PatientSite: patient centered communication, services, and access to information. In: Nelson R, Martin E, Safran C, eds. Consumer Informatics in a cyberhealth world. New York: Springer Verlag, scheduled for publication in 2003.
Streiner DL, Norman GR. Health measurement scales: a practical guide to their development and use (second edition). Oxford: Oxford University Press, 1995.
Fowler FJ. Improving survey questions: design and evaluation (Applied Social Research Methods Series Volume 38). London: SAGE Publications, 1995.
Lucas RW. Computer interrogation: investigation of patients' response times. Int Res Commun Systems J Med Sci 1974; 2: 1176.
Slack WV. The issue of privacy. MD Comput 1997; 14: 8-10.
Slee VN, Slee DA, Schmidt HJ. Slee's health care terms (fourth edition). Saint Paul: Tringa Press, 2001.

Responsible Party: Warner Slack, Professor of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00386776     History of Changes
Other Study ID Numbers: 2004P-000420, R01LM008255-01A1
Study First Received: October 11, 2006
Results First Received: March 20, 2013
Last Updated: June 11, 2013
Health Authority: United States: Federal Government

Keywords provided by Beth Israel Deaconess Medical Center:
computers
diagnosis
medical records
physician patient relations
medical history taking
medical informatics applications

ClinicalTrials.gov processed this record on October 30, 2014