DepressionNCT00130416
Improving Chronic Disease Care With PatientSite
A study testing E-mail coaching to improve patient communication with doctor in people with Depression and Pain, run by Robert Wood Johnson Foundation at 1 site in United States.
Trial summary
The overall goal of this randomized, controlled trial is to test whether educational interventions - directed toward empowering patients and delivered via the Beth Israel Deaconess Medical Center (BIDMC's) secure patient Internet portal PatientSite - can improve the outcomes and satisfaction with care of adult primary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Pain, Mobility Difficulty
- What is being tested?
- E-mail coaching to improve patient communication with doctor
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary care patients aged 18 and older, of participating physicians within 5 internal medicine practices in Boston
- Registered users of patient-provider internet portal called PatientSite
- Screened positive for depression, chronic pain, or lower extremity mobility difficulty
Who cannot join
- Current treatment for screened condition by medical or surgical specialist or other appropriate licensed health professional such as a physical therapist or mental health counselor
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The overall goal of this randomized, controlled trial is to test whether educational interventions - directed toward empowering patients and delivered via the Beth Israel Deaconess Medical Center (BIDMC's) secure patient Internet portal PatientSite - can improve the outcomes and satisfaction with care of adult primary care patients with 3 common conditions: chronic pain, depression, and progressive difficulty walking.
Read the detailed description
PURPOSE OF PROTOCOL:
The overall goal of this randomized, controlled trial is to test whether educational interventions - directed toward empowering patients and delivered via the BIDMC's secure patient Internet portal PatientSite - can improve outcomes and satisfaction with care of adult primary care patients with 3 common conditions: chronic pain, depression, and progressive difficulty walking.
Primary study outcomes include improvement among intervention patients in:
- detection and treatment of the target conditions;
- patient-reported signs and symptoms of pain, depression, and impaired lower extremity mobility;
- patient-reported quality of life, patient-clinician communication, and satisfaction with care; and
- health care utilization. The secondary outcome is physicians' views that the intervention improved the efficiency and quality of care they deliver.
The specific aims of the project are:
- to improve physicians' detection and treatment of patient-reported pain, depression, and impaired walking among intervention patients compared to controls;
- to reduce patient-reported symptoms of chronic pain, depression, and impaired walking among intervention patients compared to controls;
- to improve patient-reported quality of life, patient-clinician communication, and satisfaction with care among intervention patients compared to controls; and 4. to improve physicians' assessments of the efficiency of office visits and quality of care they provided for the 3 study conditions.
SIGNIFICANCE AND BACKGROUND FOR THE STUDY:
Chronic conditions affect 99 million Americans and limit the daily lives of 41 million (Institute for Health \& Aging 1996). Moreover, these conditions are often unrecognized. Myriad reasons contribute to the under-diagnosis of chronic conditions, including problems with patient-clinician communication, providers' lack of awareness of the prevalence of these conditions or how to screen for them, and abbreviated office visits (e.g., Beckman 1999). Many conditions are difficult to ascertain, such as depression and pain, without objective and readily apparent indicators of impairment. Some persons believe that mobility difficulties are an inevitable consequence of aging, and something that physicians can do little to help, and primary care physicians generally have little formal training in mobility assessments (Iezzoni 2003a). An accurate, timely, and inexpensive way to identify and address chronic conditions could potentially transform the care of patients, enhance their quality of life, improve clinicians' work life, and mitigate the social cost of these conditions.
This project will test whether a secure patient Internet portal is a useful conduit for information that can improve patient care, by screening patients for certain conditions, communicating the results directly to the patient and their physician, empowering patients to address these condition with their physicians, facilitating clinicians' actions, and activating patients to participate in their own care.
PATIENTSITE:
PatientSite is a secure, personalized messaging system serving BIDMC and affiliated sites. It allows patients to communicate confidentially with their physicians and the physicians' staff via the Web. Patients are eligible to enroll in PatientSite if one of their physicians has agreed to use PatientSite. Data in PatientSite are encrypted and password protected. Patients register online, and receive passwords from administrators at their own practice site in order to confirm the patient's identity. Patients and clinicians must use a confidential password to obtain access to the system. To alert PatientSite users to the presence of a message, PatientSite sends users a traditional email message that they have a PatientSite message, along with a link to the PatientSite Web portal.
DESCRIPTION OF RESEARCH PROTOCOL:
The researchers are conducting a randomized, controlled trial of a PatientSite intervention designed to improve pain, depression, and impaired mobility among primary care patients, among other outcomes.
The researchers are recruiting physicians who currently use PatientSite from among those practicing at BIDMC's academic primary care practice and at 2 community practices affiliated with BIDMC. Patients of physicians who agree to participate are potentially eligible for the study. Two weeks before their next scheduled primary care office visit, The researchers are sending these patients an e-mail invitation via PatientSite to participate in the study. The e-mail briefly describes the study (including the procedures for randomization) and links patients to a complete, electronic informed consent form as well as standard HIPAA disclosures.
Patients who electronically sign the informed consent, thereby agreeing to participate in the study, are sent a screening questionnaire asking about signs and symptoms of chronic pain, depression, and difficulty walking. Persons who screen positive for at least one of these three conditions are enrolled in the study and randomized to intervention and control groups.
Patients randomized to the intervention electronically receive an e-mail message containing additional information about ways to address the condition during their primary care visit within the upcoming two weeks. The message includes condition-specific suggestions about how to discuss the problem with their clinician, along with standard tips about communicating with doctors. It provides a confidential link to an "electronic advocate" - a clinical nurse "e-Coach" who coaches (advises) the patient online about how to address the problem with their physician in the upcoming appointment.
Patients randomized to the control group receive an e-mail containing links to federal government Web sites containing general health information unrelated to the target conditions.
The researchers are surveying both intervention and control group subjects via PatientSite 1 week and 3 months after their index visit to find out about their visit and their satisfaction with care, their clinical outcomes relating to the target conditions, and use of additional health care services. At one week post-visit, the researchers are specifically asking whether they discussed the condition with their clinician and whether the clinician did anything about it. The researchers are further asking patients who did not address the symptom with their physician for the reason. Three months after the index visit, the researchers re-administer the screening instruments used at baseline in order to ascertain change in the target conditions, quality of life, health communication, and satisfaction. The researchers also review patients' medical records to abstract demographic information (age, gender, race, ethnicity, primary language), administrative data (insurance type, utilization of health services), and clinical characteristics (from the index visit note written by the physician) to corroborate discussion and management of target conditions, and to assess medical care utilization.
The researchers are surveying participating physicians at the conclusion of the study to obtain their perceptions about the impact of the intervention on their work including time burdens and quality of care. In addition, the researchers are reviewing the electronic medical records to ascertain provider and utilization outcome information at the end of the study.
- Conditions
- Depression, Pain, Mobility Difficulty
- Being tested
- E-mail coaching to improve patient communication with doctor
- Keywords
- behavior, randomized trial, communication, patient, internet, coaching, self-efficacy, nurse, primary care, physician, screening, survey, pain, mobility, disability, depression
- Medical subject headings
- Depression, Pain, Behavior, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-mail coaching to improve patient communication with doctorBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution or improvement in screened chronic condition
Improved communication with primary care doctor
Improved patient satisfaction
Improved physician satisfaction
Secondary outcomes (1)
Favorable clinician assessment of the impact of the screening intervention on the efficiency and quality of care they deliver
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2005 (estimated)
- Study startSep 2004
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 750 participants
Sponsor and investigators
- Lead sponsor
- Robert Wood Johnson Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Lisa I Iezzoni, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130416
- Sponsor's protocol ID
- 51757
- Status last verified
- Jul 2008
- First submitted
- 12 Aug 2005
- Last updated
- 8 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Leveille SG, Huang A, Tsai SB, Allen M, Weingart SN, Iezzoni LI. Health coaching via an internet portal for primary care patients with chronic conditions: a randomized controlled trial. Med Care. 2009 Jan;47(1):41-7. doi: 10.1097/MLR.0b013e3181844dd0.
PubMed 19106729
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Chronic Disease Care With PatientSite
- ClinicalTrials.gov ID
- NCT00130416
- Acronym / sponsor ID
- 51757
- Conditions
- Depression, Pain, Mobility Difficulty
- Keywords
- behavior, randomized trial, communication, patient, internet, coaching, self-efficacy, nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants
- Lead sponsor
- Robert Wood Johnson FoundationUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this randomized, controlled trial is to test whether educational interventions - directed toward empowering patients and delivered via the Beth Israel Deaconess Medical Center (BIDMC's) secure patient Internet portal PatientSite - can improve the outcomes and satisfaction with care of adult primary care patients with 3 common conditions: chronic pain, depression, and progressive difficulty walking.
Detailed description
PURPOSE OF PROTOCOL:
The overall goal of this randomized, controlled trial is to test whether educational interventions - directed toward empowering patients and delivered via the BIDMC's secure patient Internet portal PatientSite - can improve outcomes and satisfaction with care of adult primary care patients with 3 common conditions: chronic pain, depression, and progressive difficulty walking.
Primary study outcomes include improvement among intervention patients in:
- detection and treatment of the target conditions;
- patient-reported signs and symptoms of pain, depression, and impaired lower extremity mobility;
- patient-reported quality of life, patient-clinician communication, and satisfaction with care; and
- health care utilization. The secondary outcome is physicians' views that the intervention improved the efficiency and quality of care they deliver.
The specific aims of the project are:
- to improve physicians' detection and treatment of patient-reported pain, depression, and impaired walking among intervention patients compared to controls;
- to reduce patient-reported symptoms of chronic pain, depression, and impaired walking among intervention patients compared to controls;
- to improve patient-reported quality of life, patient-clinician communication, and satisfaction with care among intervention patients compared to controls; and 4. to improve physicians' assessments of the efficiency of office visits and quality of care they provided for the 3 study conditions.
SIGNIFICANCE AND BACKGROUND FOR THE STUDY:
Chronic conditions affect 99 million Americans and limit the daily lives of 41 million (Institute for Health \& Aging 1996). Moreover, these conditions are often unrecognized. Myriad reasons contribute to the under-diagnosis of chronic conditions, including problems with patient-clinician communication, providers' lack of awareness of the prevalence of these conditions or how to screen for them, and abbreviated office visits (e.g., Beckman 1999). Many conditions are difficult to ascertain, such as depression and pain, without objective and readily apparent indicators of impairment. Some persons believe that mobility difficulties are an inevitable consequence of aging, and something that physicians can do little to help, and primary care physicians generally have little formal training in mobility assessments (Iezzoni 2003a). An accurate, timely, and inexpensive way to identify and address chronic conditions could potentially transform the care of patients, enhance their quality of life, improve clinicians' work life, and mitigate the social cost of these conditions.
This project will test whether a secure patient Internet portal is a useful conduit for information that can improve patient care, by screening patients for certain conditions, communicating the results directly to the patient and their physician, empowering patients to address these condition with their physicians, facilitating clinicians' actions, and activating patients to participate in their own care.
PATIENTSITE:
PatientSite is a secure, personalized messaging system serving BIDMC and affiliated sites. It allows patients to communicate confidentially with their physicians and the physicians' staff via the Web. Patients are eligible to enroll in PatientSite if one of their physicians has agreed to use PatientSite. Data in PatientSite are encrypted and password protected. Patients register online, and receive passwords from administrators at their own practice site in order to confirm the patient's identity. Patients and clinicians must use a confidential password to obtain access to the system. To alert PatientSite users to the presence of a message, PatientSite sends users a traditional email message that they have a PatientSite message, along with a link to the PatientSite Web portal.
DESCRIPTION OF RESEARCH PROTOCOL:
The researchers are conducting a randomized, controlled trial of a PatientSite intervention designed to improve pain, depression, and impaired mobility among primary care patients, among other outcomes.
The researchers are recruiting physicians who currently use PatientSite from among those practicing at BIDMC's academic primary care practice and at 2 community practices affiliated with BIDMC. Patients of physicians who agree to participate are potentially eligible for the study. Two weeks before their next scheduled primary care office visit, The researchers are sending these patients an e-mail invitation via PatientSite to participate in the study. The e-mail briefly describes the study (including the procedures for randomization) and links patients to a complete, electronic informed consent form as well as standard HIPAA disclosures.
Patients who electronically sign the informed consent, thereby agreeing to participate in the study, are sent a screening questionnaire asking about signs and symptoms of chronic pain, depression, and difficulty walking. Persons who screen positive for at least one of these three conditions are enrolled in the study and randomized to intervention and control groups.
Patients randomized to the intervention electronically receive an e-mail message containing additional information about ways to address the condition during their primary care visit within the upcoming two weeks. The message includes condition-specific suggestions about how to discuss the problem with their clinician, along with standard tips about communicating with doctors. It provides a confidential link to an "electronic advocate" - a clinical nurse "e-Coach" who coaches (advises) the patient online about how to address the problem with their physician in the upcoming appointment.
Patients randomized to the control group receive an e-mail containing links to federal government Web sites containing general health information unrelated to the target conditions.
The researchers are surveying both intervention and control group subjects via PatientSite 1 week and 3 months after their index visit to find out about their visit and their satisfaction with care, their clinical outcomes relating to the target conditions, and use of additional health care services. At one week post-visit, the researchers are specifically asking whether they discussed the condition with their clinician and whether the clinician did anything about it. The researchers are further asking patients who did not address the symptom with their physician for the reason. Three months after the index visit, the researchers re-administer the screening instruments used at baseline in order to ascertain change in the target conditions, quality of life, health communication, and satisfaction. The researchers also review patients' medical records to abstract demographic information (age, gender, race, ethnicity, primary language), administrative data (insurance type, utilization of health services), and clinical characteristics (from the index visit note written by the physician) to corroborate discussion and management of target conditions, and to assess medical care utilization.
The researchers are surveying participating physicians at the conclusion of the study to obtain their perceptions about the impact of the intervention on their work including time burdens and quality of care. In addition, the researchers are reviewing the electronic medical records to ascertain provider and utilization outcome information at the end of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary care patients aged 18 and older, of participating physicians within 5 internal medicine practices in Boston
- Registered users of patient-provider internet portal called PatientSite
- Screened positive for depression, chronic pain, or lower extremity mobility difficulty
Key exclusion criteria (1 listed)
- Current treatment for screened condition by medical or surgical specialist or other appropriate licensed health professional such as a physical therapist or mental health counselor
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 |
|---|---|---|
| E-mail coaching to improve patient communication with doctor | Behavioural | – |
Primary outcome
Resolution or improvement in screened chronic condition
Improved communication with primary care doctor
Improved patient satisfaction
Improved physician satisfaction
1 secondary outcome
Favorable clinician assessment of the impact of the screening intervention on the efficiency and quality of care they deliver
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2008.
- Derived from this study: PubMed 19106729Leveille SG, Huang A, Tsai SB, Allen M, Weingart SN, Iezzoni LI. Health coaching via an internet portal for primary care patients with chronic conditions: a randomized controlled trial. Med Care. 2009 Jan;47(1):41-7. doi: 10.1097/MLR.0b013e3181844dd0.
- Website for patient-doctor internet portalLink provided by the sponsor.
- website for Health e-Technologies Initiative, a national program office of the Robert Wood Johnson FoundationLink provided by the sponsor.
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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.
Lisa I Iezzoni, 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 study testing E-mail coaching to improve patient communication with doctor in people with Depression and Pain, run by Robert Wood Johnson Foundation 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 8 Jul 2008. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resolution or improvement in screened chronic condition. The study lists 4 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 NCT00130416, which also lists 1 linked publication.
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 8 Jul 2008.