CancerOPPCNCT00971139
Implementing Online Patient-Provider Communication Into Clinical Practice
A study testing Access to an OPPC service in people with Cancer and Injury of Liver, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This interdisciplinary, international collaboration study, including the the Norwegian Health Economy Administration (HELFO) will evaluate the effectiveness and real-world implementation of an online patient-provider communication (OPPC) service into rout ine practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Injury of Liver, Diabetes
- What is being tested?
- Access to an OPPC service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2009to Dec 2013
- 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
- 18 years of age.
- Able to read/speak Norwegian and have Internet with secure access (BankID) at home.
Who cannot join
- Excluded are patients who have brain metastasis and patients with cerebral affection caused by the disease (e.g., encephalopathy) as this may affect their abilities to reliably report their symptoms.
- Excluded are also patients who receive a liver transplant indicated by cancer coli, as they participate in another study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing Online Patient-Provider Communication Into Clinical Practice: Implementation Research
This interdisciplinary, international collaboration study, including the the Norwegian Health Economy Administration (HELFO) will evaluate the effectiveness and real-world implementation of an online patient-provider communication (OPPC) service into rout ine practice. In Phase I we will identify patients and care providers requirements and organizational contexts, and use participatory design methods to adapt the OPPC service to users needs and the context of clinical practice. In Phase II we will offer study participants access to the OPPC service to understand implementation issues. In addition, we will conduct a pilot randomized clinical trial (usual care; OPPC) with 40 patients in each group that will be followed over 6 months.
Read the detailed description
A rapidly growing research literature documents the importance of Health IT to improve communication between health care providers and their patients. Patient Internet portals and online patient-provider communication (OPPC) allow patients to stay connected with their care providers between clinical encounters, get help and advice for their symptoms and problems from home, better understand and manage their illness, and become more engaged in their care. Through better patient-provider partnerships and communication independent of face-to-face visits, health problems and side-effects of treatment can be more easily detected, prevented, and treated more quickly.
Therefore, the overall goal of this international collaboration study is to implement and evaluate the effects and use of a primarily nurse-administered OPPC service, including access to advice from physicians, dietitians and social counselors, as part of regular patient care; and using methods consistent with effectiveness research to bridge the gap between research evidence and translation into routine practice.
The specific aims of this study are twofold:
In Phase I the investigators will refine and implement an Internet-based OPPC service where patients can ask questions and receive advice and support from care providers and social counselors. The investigators will use participatory design methods to adapt an OPPC service to patients' needs; care providers' requirements; and the workflow and organizational and technical infrastructure of clinical practice by answering the following research questions:
What are the predisposing, enabling and reinforcing factors related to successful adoption, implementation and maintenance of the OPPC service such as: potential barriers to successful implementation; workflow adjustments, support and resources needed to implement and maintain the OPPC in daily clinical practice?
In Phase II we will offer study participants access to the OPPC service to understand implementation issues. In addition, we will conduct a pilot randomized clinical trial (usual care; OPPC) with 40 patients in each group that will be followed over 6 months to evaluate:
- participation rate and OPPC use;
- characteristics of high/low volume users, patient-caregiver communication and use patterns;
- perceived usefulness and ease of use and
- impacts on organizational change and interdisciplinary collaboration.
- Conditions
- Cancer, Injury of Liver, Diabetes
- Being tested
- Access to an OPPC service
- Keywords
- Online patient-provider communication, Organizational change, Symptom management
- Medical subject headings
- Neoplasms, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to an OPPC serviceBehavioural
Access to an Internet-based messaging system where patients can ask questions and receive advice and support from care providers at the hospital and social counsellors
| Study group | Role | What they receive |
|---|---|---|
| Access to an OPPC service | Experimental | Access to an Internet-based messaging system where patients can ask questions and receive advice and support from care providers at the hospital and social counsellors Receives: Behavioral: Access to an OPPC service |
| Control group | No intervention | Patients receiving usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impacts of the OPPC service on organizational processes/organizational change such as care processes
Measured: End of study at 6 (8) months after last included patient
Secondary outcomes (2)
Participation rate and OPPC use, perceived usefulness and ease of use
Measured: End of study at 6 (8) months after last included patient
Characteristics of high/low volume users, patient-caregiver communication and use patterns
Measured: End of study at 6 (8) months after last included patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Cornelia Ruland, Oslo University Hospital
- Investigators
- Cornelia M Ruland, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971139
- Sponsor's protocol ID
- RCN191008/V50
- Acronym
- OPPC
- Status last verified
- Nov 2015
- First submitted
- 1 Sep 2009
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruland CM, Borosund E, Varsi C. User requirements for a practice-integrated nurse-administered online communication service for cancer patients. Stud Health Technol Inform. 2009;146:221-5.
PubMed 19592838Varsi C, Gammon D, Wibe T, Ruland CM. Patients' reported reasons for non-use of an internet-based patient-provider communication service: qualitative interview study. J Med Internet Res. 2013 Nov 11;15(11):e246. doi: 10.2196/jmir.2683.
PubMed 24220233Wibe T, Helleso R, Varsi C, Ruland C, Ekstedt M. How does an online patient-nurse communication service meet the information needs of men with recently diagnosed testicular cancer? ISRN Nurs. 2012;2012:260975. doi: 10.5402/2012/260975. Epub 2012 Dec 4.
PubMed 23251816Wibe T, Ekstedt M, Helleso R, Varsi C, Ruland C. "You are not at all bothersome" - nurses' online communication with testicular cancer patients. NI 2012 (2012). 2012 Jun 23;2012:453. eCollection 2012.
PubMed 24199140Varsi C, Ekstedt M, Gammon D, Ruland CM. Using the Consolidated Framework for Implementation Research to Identify Barriers and Facilitators for the Implementation of an Internet-Based Patient-Provider Communication Service in Five Settings: A Qualitative Study. J Med Internet Res. 2015 Nov 18;17(11):e262. doi: 10.2196/jmir.5091.
PubMed 26582138
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Online Patient-Provider Communication Into Clinical Practice: Implementation Research
- ClinicalTrials.gov ID
- NCT00971139
- Acronym / sponsor ID
- OPPC / RCN191008/V50
- Conditions
- Cancer, Injury of Liver, Diabetes
- Keywords
- Online patient-provider communication, Organizational change, Symptom management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Nov 2009
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Sep 2009 (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.
This interdisciplinary, international collaboration study, including the the Norwegian Health Economy Administration (HELFO) will evaluate the effectiveness and real-world implementation of an online patient-provider communication (OPPC) service into rout ine practice. In Phase I we will identify patients and care providers requirements and organizational contexts, and use participatory design methods to adapt the OPPC service to users needs and the context of clinical practice. In Phase II we will offer study participants access to the OPPC service to understand implementation issues. In addition, we will conduct a pilot randomized clinical trial (usual care; OPPC) with 40 patients in each group that will be followed over 6 months.
Detailed description
A rapidly growing research literature documents the importance of Health IT to improve communication between health care providers and their patients. Patient Internet portals and online patient-provider communication (OPPC) allow patients to stay connected with their care providers between clinical encounters, get help and advice for their symptoms and problems from home, better understand and manage their illness, and become more engaged in their care. Through better patient-provider partnerships and communication independent of face-to-face visits, health problems and side-effects of treatment can be more easily detected, prevented, and treated more quickly.
Therefore, the overall goal of this international collaboration study is to implement and evaluate the effects and use of a primarily nurse-administered OPPC service, including access to advice from physicians, dietitians and social counselors, as part of regular patient care; and using methods consistent with effectiveness research to bridge the gap between research evidence and translation into routine practice.
The specific aims of this study are twofold:
In Phase I the investigators will refine and implement an Internet-based OPPC service where patients can ask questions and receive advice and support from care providers and social counselors. The investigators will use participatory design methods to adapt an OPPC service to patients' needs; care providers' requirements; and the workflow and organizational and technical infrastructure of clinical practice by answering the following research questions:
What are the predisposing, enabling and reinforcing factors related to successful adoption, implementation and maintenance of the OPPC service such as: potential barriers to successful implementation; workflow adjustments, support and resources needed to implement and maintain the OPPC in daily clinical practice?
In Phase II we will offer study participants access to the OPPC service to understand implementation issues. In addition, we will conduct a pilot randomized clinical trial (usual care; OPPC) with 40 patients in each group that will be followed over 6 months to evaluate:
- participation rate and OPPC use;
- characteristics of high/low volume users, patient-caregiver communication and use patterns;
- perceived usefulness and ease of use and
- impacts on organizational change and interdisciplinary collaboration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Access to an OPPC service | Experimental | Behavioral: Access to an OPPC serviceAccess to an Internet-based messaging system where patients can ask questions and receive advice and support from care providers at the hospital and social counsellors |
| Control group | No intervention | –Patients receiving usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age.
- Able to read/speak Norwegian and have Internet with secure access (BankID) at home.
Key exclusion criteria (2 listed)
- Excluded are patients who have brain metastasis and patients with cerebral affection caused by the disease (e.g., encephalopathy) as this may affect their abilities to reliably report their symptoms.
- Excluded are also patients who receive a liver transplant indicated by cancer coli, as they participate in another study.
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 |
|---|---|---|
| Access to an OPPC serviceAccess to an Internet-based messaging system where patients can ask questions and receive advice and support from care providers at the hospital and social counsellors | Behavioural | Access to an OPPC service |
Primary outcome
Impacts of the OPPC service on organizational processes/organizational change such as care processes
Time frame: End of study at 6 (8) months after last included patient
2 secondary outcomes
Participation rate and OPPC use, perceived usefulness and ease of use
Time frame: End of study at 6 (8) months after last included patient
Characteristics of high/low volume users, patient-caregiver communication and use patterns
Time frame: End of study at 6 (8) months after last included patient
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 3 Nov 2015.
- Background: PubMed 19592838Ruland CM, Borosund E, Varsi C. User requirements for a practice-integrated nurse-administered online communication service for cancer patients. Stud Health Technol Inform. 2009;146:221-5.
- Results publication: PubMed 24220233Varsi C, Gammon D, Wibe T, Ruland CM. Patients' reported reasons for non-use of an internet-based patient-provider communication service: qualitative interview study. J Med Internet Res. 2013 Nov 11;15(11):e246. doi: 10.2196/jmir.2683.
- Results publication: PubMed 23251816Wibe T, Helleso R, Varsi C, Ruland C, Ekstedt M. How does an online patient-nurse communication service meet the information needs of men with recently diagnosed testicular cancer? ISRN Nurs. 2012;2012:260975. doi: 10.5402/2012/260975. Epub 2012 Dec 4.
- Results publication: PubMed 24199140Wibe T, Ekstedt M, Helleso R, Varsi C, Ruland C. "You are not at all bothersome" - nurses' online communication with testicular cancer patients. NI 2012 (2012). 2012 Jun 23;2012:453. eCollection 2012.
- Derived from this study: PubMed 26582138Varsi C, Ekstedt M, Gammon D, Ruland CM. Using the Consolidated Framework for Implementation Research to Identify Barriers and Facilitators for the Implementation of an Internet-Based Patient-Provider Communication Service in Five Settings: A Qualitative Study. J Med Internet Res. 2015 Nov 18;17(11):e262. doi: 10.2196/jmir.5091.
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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.
Cornelia M Ruland, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to an OPPC service in people with Cancer and Injury of Liver, run by Oslo University Hospital at 1 site in Norway.
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 2 inclusion and 2 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 3 Nov 2015. 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 Norway. 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?
Impacts of the OPPC service on organizational processes/organizational change such as care processes (time frame: End of study at 6 (8) months after last included patient). 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 NCT00971139, which also lists 5 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 3 Nov 2015.