Clinical trial NCT00971139: Implementing Online Patient-Provider Communication Into Clinical Practice
Official title: Implementing Online Patient-Provider Communication Into Clinical Practice: Implementation Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Injury of Liver
Diabetes
Keywords: Online patient-provider communication
Organizational change
Symptom management
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2009-09-03
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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:

1. participation rate and OPPC use;
2. characteristics of high/low volume users, patient-caregiver communication and use patterns;
3. perceived usefulness and ease of use and
4. impacts on organizational change and interdisciplinary collaboration.

Eligibility criteria: Inclusion Criteria:

* 18 years of age.
* Able to read/speak Norwegian and have Internet with secure access (BankID) at home.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Impacts of the OPPC service on organizational processes/organizational change such as care processes
timeFrame: End of study at 6 (8) months after last included patient
Secondary outcomes:
measure: Participation rate and OPPC use, perceived usefulness and ease of use
timeFrame: End of study at 6 (8) months after last included patient
measure: Characteristics of high/low volume users, patient-caregiver communication and use patterns
timeFrame: End of study at 6 (8) months after last included patient
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital - Rikshospitalet
Study officials:
affiliation: Oslo University Hospital
name: Cornelia M Ruland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Varsi 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.
citation: Wibe 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.
citation: Wibe 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.
citation: Varsi 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.