Implementing Online Patient-Provider Communication Into Clinical Practice (OPPC)

This study has been completed.
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Cornelia Ruland, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00971139
First received: September 1, 2009
Last updated: November 2, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Cancer
Injury of Liver
Diabetes
Behavioral: Access to an OPPC service

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Implementing Online Patient-Provider Communication Into Clinical Practice: Implementation Research

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Participation rate and OPPC use, perceived usefulness and ease of use [ Time Frame: End of study at 6 (8) months after last included patient ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 199
Study Start Date: November 2009
Study Completion Date: December 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Access to an OPPC service
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
Behavioral: Access to an OPPC service
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
No Intervention: Control group
Patients receiving usual care

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00971139

Locations
Norway
Oslo University Hospital - Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
The Research Council of Norway
Investigators
Principal Investigator: Cornelia M Ruland, PhD Oslo University Hospital Rikshospitalet
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cornelia Ruland, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00971139     History of Changes
Other Study ID Numbers: RCN191008/V50 
Study First Received: September 1, 2009
Last Updated: November 2, 2015
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Online patient-provider communication
Organizational change
Symptom management

ClinicalTrials.gov processed this record on May 04, 2016