Project to Assess Feasibility of a Rapid Access Metastatic Bone Disease Program (RAMP)

August 4, 2020 updated by: Ottawa Hospital Research Institute

A Pilot Project to Assess the Feasibility of Integrating a Multidisciplinary Rapid Access Metastatic Bone Disease Program (RAMP) at The Ottawa Hospital

The skeletal system is one of the most common sites for metastatic spread of many malignancies. Metastatic bone disease (MBD) can be associated with a significant reduction in quality of life due to debilitating pain and pathologic fractures. Multiple providers are involved in treating patients with MBD which can result in fragmented and delayed delivery of care. This fragmentation also leads to poor outcomes and patient experience. This project will assess whether it is feasible to integrate a multidisciplinary Rapid Access Metastatic Bone Disease Program (RAMP) at the Investigator's institution to improve the delivery of care to patients presenting with pelvic and lower extremity MBD. The goals of RAMP are: 1) Improve outcome and quality of care provided to MBD patients. 2) Improve patients experience through the participant's treatment journey. 3) Avert extra health care costs caused by unplanned admissions through ER and decrease redundancies due to unnecessary multiple clinic visits and double-ordering of diagnostic tests. This project will be designed to optimize the use of existing clinic resources more efficiently. Cancer patients and their loved ones will be actively engaged in the design of this project to better achieve its goals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

More than 140,000 new cases of cancer are diagnosed annually in Canada, with nearly half of which metastasize to bone. The skeletal system is one of the most common sites for metastatic spread of many visceral malignancies, especially cancers originating from breast, prostate, lung, thyroid and kidney. Hematologic malignancies, such as multiple myeloma and lymphoma, also primarily manifest with multiple aggressive lytic lesions in the bone. A Skeletal Related Event (SRE) is the term given when a metastatic lesion arises in bone. With advances in effective systemic treatment and supportive care, the duration of survival of patients with bone metastases has improved substantially. This improvement in survival can be accompanied by significant morbidity and reduction in quality of life secondary to pain, pathologic fracture, and spinal cord compression from SREs. Pain and impaired mobility occur in approximately 65%-75% of patients with bone metastases. SREs are also associated with high economic burden secondary to increased costs of treatment and high rates of hospitalizations. It is estimated that a single episode of SRE can cost the medical system 36,462 USD. The current literature reflects significant diversity in the approach of diagnosing and treating MBD. Therefore, numerous studies have advocated the need for a multidisciplinary clinic to co-ordinate the diagnosis, treatment, and rehabilitation of patients with MBD patients. This strategy has also been proposed to improve the delivery of early and multimodal palliative management for patients in a cost effective approach.

Aims and Objectives: The aims of this project are: 1) Assess feasibility of establishing and integrating a multidisciplinary Rapid Access Metastatic Bone Disease Program (RAMP) at the Investigator's institution to improve the delivery of care to patients presenting with pelvic and lower extremity MBD. 2) Centralize referrals and streamline clinical care pathways for patients diagnosed with MBD to pelvis and lower extremity. 3) Assess improvement in outcome and patient experience. The objectives of this project are: 1) Establish a core multidisciplinary RAMP team to develop a patient-centered clinical care pathway for diagnosis and treatment. 2) Establish a standardized and rapid referral process for RAMP. 3) Triage consults and coordinate their integration into pre-existing weekly "musculoskeletal oncology" clinic at the cancer center. 4) Develop a centralized registry for patients presenting to RAMP to assess provider performance and evaluate the success of established clinical care pathways.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are referred and subsequently followed for a diagnosis of Bone Metastatic Disease of the pelvis or lower extremities arising from a Primary Cancer elsewhere.

Description

Inclusion Criteria:

  • Patient is 18 years of age or older and able to provide informed consent.
  • Patient with an established tissue diagnosis of cancer.
  • Patient with diagnosis of metastatic bone lesion which requires a referral to an Orthopedic Oncology Specialist.
  • Patient will receive their care and treatment for this metastatic disease at The Ottawa Hospital.

Exclusion Criteria:

  • Patient does not speak or understand adequate French or English to complete the functional outcome questionnaires.
  • Patient has a documented cognitive impairment precluding questionnaire completion (e.g. dementia).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Standardization of the referral pathways
Time Frame: 2 years
Identifying the rate of compliance from the ER, oncology (Medical, radiation and hematology), as well as primary physicians in directing referrals to RAMP. The goal is a compliance rate of 80%. This will be measured by capturing the consults for MBD of the pelvis and lower extremity that were referred outside RAMP referral pathway.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility to triage MBD patients in currently existing musculoskeletal oncology clinics
Time Frame: 2 years
The admission rate and triage of the musculoskeletal oncology clinic for MBD patients will help us identify the current systems true clinic capacity.
2 years
Improve patient flow and timely access to care.
Time Frame: 2 years
This benefit will be measured by achieving wait time < 7 days for patients to be assessed for a pending pathologic fracture. The wait time will be captured by the RAMP registry which will keep meticulous track of all referral, visits and treatment dates.
2 years
Improvement in symptom management and patient satisfaction
Time Frame: 2 years
This data will be captured by patients filling validated ESAS and patient.This data will be captured by patients filling validated ESAS and patient satisfaction questionnaires. These questionnaires will be collected during phase I (planning) of this project, and will be compared to surveys obtained during phase II(execution). We anticipate an improvement in patient satisfaction.
2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvement in counseling MBD patients about mobility aids and fall risk assessment.
Time Frame: 2 years
This metric can be captured by collaborating with our electronic chart experts (MOSAIQ) to create a field for RNs to document this item, which can then be tracked.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Hospital Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hesham Abdelbary, MD, OHRI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FORM ID 6174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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