Supporting Decision Making for Musculoskeletal Preference-Sensitive Care - Full Text View

Purpose

The purpose of this study is to compare condition oriented whole person Health Coaching along with the provision of decision aids to decision aids without condition oriented Health Coaching to neither condition oriented health coaching nor decision aids on medical cost, preference sensitive surgeries and measures of subject knowledge, decision process and decision quality.

Condition	Intervention
Knee Pain Chronic Arthritis (Hip) Arthritis (Knee) Back Pain	Behavioral: Provision of condition specific DVD and Pamphlet to support Shared Decision Making Behavioral: Telephonic outreach and support by Health Coach Behavioral: No condition specific telephonic outreach

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research
Official Title:	A Prospective, Observational Randomized Trial to Assess the Impact of Decision Aids and Health Coaching on Health Care Costs, Surgery Rates, and Decision Quality for Individuals At Risk for Musculoskeletal Preference-Sensitive Surgical Decisions

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Further study details as provided by Health Dialog:

Primary Outcome Measures:

Total medical costs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy.

Secondary Outcome Measures:

Rate of targeted conditions surgeries [ Time Frame: 6 months ] [ Designated as safety issue: No ]
rate of any one claims based instance of lumbar back, hip repair, hip replacement, knee repair, or knee replacement surgery
Intervention choices [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Self-reported rates at which subjects try surgery and other nonsurgical approaches to managing their conditions
Concordance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Self-reported consistency of choices with goals and concerns--extent to which the treatment choices subjects make are or are not consistent with the issues they state are priorities including avoiding surgery, reducing pain and regaining function
Quality of decision making process [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Self-reported measure of the extent to which subject interactions with providers involve discussions of the pros and cons of treatment options and provide an opportunity for subjects to have input into the decisions.
Knowledge [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Subject self-reported knowledge about the risks and benefits of surgical options and likely outcomes with and without surgical interventions
Decision Conflict [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Self-reported mesure of the extent to which subjects feel comfortable, supported and confident in choosing one treatment approach over others
Decision Satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Self-reported measure of subject satisfaction with decision as measured retrospectively, including how subjects feel their decision worked out and whether or not they would make the same decision again.
Health Status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Self-reported subject health status, with particular focus on pain and functional limitations
Actionable Medical Costs [ Time Frame: Six months ] [ Designated as safety issue: No ]
total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy, excluding claims for trauma, maternity and cancer and other diagnoses unlikely to be impacted by health coaching.

Estimated Enrollment:	18000
Study Start Date:	February 2011
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Decision Aid with Health Coaching	Behavioral: Provision of condition specific DVD and Pamphlet to support Shared Decision Making Subjects are mailed decision aid DVDs and pamphlets regarding lumbar back, hip osteoarthritis or knee osteoarthritis. Behavioral: Telephonic outreach and support by Health Coach Subjects are direct dial attempted by Health Coaches up to three attempts. If contacted, Health Coaches tailor support around health matters of importance to the subjects and to help individuals become active participants in their treatment plans, and make more informed decisions in consort with their health care providers. The number of total contacts is determined by mutual agreement between the subject and the Health Coach. Health Coaches may provide additional educational materials and resources.
Experimental: Decision Aid only	Behavioral: Provision of condition specific DVD and Pamphlet to support Shared Decision Making Subjects are mailed decision aid DVDs and pamphlets regarding lumbar back, hip osteoarthritis or knee osteoarthritis.
No Intervention: No condition specific support	Behavioral: No condition specific telephonic outreach No attempts at telephonic outreach for three months, with the exception of subjects newly identified with asthma, heart disease, diabetes, heart failure, or COPD or subjects with gaps in care for the above conditions, and then no back, hip or knee specific telephonic outreach for months 4, 5 and 6.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Participants in two large, commercial Blue Cross and/or Blue Shield branded insurance products with eligibility for Health Dialog services
Identified by distinct Health Dialog proprietary models for risk of lumbar back, knee or hip surgeries
Selected by simple randomization for inclusion in an IVR administered screening survey
Participated in an IVR-administered screener survey and responded affirmatively to questions on pain for any one of the three conditions, any current or planned treatment for the conditions, and responded negatively to having had a condition specific surgery within the past six months

Exclusion Criteria:

People under 18 years of age at time of identification for the IVR filtering survey, approximately 6 weeks prior to the start of the study
People with invalid phone numbers or invalid mailing addresses based on automated review of those fields
People for whom Health Dialog has information of a request for no IVR, no Health Coach outreach, or mailings prior to the start of the study
People with claims based indication of spinal stenosis prior to the start of the study
People who have been targeted for any IVR outreach within 180 days of the initiation of the IVR filtering survey
People who have a Health Coach communication record, as documented in the Health Coaching application within 90 days of the start of the study
Any members of households who have a household member already selected for inclusion in the study
People for whom there is claims evidence of any one of the targeted surgeries prior the start of the study
People with no eligibility for services through insurer after the start of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345123

Locations

United States, Massachusetts
Health Dialog
Boston, Massachusetts, United States, 02109

Sponsors and Collaborators

Health Dialog

Foundation for Informed Medical Decision Making

University of Massachusetts, Boston

Investigators

Principal Investigator:	Benjamin C Venator, AB	Health Dialog Services Corporation
Study Director:	Patricia M Gallagher, PHD	Center for Survey Research/University of Massachusetts Boston

More Information

No publications provided

Responsible Party:	Benjamin Venator, Senior Manager, Health Dialog Services Corporation
ClinicalTrials.gov Identifier:	NCT01345123 History of Changes
Other Study ID Numbers:	SDMBKH-HD012011
Study First Received:	April 28, 2011
Last Updated:	August 1, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Arthritis
Back Pain
Joint Diseases
Musculoskeletal Diseases

Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013