Clinical trial NCT01345123: Supporting Decision Making for Musculoskeletal Preference-Sensitive Care
Official title: A Prospective, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Pain Chronic
Arthritis (Hip)
Arthritis (Knee)
Back Pain
Lead sponsor: Health Dialog
Sponsor class: INDUSTRY
Collaborators: name: Foundation for Informed Medical Decision Making
name: University of Massachusetts, Boston
First posted: 2011-04-29
Enrollment: 9925
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility 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 interactive voice response (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

Primary outcomes:
measure: Total Medical Costs Per Member Per Month
timeFrame: 6 months
measure: Total Medical Costs That Can be Impacted Per Member Per Month
timeFrame: 6 months
Secondary outcomes:
measure: Rate of Targeted Conditions Surgeries
timeFrame: 6 months
measure: Concordance
timeFrame: 6 months
measure: Quality of Decision Making Process
timeFrame: 6 months
measure: Knowledge
timeFrame: 12 weeks
measure: Decision Conflict
timeFrame: 12 weeks
measure: Decision Satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Health Dialog
state: Massachusetts
Study officials:
affiliation: Health Dialog Services Corporation
name: David R Veroff, MPP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts, Boston
name: Patricia M Gallagher, PHD
role: STUDY_DIRECTOR
References: