Supporting Decision Making for Musculoskeletal Preference-Sensitive Care
- Conditions
- Knee Pain ChronicArthritis (Hip)Arthritis (Knee)Back Pain
- Interventions
- Behavioral: Provision of condition specific shared decision making (SDM) aids onlyBehavioral: Telephonic outreach and support by Health Coach
- Registration Number
- NCT01345123
- Lead Sponsor
- Health Dialog
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9925
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Decision Aid with Health Coaching Provision of condition specific shared decision making (SDM) aids only - Decision Aid with Health Coaching Telephonic outreach and support by Health Coach - Decision Aid only Provision of condition specific shared decision making (SDM) aids only -
- Primary Outcome Measures
Name Time Method Total Medical Costs Per Member Per Month 6 months 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.
Total Medical Costs That Can be Impacted Per Member Per Month 6 months 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.
Costs that cannot be impacted include: Costs related to Trauma and Accident, Psychiatric/Substance Abuse, Malignant Neoplasm, Maternity and Childbirth excluded
- Secondary Outcome Measures
Name Time Method Decision Satisfaction 6 months 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.
Rate of Targeted Conditions Surgeries 6 months rate of any one claims based instance of lumbar back, hip repair, hip replacement, knee repair, or knee replacement surgery
Concordance 6 months 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 6 months 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 12 weeks Subject self-reported knowledge about the risks and benefits of surgical options and likely outcomes with and without surgical interventions.Knowledge score calculated (score of 0-5, counting number of correct answers) for every respondent who completes at least 3 of the 5 items.
Decision Conflict 12 weeks Self-reported measure of the extent to which subjects feel comfortable, supported and confident in choosing one treatment approach over others. Score computed on a scale of 1-3, where 1 = 'No', 2='Yes, somewhat', 3='Yes, completely' (3 indicates less conflict, 1 indicates most conflict) on a 4 item survey question set- asks whether respondents feel sure, have enough support, know and are clear about benefits and risks of treatment options.
Trial Locations
- Locations (1)
Health Dialog
🇺🇸Boston, Massachusetts, United States