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Supporting Decision Making for Musculoskeletal Preference-Sensitive Care

Primary Purpose

Knee Pain Chronic, Arthritis (Hip), Arthritis (Knee)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Provision of condition specific shared decision making (SDM) aids only
Telephonic outreach and support by Health Coach
Sponsored by
Health Dialog
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Knee Pain Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Health Dialog

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Decision Aid with Health Coaching

Decision Aid only

No condition specific support

Arm Description

Outcomes

Primary Outcome Measures

Total Medical Costs Per Member Per Month
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
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

Rate of Targeted Conditions Surgeries
rate of any one claims based instance of lumbar back, hip repair, hip replacement, knee repair, or knee replacement surgery
Concordance
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
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
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
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.
Decision Satisfaction
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.

Full Information

First Posted
April 28, 2011
Last Updated
August 26, 2013
Sponsor
Health Dialog
Collaborators
Foundation for Informed Medical Decision Making, University of Massachusetts, Boston
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1. Study Identification

Unique Protocol Identification Number
NCT01345123
Brief Title
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Health Dialog
Collaborators
Foundation for Informed Medical Decision Making, University of Massachusetts, Boston

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Pain Chronic, Arthritis (Hip), Arthritis (Knee), Back Pain

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
9925 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decision Aid with Health Coaching
Arm Type
Experimental
Arm Title
Decision Aid only
Arm Type
Experimental
Arm Title
No condition specific support
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Provision of condition specific shared decision making (SDM) aids only
Intervention Description
Subjects are mailed decision aid digital video discs (DVDs) and pamphlets regarding lumbar back, hip osteoarthritis or knee osteoarthritis.
Intervention Type
Behavioral
Intervention Name(s)
Telephonic outreach and support by Health Coach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Medical Costs Per Member Per Month
Description
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.
Time Frame
6 months
Title
Total Medical Costs That Can be Impacted Per Member Per Month
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rate of Targeted Conditions Surgeries
Description
rate of any one claims based instance of lumbar back, hip repair, hip replacement, knee repair, or knee replacement surgery
Time Frame
6 months
Title
Concordance
Description
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
Time Frame
6 months
Title
Quality of Decision Making Process
Description
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.
Time Frame
6 months
Title
Knowledge
Description
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.
Time Frame
12 weeks
Title
Decision Conflict
Description
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.
Time Frame
12 weeks
Title
Decision Satisfaction
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Veroff, MPP
Organizational Affiliation
Health Dialog Services Corporation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patricia M Gallagher, PHD
Organizational Affiliation
Center for Survey Research, University of Massachusetts, Boston
Official's Role
Study Director
Facility Information:
Facility Name
Health Dialog
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02109
Country
United States

12. IPD Sharing Statement

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Supporting Decision Making for Musculoskeletal Preference-Sensitive Care

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