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Supporting Decision Making for Musculoskeletal Preference-Sensitive Care

This study has been completed.
Sponsor:
Collaborators:
Foundation for Informed Medical Decision Making
University of Massachusetts, Boston
Information provided by (Responsible Party):
Health Dialog
ClinicalTrials.gov Identifier:
NCT01345123
First received: April 28, 2011
Last updated: August 26, 2013
Last verified: August 2013
  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 shared decision making (SDM) aids only
Behavioral: Telephonic outreach and support by Health Coach

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, 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

Further study details as provided by Health Dialog:

Primary Outcome Measures:
  • Total Medical Costs Per Member Per Month [ 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.

  • Total Medical Costs That Can be Impacted Per Member Per Month [ 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.

    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 [ 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

  • 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: 12 weeks ] [ 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.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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ 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.


Enrollment: 9925
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Decision Aid with Health Coaching Behavioral: Provision of condition specific shared decision making (SDM) aids only
Subjects are mailed decision aid digital video discs (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 shared decision making (SDM) aids only
Subjects are mailed decision aid digital video discs (DVDs) and pamphlets regarding lumbar back, hip osteoarthritis or knee osteoarthritis.
No Intervention: No condition specific support

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: David R Veroff, MPP 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: Health Dialog
ClinicalTrials.gov Identifier: NCT01345123     History of Changes
Other Study ID Numbers: SDMBKH-HD012011
Study First Received: April 28, 2011
Results First Received: March 18, 2013
Last Updated: August 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 20, 2014