Trial Outcomes & Findings for Supporting Decision Making for Musculoskeletal Preference-Sensitive Care (NCT NCT01345123)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9925 participants

Primary outcome timeframe

6 months

Results posted on

2013-10-30

Participant Flow

75,795 health plan members recruited via Interactive Voice Response Telephone Call Survey to screen for study eligibility. 30,556 persons completed the screen. 9,925 were study eligible (1. Reported pain in knee, hip, or back; 2. Considering treatment; 3. Had not already had surgery for pain; 4. Not on a 'Do Not Call' list).

Participant milestones

Participant milestones
Measure	Decision Aid With Health Coaching Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.	Decision Aid Only Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).	No Condition Specific Support Study participants do not receive outreach on knee, hip or herniated disc condition.
Overall Study STARTED	3323	3311	3291
Overall Study COMPLETED	3244	3226	3203
Overall Study NOT COMPLETED	79	85	88

Reasons for withdrawal

Reasons for withdrawal
Measure	Decision Aid With Health Coaching Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.	Decision Aid Only Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).	No Condition Specific Support Study participants do not receive outreach on knee, hip or herniated disc condition.
Overall Study participants no longer with health plan	79	85	88

Baseline Characteristics

Supporting Decision Making for Musculoskeletal Preference-Sensitive Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Decision Aid With Health Coaching n=3323 Participants Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.	Decision Aid Only n=3311 Participants Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).	No Condition Specific Support n=3291 Participants Study participants do not receive outreach on knee, hip or herniated disc condition.	Total n=9925 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2880 Participants n=5 Participants	2922 Participants n=7 Participants	2861 Participants n=5 Participants	8663 Participants n=4 Participants
Age, Categorical >=65 years	443 Participants n=5 Participants	388 Participants n=7 Participants	430 Participants n=5 Participants	1261 Participants n=4 Participants
Age Continuous	55.94 years STANDARD_DEVIATION 10.37 • n=5 Participants	56.12 years STANDARD_DEVIATION 9.73 • n=7 Participants	56.06 years STANDARD_DEVIATION 10.14 • n=5 Participants	56.04 years STANDARD_DEVIATION 10.08 • n=4 Participants
Sex: Female, Male Female	1896 Participants n=5 Participants	1888 Participants n=7 Participants	1906 Participants n=5 Participants	5690 Participants n=4 Participants
Sex: Female, Male Male	1427 Participants n=5 Participants	1423 Participants n=7 Participants	1385 Participants n=5 Participants	4235 Participants n=4 Participants
Region of Enrollment United States	3323 participants n=5 Participants	3311 participants n=7 Participants	3291 participants n=5 Participants	9925 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Instituted \>= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.

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.

Outcome measures

Outcome measures
Measure	Decision Aid With Health Coaching n=2969 Participants Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.	Decision Aid Only n=2942 Participants Study participants receiving a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).	No Condition Specific Support n=2889 Participants Study participants do not receive outreach on knee, hip or herniated disc condition.
Total Medical Costs Per Member Per Month	965.63 Total dollars / member months Interval 895.66 to 1035.61	1000.22 Total dollars / member months Interval 931.56 to 1068.88	965.78 Total dollars / member months Interval 896.33 to 1035.23

PRIMARY outcome

Timeframe: 6 months

Population: Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Institutionalized \>= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.

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

Outcome measures

Outcome measures
Measure	Decision Aid With Health Coaching n=2969 Participants Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.	Decision Aid Only n=2942 Participants Study participants receiving a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).	No Condition Specific Support n=2889 Participants Study participants do not receive outreach on knee, hip or herniated disc condition.
Total Medical Costs That Can be Impacted Per Member Per Month	679.13 Total dollars / member months Interval 624.68 to 733.58	735.96 Total dollars / member months Interval 679.55 to 792.37	726.88 Total dollars / member months Interval 665.37 to 788.38

SECONDARY outcome

Timeframe: 6 months

Population: Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Institutionalized \>= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.

rate of any one claims based instance of lumbar back, hip repair, hip replacement, knee repair, or knee replacement surgery

Outcome measures

Outcome measures
Measure	Decision Aid With Health Coaching n=2969 Participants Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.	Decision Aid Only n=2942 Participants Study participants receiving a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).	No Condition Specific Support n=2889 Participants Study participants do not receive outreach on knee, hip or herniated disc condition.
Rate of Targeted Conditions Surgeries	5.42 percentage of participants	6.66 percentage of participants	6.54 percentage of participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Decision Quality Survey administered to a random sample (N=2600) of all study participants in the second study wave (N=4208): 1177 survey-eligible respondents, 1124 received a knowledge score.

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.

Outcome measures

Outcome measures
Measure	Decision Aid With Health Coaching n=550 Participants Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.	Decision Aid Only n=354 Participants Study participants receiving a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).	No Condition Specific Support n=273 Participants Study participants do not receive outreach on knee, hip or herniated disc condition.
Knowledge	1.99 number of correct answers Interval 1.8868582 to 2.0942024	2.14 number of correct answers Interval 2.0060072 to 2.2805426	1.83 number of correct answers Interval 1.6719285 to 1.9894889

SECONDARY outcome

Timeframe: 12 weeks

Population: Decision Quality Survey administered to a random sample (N=2600) of all study participants in the second study wave (N=4208): 1177 survey-eligible respondents.

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.

Outcome measures

Outcome measures
Measure	Decision Aid With Health Coaching n=550 Participants Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.	Decision Aid Only n=354 Participants Study participants receiving a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).	No Condition Specific Support n=273 Participants Study participants do not receive outreach on knee, hip or herniated disc condition.
Decision Conflict	2.2206790 units on a scale Interval 2.1678803 to 2.2734778	2.1876218 units on a scale Interval 2.1235626 to 2.2516811	2.2006866 units on a scale Interval 2.1260287 to 2.2753446

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Decision Aid With Health Coaching

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Decision Aid Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Condition Specific Support

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David R Veroff, MPP, SVP Analytic Development

Health Dialog

Phone: 617-406-5219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place