Trial · NCT02507349

Person-Centered Versus Measurement-Based Care in Mental Health

NCT02507349, Not applicable, Completed, University of Pittsburgh; results first posted 2019-02-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Person-Centered Versus Measurement-Based Care in Mental Health. Trials, record NCT02507349. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02507349

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Person-Centered Versus Measurement-Based Care in Mental Health
NCT number: NCT02507349
Status: Completed
Phases: Not applicable
Enrollment: 2,443 participants, actual
Lead sponsor: University of Pittsburgh
Conditions: Schizophrenia, Bipolar Disorder, Major Depression
Interventions: Person-Centered Care, Measurement-Based Care
First posted: 2015-07-23
Last updated: 2019-02-26
Results first posted: 2019-02-01
Limitations and caveats: The PEMM was developed for this study. For unavoidable reasons, site randomization was not maintained. Data collection timepoints were expanded.

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Patient Experience of Medication Treatment (PEMM)	Baseline and every eight months during the two-year intervention phase	The PEMM is a 12-item self-report measure of mental health patient experience of medication management with prescribers .Response options for 11 questions range from 0=Never to 4=Always, and the response options for the final question range from 0=Very Dissatisfied to 4=Very Satisfied. Overall possible range was 0 to 4. PEMM scores for each time point reflect the mean score of all measures collected within that time frame.
Primary	Shared Decision Making Questionnaire (SDM-Q-9)	Baseline and every eight months during the two-year intervention phase	The SDM-Q-9 is a 9-item self-report measure of the degree of shared decision making in clinical encounters. There are 6 possible responses ranging from: Completely Disagree (0) to Completely Agree (5). Raw score ranges from 0 to 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of shared decision making in clinical encounters. SDM-Q-9 scores for each time point reflect the mean score of all measures collected within that time frame.
Secondary	Hope	Baseline and every eight months during the two-year intervention phase	Patient hopefulness will be assessed using a single question: "Overall, how hopeful does the patient feel about his/her life?" Responses are on a scale of 1 through 10 with 1=No Hope and 10=Filled with Hope. Hopefulness scores for each time point reflect the mean score of all measures collected within that time frame.
Secondary	Medication Side Effects	Baseline and every eight months during the two-year intervention phase	Medication side effects will be assessed using a single question: "How much is the patient troubled by medication side effects?" Responses are on a scale of 1 through 10 with 1=Not Bothered at all by side effects and 10=Very Bothered by side effects. Medication side effect scores for each time point reflect the mean score of all measures collected within that time frame.
Secondary	Patient Activation Measure (PAM)	Baseline and every eight months during the two-year intervention phase	PAM is a 13-item scale that assesses the knowledge, skills, and confidence of patients essential to managing their own health and health care. Response options are: Strongly Disagree, Disagree, Agree, and Strongly Agree. The activation scale for the PAM ranges from 0 to 100. The lower values represent a poor outcome while higher values represent a better outcome. Overall possible range was 0 to 91.6. PAM scores for each time point reflect the mean score of all measures collected within that time frame.
Secondary	Behavior and Symptom Identification Scale (BASIS-24)	Baseline and every eight months during the two-year intervention phase	The BASIS-24 identifies a wide range of symptoms and problems that occur across the psychiatric diagnostic spectrum. There are 5 ordered responses either ranging from No Difficulty to Extreme Difficulty or from None of the Time to All of the Time. Each of 24 questions is scored on a 5 point scale (from 0 to 4 where 0 is the lowest severity and 4 is the highest). The overall BASIS-24 score is a weighted sum that is computed by multiplying the rating for each question by its weight and totaling the weighted ratings for each question. Overall possible range was 0 to 3.99. BASIS-24 scores for each time point reflect the mean score of all measures collected within that time frame.
Secondary	Sheehan Disability Scale	Baseline and every eight months during the two-year intervention phase	The Sheehan Disability Scale measures the extent to which three major sectors in the person's life are impaired by psychiatric symptoms (work/school, social/leisure life, and family/home life). The 3 items are summed together to form a single measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). Sheehan Disability Scale scores for each time point reflect the mean score of all measures collected within that time frame.
Secondary	Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)	Baseline and every eight months during the two-year intervention phase	Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form is a 16-item, self-report questionnaire for assessing quality of life in multiple domains (e.g., physical health, mood, leisure time activities, social relationships, and overall). Response items are on a 5-point scale ranging from Very Poor to Very Good. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70. The raw total score was transformed into a percentage maximum possible score using the following formula. The lower values/percentages represent a poor outcome while higher values/percentages represent a better outcome. Overall possible range was 0-100. QLESQ-SF scores for each time point reflect the mean score of all measures collected within that time frame.
Secondary	Engagement in Medication and Evaluation Visit	Baseline, 8 months, 24 months	Count of the number of medication checks and evaluation visits for each study participant for the 12 month period prior to and including the anchor date of the time point.
Secondary	Engagement in Psychotherapy Visit	Baseline, 8 months, 24 months	Count of the number of psychotherapy visits for each study participant for the 12 month period prior to and including the anchor date of the time point.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Patient Experience of Medication Treatment (PEMM)	Baseline and every eight months during the two-year intervention phase	Multiple records can be measured from the same participant at the same time period, so overall number of surveys analyzed can be greater than the unique number of participants except for at baseline.	Units on a scale	MEAN
PRIMARY	Shared Decision Making Questionnaire (SDM-Q-9)	Baseline and every eight months during the two-year intervention phase	Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline	Units on a scale	MEAN
SECONDARY	Hope	Baseline and every eight months during the two-year intervention phase	Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline	Units on a scale	MEAN
SECONDARY	Medication Side Effects	Baseline and every eight months during the two-year intervention phase	Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline	Units on a scale	MEAN
SECONDARY	Patient Activation Measure (PAM)	Baseline and every eight months during the two-year intervention phase	Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline	Units on a scale	MEAN
SECONDARY	Behavior and Symptom Identification Scale (BASIS-24)	Baseline and every eight months during the two-year intervention phase	Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline	Units on a scale	MEAN
SECONDARY	Sheehan Disability Scale	Baseline and every eight months during the two-year intervention phase	Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline	Units on a scale	MEAN
SECONDARY	Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)	Baseline and every eight months during the two-year intervention phase	Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline	Units on a scale	MEAN
SECONDARY	Engagement in Medication and Evaluation Visit	Baseline, 8 months, 24 months	Based on participants who had available claims data.	medication checks and evaluation visits	MEAN
SECONDARY	Engagement in Psychotherapy Visit	Baseline, 8 months, 24 months	Based on participants who had available claims data.	psychotherapy visits	MEAN

Source ClinicalTrials.gov

Results by group156

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Patient Experience of Medication Treatment (PEMM)	Person-Centered Care	Baseline	3.009	Standard Deviation 0.712	Units on a scale
Patient Experience of Medication Treatment (PEMM)	Measurement-Based Care	Baseline	3.007	Standard Deviation 0.747	Units on a scale
Patient Experience of Medication Treatment (PEMM)	Person-Centered Care	Month 3: Every record 0< month <=3	2.6	Standard Deviation 0.91	Units on a scale
Patient Experience of Medication Treatment (PEMM)	Measurement-Based Care	Month 3: Every record 0< month <=3	3.09	Standard Deviation 0.18	Units on a scale
Patient Experience of Medication Treatment (PEMM)	Person-Centered Care	Month 6: Every record 3< month <=6	3.056	Standard Deviation 0.679	Units on a scale
Patient Experience of Medication Treatment (PEMM)	Measurement-Based Care	Month 6: Every record 3< month <=6	3.068	Standard Deviation 0.675	Units on a scale
Patient Experience of Medication Treatment (PEMM)	Person-Centered Care	Month 8: Every record 6< month <=8	3.015	Standard Deviation 0.713	Units on a scale
Patient Experience of Medication Treatment (PEMM)	Measurement-Based Care	Month 8: Every record 6< month <=8	3.083	Standard Deviation 0.735	Units on a scale
Patient Experience of Medication Treatment (PEMM)	Person-Centered Care	Month 12: Every record 8< month <=12	3.055	Standard Deviation 0.715	Units on a scale
Patient Experience of Medication Treatment (PEMM)	Measurement-Based Care	Month 12: Every record 8< month <=12	3.119	Standard Deviation 0.682	Units on a scale

1 to 10 of 156Source ClinicalTrials.gov

See all 156 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Person-Centered Care	1,232
Overall Study	STARTED	Measurement-Based Care	1,211
Overall Study	COMPLETED	Person-Centered Care	1,045
Overall Study	COMPLETED	Measurement-Based Care	1,050
Overall Study	NOT COMPLETED	Person-Centered Care	187
Overall Study	NOT COMPLETED	Measurement-Based Care	161

Source ClinicalTrials.gov

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Person-Centered Care	12	1,232
Total, all-cause mortality	Measurement-Based Care	16	1,211
Total, other adverse events	Person-Centered Care	0	1,232
Total, other adverse events	Measurement-Based Care	0	1,211
Total, serious adverse events	Person-Centered Care	0	1,232
Total, serious adverse events	Measurement-Based Care	0	1,211

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Person-Centered Care vs Measurement-Based Care: deaths from any cause	Trial comparisons
Person-Centered Care vs Measurement-Based Care: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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